(157 days)
No
The summary describes a standard patient monitoring system that acquires, stores, calculates, displays, and exports physiological data. There is no mention of AI or ML being used for data analysis, interpretation, or prediction. The performance studies focus on standard clinical validation of the algorithms for SpO2 and respiration rate measurement, not on AI/ML model performance.
No.
The "Intended Use / Indications for Use" section states that the device is for "monitoring adult and pediatric patients" and explicitly says, "This device should not be used for life sustaining/supporting purposes." Monitoring devices do not provide therapy; they collect and display physiological data.
Yes
Explanation: The device is intended to acquire, store, calculate, display, and export patient monitoring data for physiological parameters like pulse oximetry (SpO2/pulse rate) and respiration rate. This measurement and display of physiological data for clinical interpretation makes it a diagnostic device. The "Indications for Use" section explicitly states its role in "monitoring adult and pediatric patients," which is a form of diagnostic activity.
No
The device description explicitly lists multiple hardware components, including the Portrait Mobile Patient Monitor, wearable sensors, sensor battery, bedside charger, and attachment accessories. While it includes software components, it is not solely software.
Based on the provided information, the Portrait Mobile Monitoring Solution is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Portrait Mobile Monitoring Solution Function: The Portrait Mobile Monitoring Solution directly monitors physiological parameters from the patient's body (SpO2, pulse rate, respiration rate) using non-invasive sensors. It does not analyze samples taken from the body.
The device falls under the category of patient monitoring systems which are typically considered medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
· Pulse oximetry (SpO2/pulse rate)
· Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.
Portrait Central Viewer Application (Portrait CVA01):
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.
The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Core Services (Portrait CSS01):
The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution.
Portrait Clinical Alarming Unit (Portrait CAU01):
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.
The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Mobile Patient Monitor (Portrait HUB01):
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.
The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait SpO2 Attachment Accessory Band (Portrait AAB01):
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.
The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01):
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait RR Electrode Patch (Portrait RRP01):
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor.
The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment.
Portrait Sensor Battery (Portrait SBT01):
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device.
The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Bedside Charger (Portrait BCH01):
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).
The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Mobile Patient Monitor Pouch (Portrait MMP01):
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory.
The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Product codes (comma separated list FDA assigned to the subject device)
MHX, MSX, DRG, BZQ, DQA
Device Description
The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea.
The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices:
Central Monitoring Devices:
Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
Portrait Central Viewer Application software hosted on a Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.
Mobile Monitoring Devices:
Portrait Mobile Patient Monitor, a battery-powered, wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR).
Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.
Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly.
Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor.
Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use).
Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist.
Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and pediatric patients (3 years of age and older, and weighing more than 10 kg)
Intended User / Care Setting
Under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Two clinical studies are presented in support of substantial equivalence. The first is a standard clinical study to support the new SpO2 algorithm and sensors used and is conducted in accordance with ISO 80601-2-61:2017 Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment and FDA guidance: Pulse Oximeters --Premarket Notification Submissions [510(k)s] -Guidance for Industry and Food and Drug Administration Staff Issued March 2013.
The second study evaluated the performance of the Portrait Mobile Monitoring Solution dual vector impedance-based respiration rate monitoring in general ward patients. The population was representative of the general population anticipated to require Portrait Mobile Monitoring Solution in clinical practice. During the study, patients were able to perform normal activities, for example, eat, talk, sit, walk, and ability to use toilet. Reference method was CO2 monitoring, which is considered a gold standard for RR. In the data analysis, mean absolute difference between Portrait Mobile and CO2 RR was used as the metric to quantify performance of the Portrait Mobile RR measurement.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K171121 Masimo Root Monitoring System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2023
GE Medical Systems Information Technologies, Inc. Joel Kent Director, Regulatory Affairs Strategy 9900 Innovation Drive Wauwatosa, Wisconsin 53226
Re: K230626
Trade/Device Name: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MSX, DRG, BZQ, DQA Dated: March 6, 2023 Received: March 7, 2023
Dear Joel Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
1
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K230626
Device Name Portrait Mobile Monitoring Solution
Indications for Use (Describe)
Portrait Mobile Monitoring Solution:
The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
· Pulse oximetry (SpO2/pulse rate)
· Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.
Portrait Central Viewer Application (Portrait CVA01):
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.
The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Core Services (Portrait CSS01):
The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution.
Portrait Clinical Alarming Unit (Portrait CAU01):
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.
The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
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Portrait Mobile Patient Monitor (Portrait HUB01):
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.
The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
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Portrait SpO2 Attachment Accessory Band (Portrait AAB01):
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.
The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01):
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait RR Electrode Patch (Portrait RRP01):
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor.
The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment.
Portrait Sensor Battery (Portrait SBT01):
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device.
The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Bedside Charger (Portrait BCH01):
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).
The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.
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Portrait Mobile Patient Monitor Pouch (Portrait MMP01):
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory.
The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226, USA
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Owner/Contact/Date (807.92(a)(1)):
Date: August 11, 2023
GE Medical Systems Information Technologies, Inc. Owner/Submitter: 9900 Innovation Drive Wauwatosa, WI 53226, USA
- Joel Kent Primary Contact Person: Director, Regulatory Affairs Strategy GE HealthCare, Patient Care Solutions Phone: 617-851-0943 E-mail: joel.kent@ge.com
- Secondary Contact Person: William Jung Regulatory Affairs Director GE HealthCare, Monitoring Solutions Phone: 571-396-1558 E-mail: william.jung@ge.com
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Device names (807.92(a)(2)):
| Trade Name: | Portrait Mobile Monitoring Solution consists of the following: |
|---|---|
| Portrait™ Central Viewer Application (Portrait CVA01) | |
| Portrait™ Core Services (Portrait CSS01) | |
| Portrait™ Clinical Alarming Unit (Portrait CAU01) | |
| Portrait™ Mobile Patient Monitor (Portrait HUB01) | |
| Portrait™ Sensor Battery (Portrait SBT01) | |
| Portrait™ Bedside Charger (Portrait BCH01) | |
| Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P- | |
| SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait | |
| SpO2 P-SE01) | |
| Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) | |
| Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) | |
| Portrait™ Wearable Respiration Rate Sensor (Portrait RR P- | |
| RR01) | |
| Portrait™ RR Electrode Patch (Portrait RRP01) | |
| Common/Usual Name: | Multiparameter patient monitor (Monitor, Physiological, Patient |
| (Without Arrhythmia Detection Or Alarms)) | |
| Classification Names: | 21 CFR 870.2300 Cardiac monitor (including cardiotachometer |
| and rate alarm | |
| 21 CFR 870.2910 Radiofrequency physiological signal | |
| transmitter and receiver | |
| 21 CFR 868.2375 monitor, breathing frequency | |
| 21 CFR 870.2700 oximeter | |
| Product Code: | MWI |
| Subsequent Product Codes: | MSX |
| DRG | |
| BZQ | |
| DOA |
8
| Predicate Device(s) (807.92(a)(3)): | The primary predicate for this submission is K171121 Masimo Root Monitoring System |
|---|---|
| ------------------------------------- | ------------------------------------------------------------------------------------ |
Additional reference devices: K180472, Sotera Wireless ViSi Mobile Monitoring System K213234, CARESCAPE ONE
Device Description (807.92(a)(4)):
The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea.
The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices:
Central Monitoring Devices:
Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
Portrait Central Viewer Application software hosted on a . Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
. Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.
Mobile Monitoring Devices:
Portrait Mobile Patient Monitor, a battery-powered, . wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor
9
including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). . Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. . Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. . Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. . Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). . Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist. . Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory. Intended Use: The Intended Use of the Portrait™ Mobile Monitoring Solution (807.92(a)(5)): as a vital sign monitor is identical to the predicate primary predicate K171121 Masimo Root Monitoring System. The indications for use are described separately for each of the individual subsystems/components of the Portrait Mobile Monitoring Solution and for the system as a whole. Indications for Use are described below: Portrait™ Mobile Monitoring Solution The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
- Pulse oximetry (SpO2/pulse rate) ●
- . Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious 510(k) Summary K230626 GE HealthCare Portrait Mobile Monitoring Solution
10
complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Central Viewer Application (Portrait CVA01)
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.
The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait™ Core Services (Portrait CSS01)
The Portrait Core Services (Portrait CSS01) are a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Mobile Monitoring Solution.
Portrait™ Clinical Alarming Unit (Portrait CAU01)
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.
The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
11
Portrait™ Mobile Patient Monitor (Portrait HUB01)
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The Portrait Mobile Patient Monitor can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.
The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry
12
Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01)
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.
The Portrait SpO2 Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01)
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR)
13
parameter. The Portrait Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Respiration rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ RR Electrode Patch (Portrait RRP01)
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR) parameter. The Portrait Electrode Patch transfers carrier signals from the Portrait Wearable Respiration Rate Sensor and transfers impedance and biopotential signals from the patient and transmits them to the Portrait Wearable Respiration Rate Sensor.
The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait RR Electrode Patch is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Sensor Battery (Portrait SBT01)
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait Wearable Sensors and to provide wireless communication to a host device.
The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait™ Bedside Charger (Portrait BCH01)
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).
The Portrait Bedside Charger is intended for use under the direct 510(k) Summary K230626 GE HealthCare Portrait Mobile Monitoring Solution
14
| | supervision of a licensed practitioner, or by personnel trained in
proper use of the equipment in a professional healthcare facility. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Portrait Bedside Charger is not intended for use in a
controlled Magnetic Resonance (MR) environment. |
| | Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01)
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is
an optional accessory intended to enable the Portrait Mobile
Patient Monitor to be carried while the patient is ambulatory. |
| | The Portrait Mobile Patient Monitor pouch is intended for use
under the direct supervision of a licensed practitioner, or by
personnel trained in proper use of the equipment in a
professional healthcare facility. |
| Technology (807.92(a)(6)): | The Portrait Mobile Monitoring Solution uses the same
fundamental technology and functionality as the primary
predicate primary predicate K171121 Masimo Root Monitoring
System. |
| | Both the Portrait Mobile Monitoring Solution and the primary
predicate K171121 Masimo Root Monitoring System are
lightweight, portable, wireless monitoring systems for
monitoring of patient physiological parameters in a professional
healthcare environment. Both have similar system topologies,
which include sensors that attach to the patient, small portable
patient monitors that can be worn or carried by the patient, a set
of centralized services installed on a server which is connected
to the healthcare facility's enterprise network, and remote
viewers with alarming capability that can monitor multiple
patients simultaneously. |
| | The main difference between the Portrait Mobile Monitoring
Solution and the predicate is that the Portrait Mobile Monitoring
Solution only supports SpO2, Pulse Rate, and Respiration Rate
while the predicate also supports additional optional parameters
The Portrait Mobile Monitoring Solution is substantially
equivalent to the predicate. |
| | A summary of the main changes compared to the predicate are
listed below in the comparison table. |
15
Product Comparison versus Predicate Main features chart follows below.
16
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Vital Sign Monitor | Vital Sign Monitor | Vital Sign Monitor | Identical |
| FDA Primary
Product Code | MWI | MHX | MWI | Identical to primary
predicate |
| FDA
Classification
Regulation | 21 CFR 2300 | 21 CFR 1025 | 21 CFR 2300 | Identical to primary
predicate |
| Indications for
Use (entire
system) | The Masimo Root Monitoring system and
Accessories are indicated for use by
healthcare professionals for the
monitoring of multiple physiological
parameters in healthcare environments.
The Root Monitoring System, when used
with the optional ISA module, is not
intended to be used in road
ambulances. | The ViSi Mobile
Monitoring
System is
intended for use
by clinicians and
medically qualified
personnel for
single or multi-
parameter vital
signs monitoring
of adult patients
(18 years or
older).
It is indicated for
ECG (3 or 5 lead-
wire), respiration
rate (RESP), heart
rate (HR), non-
invasive blood
pressure (NIBP),
continuous non-
invasive blood
pressure (cNIBP),
non-invasive
monitoring of
functional oxygen
saturation of
arterial
hemoglobin
(SpO2), pulse rate
(PR), and skin
temperature
(TEMP), posture
tracking and
alarms, skin
temperature
(TEMP) and basic
arrhythmia
(Ventricular
Tachycardia,
Ventricular
Fibrillation,
Asystole, Atrial
Fibrillation)
analysis/alarm in
hospital-based
facilities;
including, general
medical- surgical
floors,
intermediate care
floors and | The Portrait Mobile
Monitoring Solution is
intended to acquire, store,
calculate, display and export
patient monitoring data as
well as provide real time
alarming for monitoring
adult and pediatric patients
(3 years of age and older,
and weighing more than 10
kg).
Physiological parameters
and waveforms supported
are:
• Pulse oximetry
(SpO2/pulse rate)
•Respiration rate (RR)
Continuous pulse oximetry
and respiration rate
monitoring may be used for
patients at risk of
cardiorespiratory and
infectious complications.
The Portrait Mobile
Monitoring Solution is
intended for use under the
direct supervision of a
licensed practitioner, or by
personnel trained in proper
use of the equipment in a
professional healthcare
facility.
This device is not an Apnea
monitor (i.e., do not rely on
the device for detection or
alarm for the cessation of
breathing). This device
should not be used for life
sustaining/supporting
purposes.
The PORTRAIT Mobile
Monitoring Solution is not
intended for use in a
controlled Magnetic
Resonance (MR)
environment. | Equivalent
The Portrait Mobile
Monitoring Solution
provides substantially
equivalent vital sign
monitoring parameters
including SpO2, Pulse Rate
(PR), and Respiration Rate
(RR) in adults and pediatrics
patients as indicated in the
primary predicate device.
While the primary predicate
device provides optional
additional parameters not
available in the subject
device and allows neonatal
monitoring for some
parameters, the monitoring
parameters needed are
based on the individual
monitoring needs as
determined by a clinician.
Neither the subject device
nor the primary predicate
device monitors ECG or
arrhythmia.
The Portrait Mobile
Monitoring Solution
provides substantially
equivalent vital sign
monitoring parameters
including SpO2, Pulse Rate
(PR), and Respiration Rate
(RR) compared to the
secondary predicate as well.
The secondary predicate
only measures in adult
patients and can monitor
ECG and other vital signs in
addition to those monitored
by the subject device.
The subject device and
predicate devices have
similar system topologies,
which include sensors that
attach to the patient, small
portable patient monitors
that can be worn or carried |
| saturation of arterial hemoglobin (SpO2), | | including, general | controlled Magnetic | similar system topologies, |
| | pulse rate, carboxyhemoglobin saturation
(SpCO), methemoglobin saturation | medical- surgical | Resonance (MR) | which include sensors that |
| | (SpMet), total hemoglobin concentration | floors, | environment. | attach to the patient, small |
| | (SpHb), and/or respiratory rate (Rra). The | intermediate care | | portable patient monitors |
| | | floors, and | | that can be worn or carried |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference Predicate Device
ViSi Mobile Monitoring System –
Predicate (K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicated
for use with adult and pediatric patients
during both no motion and motion
conditions, and for patients who are well
or poorly perfused in hospitals and
hospital-type facilities. | emergency
departments. | | by the patient, a set of
centralized services
installed on a server which
is connected to the
healthcare facility's
enterprise network, and
remote viewers with
alarming capability that can
monitor multiple patients
simultaneously. |
| | The optional ISA product family consists
of three types of sidestream gas analyzers
(ISA CO2, ISA AX+ and ISA OR+) and
accessories including Nomoline, intended
to be connected to other medical
backboard devices for monitoring of
breath rate and the following breathing
gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane,
Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane,
Isoflurane, Enflurane, Sevoflurane and
Desflurane
ISA CO2, ISA AX+ and ISA OR+ are
intended to be connected to a patient
breathing circuit for monitoring of
inspired/expired gases during anesthesia,
recovery and respiratory care. The
intended environment is the operating
suite, intensive care unit and patient
room. ISA CO2 is also intended to be used
in road ambulances. The intended patient
population is adult, pediatric, infant, and
neonatal patients. | Continuous non-
invasive blood
pressure (cNIBP)
measurements
have not been
evaluated on
patients during
ambulation. | | |
| | 1 The Root Monitoring System, when used
with the optional ISA module, is not
intended to be used in road ambulances.
The optional ISA module can be used in
road ambulances with other monitoring
systems in accordance with the intended
environment of use for those systems. | The arrhythmia
analysis feature is
intended for use
by healthcare
professionals
trained in the
identification and
treatment of
arrhythmia
events.
Automated
arrhythmia
analysis is an
adjunct to clinical
assessment;
clinician review of
the analysis
should precede
any therapeutic
intervention. | | This difference does not
significantly affect safety
and/or effectiveness. |
| | The optional SEDLine Sedation Monitor is
indicated for use in the operating room
(OR), intensive care unit (ICU), and clinical
research laboratory. It is intended to
monitor the state of the brain by real-
time data acquisition and processing of
EEG signals. The system includes the
Patient State Index (PSI), a proprietary
computed EEG variable that is related to
the effect of anesthetic agents. | | | |
| | The optional temperature module is
indicated to measure temperature (oral, | | | |
17
18
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|
| rectal) of adult and pediatric patients. The
device is intended to be used by clinicians
and medically qualified personnel. It is
available for sale only upon the order of a
physician or licensed health care
provider.
The optional non-invasive blood pressure
(NIBP) module is indicated for the
noninvasive measurement of arterial
blood pressure in healthcare
environments. The NIBP module is
designed to measure blood pressure for
patient population described in the
following table:
Patient
Population Approximate Age Range Newborn
(neonate) Birth to 1 month of age Infant 1 month to 2 years of age Child 2 to 12 years of age Adolescent 12-21 years of age Adult 21 years of age and older | | | | | | | | | | | | | | | |
| Patient
Population | adult, pediatric, and neonatal patients | Adult patients (18
years or older) | Adult and pediatric patients
(3 years of age and older,
and weighing more than 10
kg). | Equivalent
The specified patient
population for the proposed
device is a subset of the
patient population of the
primary predicate.
While the primary predicate
device allows neonatal
monitoring for some
parameters, the monitoring
parameters needed are
based on the individual
monitoring needs as
determined by a clinician.
This difference does not
significantly affect safety
and/or effectiveness. | | | | | | | | | | | |
19
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environments of
Use | Hospitals, Hospital-type facilities, mobile,
and home environments | Hospital-based
facilities; including
general medical-
surgical floors,
intermediate care
floors, and
emergency
departments | A professional healthcare
facility | Equivalent
The Environment of Use for
the Portrait Mobile
Monitoring Solution is a
subset of the Environment
of Use for the primary
predicate.
This difference does not
significantly affect safety
and/or effectiveness. |
| Location of
devices in the
patient vicinity | In the Masimo Root Monitoring System
and Accessories, the sensor must be
located on the patient. The Masimo Root
is connected wirelessly to the sensor, and
as such, must only be located in the
vicinity of the patient. The Battery
Module connected to the sensor also has
a small display for viewing clinical data
and user interaction, including alarming
capability and connection to Patient
SafetyNet in case connectivity to the
Masimo Root is lost. | In the ViSi Mobile
Monitoring
System, the
Monitor and
Sensors are
located on the
patient. The
monitor is wired
to the sensors,
and as such, must
be worn on the
patent's wrist. | In the Portrait Mobile
Monitoring Solution, only
the sensors must be located
on the patient. The monitor
is connected wirelessly to
the sensors, and as such,
must only be located in the
vicinity of the patient.
However, the monitor may
be worn by the patient
using Portrait Mobile
Patient Monitor Pouch. The
monitor is also capable of
being carried in one hand. | Equivalent
As in the primary predicate
the Portrait Mobile Patient
Monitor component of the
Portrait Mobile Monitoring
Solution wirelessly
aggregates data from
patient worn sensors and
therefore does not need to
be located on the patient. If
the patient moves out of
range of the Portrait Mobile
Patient Monitor, an alarm
will sound warning the
clinician and patient that
the patient has moved out
of range. Data from the
sensors will not be collected
or displayed until the
patient returns within range
of the Mobile Patient
Monitor.
The Portrait Mobile Patient
Monitor is capable of being
worn or carried by the
patient. In this
configuration, patient
monitoring continues as
long as the patient stays
within the range of the
wireless network, exactly as
with the primary predicate
device. This difference does
not significantly affect
safety and/or effectiveness. |
| Specification
Remote Viewing
and Monitoring
Modes | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121)
The Masimo Root Monitoring System and
Accessories can communicate with
network systems for supplemental
remote viewing and alarming (e.g., at a
central station) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472)
The ViSi Mobile
Monitoring
System may be
used as
standalone
devices or
networked to ViSi
Mobile Remote
Viewers through | Proposed device
Portrait Mobile Monitoring
Solution -
Once a patient is admitted,
the Portrait Mobile Patient
Monitor component of the
Portrait Mobile Monitoring
Solution can be used
standalone (viewing of data
and alarm annunciation) if
properly configured or if it
becomes disconnected from | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates
Equivalent
Both the Portrait Mobile
Patient Monitor and the
predicate allow for local and
remote (i.e., networked)
monitoring, even though
the system topology is
different. This difference |
| | | wireless 802.11
communication. | the rest of the system. In
addition, patient data and
alarms are always remotely
displayed on the Portrait
Central Viewer unless there
is a system or network
failure. | does not significantly affect
safety and/or effectiveness. |
| | STANDARDS COMPLIANCE | | | |
| Medical
Standards | IEC 60601-1
IEC 60601-1-2
ISO 80601-2-55
ISTA 2A, MIL-STD 810E
ISO-18562-2
ISO-10993-1
ISO-10993-5
ISO-10993-10
ISO-10993-12
ISO-10993-17
ISO-10993-18
IEC 60601-1-8 | IEC 60601-1 3rd
Edition
IEC 60601-1-2
IEC 60601-1-8
IEC 60601-2-27
(ECG)
IEC 60601-2-49
IEC 80601-1-30
(NIBP)
IEC 60601-1-6
IEC 62471
ANSI/AAMI EC13
ANSI/AAMI EC53
ISO 80601-2-61
ISO 81060-1 | IEC 60601-1:2005 + A1:2012
IEC 60601-1-2:2014
IEC 60601-1-8:2012 / EN
60601-1-8:2007/A1:2013
IEC 80601-2-49:2018
ISO 80601-2-61:2017/EN
ISO 80601-2-61:2017
IEC 60601-1-6:2013/EN
60601-1-6:2010/A1:2015
IEC 62366-1:2015 / EN
62366-1:2015
ISO 10993-1:2018
IEC 62304:2015 / EN
62304:2006 / A1:2016
Labeling
ISO 20417:2021
ISO 15223-1:2021
ISO 17664:2017
ISO 17664-2:2021
Battery:
UL 2054:2004
IEC 62133-2:2017
UL 1642:2012
RFID:
AIM 7351731:2017
Wireless Coexistence:
ANSI IEEE C63.27:2017 | Equivalent
The Portrait Mobile
Monitoring Solution
complies with the FDA
recognized standards
applicable to the product
and supported parameters.
This difference does not
significantly affect safety
and/or effectiveness. |
| | System Components | | | |
| Patient Device | Masimo Radius-7 Wearable Pulse CO-
Oximeter | ViSi Mobile
Monitor | PORTRAIT Mobile Patient
Monitor | Equivalent
Both devices are battery
powered handheld
monitors displaying
numerics and waveforms.
The predicate has a larger
monitoring unit at bedside
for numerics, waveforms
and alarms. This difference
does not significantly affect
safety and/or effectiveness. |
| Specification | Primary Predicate | Reference | Proposed device | Discussion of differences |
| | Masimo Root Monitoring System and | Predicate Device | Portrait Mobile Monitoring | between Portrait Mobile |
| | Accessories (K171121) | Visi Mobile | Solution - | Monitoring Solution and |
| | | Monitoring | | Predicates |
| | | System - | | |
| | | Predicate | | |
| | | (K180472) | | |
| Sensors | Masimo SpO2 Sensors | Visi Mobile Thumb | PORTRAIT SpO2 Wearable | Equivalent |
| | Masimo Acoustic Respiration Rate (RRa) | Sensor (SpO2) | Pulse Oximetry Sensors | |
| | RAS-125c Sensor - Cloth | Visi Mobile Chest | PORTRAIT Wearable | Parameters supported on |
| | | Sensor (RR)
(wired to the | Respiration Rate Sensor
(wireless to the Mobile | the Portrait Mobile
Monitoring Solution are also |
| | | Mobile Monitor) | Patient Monitor) | available on the predicate. |
| | | | | This difference does not |
| | | | | significantly affect safety |
| | | | | and/or effectiveness. |
| Sensor Battery | Masimo Radius-7 Battery Module, | RR and SpO2 | Detachable sensor battery. | Equivalent |
| | detachable, interchangeable. | Sensors powered | Interchangeable. May be | |
| | | by Mobile Patient | used with any sensor. | The primary predicate |
| | | Monitor | | Battery Module has a small |
| | | | | display. This difference does |
| | | | | not significantly affect |
| | | | | safety and/or effectiveness. |
| SpO2 Probes | Multiple alternatives, probe is connected
to Instrument Module. | Integrated in
sensors | Integrated in sensors | Equivalent |
| | | | | The Portrait Mobile |
| | | | | Monitoring Solution has the |
| | | | | SpO2 probe integrated to |
| | | | | the SpO2 sensor while the |
| | | | | predicate has |
| | | | | interchangeable probes |
| | | | | connected to the SpO2 |
| | | | | sensor (Instrument |
| | | | | Module). This difference |
| | | | | does not significantly affect |
| | | | | safety and/or effectiveness. |
| Respiration
Electrode | Masimo Acoustic Respiration Rate (RRa)
RAS-125c Sensor - Cloth | Integrated with
Chest Sensor | Portrait RR Electrode Patch | Equivalent |
| Patches | | | | The operating principle of |
| | | | | the primary predicate |
| | | | | sensor differs from the |
| | | | | operating principle of the |
| | | | | Portrait Mobile Monitoring |
| | | | | Solution (acoustic vs. |
| | | | | impedance), but the |
| | | | | measured parameter is the |
| | | | | same (Respiration Rate). |
| | | | | The subject device uses |
| | | | | impedance based |
| | | | | respiration measurement
technology, same as the |
| | | | | secondary predicate Visi |
| | | | | Mobile Monitoring system. |
| | | | | This difference does not |
| | | | | significantly affect safety |
| | | | | and/or effectiveness. |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| Battery Charger | Masimo Root | Visi Mobile
Charger | Portrait Bedside Charger | Equivalent
The Portrait Bedside
Charger can charge the
Portrait Mobile Patient
Monitor while in use and
can also charge the
detachable sensor batteries.
The Masimo Root acts as
both a charger for the
Battery Module and as a
bedside patient monitor.
This difference does not
significantly affect safety
and/or effectiveness. |
| Central Viewing | Masimo Patient SafetyNet | Visi Mobile
Remote Viewer | Portrait Central Viewer
Software Application with
Portrait Clinical Alarming
Unit | Equivalent
Portrait Central Viewer
software on an off-the-shelf
PC, along with the Portrait
Clinical Alarming Unit,
provide for central
viewing/monitoring and
standards compliant alarms.
Portrait Central Viewer
software can only be
installed on hardware that
meets minimum
specifications which are
checked during the
installation process.
The PC on which the
Portrait Central Viewer is
installed is customer
supplied, while the viewer
PC for the predicate is
always supplied by the
manufacturer of the
Masimo Patient SafetyNet
System.
This difference does not
significantly affect safety
and/or effectiveness. |
| Storage and
Centralized
Services | Masimo Patient SafetyNet | ViSi Mobile
Appliance | Portrait Core Services | Equivalent
Both the Portrait Core
Services within the Portrait
Mobile Monitoring System
and the Masimo Patient
SafetyNet in the predicate
distribute data between the
bedside devices and other
devices such as a central
monitoring unit or EMR
system. This difference does
not significantly affect
safety and/or effectiveness. |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| Accessories for
SpO2 and Resp | Masimo Radius-7 Armband | ViSi Mobile Wrist
Cradle
ViSi Mobile Thumb
Wrap
ViSi Mobile Chest
Sensor
Securements | Portrait Mobile Patient
Monitor Pouch
Portrait SpO2 Attachment
Accessory Band | Equivalent
Both the Portrait Mobile
Monitoring Solution and the
predicate have accessories
allowing the sensors to be
attached to or carried by
the patient. This difference
does not significantly affect
safety and/or effectiveness. |
| Patient Device – General Hardware Specifications | | | | |
| Device Name | | ViSi Mobile
Monitor | Portrait Mobile Patient
Monitor | |
| Size (H x W x D) | 119.5 mm x 63.2 mm x 27.2 mm | 9.4 cm x 4.9 cm x
2.6 cm | 14.1 cm x 6.3 cm x 2.1 cm | Equivalent
Both the Portrait Mobile
Patient Monitor and the
predicate device are small
enough to be held in one
hand and are capable of
being worn by the patient.
This difference does not
significantly affect safety
and/or effectiveness. |
| Weight | Battery Module 93 g
Instrument Module 67g
Total 160 g | 110 g | 223 g | Equivalent
Both the Portrait Mobile
Patient Monitor and the
primary predicate device
are small enough to be held
in one hand and are capable
of being worn by the
patient. During normal use,
the Portrait Mobile Patient
Monitor does not need to
be held or worn by the
patient because the device
is completely wireless. This
difference does not
significantly affect safety
and/or effectiveness. |
| Power source | Battery (integrated into device) | Battery
(integrated into
device) | Battery (integrated into
device) | Identical |
| Battery Type | Lithium-ion | Lithium-ion | Lithium-ion | Identical |
| Patient Device – User Interface | | | | |
| Device Name | | ViSi Mobile
Monitor | Portrait Mobile Patient
Monitor | |
| Touch display
interface | Yes (Touchpad for Battery Module and
Touch Screen for Root) | Yes | Yes | Identical |
| Visual and
Audible Alarm
capability | Available | Available | Available | Identical |
20
21
22
23
24
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates | | | | | |
|---------------------------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------------------------------------------------------------------------------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device Name | | ViSi Mobile
Monitor | Portrait Mobile Patient
Monitor | | | | | | |
| Display type | OLED | OLED | SFT LCD (Super Fine TFT) | Equivalent
Both the Portrait Mobile
Patient Monitor and the
predicates utilize proven
display technologies that
are widely used across a
variety of industries. This
difference does not
significantly affect safety
and/or effectiveness. | | | | | |
| Display Size and
resolution | 160 X 128 (Dot pitch 0.073 (W) mm X
0.219 (H) mm) | 160 x 128 pixels
(size unspecified) | 480 x 800 pixels, 3.7 inches
in 16:9 format | Equivalent
Greater resolution on
Portrait Mobile Patient
Monitor display allows for
more information to be
displayed than the
predicate devices. This
difference does not
significantly affect safety
and/or effectiveness. | | | | | |
| Number of traces
(waveforms) | One waveform | One waveform,
user selectable | One waveform per page in
detailed parameter view | Identical | | | | | |
| Trends | | Trends available on the Masimo Root. No
trends on the Battery Module. | Patient Device – Connectivity | Not available for
comparison / Not
specified | | Displays graphical trend of
connected parameters for
the last 4 hours. Movable
cursor displays details for
the given point in time. | | Equivalent
The Portrait Mobile Patient
Monitor is capable of
displaying the last 4 hours
of trend data directly on the
monitor. Trends are
available on the Masimo
Root, but not on the Battery
Module. This difference
does not significantly affect
safety and/or effectiveness. | |
25
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | | Visi Mobile
Monitor | Portrait Mobile Patient
Monitor | |
| Wireless
connection to
network | May be networked to Masimo Patient
SafetyNet through wireless IEEE 802.11
a/b/g communication. | May be
networked to ViSi
Mobile Remote
Viewers through
wireless 802.11
communication.
(802.11a/b/g/n -
Dual band) | Requires a wireless network
connection to begin
monitoring. IEEE 802.11
a/b/g/n supported (dual
band). After patient
admission, the Portrait
Mobile Patient Monitor will
continue to monitor locally
in the event of a network
failure. | Equivalent
Both the Portrait Mobile
Patient Monitor and the
predicate support a dual
band 802.11 a/b/g
connection to the Wi-Fi
network of the responsible
organization (i.e., hospital
wireless network). The
Portrait Mobile Patient
Monitor requires a network
connection for admitting
the patient and beginning
monitoring but can monitor
locally after admission in
the event of a network
failure. The predicate
Masimo Radius-7 does not
require a network
connection to begin
monitoring. This difference
does not significantly affect
safety and/or effectiveness. |
| Connection to
Sensors | The Masimo Instrument Module and
Battery Module communicates with the
sensors via a wired interface and with the
Masimo Root over a Bluetooth interface. | The Visi Mobile
Monitor
communicates
with the sensors
via a wired
interface. | The Portrait Mobile Patient
Monitor communicates with
the sensors over a wireless
Medical Body Area Network
(MBAN) using a proprietary
protocol.
The MBAN connection to
the sensors includes a GE-
proprietary protocol and a
low-power radio interface
that can operate on both
the unlicensed 2.4 GHz ISM
band and certain other
protected frequency bands
where MBAN traffic is
allowed. In the USA, the
MBAN communication
occurs in the 2390-2400
MHz band, which has been
reserved by the FCC for use
by Medical Body Area
Networks. | Equivalent
The Portrait Mobile Patient
Monitor communicates to
the sensors over a wireless
Medical Body Area Network
(MBAN), a feature that is
not supported by the
predicate. MBAN
communication includes
multiple retries spread over
time and frequency to
ensure reliable transmission
of data. Loss of MBAN
communication (e.g.,
moving out of range) results
in a technical alarm
informing the caregiver of
the communication loss.
This difference does not
significantly affect safety
and/or effectiveness.
See GE's response to the
FDA Guidance document
"Radio Frequency Wireless
Technology in Medical
Devices; Guidance for
Industry and Food and Drug
Administration Staff,
Document issued on:
August 14, 2013", |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | this 510(k) submission, for
detailed information about
the wireless interfaces in
the Portrait Mobile
Monitoring Solution. |
| | Respiration Sensors – Hardware | | | |
| Device Name | | ViSi Mobile Chest
Sensor | Portrait Wearable
Respiration Rate Sensor | |
| Dimensions | 119.5 mm x 63.2 mm x 27.2 mm | 152.4 cm L | 6.9 x 5.3 x 1.9 cm | Equivalent
Both the Portrait Wearable
Respiration Rate Sensor and
the sensor in the predicate
device (i.e., the Masimo
Radius-7) are small,
lightweight sensors that
attach to the patient for
measuring respiration rate,
although they differ
somewhat in weight and
geometry. This difference
does not significantly affect
safety and/or effectiveness. |
| Weight | 67 g | 62 g (3-Lead wire) | 34 g | Equivalent
Both the Portrait Wearable
Respiration Rate Sensor and
the predicate sensor
(Masimo Radius-7) are
small, lightweight sensors
that attach to the patient,
although they differ
somewhat in weight and
geometry. This difference
does not significantly affect
safety and/or effectiveness. |
26
27
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates | | | | | |
|--------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Name | | ViSi Mobile
Thumb Sensor | Portrait Wearable Pulse
Oximetry Sensor | | | | | | |
| Sensor
Application Site | Finger | Thumb | Finger | Identical | | | | | |
| Dimensions | 119.5 mm x 63.2 mm x 27.2 mm | 22.5 cm L | SpO2 P-SA01: 27.2 x 5.3 x
1.9 cm - or -
SpO2 P-SP01: 23.6 x 5.3 x
1.9 cm - or -
SpO2 P-W01: 26.2 x 5.3 x
1.9 cm - or -
SpO2 P-SE01: 27.1 x 5.3 x
1.9 cm | Equivalent
Both the Portrait Wearable
Pulse Oximetry Sensor and
the Masimo Radius-7 in the
predicate device are small,
lightweight SpO2 sensors
that attach to the patient
for measuring SpO2 and
pulse rate. The Portrait
Wearable Pulse Oximetry
Sensor also contains the
electronics and software for
calculating SpO2 and pulse
rate. This difference does
not significantly affect
safety and/or effectiveness. | | | | | |
| Weight | 67 g | 8 g | SpO2 P-SA01: 52 g - or -
SpO2 P-SP01: 43 g - or -
SpO2 P-W01: 38 g - or -
SpO2 P-SE01: 38 g | Equivalent
Both the Portrait Wearable
Pulse Oximetry Sensor and
the Masimo Radius-7 in the
predicate device are small,
lightweight SpO2 sensors
that attach to the patient
for measuring SpO2 and
pulse rate. The Portrait
Wearable Pulse Oximetry
Sensor also contains the
electronics and software for
calculating SpO2 and pulse
rate. This difference does
not significantly affect
safety and/or effectiveness. | | | | | |
| | Sensor Batteries - Hardware | | | | | | | | |
| | | N/A | Portrait Sensor Battery | | | | | | |
| Battery Type | Dimensions | Lithium-ion | $119.5 mm x 63.2 mm x 27.2 mm$ | N/A - ViSi Mobile
Chest Sensor
(Respiration Rate)
and ViSi Mobile
Thumb Sensor
(SpO2) are
powered by Visi
Mobile Monitor.
See comparison of
Portrait Mobile
Patient Monitor
vs. ViSi Mobile
Monitor (above) | N/A - ViSi Mobile
Chest Sensor
(Respiration Rate)
and ViSi Mobile | Lithium-ion | $3.6 x 5.3 x 1.7 cm$ | Identical | Equivalent
Portrait Sensor batteries are
small and lightweight and so |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile Monitoring System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates | | | | | |
| | | Thumb Sensor (SpO2) are
powered by Visi Mobile Monitor.
See comparison of Portrait Mobile Patient Monitor vs. ViSi Mobile Monitor (above) | | not significantly increase the size or weight of the components attached to or carried by the patient. This difference does not significantly affect safety and/or effectiveness. | | | | | |
| Weight | 93 g | N/A - ViSi Mobile Chest Sensor
(Respiration Rate) and ViSi Mobile Thumb Sensor (SpO2) are
powered by Visi Mobile Monitor.
See comparison of Portrait Mobile Patient Monitor vs. ViSi Mobile Monitor (above) | 31 g | Equivalent
Portrait Sensor batteries are small and lightweight and so not significantly increase the size or weight of the components attached to or carried by the patient. This difference does not significantly affect safety and/or effectiveness. | | | | | |
| | Charger - Hardware | | | | | | | | |
| Input voltage and
frequency | Masimo Root 100-240 VAC~, 47-63 Hz | VISI MOBILE
BATTERY
CHARGER
100-240 V, 50-60 Hz (using external power supply) | Portrait Bedside Charger
100-240 V, 50-60 Hz (using external power supply) | Equivalent.
The slight difference in AC frequency range does not significantly affect safety and/or effectiveness. | | | | | |
| Power | Input voltage and frequency | 65 VA | Masimo Root 100-240 VAC~, 47-63 Hz | 2 Position: 30 W
(all bays charging)
8 Position: 75 W
(all bays charging) | 100-240 V, 50-60 Hz (using external power supply) | 36 W (Output power - 3.0 A at 12 Vdc) | 100-240 V, 50-60 Hz (using external power supply) | Equivalent.
Both the Portrait Bedside charger and the chargers for the predicate have sufficient output power to charge the devices specified in their use. The Portrait Bedside Charger is capable of charging the Portrait Mobile Patient Monitor while it is in use. This difference does not significantly affect safety and/or effectiveness. | Equivalent.
The slight difference in AC frequency range does not significantly affect safety and/or effectiveness. |
| Power | 65 VA | 2 Position: 30 W (all bays charging)
8 Position: 75 W (all bays charging) | 36 W (Output power - 3.0 A at 12 Vdc) | Equivalent.
Both the Portrait Bedside charger and the chargers for the predicate have sufficient output power to charge the devices specified in their use. The Portrait Bedside Charger is capable of charging the Portrait Mobile Patient Monitor while it is in use. This difference does not significantly affect safety and/or effectiveness. | | | | | |
| Dimensions (exclusive of power supply and cable) | Masimo Root 27.94 cm x 26.67 cm x 13.97 cm | 2 Position: 7.6 cm H x 6.0 cm W x 12.7 cm L
8 Position: 7.6 cm H x 6.0 cm W x 47 cm L | 11.5 x 23.8 x 4.3 cm | Equivalent.
The Portrait Bedside Charger is intended to be installed in the patient room and can charge the Portrait Mobile Patient Monitor | | | | | |
28
29
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | while use in addition to 4
Portrait Sensor Batteries.
The Masimo Root in the
predicate charges one
Battery Unit. Both the
Portrait Bedside charger
and the predicate are small
and easily transportable.
This difference does not
significantly affect safety
and/or effectiveness. |
| Weight
(exclusive of
power supply
and cable) | Masimo Root 3.63 kg | 2 Position: 240 g
8 Position: 670 g | 412 g
Wall mount: 603 g
Table mount: 908 g | Equivalent.
Both the Portrait Bedside
charger and the predicate
charger are lightweight and
easily transportable. This
difference does not
significantly affect safety
and/or effectiveness. |
| | Central/Remote Viewer | | | |
| | | ViSi Remote
Viewer | Portrait Central Viewer
Application with Portrait
Clinical Alarming Unit | |
| Display | 23" | 23 in display /
1920 x 1080
resolution
(screen is touch
sensitive to issue
commands
alternative to
mouse/keyboard) | Required Specification for
customer supplied display:
20 in (minimum),
1920 x 1080 resolution
(minimum) | Equivalent
The display for the Portrait
Central Viewer Application
is customer supplied and
needs to meet certain
minimum requirements
which are checked by the
installer at the time of
install. The display for the
remote viewer of the
predicate is supplied by the
manufacturer. This
difference does not
significantly affect safety
and/or effectiveness. |
| Operating
System | Windows 7 Professional Edition | Microsoft®
Windows® 7
Professional
(version 6.1) x64
Bit SP1 | Required Specification for
customer supplied PC:
Windows 10, build
10.0.17763 (minimum) | Equivalent
The PC on which the
Portrait Central Viewer
Application is installed is
customer supplied and
needs to meet certain
minimum requirements |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | which are checked by the
installer at the time of
install. The PC for the
remote viewer of the
predicate is supplied by the
manufacturer. This
difference does not
significantly affect safety
and/or effectiveness. |
| Number of
patients per
viewer | Maximum 40 | Maximum 32 | Maximum 24 | Equivalent
Each Portrait Central Viewer
Application with Portrait
Clinical Alarming Unit
supports up to 24 patients,
vs. 40 for the predicate.
Multiple instances of the
Portrait Central Viewer
Application with Portrait
Clinical Alarming Unit (one
per PC) can be used in order
to view all patients being
monitored by the Portrait
Mobile Monitoring Solution
(up to maximum system
capacity). This difference
does not significantly affect
safety and/or effectiveness. |
| Simultaneous
view of numerics
for all patients
on viewer | Supported for all measured parameters | Supported for all
measured
parameters | Supported on for all
measured parameters on
Multiple Patient View -
SpO2%, Pulse Rate,
Respiration Rate | Equivalent
Both the Portrait Central
Viewer Application and the
predicate are capable of
simultaneously displaying
numerics of monitored
parameters for all patients
monitored for that viewer.
This difference does not
significantly affect safety
and/or effectiveness. |
| Viewing of
patient
waveforms | One patient at a time | One patient at a
time | One patient at time -
Supported on single patient
view | Equivalent
Both the Portrait Central
Viewer Application and the
Predicate are capable of
viewing waveforms for all
parameters in scope of their
intended use. Waveforms |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | are only viewable for one
patient at a time. For the
Portrait Central Viewer
Application, waveforms are
viewable by selecting an
individual patient, which
brings up the single patient
view. The single patient
view obscures numerics for
other patients will that
window is opened.
However, the highest
priority, most recent active
alarms for all patients
viewed by that instance of
the Portrait Central Viewer
Application are always
visible in a protected area
on the top of the screen.
Numeric values for all
monitored patients are
visible while viewing
waveforms for a single
patient on the predicate.
This difference does not
significantly affect safety
and/or effectiveness. |
| Viewing of
patient trends | Graphical trend view supported for one
patient at time | One patient at a
time. Tabular or
graphic trends | Graphical trend view
supported for one patient at
time – single patient view | Equivalent
Both the Portrait Central
Viewer Application and the
Predicate are capable of
viewing trends for all
parameters in scope of their |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | only viewable for one
patient at a time. For the
Portrait Central Viewer
Application, graphical
trends are viewable by
selecting an individual
patient, which brings up the
single patient view. The
single patient view obscures
numerics for other patients
will that window is opened.
However, the highest
priority, most recent active
alarms for all patients
viewed by that instance of
the Portrait Central Viewer
Application are always
visible in a protected area
on the top of the screen.
These differences do not |
| Visual/Audible
alarms supported | Supported | Supported | Supported | significantly affect safety
and/or effectiveness.
Identical |
| | Storage and Centralized Services - General | | | |
| | | ViSi Mobile
Appliance | Portrait Core Services | |
| Description | Patient SafetyNet™ is a supplemental
remote monitoring and clinician
notification system. It provides a
secondary display of Masimo SET® pulse
oximetry, rainbow® SET pulse CO-
Oximetry and acoustic respiration rate
monitors. Patient SafetyNet enables
clinicians to view and monitor patient
physiological conditions when used in
hospitals or hospital-type environments. | In the ViSi Mobile
Monitoring
System, data is
captured in the
ViSi Mobile
Appliance, which
acts as an
enterprise hub.
The Appliance is
dedicated
hardware installed
in the IT
datacenter for
secure network
connectivity and
emergency power
backup. | The Portrait Core Services
are a set of software
services that enable the
communication and
interaction of the Portrait
Monitoring Solution
components and will
integrate into existing
healthcare facility
infrastructure and clinical
information systems. The
Portrait Core Services
provide system
configuration,
administration, data
storage, and transmission of
patient physiological trends
and events. The Portrait
Core Services are installed
on the Portrait non-medical
device EHL (Edison Health
Link) Server. | Equivalent
The Portrait Core Services
and the Masimo Patient
SafetyNet system provide
for centralized services and
data storage. This difference
does not significantly affect
safety and/or effectiveness. |
| HL7 outbound
support | Supported | Supported - Vital
signs. | Supported - The Portrait
Core Services can transmit
patient physiological trends
and numerics (IHE PCD DEC)
and alarm events (IHE PCD
ACM) outbound. | Equivalent
The Portrait Core Services
and the Masimo Patient
SafetyNet support
outbound HL7 for patient
vital signs. The Portrait Core
Services additionally
supports patient |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | physiological trends and
alarm events. This
difference does not
significantly affect safety
and/or effectiveness. |
| HL7 Inbound
support | Supported | Supported - The
inbound ADT data
is utilized by the
Sotera application
to provide patient
identity
information for
display on the ViSi
Mobile Monitors. | Supported - The Portrait
Core Services can also
receive HL7 ADT
information to admit
patients to the Portrait
Monitoring Solution. | Equivalent
The Portrait Core Services
and the Masimo Patient
SafetyNetsupport inbound
ADT data. The inbound ADT
data can be used to admit
patients to the Portrait
Mobile Monitoring Solution.
This difference does not
significantly affect safety
and/or effectiveness. |
| | Storage and Centralized Services – Hardware | | | |
| | | ViSi Mobile
Appliance (when
using Sotera
supplied
hardware) | Portrait Core Services | |
| Server Model | minimum Quad-Core Intel Xeon 2.0 GHz
minimum 4 GB RAM
minimum 1 TB RAID 1 storage array | Not available for
comparison / Not
specified | HP ProLiant DL360 Gen10 | Equivalent
Portrait Core Services use a
HP ProLiant server which is
widely used in multiple
industries. This difference
does not significantly affect
safety and/or effectiveness. |
| | Monitored Parameters | | | |
| Monitored
Parameters | Arterial oxygen saturation (SpO2)
Pulse rate (PR)
Perfusion index (Pi)
Pleth Variability Index (PVi) Hemoglobin
(SpHb)
Carboxyhemoglobin (SpCO)
Total oxygen content (SpOC)
Methemoglobin (SpMet)
Acoustic Respiration Rate (RRa). | Oxygen saturation
(SpO2)
Pulse Rate (PR)
Respiration Rate
(RR)
Heart Rate (HR)
Non-Invasive
Blood Pressure
(NIBP)
Continuous NIBP
(cNIBP)
Skin Temperature | Oxygen saturation (SpO2)
Pulse rate (PR)
Respiration Rate (RR) | Equivalent.
The parameters monitored
by the proposed device are
also monitored by the
predicate. This difference
does not significantly affect
safety and/or effectiveness. |
| Parameters
Acquisition
Method | The Masimo Radius-7 acquires
parameters from a wireless Instrument
module to which an SpO2 probe and an
acoustic respiration rate sensor are
connected. | The Sotera Visi
Mobile Monitor
acquires
parameter data
from wired
sensors. The
available wired
sensors include:
ViSi Mobile Chest
Sensor
(Respiration,
Heart Rate, Skin
Temperature)
ViSi Mobile
Thumb Sensor | The Portrait Mobile Monitor
acquires parameter data
from wireless patient
sensors over the MBAN
wireless link. The
parameter electronics are
encapsulated into the
respective wireless sensors.
The sensors include:
Portrait SpO2 P-SA01, SpO2
Wearable Pulse Oximetry
Sensor (SpO2, Pulse Rate)
Portrait SpO2 P-SP01, SpO2
Wearable Pulse Oximetry
Sensor (SpO2, Pulse Rate) | Equivalent
Both the Portrait Mobile
Monitoring Solution and the
predicate include sensors
for collecting of
physiological data from all
monitored parameters
included in their intended
use. The sensors for the
Portrait Mobile Monitoring
Solution communicate to
the Portrait Mobile Patient
Monitor via a wireless
MBAN connection, while |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | (SpO2, Pulse Rate)
Visi Mobile Cuff
Module (NIBP) | Portrait SpO2 P-W01, SpO2
Wearable Pulse Oximetry
Sensor (SpO2, Pulse Rate)
Portrait SpO2 P-SE01, SpO2
Wearable Pulse Oximetry
Sensor (SpO2, Pulse Rate)
Portrait RR P-RR01,
Wearable Respiration Rate
Sensor (Respiration Rate) | the sensors for the
predicate communicate
over a wired connection to
the Instrument Module and
Battery Module which
communicate wirelessly
with the Masimo Root over
Bluetooth. This difference
does not significantly affect
safety and/or effectiveness. |
| | Alarms | | | |
| Classification /
Alarm Levels | Two levels – High (flashing red) and
Medium (flashing yellow) | Four levels - Life
Threatening
(white/red), High
(red), Equipment
High (cyan).
Equipment Low
(cyan) | Three levels - High (red),
Medium (yellow), Low
(cyan) in compliance with
IEC 60601-1-8
Informational messages
(gray) also included | Equivalent
Both the Portrait Mobile
Monitoring Solution and the
predicate contain multiple
alarm levels to distinguish
between alarms based on
criticality (i.e., the level of
hazard to the patient). The
alarm system for the Patient
Mobile Monitoring Solution
is compliant to IEC 60601-1-
8:2012. This difference does
not significantly affect
safety and/or effectiveness. |
| Notification | Audible and visual | Audible and visual | Audible and visual | Identical |
| List of
Physiological
Alarms
supported (for
parameters
included in the
proposed device) | PR High
PR Low
SpO2 High
SpO2 Low
Rapid Desat
RR High
RR Low
Respiratory Pause | HIGH PULSE RATE
LOW PULSE RATE
HIGH RESP
LOW RESP
LOW SpO2
THUMB NO PULSE | PR High
PR Low
RR High
RR Low
SpO2 High
SpO2 Low
SpO2 Critically low
Apnea (This device is not an
apnea monitor (i.e., do not
to rely on the device for
detection or alarm for the
cessation of breathing ).
This device should not be
used for life
sustaining/supporting
purposes) . | Equivalent
Both the Portrait Mobile
Monitoring Solution and the
predicate contain a list of
physiological alarms
consistent with the
parameters monitored as
part of their intended use.
This difference does not
significantly affect safety
and/or effectiveness.
All physiological alarms
supported in the Portrait
Mobile Monitoring Solution |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | are also supported in the
CARESCAPE ONE reference
device (K213234). |
| Technical /
Equipment
Alarms | Supported | Supported | Supported | Equivalent
Both the Portrait Mobile
Monitoring Solution and the
predicate device contain
alarms to indicate
equipment failure, low
battery, loss of wireless
connection, etc. The list of
alarms is different between
the two devices due to the
differences in the design of
the equipment. This
difference does not
significantly affect safety |
| | Trending | | | and/or effectiveness. |
| Trend
Visualization | Graphical Trends | Graphical Trends
and List (tabular)
Trends | Graphical Trends only.
Individual values for each
trended value are visible at
the position of the cursor. | Identical |
| Trend
Visualization
Duration | Up to 96 hours | Not available for
comparison / Not
specified | Up to 4 Hours on the
Portrait Mobile Patient
Monitor
Up to 24 Hours on the
Portrait Central Viewer
Application | Equivalent
The Portrait Mobile
Monitoring Solution
supports viewing of up to
the last 4 Hours of trend
data on the Portrait Mobile
Patient Monitor and up to
the last 24 Hours on the
Portrait Central Viewer
Application. The duration of
trend data viewable on the
predicate is 96 hours. The
Portrait Mobile Patient
Monitoring Solution also
supports transmission of
trend data to an EMR
system over an HL7
interface, to allow for a
complete record of patient
trends to be accessed. This
difference does not
significantly affect safety
and/or effectiveness. |
| Trend Smoothing | Not specified | Not specified | On the Portrait Central
Viewer Application, the
trend data undergoes an
additional smoothing
process. The purpose of this
smoothing is to remove
brief changes and normal
variations in the
physiological trend data
acquired by the Portrait | Equivalent
The trended data that is
displayed on the Portrait
Central Viewing Application
undergoes an additional
smoothing process to
remove brief variations (i.e.,
discontinuities) in the raw
trend data to make
visualization of trends over |
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121)
RESPIRATION | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution – | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates |
| | | | | a period of time easier. This
feature is not available
when viewing trend data at
the source (i.e., the Portrait
Mobile Patient Monitor) or
the predicate. This
difference does not
significantly affect safety
and/or effectiveness. |
| Event
management | Clinical and Technical events are stored
and can be exported as Event Reports | Not available for
comparison / Not
specified | Physiological Events (i.e.,
alarms) of medium or high
priority are stored in the
Portrait Mobile Monitoring
Solution and are viewable in
the Trend display on the
Portrait Central Viewer
Application. | Equivalent
The Portrait Mobile
Monitoring Solution
supports viewing of
historical events (i.e.,
alarms) in the Trend display.
The predicate provides
event storage and viewing
through even reports. This
difference does not
significantly affect safety
and/or effectiveness. |
| Measurement
Method | Acoustic Respiration Measurement | Impedance
Pneumography
(i.e., Impedance
Respiration) | Impedance Respiration (i.e.,
Impedance Pneumography) | Equivalent
Although the measurement
method is different, both
methods measure the same
parameter, i.e., respiration
rate. The subject devices
uses the same impedance
respiration technology as
the secondary predicate Visi
Mobile Monitoring system.
This difference does not
significantly affect safety
and/or effectiveness. |
| Display Range | 0 bpm to 70 bpm | 0 to 50
breaths/min | 0 to 99 breaths/min | Equivalent
Respiration display range on
the Portrait Mobile
Monitoring Solution is
slightly wider than on
predicate. This difference
does not significantly affect
safety and/or effectiveness. |
| Units | Respiration Rate (RR) in breaths/min | Respiration Rate
(RR) in
breaths/min | Respiration Rate (RR) in
breaths/min | Identical |
| Resolution | 1 breath/min | 1 breath/min | 1 breath/min | Identical |
30
31
32
33
34
35
36
37
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System –
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and
Predicates | | | | | |
|----------------|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accuracy Range | 4 to 70 bpm | 3 to 50 breaths/min | 4 to 60 breaths/min | Equivalent
Both the Portrait Mobile Monitoring Solution and the predicate specify accuracy over a wide range of respiration rate values. These ranges encompass the range of respiration rate values expected from patient populations included in the intended use of the product. This difference does not significantly affect safety and/or effectiveness. | | | | | |
| Accuracy | 1 bpm | +/- 3 breaths/min
or 10% or reading,
whichever is
greater | +/- 3 breaths/min | Equivalent
The primary predicate has somewhat better accuracy. Both the Portrait Mobile Monitoring Solution and the predicate have sufficient accuracy to meet the clinical needs of the intended use environment. The subject devices have the same accuracy as the secondary predicate Visi Mobile Monitoring system. This difference does not significantly affect safety and/or effectiveness. | | | | | |
| Waveforms | | Acoustic Respiration waveform | PULSE OXIMETRY - SpO2 | | | | Impedance
Respiration
waveform,
6.25mm/s sweep
speed | Impedance Respiration
waveform with automatic
scaling, 6.25 mm/s sweep
speed (Portrait Mobile
Patient Monitor), 25 m/s
sweep speed (Portrait
Central Viewer Application) | Equivalent
Both the Portrait Mobile Monitoring Solution and the predicate support impedance respiration waveforms. This difference does not significantly affect safety |
| Measurement | Arterial oxygen saturation (SpO2) | Arterial oxygen saturation (SpO2) | Arterial oxygen saturation (SpO2) | Identical | | | | | |
38
| Specification | Primary Predicate
Masimo Root Monitoring System and
Accessories (K171121) | Reference
Predicate Device
ViSi Mobile
Monitoring
System -
Predicate
(K180472) | Proposed device
Portrait Mobile Monitoring
Solution - | Discussion of differences
between Portrait Mobile
Monitoring Solution and Predicates |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Units | Percent | Percent | Percent | Identical |
| Display Range | 0% to 100% | 49 to 100% | 0 to 100% | Identical |
| Resolution | 1% | 1% | 1% | Identical |
| Accuracy Range | 70 to 100% | 70 to 100% | 70 to 100% | Identical |
| Accuracy | No Motion (SpO2 from 60% to 80%),
Adults, Pediatrics - 3%
No Motion (SpO2 from 70% to 100%),
Adults, Pediatrics - 2%
Motion (SpO2 from 70% to 100%), Adults,
Pediatrics - 3%
Low perfusion (SpO2 from 70% to 100%),
Adults, Pediatrics - 2% |