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 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 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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria for the GE HealthCare Portrait Mobile Monitoring Solution.

Here's an analysis structured according to your request:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria for the Portrait Mobile Monitoring Solution are primarily based on performance specifications for its physiological parameters (Respiration Rate, SpO2, Pulse Rate) and its compliance with relevant medical device standards. The document provides comparison tables indicating how the proposed device's performance aligns with or is considered equivalent to predicate devices.

Key Performance Specifications and Reported Performance:

Parameter	Acceptance Criteria (typically derived from predicate or standards)	Reported Device Performance (Portrait Mobile Monitoring Solution)	Basis of Equivalence/Discussion
Respiration Rate (RR)
Measurement Method	Acoustic Respiration Measurement (Primary Predicate); Impedance Pneumography (Reference Predicate)	Impedance Respiration (i.e., Impedance Pneumography)	Equivalent. Although the primary predicate uses acoustic measurement, the proposed device uses impedance respiration, which is the same as the secondary predicate. Both methods measure the same parameter (RR). This difference does not significantly affect safety/effectiveness.
Display Range	0-70 bpm (Primary Predicate); 0-50 breaths/min (Reference Predicate)	0-99 breaths/min	Equivalent. Wider display range than predicates, encompassing expected values. Does not significantly affect safety/effectiveness.
Accuracy Range	4-70 bpm (Primary Predicate); 3-50 breaths/min (Reference Predicate)	4-60 breaths/min	Equivalent. The specified range covers expected values for the intended patient population. Does not significantly affect safety/effectiveness.
Accuracy	1 bpm (Primary Predicate); +/- 3 breaths/min or 10% (Reference Predicate)	+/- 3 breaths/min	Equivalent. While the primary predicate has slightly better accuracy (1 bpm), the proposed device's +/- 3 bpm accuracy is deemed sufficient for clinical needs and is the same as the secondary predicate. This difference does not significantly affect safety/effectiveness.
Pulse Oximetry (SpO2)
Units / Display Range / Resolution / Accuracy Range	% / 0-100% / 1% / 70-100% (Similar across predicates)	% / 0-100% / 1% / 70-100%	Identical.
Accuracy	No Motion (SpO2 70-100%): 2%; Motion: 3%; Low Perfusion: 2-3% (from predicates)	SpO2 (70-100%) <= 2%; Low perfusion <= 3%; With motion <= 3%	Equivalent. Consistent with predicate performance, slight difference at low perfusion is not significant for safety/effectiveness.
Averaging	Variable (e.g., 2-16s, 12 beat)	Adjustable 0-60 seconds (default 10s)	Equivalent. Range differs from predicate, but adjustability on proposed device and authorized user restriction make it acceptable. Does not significantly affect safety/effectiveness.
Waveforms	Pleth Waveform, normalized/unspecified	Pleth Waveform, Not normalized	Equivalent. Both support pleth waveforms. The unnormalized amplitude reflects arterial blood pulsation strength, differing from the secondary predicate's normalized waveform, but this difference does not significantly affect safety/effectiveness.
Pulse Rate (PR)
Measurement Method	Peripheral Pulse rate (from SpO2)	Peripheral Pulse rate	Identical.
Units / Resolution	bpm / 1 bpm	bpm / 1 bpm	Identical.
Display Range	0-240 bpm (Similar across predicates)	30-300 bpm	Equivalent. Wider display range compared to predicates, allowing for monitoring across a broader spectrum of physiological states. Values outside the range trigger alarms. Does not significantly affect safety/effectiveness.
Accuracy Range	25-240 bpm (Primary Predicate); 30-240 bpm (Reference Predicate)	30-250 bpm	Equivalent. The range of accuracy is similar and considered sufficiently broad for clinical use. Does not significantly affect safety/effectiveness.
Accuracy	No motion: 3 bpm; Motion: 5 bpm; Low Perfusion: 3 bpm (from predicates)	<= 2 bpm (all conditions except motion); <=5 bpm (motion)	Equivalent. The proposed device shows slightly better accuracy under non-motion/low perfusion conditions (<=2 bpm vs. 3 bpm) and identical accuracy under motion (<=5 bpm). This difference does not significantly affect safety/effectiveness.

2. Sample Size and Data Provenance

The document specifies two clinical studies:

SpO2 Algorithm and Sensors Study: This study was conducted in accordance with ISO 80601-2-61:2017 and FDA guidance: "Pulse Oximeters—Premarket Notification Submissions [510(k)s] - Guidance for Industry and Food and Drug Administration Staff Issued March 2013." While the exact sample size is not explicitly stated in the provided text, adherence to these specific standards and guidance documents implies that the sample size would meet the rigorous requirements for pulse oximetry accuracy claims (typically involving a range of healthy adult volunteers and induced hypoxia studies). The provenance (e.g., country) is not explicitly stated, but given FDA submission, it's typically a multi-center study, often including US sites. The nature of these studies is prospective.
Respiration Rate (RR) Monitoring Study:
- Sample Size: Not explicitly stated, but the population was described as "representative of the general population anticipated to require Portrait Mobile Monitoring Solution in clinical practice," suggesting a sufficient sample size for general ward patients.
- Data Provenance: The study was conducted on "general ward patients" and while the country of origin is not directly stated, common practice for FDA submissions implies data from a well-regulated clinical environment, often within the US or compliant international sites. It was a prospective study where patients performed normal activities.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth in the traditional sense of image interpretation for AI. Instead, the ground truth for physiological parameters appears to be established through:

SpO2: Defined by the methodologies outlined in ISO 80601-2-61:2017, which involves controlled hypoxia studies where reference arterial oxygen saturation (SaO2) is measured directly from arterial blood samples via a co-oximeter. This method does not typically involve expert "readers" for ground truth but rather highly precise laboratory measurements.
Respiration Rate: "Reference method was CO2 monitoring, which is considered a gold standard for RR." This is an objective physiological measurement, not reliant on expert interpretation.

Therefore, the concepts of "number of experts" and "qualifications of those experts" as they relate to human readers establishing ground truth for perception tasks (like radiology) are not applicable here.

4. Adjudication Method for the Test Set

As the ground truth for both SpO2 and Respiration Rate is based on objective physiological measurements (co-oximetry for SpO2, CO2 monitoring for RR), an "adjudication method" involving human consensus (e.g., 2+1, 3+1) is not relevant. The ground truth is established by the direct laboratory or reference measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was described because this device is a physiological monitor, not an AI-assisted diagnostic imaging device where human readers interact with AI outputs. The device's performance is assessed against objective physiological measurements, not against human reader performance. Therefore, there is no mention of an effect size for human readers improving with AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, standalone performance studies were done.

For SpO2, the device's SpO2 algorithm and sensors were studied to perform measurements in accordance with ISO 80601-2-61:2017. This standard inherently evaluates the device's ability to measure physiological parameters accurately, independent of human interpretation or intervention beyond initial setup and data collection.
For Respiration Rate, the "performance of the Portrait Mobile Monitoring Solution dual vector impedance-based respiration rate monitoring" was evaluated against CO2 monitoring as a gold standard. This is a direct measurement of the algorithm/device's accuracy.

7. Type of Ground Truth Used

SpO2: Physiological ground truth established by co-oximetry.
Respiration Rate: Physiological ground truth established by CO2 monitoring (described as the "gold standard").

8. Sample Size for the Training Set

The document does not explicitly state the sample size for any training sets. For physiological monitoring devices, "training sets" might refer to data used for algorithm development and calibration rather than distinct supervised learning in the same way as, for example, a deep learning model for image analysis. The focus here is on validation against established standards and gold-standard measurements rather than a separate training/test split for a complex AI model.

9. How the Ground Truth for the Training Set Was Established

Since no explicit "training set" is detailed, the method for establishing its ground truth is also not described. If internal algorithm development involves data 'training,' it would likely use similar objective physiological measurement methods (e.g., controlled studies with co-oximetry and CO2 monitoring) as those used for validation, ensuring consistency and accuracy.

Summary

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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.

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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:

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.

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.

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.

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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 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 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 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 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.

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 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 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.

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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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is black and white.

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 PortraitSpO2 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

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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 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 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

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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

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complications.

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)

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.

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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 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 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 not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)

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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 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 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)

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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 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 is intended for use under the direct 510(k) Summary K230626 GE HealthCare Portrait Mobile Monitoring Solution

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	supervision of a licensed practitioner, or by personnel trained inproper use of the equipment in a professional healthcare facility.
	The Portrait Bedside Charger is not intended for use in acontrolled Magnetic Resonance (MR) environment.
	Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01)The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) isan optional accessory intended to enable the Portrait MobilePatient Monitor to be carried while the patient is ambulatory.
	The Portrait Mobile Patient Monitor pouch is intended for useunder the direct supervision of a licensed practitioner, or bypersonnel trained in proper use of the equipment in aprofessional healthcare facility.
Technology (807.92(a)(6)):	The Portrait Mobile Monitoring Solution uses the samefundamental technology and functionality as the primarypredicate primary predicate K171121 Masimo Root MonitoringSystem.
	Both the Portrait Mobile Monitoring Solution and the primarypredicate K171121 Masimo Root Monitoring System arelightweight, portable, wireless monitoring systems formonitoring of patient physiological parameters in a professionalhealthcare environment. Both have similar system topologies,which include sensors that attach to the patient, small portablepatient monitors that can be worn or carried by the patient, a setof centralized services installed on a server which is connectedto the healthcare facility's enterprise network, and remoteviewers with alarming capability that can monitor multiplepatients simultaneously.
	The main difference between the Portrait Mobile MonitoringSolution and the predicate is that the Portrait Mobile MonitoringSolution only supports SpO2, Pulse Rate, and Respiration Ratewhile the predicate also supports additional optional parametersThe Portrait Mobile Monitoring Solution is substantiallyequivalent to the predicate.
	A summary of the main changes compared to the predicate arelisted below in the comparison table.

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Product Comparison versus Predicate Main features chart follows below.

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Intended Use	Vital Sign Monitor	Vital Sign Monitor	Vital Sign Monitor	Identical
FDA PrimaryProduct Code	MWI	MHX	MWI	Identical to primarypredicate
FDAClassificationRegulation	21 CFR 2300	21 CFR 1025	21 CFR 2300	Identical to primarypredicate
Indications forUse (entiresystem)	The Masimo Root Monitoring system andAccessories are indicated for use byhealthcare professionals for themonitoring of multiple physiologicalparameters in healthcare environments.The Root Monitoring System, when usedwith the optional ISA module, is notintended to be used in roadambulances.	The ViSi MobileMonitoringSystem isintended for useby clinicians andmedically qualifiedpersonnel forsingle or multi-parameter vitalsigns monitoringof adult patients(18 years orolder).It is indicated forECG (3 or 5 lead-wire), respirationrate (RESP), heartrate (HR), non-invasive bloodpressure (NIBP),continuous non-invasive bloodpressure (cNIBP),non-invasivemonitoring offunctional oxygensaturation ofarterialhemoglobin(SpO2), pulse rate(PR), and skintemperature(TEMP), posturetracking andalarms, skintemperature(TEMP) and basicarrhythmia(VentricularTachycardia,VentricularFibrillation,Asystole, AtrialFibrillation)analysis/alarm inhospital-basedfacilities;including, generalmedical- surgicalfloors,intermediate carefloors and	The Portrait MobileMonitoring Solution isintended to acquire, store,calculate, display and exportpatient monitoring data aswell as provide real timealarming for monitoringadult and pediatric patients(3 years of age and older,and weighing more than 10kg).Physiological parametersand waveforms supportedare:• Pulse oximetry(SpO2/pulse rate)•Respiration rate (RR)Continuous pulse oximetryand respiration ratemonitoring may be used forpatients at risk ofcardiorespiratory andinfectious complications.The Portrait MobileMonitoring Solution isintended for use under thedirect supervision of alicensed practitioner, or bypersonnel trained in properuse of the equipment in aprofessional healthcarefacility.This device is not an Apneamonitor (i.e., do not rely onthe device for detection oralarm for the cessation ofbreathing). This deviceshould not be used for lifesustaining/supportingpurposes.The PORTRAIT MobileMonitoring Solution is notintended for use in acontrolled MagneticResonance (MR)environment.	EquivalentThe Portrait MobileMonitoring Solutionprovides substantiallyequivalent vital signmonitoring parametersincluding SpO2, Pulse Rate(PR), and Respiration Rate(RR) in adults and pediatricspatients as indicated in theprimary predicate device.While the primary predicatedevice provides optionaladditional parameters notavailable in the subjectdevice and allows neonatalmonitoring for someparameters, the monitoringparameters needed arebased on the individualmonitoring needs asdetermined by a clinician.Neither the subject devicenor the primary predicatedevice monitors ECG orarrhythmia.The Portrait MobileMonitoring Solutionprovides substantiallyequivalent vital signmonitoring parametersincluding SpO2, Pulse Rate(PR), and Respiration Rate(RR) compared to thesecondary predicate as well.The secondary predicateonly measures in adultpatients and can monitorECG and other vital signs inaddition to those monitoredby the subject device.The subject device andpredicate devices havesimilar system topologies,which include sensors thatattach to the patient, smallportable patient monitorsthat 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 PredicateMasimo Root Monitoring System andAccessories (K171121)	Reference Predicate DeviceViSi Mobile Monitoring System –Predicate (K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
	Masimo Radius-7 Wearable Pulse CO-Oximeter and accessories are indicatedfor use with adult and pediatric patientsduring both no motion and motionconditions, and for patients who are wellor poorly perfused in hospitals andhospital-type facilities.	emergencydepartments.		by the patient, a set ofcentralized servicesinstalled on a server whichis connected to thehealthcare facility'senterprise network, andremote viewers withalarming capability that canmonitor multiple patientssimultaneously.
	The optional ISA product family consistsof three types of sidestream gas analyzers(ISA CO2, ISA AX+ and ISA OR+) andaccessories including Nomoline, intendedto be connected to other medicalbackboard devices for monitoring ofbreath rate and the following breathinggases:ISA CO2: CO2ISA AX+: CO2, N2O, Halothane, Isoflurane,Enflurane, Sevoflurane and DesfluraneISA OR+: CO2, O2, N2O, Halothane,Isoflurane, Enflurane, Sevoflurane andDesfluraneISA CO2, ISA AX+ and ISA OR+ areintended to be connected to a patientbreathing circuit for monitoring ofinspired/expired gases during anesthesia,recovery and respiratory care. Theintended environment is the operatingsuite, intensive care unit and patientroom. ISA CO2 is also intended to be usedin road ambulances. The intended patientpopulation is adult, pediatric, infant, andneonatal patients.	Continuous non-invasive bloodpressure (cNIBP)measurementshave not beenevaluated onpatients duringambulation.
	1 The Root Monitoring System, when usedwith the optional ISA module, is notintended to be used in road ambulances.The optional ISA module can be used inroad ambulances with other monitoringsystems in accordance with the intendedenvironment of use for those systems.	The arrhythmiaanalysis feature isintended for useby healthcareprofessionalstrained in theidentification andtreatment ofarrhythmiaevents.Automatedarrhythmiaanalysis is anadjunct to clinicalassessment;clinician review ofthe analysisshould precedeany therapeuticintervention.		This difference does notsignificantly affect safetyand/or effectiveness.
	The optional SEDLine Sedation Monitor isindicated for use in the operating room(OR), intensive care unit (ICU), and clinicalresearch laboratory. It is intended tomonitor the state of the brain by real-time data acquisition and processing ofEEG signals. The system includes thePatient State Index (PSI), a proprietarycomputed EEG variable that is related tothe effect of anesthetic agents.
	The optional temperature module isindicated to measure temperature (oral,

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
rectal) of adult and pediatric patients. Thedevice is intended to be used by cliniciansand medically qualified personnel. It isavailable for sale only upon the order of aphysician or licensed health careprovider.The optional non-invasive blood pressure(NIBP) module is indicated for thenoninvasive measurement of arterialblood pressure in healthcareenvironments. The NIBP module isdesigned to measure blood pressure forpatient population described in thefollowing table:PatientPopulation 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
PatientPopulation	adult, pediatric, and neonatal patients	Adult patients (18years or older)	Adult and pediatric patients(3 years of age and older,and weighing more than 10kg).	EquivalentThe specified patientpopulation for the proposeddevice is a subset of thepatient population of theprimary predicate.While the primary predicatedevice allows neonatalmonitoring for someparameters, the monitoringparameters needed arebased on the individualmonitoring needs asdetermined by a clinician.This difference does notsignificantly affect safetyand/or effectiveness.

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Environments ofUse	Hospitals, Hospital-type facilities, mobile,and home environments	Hospital-basedfacilities; includinggeneral medical-surgical floors,intermediate carefloors, andemergencydepartments	A professional healthcarefacility	EquivalentThe Environment of Use forthe Portrait MobileMonitoring Solution is asubset of the Environmentof Use for the primarypredicate.This difference does notsignificantly affect safetyand/or effectiveness.
Location ofdevices in thepatient vicinity	In the Masimo Root Monitoring Systemand Accessories, the sensor must belocated on the patient. The Masimo Rootis connected wirelessly to the sensor, andas such, must only be located in thevicinity of the patient. The BatteryModule connected to the sensor also hasa small display for viewing clinical dataand user interaction, including alarmingcapability and connection to PatientSafetyNet in case connectivity to theMasimo Root is lost.	In the ViSi MobileMonitoringSystem, theMonitor andSensors arelocated on thepatient. Themonitor is wiredto the sensors,and as such, mustbe worn on thepatent's wrist.	In the Portrait MobileMonitoring Solution, onlythe sensors must be locatedon the patient. The monitoris connected wirelessly tothe sensors, and as such,must only be located in thevicinity of the patient.However, the monitor maybe worn by the patientusing Portrait MobilePatient Monitor Pouch. Themonitor is also capable ofbeing carried in one hand.	EquivalentAs in the primary predicatethe Portrait Mobile PatientMonitor component of thePortrait Mobile MonitoringSolution wirelesslyaggregates data frompatient worn sensors andtherefore does not need tobe located on the patient. Ifthe patient moves out ofrange of the Portrait MobilePatient Monitor, an alarmwill sound warning theclinician and patient thatthe patient has moved outof range. Data from thesensors will not be collectedor displayed until thepatient returns within rangeof the Mobile PatientMonitor.The Portrait Mobile PatientMonitor is capable of beingworn or carried by thepatient. In thisconfiguration, patientmonitoring continues aslong as the patient stayswithin the range of thewireless network, exactly aswith the primary predicatedevice. This difference doesnot significantly affectsafety and/or effectiveness.
SpecificationRemote Viewingand MonitoringModes	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)The Masimo Root Monitoring System andAccessories can communicate withnetwork systems for supplementalremote viewing and alarming (e.g., at acentral station)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)The ViSi MobileMonitoringSystem may beused asstandalonedevices ornetworked to ViSiMobile RemoteViewers through	Proposed devicePortrait Mobile MonitoringSolution -Once a patient is admitted,the Portrait Mobile PatientMonitor component of thePortrait Mobile MonitoringSolution can be usedstandalone (viewing of dataand alarm annunciation) ifproperly configured or if itbecomes disconnected from	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicatesEquivalentBoth the Portrait MobilePatient Monitor and thepredicate allow for local andremote (i.e., networked)monitoring, even thoughthe system topology isdifferent. This difference
		wireless 802.11communication.	the rest of the system. Inaddition, patient data andalarms are always remotelydisplayed on the PortraitCentral Viewer unless thereis a system or networkfailure.	does not significantly affectsafety and/or effectiveness.
	STANDARDS COMPLIANCE
MedicalStandards	IEC 60601-1IEC 60601-1-2ISO 80601-2-55ISTA 2A, MIL-STD 810EISO-18562-2ISO-10993-1ISO-10993-5ISO-10993-10ISO-10993-12ISO-10993-17ISO-10993-18IEC 60601-1-8	IEC 60601-1 3rdEditionIEC 60601-1-2IEC 60601-1-8IEC 60601-2-27(ECG)IEC 60601-2-49IEC 80601-1-30(NIBP)IEC 60601-1-6IEC 62471ANSI/AAMI EC13ANSI/AAMI EC53ISO 80601-2-61ISO 81060-1	IEC 60601-1:2005 + A1:2012IEC 60601-1-2:2014IEC 60601-1-8:2012 / EN60601-1-8:2007/A1:2013IEC 80601-2-49:2018ISO 80601-2-61:2017/ENISO 80601-2-61:2017IEC 60601-1-6:2013/EN60601-1-6:2010/A1:2015IEC 62366-1:2015 / EN62366-1:2015ISO 10993-1:2018IEC 62304:2015 / EN62304:2006 / A1:2016LabelingISO 20417:2021ISO 15223-1:2021ISO 17664:2017ISO 17664-2:2021Battery:UL 2054:2004IEC 62133-2:2017UL 1642:2012RFID:AIM 7351731:2017Wireless Coexistence:ANSI IEEE C63.27:2017	EquivalentThe Portrait MobileMonitoring Solutioncomplies with the FDArecognized standardsapplicable to the productand supported parameters.This difference does notsignificantly affect safetyand/or effectiveness.
	System Components
Patient Device	Masimo Radius-7 Wearable Pulse CO-Oximeter	ViSi MobileMonitor	PORTRAIT Mobile PatientMonitor	EquivalentBoth devices are batterypowered handheldmonitors displayingnumerics and waveforms.The predicate has a largermonitoring unit at bedsidefor numerics, waveformsand alarms. This differencedoes not significantly affectsafety 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 MobileMonitoring 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 connectedto Instrument Module.	Integrated insensors	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.
RespirationElectrode	Masimo Acoustic Respiration Rate (RRa)RAS-125c Sensor - Cloth	Integrated withChest 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 measurementtechnology, same as the
				secondary predicate Visi
				Mobile Monitoring system.
				This difference does not
				significantly affect safety
				and/or effectiveness.









Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Battery Charger	Masimo Root	Visi MobileCharger	Portrait Bedside Charger	EquivalentThe Portrait BedsideCharger can charge thePortrait Mobile PatientMonitor while in use andcan also charge thedetachable sensor batteries.The Masimo Root acts asboth a charger for theBattery Module and as abedside patient monitor.This difference does notsignificantly affect safetyand/or effectiveness.
Central Viewing	Masimo Patient SafetyNet	Visi MobileRemote Viewer	Portrait Central ViewerSoftware Application withPortrait Clinical AlarmingUnit	EquivalentPortrait Central Viewersoftware on an off-the-shelfPC, along with the PortraitClinical Alarming Unit,provide for centralviewing/monitoring andstandards compliant alarms.Portrait Central Viewersoftware can only beinstalled on hardware thatmeets minimumspecifications which arechecked during theinstallation process.The PC on which thePortrait Central Viewer isinstalled is customersupplied, while the viewerPC for the predicate isalways supplied by themanufacturer of theMasimo Patient SafetyNetSystem.This difference does notsignificantly affect safetyand/or effectiveness.
Storage andCentralizedServices	Masimo Patient SafetyNet	ViSi MobileAppliance	Portrait Core Services	EquivalentBoth the Portrait CoreServices within the PortraitMobile Monitoring Systemand the Masimo PatientSafetyNet in the predicatedistribute data between thebedside devices and otherdevices such as a centralmonitoring unit or EMRsystem. This difference doesnot significantly affectsafety and/or effectiveness.
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Accessories forSpO2 and Resp	Masimo Radius-7 Armband	ViSi Mobile WristCradleViSi Mobile ThumbWrapViSi Mobile ChestSensorSecurements	Portrait Mobile PatientMonitor PouchPortrait SpO2 AttachmentAccessory Band	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate have accessoriesallowing the sensors to beattached to or carried bythe patient. This differencedoes not significantly affectsafety and/or effectiveness.
Patient Device – General Hardware Specifications
Device Name		ViSi MobileMonitor	Portrait Mobile PatientMonitor
Size (H x W x D)	119.5 mm x 63.2 mm x 27.2 mm	9.4 cm x 4.9 cm x2.6 cm	14.1 cm x 6.3 cm x 2.1 cm	EquivalentBoth the Portrait MobilePatient Monitor and thepredicate device are smallenough to be held in onehand and are capable ofbeing worn by the patient.This difference does notsignificantly affect safetyand/or effectiveness.
Weight	Battery Module 93 gInstrument Module 67gTotal 160 g	110 g	223 g	EquivalentBoth the Portrait MobilePatient Monitor and theprimary predicate deviceare small enough to be heldin one hand and are capableof being worn by thepatient. During normal use,the Portrait Mobile PatientMonitor does not need tobe held or worn by thepatient because the deviceis completely wireless. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Power source	Battery (integrated into device)	Battery(integrated intodevice)	Battery (integrated intodevice)	Identical
Battery Type	Lithium-ion	Lithium-ion	Lithium-ion	Identical
Patient Device – User Interface
Device Name		ViSi MobileMonitor	Portrait Mobile PatientMonitor
Touch displayinterface	Yes (Touchpad for Battery Module andTouch Screen for Root)	Yes	Yes	Identical
Visual andAudible Alarmcapability	Available	Available	Available	Identical

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Device Name		ViSi MobileMonitor	Portrait Mobile PatientMonitor
Display type	OLED	OLED	SFT LCD (Super Fine TFT)	EquivalentBoth the Portrait MobilePatient Monitor and thepredicates utilize provendisplay technologies thatare widely used across avariety of industries. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Display Size andresolution	160 X 128 (Dot pitch 0.073 (W) mm X0.219 (H) mm)	160 x 128 pixels(size unspecified)	480 x 800 pixels, 3.7 inchesin 16:9 format	EquivalentGreater resolution onPortrait Mobile PatientMonitor display allows formore information to bedisplayed than thepredicate devices. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Number of traces(waveforms)	One waveform	One waveform,user selectable	One waveform per page indetailed parameter view	Identical
Trends		Trends available on the Masimo Root. Notrends on the Battery Module.	Patient Device – Connectivity	Not available forcomparison / Notspecified	Displays graphical trend ofconnected parameters forthe last 4 hours. Movablecursor displays details forthe given point in time.	EquivalentThe Portrait Mobile PatientMonitor is capable ofdisplaying the last 4 hoursof trend data directly on themonitor. Trends areavailable on the MasimoRoot, but not on the BatteryModule. This differencedoes not significantly affectsafety and/or effectiveness.

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Device Name		Visi MobileMonitor	Portrait Mobile PatientMonitor
Wirelessconnection tonetwork	May be networked to Masimo PatientSafetyNet through wireless IEEE 802.11a/b/g communication.	May benetworked to ViSiMobile RemoteViewers throughwireless 802.11communication.(802.11a/b/g/n -Dual band)	Requires a wireless networkconnection to beginmonitoring. IEEE 802.11a/b/g/n supported (dualband). After patientadmission, the PortraitMobile Patient Monitor willcontinue to monitor locallyin the event of a networkfailure.	EquivalentBoth the Portrait MobilePatient Monitor and thepredicate support a dualband 802.11 a/b/gconnection to the Wi-Finetwork of the responsibleorganization (i.e., hospitalwireless network). ThePortrait Mobile PatientMonitor requires a networkconnection for admittingthe patient and beginningmonitoring but can monitorlocally after admission inthe event of a networkfailure. The predicateMasimo Radius-7 does notrequire a networkconnection to beginmonitoring. This differencedoes not significantly affectsafety and/or effectiveness.
Connection toSensors	The Masimo Instrument Module andBattery Module communicates with thesensors via a wired interface and with theMasimo Root over a Bluetooth interface.	The Visi MobileMonitorcommunicateswith the sensorsvia a wiredinterface.	The Portrait Mobile PatientMonitor communicates withthe sensors over a wirelessMedical Body Area Network(MBAN) using a proprietaryprotocol.The MBAN connection tothe sensors includes a GE-proprietary protocol and alow-power radio interfacethat can operate on boththe unlicensed 2.4 GHz ISMband and certain otherprotected frequency bandswhere MBAN traffic isallowed. In the USA, theMBAN communicationoccurs in the 2390-2400MHz band, which has beenreserved by the FCC for useby Medical Body AreaNetworks.	EquivalentThe Portrait Mobile PatientMonitor communicates tothe sensors over a wirelessMedical Body Area Network(MBAN), a feature that isnot supported by thepredicate. MBANcommunication includesmultiple retries spread overtime and frequency toensure reliable transmissionof data. Loss of MBANcommunication (e.g.,moving out of range) resultsin a technical alarminforming the caregiver ofthe communication loss.This difference does notsignificantly affect safetyand/or effectiveness.See GE's response to theFDA Guidance document"Radio Frequency WirelessTechnology in MedicalDevices; Guidance forIndustry and Food and DrugAdministration Staff,Document issued on:August 14, 2013",
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				this 510(k) submission, fordetailed information aboutthe wireless interfaces inthe Portrait MobileMonitoring Solution.
	Respiration Sensors – Hardware
Device Name		ViSi Mobile ChestSensor	Portrait WearableRespiration 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	EquivalentBoth the Portrait WearableRespiration Rate Sensor andthe sensor in the predicatedevice (i.e., the MasimoRadius-7) are small,lightweight sensors thatattach to the patient formeasuring respiration rate,although they differsomewhat in weight andgeometry. This differencedoes not significantly affectsafety and/or effectiveness.
Weight	67 g	62 g (3-Lead wire)	34 g	EquivalentBoth the Portrait WearableRespiration Rate Sensor andthe predicate sensor(Masimo Radius-7) aresmall, lightweight sensorsthat attach to the patient,although they differsomewhat in weight andgeometry. This differencedoes not significantly affectsafety and/or effectiveness.

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Device Name		ViSi MobileThumb Sensor	Portrait Wearable PulseOximetry Sensor
SensorApplication 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 x1.9 cm - or -SpO2 P-SP01: 23.6 x 5.3 x1.9 cm - or -SpO2 P-W01: 26.2 x 5.3 x1.9 cm - or -SpO2 P-SE01: 27.1 x 5.3 x1.9 cm	EquivalentBoth the Portrait WearablePulse Oximetry Sensor andthe Masimo Radius-7 in thepredicate device are small,lightweight SpO2 sensorsthat attach to the patientfor measuring SpO2 andpulse rate. The PortraitWearable Pulse OximetrySensor also contains theelectronics and software forcalculating SpO2 and pulserate. This difference doesnot significantly affectsafety 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	EquivalentBoth the Portrait WearablePulse Oximetry Sensor andthe Masimo Radius-7 in thepredicate device are small,lightweight SpO2 sensorsthat attach to the patientfor measuring SpO2 andpulse rate. The PortraitWearable Pulse OximetrySensor also contains theelectronics and software forcalculating SpO2 and pulserate. This difference doesnot significantly affectsafety 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 MobileChest Sensor(Respiration Rate)and ViSi MobileThumb Sensor(SpO2) arepowered by VisiMobile Monitor.See comparison ofPortrait MobilePatient Monitorvs. ViSi MobileMonitor (above)	N/A - ViSi MobileChest Sensor(Respiration Rate)and ViSi Mobile	Lithium-ion	$3.6 x 5.3 x 1.7 cm$	Identical	EquivalentPortrait Sensor batteries aresmall and lightweight and so
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi Mobile Monitoring System –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
		Thumb Sensor (SpO2) arepowered 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) arepowered by Visi Mobile Monitor.See comparison of Portrait Mobile Patient Monitor vs. ViSi Mobile Monitor (above)	31 g	EquivalentPortrait 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 andfrequency	Masimo Root 100-240 VAC~, 47-63 Hz	VISI MOBILEBATTERYCHARGER100-240 V, 50-60 Hz (using external power supply)	Portrait Bedside Charger100-240 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 L8 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

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				while use in addition to 4Portrait Sensor Batteries.The Masimo Root in thepredicate charges oneBattery Unit. Both thePortrait Bedside chargerand the predicate are smalland easily transportable.This difference does notsignificantly affect safetyand/or effectiveness.
Weight(exclusive ofpower supplyand cable)	Masimo Root 3.63 kg	2 Position: 240 g8 Position: 670 g	412 gWall mount: 603 gTable mount: 908 g	Equivalent.Both the Portrait Bedsidecharger and the predicatecharger are lightweight andeasily transportable. Thisdifference does notsignificantly affect safetyand/or effectiveness.
	Central/Remote Viewer
		ViSi RemoteViewer	Portrait Central ViewerApplication with PortraitClinical Alarming Unit
Display	23"	23 in display /1920 x 1080resolution(screen is touchsensitive to issuecommandsalternative tomouse/keyboard)	Required Specification forcustomer supplied display:20 in (minimum),1920 x 1080 resolution(minimum)	EquivalentThe display for the PortraitCentral Viewer Applicationis customer supplied andneeds to meet certainminimum requirementswhich are checked by theinstaller at the time ofinstall. The display for theremote viewer of thepredicate is supplied by themanufacturer. Thisdifference does notsignificantly affect safetyand/or effectiveness.
OperatingSystem	Windows 7 Professional Edition	Microsoft®Windows® 7Professional(version 6.1) x64Bit SP1	Required Specification forcustomer supplied PC:Windows 10, build10.0.17763 (minimum)	EquivalentThe PC on which thePortrait Central ViewerApplication is installed iscustomer supplied andneeds to meet certainminimum requirements
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				which are checked by theinstaller at the time ofinstall. The PC for theremote viewer of thepredicate is supplied by themanufacturer. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Number ofpatients perviewer	Maximum 40	Maximum 32	Maximum 24	EquivalentEach Portrait Central ViewerApplication with PortraitClinical Alarming Unitsupports up to 24 patients,vs. 40 for the predicate.Multiple instances of thePortrait Central ViewerApplication with PortraitClinical Alarming Unit (oneper PC) can be used in orderto view all patients beingmonitored by the PortraitMobile Monitoring Solution(up to maximum systemcapacity). This differencedoes not significantly affectsafety and/or effectiveness.
Simultaneousview of numericsfor all patientson viewer	Supported for all measured parameters	Supported for allmeasuredparameters	Supported on for allmeasured parameters onMultiple Patient View -SpO2%, Pulse Rate,Respiration Rate	EquivalentBoth the Portrait CentralViewer Application and thepredicate are capable ofsimultaneously displayingnumerics of monitoredparameters for all patientsmonitored for that viewer.This difference does notsignificantly affect safetyand/or effectiveness.
Viewing ofpatientwaveforms	One patient at a time	One patient at atime	One patient at time -Supported on single patientview	EquivalentBoth the Portrait CentralViewer Application and thePredicate are capable ofviewing waveforms for allparameters in scope of theirintended use. Waveforms
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				are only viewable for onepatient at a time. For thePortrait Central ViewerApplication, waveforms areviewable by selecting anindividual patient, whichbrings up the single patientview. The single patientview obscures numerics forother patients will thatwindow is opened.However, the highestpriority, most recent activealarms for all patientsviewed by that instance ofthe Portrait Central ViewerApplication are alwaysvisible in a protected areaon the top of the screen.Numeric values for allmonitored patients arevisible while viewingwaveforms for a singlepatient on the predicate.This difference does notsignificantly affect safetyand/or effectiveness.
Viewing ofpatient trends	Graphical trend view supported for onepatient at time	One patient at atime. Tabular orgraphic trends	Graphical trend viewsupported for one patient attime – single patient view	EquivalentBoth the Portrait CentralViewer Application and thePredicate are capable ofviewing trends for allparameters in scope of their
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				only viewable for onepatient at a time. For thePortrait Central ViewerApplication, graphicaltrends are viewable byselecting an individualpatient, which brings up thesingle patient view. Thesingle patient view obscuresnumerics for other patientswill that window is opened.However, the highestpriority, most recent activealarms for all patientsviewed by that instance ofthe Portrait Central ViewerApplication are alwaysvisible in a protected areaon the top of the screen.These differences do not
Visual/Audiblealarms supported	Supported	Supported	Supported	significantly affect safetyand/or effectiveness.Identical
	Storage and Centralized Services - General
		ViSi MobileAppliance	Portrait Core Services
Description	Patient SafetyNet™ is a supplementalremote monitoring and cliniciannotification system. It provides asecondary display of Masimo SET® pulseoximetry, rainbow® SET pulse CO-Oximetry and acoustic respiration ratemonitors. Patient SafetyNet enablesclinicians to view and monitor patientphysiological conditions when used inhospitals or hospital-type environments.	In the ViSi MobileMonitoringSystem, data iscaptured in theViSi MobileAppliance, whichacts as anenterprise hub.The Appliance isdedicatedhardware installedin the ITdatacenter forsecure networkconnectivity andemergency powerbackup.	The Portrait Core Servicesare a set of softwareservices that enable thecommunication andinteraction of the PortraitMonitoring Solutioncomponents and willintegrate into existinghealthcare facilityinfrastructure and clinicalinformation systems. ThePortrait Core Servicesprovide systemconfiguration,administration, datastorage, and transmission ofpatient physiological trendsand events. The PortraitCore Services are installedon the Portrait non-medicaldevice EHL (Edison HealthLink) Server.	EquivalentThe Portrait Core Servicesand the Masimo PatientSafetyNet system providefor centralized services anddata storage. This differencedoes not significantly affectsafety and/or effectiveness.
HL7 outboundsupport	Supported	Supported - Vitalsigns.	Supported - The PortraitCore Services can transmitpatient physiological trendsand numerics (IHE PCD DEC)and alarm events (IHE PCDACM) outbound.	EquivalentThe Portrait Core Servicesand the Masimo PatientSafetyNet supportoutbound HL7 for patientvital signs. The Portrait CoreServices additionallysupports patient
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				physiological trends andalarm events. Thisdifference does notsignificantly affect safetyand/or effectiveness.
HL7 Inboundsupport	Supported	Supported - Theinbound ADT datais utilized by theSotera applicationto provide patientidentityinformation fordisplay on the ViSiMobile Monitors.	Supported - The PortraitCore Services can alsoreceive HL7 ADTinformation to admitpatients to the PortraitMonitoring Solution.	EquivalentThe Portrait Core Servicesand the Masimo PatientSafetyNetsupport inboundADT data. The inbound ADTdata can be used to admitpatients to the PortraitMobile Monitoring Solution.This difference does notsignificantly affect safetyand/or effectiveness.
	Storage and Centralized Services – Hardware
		ViSi MobileAppliance (whenusing Soterasuppliedhardware)	Portrait Core Services
Server Model	minimum Quad-Core Intel Xeon 2.0 GHzminimum 4 GB RAMminimum 1 TB RAID 1 storage array	Not available forcomparison / Notspecified	HP ProLiant DL360 Gen10	EquivalentPortrait Core Services use aHP ProLiant server which iswidely used in multipleindustries. This differencedoes not significantly affectsafety and/or effectiveness.
	Monitored Parameters
MonitoredParameters	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-InvasiveBlood Pressure(NIBP)Continuous NIBP(cNIBP)Skin Temperature	Oxygen saturation (SpO2)Pulse rate (PR)Respiration Rate (RR)	Equivalent.The parameters monitoredby the proposed device arealso monitored by thepredicate. This differencedoes not significantly affectsafety and/or effectiveness.
ParametersAcquisitionMethod	The Masimo Radius-7 acquiresparameters from a wireless Instrumentmodule to which an SpO2 probe and anacoustic respiration rate sensor areconnected.	The Sotera VisiMobile Monitoracquiresparameter datafrom wiredsensors. Theavailable wiredsensors include:ViSi Mobile ChestSensor(Respiration,Heart Rate, SkinTemperature)ViSi MobileThumb Sensor	The Portrait Mobile Monitoracquires parameter datafrom wireless patientsensors over the MBANwireless link. Theparameter electronics areencapsulated into therespective wireless sensors.The sensors include:Portrait SpO2 P-SA01, SpO2Wearable Pulse OximetrySensor (SpO2, Pulse Rate)Portrait SpO2 P-SP01, SpO2Wearable Pulse OximetrySensor (SpO2, Pulse Rate)	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate include sensorsfor collecting ofphysiological data from allmonitored parametersincluded in their intendeduse. The sensors for thePortrait Mobile MonitoringSolution communicate tothe Portrait Mobile PatientMonitor via a wirelessMBAN connection, while
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
		(SpO2, Pulse Rate)Visi Mobile CuffModule (NIBP)	Portrait SpO2 P-W01, SpO2Wearable Pulse OximetrySensor (SpO2, Pulse Rate)Portrait SpO2 P-SE01, SpO2Wearable Pulse OximetrySensor (SpO2, Pulse Rate)Portrait RR P-RR01,Wearable Respiration RateSensor (Respiration Rate)	the sensors for thepredicate communicateover a wired connection tothe Instrument Module andBattery Module whichcommunicate wirelesslywith the Masimo Root overBluetooth. This differencedoes not significantly affectsafety and/or effectiveness.
	Alarms
Classification /Alarm Levels	Two levels – High (flashing red) andMedium (flashing yellow)	Four levels - LifeThreatening(white/red), High(red), EquipmentHigh (cyan).Equipment Low(cyan)	Three levels - High (red),Medium (yellow), Low(cyan) in compliance withIEC 60601-1-8Informational messages(gray) also included	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate contain multiplealarm levels to distinguishbetween alarms based oncriticality (i.e., the level ofhazard to the patient). Thealarm system for the PatientMobile Monitoring Solutionis compliant to IEC 60601-1-8:2012. This difference doesnot significantly affectsafety and/or effectiveness.
Notification	Audible and visual	Audible and visual	Audible and visual	Identical
List ofPhysiologicalAlarmssupported (forparametersincluded in theproposed device)	PR HighPR LowSpO2 HighSpO2 LowRapid DesatRR HighRR LowRespiratory Pause	HIGH PULSE RATELOW PULSE RATEHIGH RESPLOW RESPLOW SpO2THUMB NO PULSE	PR HighPR LowRR HighRR LowSpO2 HighSpO2 LowSpO2 Critically lowApnea (This device is not anapnea monitor (i.e., do notto rely on the device fordetection or alarm for thecessation of breathing ).This device should not beused for lifesustaining/supportingpurposes) .	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate contain a list ofphysiological alarmsconsistent with theparameters monitored aspart of their intended use.This difference does notsignificantly affect safetyand/or effectiveness.All physiological alarmssupported in the PortraitMobile Monitoring Solution
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				are also supported in theCARESCAPE ONE referencedevice (K213234).
Technical /EquipmentAlarms	Supported	Supported	Supported	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate device containalarms to indicateequipment failure, lowbattery, loss of wirelessconnection, etc. The list ofalarms is different betweenthe two devices due to thedifferences in the design ofthe equipment. Thisdifference does notsignificantly affect safety
	Trending			and/or effectiveness.
TrendVisualization	Graphical Trends	Graphical Trendsand List (tabular)Trends	Graphical Trends only.Individual values for eachtrended value are visible atthe position of the cursor.	Identical
TrendVisualizationDuration	Up to 96 hours	Not available forcomparison / Notspecified	Up to 4 Hours on thePortrait Mobile PatientMonitorUp to 24 Hours on thePortrait Central ViewerApplication	EquivalentThe Portrait MobileMonitoring Solutionsupports viewing of up tothe last 4 Hours of trenddata on the Portrait MobilePatient Monitor and up tothe last 24 Hours on thePortrait Central ViewerApplication. The duration oftrend data viewable on thepredicate is 96 hours. ThePortrait Mobile PatientMonitoring Solution alsosupports transmission oftrend data to an EMRsystem over an HL7interface, to allow for acomplete record of patienttrends to be accessed. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Trend Smoothing	Not specified	Not specified	On the Portrait CentralViewer Application, thetrend data undergoes anadditional smoothingprocess. The purpose of thissmoothing is to removebrief changes and normalvariations in thephysiological trend dataacquired by the Portrait	EquivalentThe trended data that isdisplayed on the PortraitCentral Viewing Applicationundergoes an additionalsmoothing process toremove brief variations (i.e.,discontinuities) in the rawtrend data to makevisualization of trends over
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)RESPIRATION	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution –	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
				a period of time easier. Thisfeature is not availablewhen viewing trend data atthe source (i.e., the PortraitMobile Patient Monitor) orthe predicate. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Eventmanagement	Clinical and Technical events are storedand can be exported as Event Reports	Not available forcomparison / Notspecified	Physiological Events (i.e.,alarms) of medium or highpriority are stored in thePortrait Mobile MonitoringSolution and are viewable inthe Trend display on thePortrait Central ViewerApplication.	EquivalentThe Portrait MobileMonitoring Solutionsupports viewing ofhistorical events (i.e.,alarms) in the Trend display.The predicate providesevent storage and viewingthrough even reports. Thisdifference does notsignificantly affect safetyand/or effectiveness.
MeasurementMethod	Acoustic Respiration Measurement	ImpedancePneumography(i.e., ImpedanceRespiration)	Impedance Respiration (i.e.,Impedance Pneumography)	EquivalentAlthough the measurementmethod is different, bothmethods measure the sameparameter, i.e., respirationrate. The subject devicesuses the same impedancerespiration technology asthe secondary predicate VisiMobile Monitoring system.This difference does notsignificantly affect safetyand/or effectiveness.
Display Range	0 bpm to 70 bpm	0 to 50breaths/min	0 to 99 breaths/min	EquivalentRespiration display range onthe Portrait MobileMonitoring Solution isslightly wider than onpredicate. This differencedoes not significantly affectsafety and/or effectiveness.
Units	Respiration Rate (RR) in breaths/min	Respiration Rate(RR) inbreaths/min	Respiration Rate (RR) inbreaths/min	Identical
Resolution	1 breath/min	1 breath/min	1 breath/min	Identical

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem –Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
Accuracy Range	4 to 70 bpm	3 to 50 breaths/min	4 to 60 breaths/min	EquivalentBoth 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/minor 10% or reading,whichever isgreater	+/- 3 breaths/min	EquivalentThe 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		ImpedanceRespirationwaveform,6.25mm/s sweepspeed	Impedance Respirationwaveform with automaticscaling, 6.25 mm/s sweepspeed (Portrait MobilePatient Monitor), 25 m/ssweep speed (PortraitCentral Viewer Application)	EquivalentBoth 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

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Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring 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%	<= 2% from 70 to100% (no motion)Unspecified from49 to 69%	SpO2 (70 to 100%) <= 2%Low perfusion SpO2: <= 3%With motion: <= 3%SpO2 (<70%) - Unspecified	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicates have a specifiedaccuracy of 2% from 70 to100% SpO2 under normalcondition. The proposeddevice has identicalaccuracy specificationcompared to the primarypredicate under motionconditions. The accuracyspecification at lowperfusion is slightly betterfor the primary predicate.This difference does notsignificantly affect safetyand/or effectiveness.
Averaging	2-4, 4-6, 8, 10, 12, 14, or 16 seconds,default 8	12 beat averagingfollowinginitialization	Adjustable from 0 to 60seconds (default 10seconds)	EquivalentSpO2 averaging in thePortrait Mobile MonitoringSolution from 0 to 60seconds with a 10 seconddefault. Adjustments arerestricted to an authorizeduser. The SpO2 averaging inthe primary predicate isadjustable between 2 and16 seconds with a default of8 seconds. This difference does not significantly affectsafety and/or effectiveness.
Waveforms	Pleth Waveform	Pleth Waveform,normalizedamplitude,25mm/s sweepspeed	Pleth Waveform, Notnormalized (Amplitude ofthe displayedplethysmographicwaveform reflects thestrength of the arterialblood pulsation at themeasurement site.)25mm/s sweep speed(Portrait Mobile PatientMonitors and PortraitCentral Viewer Application)	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicates support plethwaveform. The PortraitMobile Monitoring Solutiondiffers from the secondarypredicate in that thewaveform is not normalizedbut instead the waveformamplitude reflects thestrength of the arterialblood pulsation at themeasurement site. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Specification	Primary PredicateMasimo Root Monitoring System andAccessories (K171121)	ReferencePredicate DeviceViSi MobileMonitoringSystem -Predicate(K180472)	Proposed devicePortrait Mobile MonitoringSolution -	Discussion of differencesbetween Portrait MobileMonitoring Solution andPredicates
	PULSE OXIMETRY - Pulse Rate
Measurement	Peripheral Pulse rate (PR)	Pulse rate (PR)(From SpO2)	Peripheral Pulse rate (PR)	Identical
Units	Beats per minute (bpm)	Beats per minute(bpm)	Beats per minute (bpm)	Identical
Display Range	0 to 240 bpm	0 to 240 bpm	30 to 300 bpm	EquivalentBoth the Portrait MobileMonitoring Solution and thepredicate are capable ofdisplaying a wide range ofpulse rate values, althoughthe display range betweenthe two devices is slightlydifferent. Measured valuesoutside the display rangewill automatically result in alimit alarm violation forboth products. Thisdifference does notsignificantly affect safetyand/or effectiveness.
Resolution	1 bpm	1 bpm	1 bpm	Identical
Accuracy Range	25 to 240 bpm	30 to 240 bpm	30 to 250 bpm	EquivalentThe Portrait MobileMonitoring Solutionspecifies accuracy up to 250bpm, vs. 240 bpm for thepredicate and 30 bpm vs. 25bpm for the primarypredicate. This differencedoes not significantly affectsafety and/or effectiveness.
Accuracy	No motion, Adults, Pediatrics - 3 bpmMotion, Adults, Pediatrics - 5 bpmLow Perfusion, Adults, Pediatrics - 3 bpm	<= 3 bpm (fromSpO2)	<= 2 bpm (30 to 250 bpm)Low perfusion: <= 2 bpm(30 to 250 bpm)With motion: <=5 bpm (30to 250 bpm)	EquivalentThe Pulse rate accuracy ofthe Portrait MobileMonitoring Solution is <= 2bpm under all conditionsexcept under motion, whichis <= 5 bpm. The pulse rateaccuracy for the predicate isspecified as <= 3 bpm underall conditions except undermotion, which is <= 5 bpm.This difference does notsignificantly affect safetyand/or effectiveness.

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Determination of Substantial Equivalence (807.92(b)(1)):

Summary of Non-Clinical Tests:

Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the Portrait Mobile Monitoring Solution, demonstrating the design meets the specifications.

This section addresses the Non-Clinical testing for Portrait Mobile Monitoring Solution relied on for a determination of substantial equivalence to the predicate K171121 Masimo Root Monitoring System.

Per the FDA guidance titled "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff, Document issued on December 20, 2019", the following was verified:

. SpO2 measurement,
Impedance Respiration
Testing of Wireless Interfaces (WLAN and MBAN ● testing)
Hardware Bench Testing
Packaging Bench Testing ●
Alarms Bench Testing ●
Manuals Bench Testing

The Portrait Mobile Monitoring Solution meets the EMC requirements described in IEC 60601-1-2 Edition 4.0 2014-02 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests". Compliance according to the "Electromagnetic Compatibility (EMC) of Medical Devices Guidance for Industry and Food and Drug Administration Staff, issued on June 6, 2022" The Portrait Mobile Monitoring Solution has been evaluated for electromagnetic compatibility and potential risks from common emitters in the Portrait Mobile Monitoring Solution environment. such as radio frequency identification readers, by testing per the AIM 7351731 Rev 2.00 "Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers" standard.

The Portrait Mobile Monitoring Solution meets the electrical

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safety requirements of IEC 60601-1:2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Edition 3.1".This testing was performed by a recognized independent and Certified Body Testing Laboratory (CBTL) under the IECEE CB Scheme. The Portrait Mobile Monitoring Solution was designed and tested for compliance to the FDA 21 CFR Part 898. § 898.12 (Performance standard for electrode lead wires and cables). The performance standard is fulfilled because of compliance with IEC 60601-1:2012, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance -Edition 3.1. clause 8.5.2.3 which is equivalent with clause 56.3c in IEC 60601-1:1988.

Additional data is provided for compliance to:

. IEC 60601-1-8 Edition 2.1 2012-11 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 80601-2-49 Edition 1.0 2018-03 Medical electrical ● equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors - Edition 1.0
ISO 80601-2-61 Second edition 2017-12 (Corrected . version 2018-02) Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Environmental testing, based on the Portrait Mobile Monitoring Solution proposed uses and locations, was confirmed to meet the specifications listed in the requirements. Portrait Mobile Monitoring Solution specifications verification evidence is included for the following:

Operating temperature
Operating humidity ●
Operating pressure ●
Storage and transport temperature ●
Storage and transport humidity ●
Storage and transport pressure
Fluid ingress ●

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The Portrait Mobile Monitoring Solution follows the FDA Biocompatibility guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Guidance for Industry and Food and Drug Administration Staff issued on September 4, 2020" and ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. Testing data for showing biocompatibility of patient contacting devices is provided in the submission.

The Portrait Mobile Monitoring Solution follows the guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff. Document issued on: March 17, 2015" and the following standards:

ISO 17664 Second edition 2017-10 Processing of health . care products - Information to be provided by the medical device manufacturer for the processing of medical devices
17664-2 First edition 2021-02 Processing of health care . products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices.

Reprocessing efficacy validation has been conducted in accordance with the documented reprocessing instructions using worst-case devices/components of the Portrait Mobile Monitoring Solution. The reprocessing efficacy validation met the acceptance criteria for the reprocessing efficacy validation tests.

The Portrait Mobile Monitoring Solution follows the Applying Human Factors and Usability Engineering to Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on: February 3, 2016 and the following standards:

. IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1 Edition 1.0 2015-02 Medical devices Part . 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)]

Summative Usability testing has been concluded with 15 US

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Clinical and 15 US Technical users. The usability testing of the Portrait Mobile Monitoring Solution follows the FDA Guidance for Industry and Food and Drug Administration Staff "Applying Human Factors and Usability Engineering to Medical Devices" (Feb 3, 2016).

Batteries performance data is provided related to:

. IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
UL 2054 2nd Edition Household and Commercial ● Batteries

Wireless performance data was provided related to:

. Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug Administration Staff, Document issued on: August 14, 2013
IEEE ANSI C63.27-2017 American National Standard for . Evaluation of Wireless Coexistence

Additional Labeling standards followed:

. ISO 20417:2021 Medical devices - Information to be supplied by the manufacturer
. ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements

The Portrait Mobile Monitoring Solution follows the FDA software guidance documents as outlined in this submission.

. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on May 11, 2005
. General Principles of Software Validation: Final Guidance for Industry and FDA Staff, Document issued on January 11, 2002
Off-The-Shelf Software Use in Medical Devices; ● Guidance for Industry and Food and Drug Administration Staff, Document issued on September 27, 2019
Content of Premarket Submissions for Management of ●

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Cybersecurity in Medical Devices. Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018

. Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Document issued on September 6, 2017
Software testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered as a "Major" level of concern. Software standards IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes and risk management standard ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices were also applied to the design.

Patient safety, security, and privacy risks have been addressed in the design and development of Portrait Mobile Monitoring Solution including a Security Risk Assessment, Threat model and Penetration testing. This includes system integrity controls, access controls, audit controls, network controls, and remote service controls which address the General Principles and Security Capabilities outlined in the "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Draft Guidance for Industry and Food and Drug Administration Staff issued October 18, 2018".

Summary of Clinical Tests: Clinical (807.92(b)(2)):

The Portrait Mobile Monitoring Solution measures SpO2, Respiration Rate and Pulse Rate. Two clinical studies are presented below 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.

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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.

Conclusion (807.92(b)(3)): GE HealthCare considers the Portrait Mobile Monitoring Solution to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).