Predicate Devices

K230626 Portrait Mobile Monitoring Solution v1.0

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard physiological monitoring and data processing without mentioning AI or ML algorithms for analysis or interpretation. The focus is on data acquisition, display, storage, and alarming based on predefined thresholds.

Therapeutic

No

Explanation: The device is clearly stated as a "monitoring solution" that "acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information." Its intended use repeatedly emphasizes "monitoring" and "alarming" for physiological parameters (SpO2, pulse rate, respiration rate). Furthermore, the document explicitly states, "This device should not be used for life sustaining/supporting purposes." These statements indicate that the device's primary function is to observe and report, not to provide therapy or treatment.

Diagnostic

No

Explanation: The device is described as a "Mobile Monitoring Solution" that "acquire[s], store[s], calculate[s], display[s] and export[s] patient monitoring data" for physiological parameters (SpO2/pulse rate and respiration rate). It is intended for monitoring and provides real-time alarming. While monitoring data can be used to inform a diagnosis, the device's stated purpose is to monitor and collect data, not to directly provide a diagnosis for a disease or condition. It explicitly states it is "not an Apnea monitor (i.e., do not rely on the device for detection of alarm for the cessation of breathing)" and "should not be used for life sustaining/supporting purposes." This reinforces its role as a monitoring device rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components, including the Portrait Mobile Patient Monitor Hardware, Portrait Wearable SpO2 sensors, Portrait Wearable Respiration Rate sensor, Portrait RR electrode patch, Portrait Sensor battery, Portrait Bedside Charger, Portrait SpO2 Attachment accessory band, and Portrait Mobile Patient Monitor Pouch. While it includes software components, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Portrait Mobile Monitoring Solution is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for acquiring, storing, calculating, displaying, and exporting patient monitoring data (SpO2, pulse rate, respiration rate) and providing real-time alarming. This involves monitoring physiological parameters directly from the patient's body.
Device Description: The description details a system of hardware and software components designed to measure and display these physiological parameters. It involves sensors attached to the patient (SpO2 sensors on the finger, RR electrodes on the torso).
Lack of In Vitro Activity: An IVD device is specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Portrait Mobile Monitoring Solution does not perform any analysis on such specimens. It directly measures physiological signals from the living patient.
Performance Studies: The performance studies described focus on bench testing of the device's ability to accurately measure physiological parameters, comply with electrical safety and EMC standards, and meet usability requirements. There are no studies related to the analysis of biological specimens.

In summary, the Portrait Mobile Monitoring Solution is a patient monitoring device that measures physiological parameters directly from the patient's body, which is characteristic of a medical device but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 pediatic 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 healthcare 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 breatling), 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, MSX, DRG, BZQ, DQA

Device Description

The Portrait Mobile Monitoring Solution V1.1 is a 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.

The Portrait Mobile Monitoring Solution V1.1 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 Hardware, 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 alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.
Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this submission.
Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly.
Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor.
Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use).
Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist
Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Intended User / Care Setting

under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing related to software, hardware and performance including applicable consensus standards was conducted on the Portrait Mobile Monitoring Solution v1.1, demonstrating the design meets the specifications.

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 (no changes have been made to the SpO2 algorithms since K230626, only regression testing performed)
low perfusion condition (this testing covers the full accuracy range in challenging low-perfusion conditions using a simulator, proving that there has been no system regression)
Pulse Rate (PR) measurement, non-motion condition
Pulse Rate (PR) measurement, motion condition
Pulse Rate (PR) measurement, low perfusion condition
Impedance Respiration (no changes have been made to the Respiration Rate algorithms since K230626, only regression testing performed)
Respiration Rate (RR)
Apnea
Alarms Bench Testing
Manuals Bench Testing
Compliance to FDA Recognized Standards
Compliance to FDA Human Factors Guidance
Compliance to FDA ECG Electrodes Guidance
Compliance to FDA Pulse Oximeters Guidance

The Portrait Mobile Monitoring Solution v1.1 meets the EMC requirements described in 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. In addition, Portrait Mobile Monitoring Solution v1.1 shows 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 meets the electrical safety requirements of ANSI AAMI ES60601-1:2005/2012 & A1:2012, C1:2009/2012 & A2:2010/2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]".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 60601-1:2005 + A1:2012+A2:2020, Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance - Edition 3.2, clause 8.5.2.3, which is equivalent with clause 56.3c in IEC 60601-1:1988.

Additional data is provided for compliance to:

60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION 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
Guidance for Industry - Pulse Oximeters-Premarket Notification submission 510(k)s: Document issued on March 4, 2013
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes, Document issued on: July 21, 2011, NOTE: Included because the Portrait Mobile Monitoring Solution includes electrodes used to measure changes in thoracic impedance in order to measure a patient's respiratory rate.

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- Document issued on: September 8, 2023" 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:

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.

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 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical devices - Part 1: Application of usability engineering to medical devices
Summative Usability testing has been concluded with 15 US 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 62133-2:2017/AMD1:2021 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 C63.27-2021 American National Standard for Evaluation of Wireless Coexistence

Additional Labeling standards followed:

ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices — Information to be supplied by the manufacturer
15223-1 Fourth edition 2021-07 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.

Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff Document issued on June 14, 2023
General Principles of Software Validation: Final Guidance for Industry and FDA Staff, January 11, 2002
Off-The-Shelf Software Use in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, August 11, 2023
Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices, Guidance for Industry and Food and Drug Administration Staff. Document issued on: September 6, 2017

Software testing was conducted, and documentation was provided as recommended by Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff: Document issued on June 14, 2023" The software for this device is considered as a "Enhanced" documentation level. Software standards IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes and the 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 v1.1 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 "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff Document issued on September 27, 2023".

In addition, the Portrait Mobile Monitoring Solution v1.1 complies with section 524B "Ensuring Cybersecurity of Medical Devices" of the FD&C Act. The Portrait Mobile Monitoring Solution v1.1 meets the definition of a "cyber device" per Section 524B(c) of the FD&C Act. To meet the requirements under section "3305 of the Consolidated Appropriations Act, 2023, enacted on December 29, 2022, section 524B "Ensuring Cybersecurity of Medical Devices" to the FD&C Act" GE HealthCare has also specifically attached a complete cybersecurity management plan and SBOMs.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K230626 Portrait Mobile Monitoring Solution v1.0

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger font size than the rest of the text.

GE Medical Systems Information Technologies, Inc. Joel Kent Director, Regulatory Affairs, Strategy 9900 Innovation Drive Wauwatosa, Wisconsin 53226

March 20, 2024

Re: K234130

Trade/Device Name: Portrait™ Mobile Monitoring Solution consists of:

Portrait™ Central Viewer Application (Portrait CVAXB) ●
Portrait™ Core Services (Portrait CSSXB) ●
Portrait™ Clinical Alarming Unit (Portrait CAU01)
Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB)
Portrait™ Mobile Patient Monitor Software (Portrait HSWXB)
Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)
Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) ●
. Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)
Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01)
Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01)
. Portrait™ RR Electrode Patch (Portrait RRP01)
Portrait™ Sensor Battery (Portrait SBT01) ●
. Portrait™ Bedside Charger (Portrait BCH01)
Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) ●

Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, MSX, DRG, BZQ, DQA Dated: December 28, 2023 Received: December 28, 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls

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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 available 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.

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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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

Enclosure

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Indications for Use

510(k) Number (if known) K234130

Device Name

Portrait™ Mobile Monitoring Solution

Indications for Use (Describe) Portrait™ Mobile Monitoring Solution:

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatic 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 healthcare 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 breatling), 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.

The Portrait™ Mobile Monitoring Solution consists of:

Portrait™ Central Viewer Application (Portrait CVAXB):

The Portrait Central Viewer Application (Portrait CVAXB) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution 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 healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait™ Core Services (Portrait CSSXB):

The Portrait Core Services (Portrait CSSXB) 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), waveforms (IHE PCD WCM), 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 Apolication that provides audio alarming capability.

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The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB):

The Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) is intended for use with adult and pediatric patients as a handheld, mobile device which supports running the Portrait Monitor Software to monitor patients, and to provide and visual alarms. The Portrait Mobile Patient Monitor Hardware enables non-invasive continuous vital sign montoring of patients by acquiring signals wirelessly from Portrait wearable sensors, as well as wireless clinical and service data communication.

The Portrait Mobile Patient Monitor Hardware is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Patient Monitor Hardware is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Mobile Patient Monitor Software (Portrait HSWXB):

The Portrait Mobile Patient Monitor Software (Portrait HSWXB) is intended to run on Portrait Monitor Hardware for the continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. Portrait Mobile Patient Monitor Software is intended for use with adult and pediatic patients (3 years of age and older, and weighing more than 10 kg). It enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors, as well as displaying trends, events, and a QR code containing patient demographics and parameter data. When installed on the Portrait Monitor Hardware, the Portrait Mobile Patient Monitor Software provides real-time, trend and event data to Portrait Mobile Patient Mobile Patient Monitor Software, when configured to do so, also enables the Portrait Monitor Hardware to provide audible and visual alarms locally.

The Portrait Mobile Patient Monitor Software is intended for use under the direct supervision of a licensed healtheare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01):

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healtheare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

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

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healtheare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

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The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait SpO2 Attachment Accessory Band (Portrait AAB01):

The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.

The Portrait SpO2 Attachment Accessory Band is intended for use under the direct supervision of a licensed healthcare 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) parameter. The Portrait Wearable Respiration Rate Sensor acquires parameter data from the patient it to the Portrait Sensor Battery for communication to a host devical Body Area Network (MBAN) connection.

The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed healthcare 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 pediatic 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 RR Electrode Patch transfers impedance and biopotential signals from the patient and transmits them to the Portrait Wearable Respiration Rate Sensor.

The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed healthcare 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 healthcare 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.

6

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 healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01):

The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory.

The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear in white against a black background, with the circle also outlined in 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: February 26, 2024

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(@gehealthcare.com

Secondary Contact Person: William Jung Regulatory Affairs Director GE HealthCare, Monitoring Solutions Phone: 571-396-1558 E-mail: william.jung@gehealthcare.com

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Device names (807.92(a)(2)):
Trade Name:	Portrait Mobile Monitoring Solution V1.1 consists of the following:
PortraitTM Central Viewer Application (Portrait CVAXB)
PortraitTM Core Services (Portrait CSSXB)
PortraitTM Clinical Alarming Unit (Portrait CAU01)
PortraitTM Mobile Patient Monitor Hardware (Portrait HUBXB)
PortraitTM Mobile Patient Monitor Software (Portrait HSWXB)
PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)
PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)
PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)
PortraitTM SpO2 Attachment Accessory Band (Portrait AAB01)
PortraitTM Wearable Respiration Rate Sensor (Portrait RR P-RR01)
PortraitTM RR Electrode Patch (Portrait RRP01)
PortraitTM Sensor Battery (Portrait SBT01)
PortraitTM Bedside Charger (Portrait BCH01)
PortraitTM Mobile Patient Monitor Pouch (Portrait MMP01)
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
DQA
Predicate Device(s) (807.92(a)(3)):	The primary predicate for this submission is K230626 Portrait Mobile Monitoring Solution v1.0
Device Description (807.92(a)(4)):	The Portrait Mobile Monitoring Solution V1.1 is a 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

510(k) Summary GE HealthCare Portrait Mobile Monitoring Solution v1.1 Page 2 of 27

9

numbers, and when applicable, also as alarm messages.

The Portrait Mobile Monitoring Solution V1.1 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 Hardware, 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 alarms, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). Compared to the predicate (K230626), the Portrait Mobile Patient Monitor has been split into separate hardware and software components for serviceability. The Portrait Mobile Patient Monitor Hardware is shipped with no clinical software installed. The clinical software (i.e., Portrait Mobile Patient Monitor Software) is installed at the customer site before the device is put into use. The Portrait Mobile Patient Monitor Hardware when the Portrait Mobile Patient Monitor Software is installed (prior to patient use) is then what we will refer to as the Portrait Mobile Patient Monitor. Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly.

· Portrait Mobile Patient Monitor Software is the clinical software which gets installed at the customer site on the Portrait Mobile Patient Monitor Hardware. The Portrait Mobile Patient Monitor Software is this submission is equivalent to the software installed on the predicate Portrait Mobile Patient Monitor cleared in K230626 with minor changes as discussed in this

10

submission.

· 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: (807.92(a)(5)):

The Intended Use of the Portrait™ Mobile Monitoring Solution v1.1 as a vital sign monitor is identical to the primary predicate K230626 Portrait Mobile Monitoring Solution v1.0.

The indications for use are described separately for each of the individual subsystems/components of the Portrait Mobile Monitoring Solution V1.1 and for the system as a whole.

Portrait™ Mobile Monitoring Solution

The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).

Physiological parameters and waveforms supported are:

. Pulse oximetry (SpO2/pulse rate)
Respiration rate (RR)

Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.

The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a

11

professional healthcare facility.

This device is not an Apnea monitor (i.e., do not rely on the device for detection of 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.

The Portrait Mobile Monitoring Solution consists of:

Portrait™ Central Viewer Application (Portrait CVAXB)

The Portrait Central Viewer Application (Portrait CVAXB) 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 healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

Portrait™ Core Services (Portrait CSSXB)

The Portrait Core Services (Portrait CSSXB) 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), waveforms (IHE PCD WCM), and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Mobile Monitoring Solution.

Portrait™ Clinical Alarming Unit (Portrait CAU01)

The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.

The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

12

Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB)

The Portrait Mobile Patient Monitor Hardware (Portrait HUBXB) is intended for use with adult and pediatric patients as a handheld, mobile device which supports running the Portrait Mobile Patient Monitor Software to monitor patients, and to provide audible and visual alarms. The Portrait Mobile Patient Monitor Hardware enables non-invasive continuous vital sign monitoring of patients by acquiring signals wirelessly from Portrait wearable sensors, as well as wireless clinical and service data communication.

The Portrait Mobile Patient Monitor Hardware is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Mobile Patient Monitor Hardware is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Mobile Patient Monitor Software (Portrait HSWXB)

The Portrait Mobile Patient Monitor Software (Portrait HSWXB) is intended to run on Portrait Mobile Patient Monitor Hardware for the continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. Portrait Mobile Patient Monitor Software is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). It enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors, as well as displaying trends, events, and a QR code containing patient demographics and parameter data. When installed on the Portrait Mobile Patient Monitor Hardware, the Portrait Mobile Patient Monitor Software provides real-time, trend and event data to Portrait Core Services. The Portrait Mobile Patient Monitor Software, when configured to do so, also enables the Portrait Mobile Patient Monitor Hardware to provide audible and visual alarms locally.

The Portrait Mobile Patient Monitor Software is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

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Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

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

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

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Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)

The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.

The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01)

The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.

The Portrait SpO2 Attachment Accessory Band is intended for use under the direct supervision of a licensed healthcare 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) 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 healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

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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 RR Electrode Patch transfers impedance and biopotential signals from the patient and transmits them to the Portrait Wearable Respiration Rate Sensor.

The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.

The Portrait RR Electrode Patch is not intended for use in a controlled Magnetic Resonance (MR) environment.

Portrait™ Sensor Battery (Portrait SBT01)

The Portrait Sensor Batterv (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 healthcare 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 healthcare 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 Portrait Mobile
Patient Monitor to be carried while the patient is ambulatory.
The Portrait Mobile Patient Monitor pouch is intended for use
under the direct supervision of a licensed healthcare practitioner,
or by personnel trained in proper use of the equipment in a
professional healthcare facility.
Technology (807.92(a)(6)): The Portrait Mobile Monitoring Solution uses the same
fundamental technology and functionality as the primary
predicate primary predicate K230626 Portrait Mobile
Monitoring Solution v1.0.

The basis for this TRADITIONAL 510(k) submission is that the
Portrait Mobile Monitoring Solution with software v1.1 is a
revised version of the predicate Portrait™ Mobile Monitoring
Solution K230626 with changes as described below.

The Intended Use of the Portrait™ Mobile Monitoring Solution
with software v1.1 as a vital sign monitor is identical to the
predicate primary predicate Portrait™ Mobile Monitoring
Solution K230626 with software version 1.0.

The Portrait Mobile Monitoring Solution with software v1.1 uses
the same fundamental technology and functionality as the
primary predicate primary predicate Portrait™ Mobile
Monitoring Solution K230626.

Changes since the previous submission (K230626)
The main change is a new software version 1.1 replacing
software 1.0 and revised labeling. There are no changes to the
hardware of the devices that comprise Portrait Mobile
Monitoring Solution.

The main differences with respect to the predicate discussed
throughout this submission are summarized below:

Service enhancements to support ease of deployment

Installation enhancements for Portrait Core Services to
make for a more streamlined software installation
process.
Ability to do over-the-air updates to sensor software from
the Portrait Mobile Patient Monitor and to update

510(k) Summary GE HealthCare Portrait Mobile Monitoring Solution v1.1 Page 10 of 27

17

batteries from the Portrait Mobile Patient Monitor when both are docked on the charger

Service enhancements to allow the ability for a reset of ● all configured parameters to factory defaults when performing a software update of the Portrait Mobile Patient Monitor.
Electronic delivery to a field engineer laptop of software for the Portrait Central Viewer and Portrait Mobile Patient Monitor, as well as electronic delivery of software updates for sensors, sensor battery, and charger to a field engineer laptop. This feature eliminates the need to ship physical software kits (i.e., USB sticks) to customer sites.

Cybersecurity improvements

. Updates to off-the-shelf software to address open cybersecurity vulnerabilities and software end-of-life issues.
Software signing key updates.
Improvements to device authentication of a Sensor Battery and Sensor (from the Portrait Mobile Patient Monitor).
Adding support for WPA3 wireless security to the ● Portrait Mobile Patient Monitor.

Minor Software functional enhancements

. Alarm improvements to support a 2 stage check probe alarm and adding a 60s delay option for Resp High, Resp Low, Pulse Rate High and Pulse Rate Low.
OR code display in the Portrait Mobile Patient Monitor ● to allow patient vital signs to be read by an external vital signs monitor.
Adding IHE WCM outbound feeds (i.e., HL7) for ● Pleth/Resp waveforms.

Minor Changes to the Indications for Use

We have revised the Indications for Use statement from the predicate for clarity and to reflect the following changes that are new for this submission:

. Separating the Portrait Mobile Patient Monitor hardware and software into 2 separate medical devices with corresponding indication statements (Portrait HUBXB and Portrait HSWXB).
Updates to device model numbers for the Portrait Central . Viewer Application and Portrait Core Services.

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. Addition of IHE WCM outbound feeds (i.e., HL7) to the indications for Portrait Core Services (licensed feature).
. Addition of a QR code containing patient demographics and parameter data (used to allow patient vital signs to be read by external vital signs monitor) to the indications for the Portrait Mobile Patient Monitor Software.

The scope of modifications does not affect the patient population or environment of use or parameters monitored compared to the predicate Portrait Mobile Monitoring Solution (K230626).

Miscellaneous updates

. Bluetooth beaconing to enable RTLS (real-time location system) support. Used for device tracking only. This added feature is not used for clinical use.
Localization support of Portrait Mobile Monitoring Solution user interface and manuals to support new languages required for new target countries.
Adding a compatibility check to Sensor, Sensor Battery, ● and Portrait Mobile Patient Monitor Software to ensure that only verified software configurations can be used for patient monitoring.
. Updates to shared communication libraries to support functional enhancements referenced above.
Separating the Portrait Mobile Patient Monitor hardware . and software into 2 separate medical devices, which resulted in changes to device labels.
Miscellaneous updates to packaging labels including the ● following:
Updates to the minimum hardware specifications ● required for the Portrait Central Viewer Application software (to support expanded functionality in the future).
Updates to the humidity specifications for the Portrait Mobile Patient Monitor to 10-90% from 5-95%.
Deliver new IOU and software upgrade parts (i.e., new ● part numbers for service parts).
. Updates to user and service documentation needed to explain the changes, as well as continuous improvement clarifications

A summary of the main changes compared to the predicate are listed below in the comparison table.

Product Comparison versus Predicate Main features chart follows below.

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| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution -
K230626 | Proposed device
Portrait Mobile Monitoring Solution - | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Vital Sign Monitor | Vital Sign Monitor | Identical |
| FDA Primary Product Code | MWI | MWI | Identical |
| FDA Classification Regulation | 21 CFR 870.2300 | 21 CFR 870.2300 | Identical |
| Indications for Use (entire system) | The Portrait Mobile Monitoring
Solution is intended to acquire, store,
calculate, display and export patient
monitoring data as well as provide real
time alarming for monitoring adult
and pediatric patients (3 years of age
and older, and weighing more than 10
kg).
Physiological parameters and
waveforms supported are:
• Pulse oximetry (SpO2/pulse
rate)
• Respiration rate (RR)
Continuous pulse oximetry and
respiration rate monitoring may be
used for patients at risk of
cardiorespiratory and infectious
complications.
The Portrait Mobile Monitoring
Solution is intended for use under the
direct supervision of a licensed
practitioner, or by personnel trained in
proper use of the equipment in a
professional healthcare facility.
This device is not an Apnea monitor
(i.e., do not rely on the device for
detection of 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 | 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
healthcare practitioner, or by
personnel trained in proper use of the
equipment in a professional healthcare
facility.
This device is not an Apnea monitor
(i.e., do not rely on the device for
detection of 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 | Equivalent
A typo was corrected in the indications
statement to add the word
"healthcare" so that "…licensed
professional, " changes to "…licensed
healthcare professional, "
This difference does not significantly
affect safety and/or effectiveness. |
| | controlled Magnetic Resonance (MR)
environment. | controlled Magnetic Resonance (MR)
environment. | |
| Patient Population | Adult and pediatric patients (3 years of
age and older, and weighing more
than 10 kg). | Adult and pediatric patients (3 years of
age and older, and weighing more
than 10 kg). | Identical |
| Environments of Use | A professional healthcare facility | A professional healthcare facility | Identical |
| Location of devices in the patient
vicinity | In the Portrait Mobile Monitoring
Solution, only the sensors must be
located on the patient. The monitor is
connected wirelessly to the sensors,
and as such, must only be located in
the vicinity of the patient. However,
the monitor may be worn by the
patient using Portrait Mobile Patient
Monitor Pouch. The monitor is also
capable of being carried in one hand. | In the Portrait Mobile Monitoring
Solution, only the sensors must be
located on the patient. The monitor is
connected wirelessly to the sensors,
and as such, must only be located in
the vicinity of the patient. However,
the monitor may be worn by the
patient using Portrait Mobile Patient
Monitor Pouch. The monitor is also
capable of being carried in one hand. | Identical |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution –
K230626 | Proposed device
Portrait Mobile Monitoring Solution – | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| Remote Viewing and Monitoring
Modes | Once a patient is admitted, the
Portrait Mobile Patient Monitor
component of the Portrait Mobile
Monitoring Solution can be used
standalone (viewing of data and alarm
annunciation) if properly configured or
if it becomes disconnected from the
rest of the system. In addition, patient
data and alarms are always remotely
displayed on the Portrait Central
Viewer unless there is a system or
network failure. | Once a patient is admitted, the
Portrait Mobile Patient Monitor
component of the Portrait Mobile
Monitoring Solution can be used
standalone (viewing of data and alarm
annunciation) if properly configured or
if it becomes disconnected from the
rest of the system. In addition, patient
data and alarms are always remotely
displayed on the Portrait Central
Viewer unless there is a system or
network failure. | Identical |
| | STANDARDS COMPLIANCE | | |
| Medical Standards | IEC 60601-1:2005 + A1:2012
IEC 60601-1-2:2014
IEC 60601-1-8:2012 / EN 60601-1-
8:2007/A1:2013
IEC 80601-2-49:2018
ISO 80601-2-61:2017/EN ISO 80601-2-
61:2017
IEC 60601-1-6:2013/EN 60601-1-
6:2010/A1:2015
IEC 62366-1:2015 / EN 62366-1:2015
ISO 10993-1:2018
IEC 62304:2015 / EN 62304:2006 /
A1:2016
ISO 14971 Third Edition 2019-12
Labeling
ISO 20417:2021
ISO 15223-1:2021
ISO 17664:2017
ISO 17664-2:2021
Battery:
UL 2054:2004
IEC 62133-2:2017
UL 1642:2012
RFID:
AIM 7351731:2017
Wireless:
ANSI IEEE C63.27:2017 | ANSI AAMI ES60601-1:2005/®2012 &
A1:2012, C1:2009/®2012 &
A2:2010/®2012 (Cons. Text) [Incl.
AMD2:2021]
60601-1-2 Edition 4.1 2020-09
IEC 60601-1-8 Edition 2.2 2020-07
IEC 80601-2-49 Edition 1.0 2018-03
ISO 80601-2-61 Second edition 2017-
12
IEC 60601-1-6 Edition 3.2 2020-07
IEC 62366-1 Edition 1.1 2020-06
ISO 10993-1 Fifth edition
IEC 62304 Edition 1.1 2015-06
ISO 14971 Third Edition 2019-12
Labeling
ISO 20417 First edition 2021-04
Corrected version 2021-12
15223-1 Fourth edition 2021-07
17664-2 First edition 2021-02
Battery:
UL 2054 2nd Edition
IEC 62133-2:2017/AMD1:2021
UL 1642:2012
Wireless:
IEEE ANSI C63.27-2021 | Equivalent
Newer updated versions of standards
were used for the following standards:
ANSI AAMI ES60601-
1:2005/®2012 & A1:2012,
C1:2009/®2012 &
A2:2010/®2012 (Cons.
Text) [Incl. AMD2:2021]60601-1-2 Edition 4.1
2020-0960601-1-8 Edition 2.2
2020-0760601-1-6 Edition 3.2
2020-07IEC 62366-1 Edition 1.1
2020-06IEEE ANSI C63.27-2021The AIM 7351731 standard was
removed since the new IEC 60601-1-2
Edition 4.1 now takes the same testing
into account. Similarly, the ISO
17664:2017 standard was dropped
since relevant content for Portrait V1.1
devices are covered by the newer ISO
17664-2: 2021.
Updating to newer standard versions
does not significantly affect safety
and/or effectiveness. |
| | System Components | | |
| Patient Device | PORTRAIT Mobile Patient Monitor | Portrait HUBXB with software Portrait
HSWXB | Equivalent
The Portrait Mobile Patient Monitor
had been split into separate hardware
and software components. The
Portrait Mobile Patient Monitor is
shipped with no clinical software
installed. The clinical software (i.e.,
Portrait Mobile Patient Monitor
Software) is installed at the customer
site before the device is put into use.
This difference does not significantly
affect safety and/or effectiveness. |
| Sensors | PORTRAIT SpO2 Wearable Pulse
Oximetry Sensors
PORTRAIT Wearable Respiration Rate
Sensor
(wireless connection to the Mobile | PORTRAIT SpO2 Wearable Pulse
Oximetry Sensors
PORTRAIT Wearable Respiration Rate
Sensor
(wireless connection to the Mobile | Identical |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution –
K230626 | Proposed device
Portrait Mobile Monitoring Solution – | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| Sensor Battery | Detachable sensor battery.
Interchangeable. May be used with
any sensor. | Detachable sensor battery.
Interchangeable. May be used with
any sensor. | Identical |
| SpO2 Probes | Integrated in sensors | Integrated in sensors | Identical |
| Respiration Electrode Patches | Portrait RR Electrode Patch | Portrait RR Electrode Patch | Identical |
| Battery Charger | Portrait Bedside Charger | Portrait Bedside Charger | Identical |
| Accessories for Portrait Mobile
Patient Monitor | Portrait Mobile Patient Monitor Pouch | Portrait Mobile Patient Monitor Pouch | Identical |
| Central Viewing | Portrait Central Viewer Software
Application with
Portrait Clinical Alarming Unit | Portrait Central Viewer Software
Application with
Portrait Clinical Alarming Unit | Identical |
| Storage and Centralized Services | Portrait Core Services | Portrait Core Services | Identical |
| Accessories for SpO2 | Portrait SpO2 Attachment Accessory
Band | Portrait SpO2 Attachment Accessory
Band | Identical |
| | Patient Device – General Hardware
Specifications | | |
| Device Name | Portrait Mobile Patient Monitor | Portrait HUBXB with software Portrait
HSWXB | Equivalent
The Portrait Mobile Patient Monitor
had been split into separate hardware
and software components. The
Portrait Mobile Patient Monitor is
shipped with no clinical software
installed. The clinical software (i.e.,
Portrait Mobile Patient Monitor
Software) is installed at the customer
site before the device is put into use.
This difference does not significantly
affect safety and/or effectiveness. |
| Size (H x W x D) | 14.1 cm x 6.3 cm x 2.1 cm | 14.1 cm x 6.3 cm x 2.1 cm | Identical |
| Weight | 223 g | 223 g | Identical |
| Power source | Battery (integrated into device) | Battery (integrated into device) | Identical |
| Battery Type | Lithium-ion | Lithium-ion | Identical |
| Run-time on battery | 16 Hours with full capacity (display off) | 16 Hours with full capacity (display off) | Identical |
| Charge time | 8 Hours from empty to full capacity. | 8 Hours from empty to full capacity. | Identical |
| | Patient Device – User Interface | | |
| Device Name | Portrait Mobile Patient Monitor | | |
| Touch display interface | Yes | Yes | Identical |
| Visual and Audible Alarm capability | Available | Available | Identical |
| | Patient Device – Display
Specifications | | |
| Display type | SFT LCD (Super Fine TFT) | SFT LCD (Super Fine TFT) | Identical |
| Display Size and resolution | 480 x 800 pixels, 3.7 inches in 16:9
format | 480 x 800 pixels, 3.7 inches in 16:9
format | Identical |
| Parameter Blocks Displayed
Simultaneously | 3 Parameters (all available
parameters) | 3 Parameters (all available
parameters) | Identical |
| Number of traces (waveforms) | One waveform per page in detailed
parameter view | One waveform per page in detailed
parameter view | Identical |
| Trends | Displays graphical trend of connected
parameters for the last 4 hours.
Movable cursor displays details for the
given point in time. | Displays graphical trend of connected
parameters for the last 4 hours.
Movable cursor displays details for the
given point in time. | Identical |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution -
K230626 | Proposed device
Portrait Mobile Monitoring Solution - | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| | Patient Device - Connectivity | | |
| Wireless connection to network | Requires a wireless network
connection to begin monitoring. IEEE
802.11 a/b/g/n supported (dual band).
After patient admission, the Portrait
Mobile Patient Monitor will continue
to monitor locally in the event of a
network failure. | Requires a wireless network
connection to begin monitoring. IEEE
802.11 a/b/g/n supported (dual band).
After patient admission, the Portrait
Mobile Patient Monitor will continue
to monitor locally in the event of a
network failure. | Identical |
| Connection to Sensors | Communicates with the sensors over a
wireless Medical Body Area Network
(MBAN) using a proprietary protocol.
The MBAN connection to the sensors
includes a GE-proprietary protocol and
a low-power radio interface that can
operate on both the unlicensed 2.4
GHz ISM band and certain other
protected frequency bands where
MBAN traffic is allowed. In the USA,
the MBAN communication occurs in
the 2390-2400 MHz band, which has
been reserved by the FCC for use by
Medical Body Area Networks. | Communicates with the sensors over a
wireless Medical Body Area Network
(MBAN) using a proprietary protocol.
The MBAN connection to the sensors
includes a GE-proprietary protocol and
a low-power radio interface that can
operate on both the unlicensed 2.4
GHz ISM band and certain other
protected frequency bands where
MBAN traffic is allowed. In the USA,
the MBAN communication occurs in
the 2390-2400 MHz band, which has
been reserved by the FCC for use by
Medical Body Area Networks. | Identical |
| RTLS | None | Portrait HUBXB with software Portrait
HSWXB transmits Bluetooth beacons
to support RTLS (real time location
services). | Equivalent
Bluetooth beacons sent in the
proposed device are intended for
asset tracking only and are not
intended for clinical use.
This difference does not significantly
affect safety and/or effectiveness. |
| QR Code | None | Portrait HUBXB with software Portrait
HSWXB supports QR code for reading
of patient demographics and vital signs
by external device. | Equivalent
In V1.1, Portrait HUBXB with software
Portrait HSWXB adds a QR code that
can be read by an external device to
transfer patient demographics and
current vital signs information.
This difference does not significantly
affect safety and/or effectiveness. |
| | Accessories for Portrait Mobile Patient | | |
| Device Name | Monitor
Portrait Mobile Patient Monitor Pouch | | |
| Single Use / Multiple Use | Single Use | Single Use | Identical |
| | Respiration Sensors - Hardware | | |
| Device Name | Portrait Wearable Respiration Rate
Sensor | | |
| Dimensions | 6.9 x 5.3 x 1.9 cm | 6.9 x 5.3 x 1.9 cm | Identical |
| Weight | 34 g | 34 g | Identical |
| | Accessories for Respiration Rate | | |
| Device Name | sensor
Portrait RR Electrode Patch | | |
| Operating Temperature | 0 to 40 °C | 0 to 40 °C | Identical |
| Single Use / Multiple Use | Single Use | Single Use | Identical |
| Shelf Life | 18 months | 18 months | Identical |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution -
K230626 | Proposed device
Portrait Mobile Monitoring Solution - | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| | Pulse Oximetry Sensor - Hardware | | |
| Device Name | Portrait Wearable Pulse Oximetry
Sensor | | |
| Sensor Application Site | Finger | Finger | Identical |
| Dimensions | SpO2 P-SA01: 27.2 x 5.3 x 1.9 cm
SpO2 P-SP01: 23.6 x 5.3 x 1.9 cm
SpO2 P-W01: 26.2 x 5.3 x 1.9 cm
SpO2 P-SE01: 27.1 x 5.3 x 1.9 cm | SpO2 P-SA01: 27.2 x 5.3 x 1.9 cm
SpO2 P-SP01: 23.6 x 5.3 x 1.9 cm
SpO2 P-W01: 26.2 x 5.3 x 1.9 cm
SpO2 P-SE01: 27.1 x 5.3 x 1.9 cm | Identical |
| Weight | SpO2 P-SA01: 52 g
SpO2 P-SP01: 43 g
SpO2 P-W01: 38 g
SpO2 P-SE01: 38 g | SpO2 P-SA01: 52 g
SpO2 P-SP01: 43 g
SpO2 P-W01: 38 g
SpO2 P-SE01: 38 g | Identical |
| Fluid Ingress Rating | SpO2 P-SA01, SpO2 P-SP01: IP67
SpO2 P-W01 and SpO2 P-SE01: IP44 | SpO2 P-SA01, SpO2 P-SP01: IP67
SpO2 P-W01 and SpO2 P-SE01: IP44 | Identical |
| Operating Temperature | 0 to 40 °C | 0 to 40 °C | Identical |
| Non-Operating Temperature | -30 to 70 °C | -30 to 70 °C | Identical |
| Operating Humidity | 5 to 95% non-condensing | 5 to 95% non-condensing | Identical |
| Non-Operating Humidity | 5 to 95% non-condensing | 5 to 95% non-condensing | Identical |
| Operating Pressure | 620 to 1060 hPa | 620 to 1060 hPa | Identical |
| | Note: For comparison purposes this is
62 kPa to 106 kPa | Note: For comparison purposes this is
62 kPa to 106 kPa | |
| Non-Operating Pressure | 500 to 1060 hPa | 500 to 1060 hPa | Identical |
| | Note: For comparison purposes this is
50 kPa to 106 kPa | Note: For comparison purposes this is
50 kPa to 106 kPa | |
| | | | |
| | Accessories for SpO2 sensors | | |
| Device Name | Portrait SpO2 Attachment Accessory
Band | | |
| Indications for Use | 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 | 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 healthcare practitioner, or by
personnel trained in proper use of the
equipment in a professional healthcare
facility. | Equivalent
A typo was corrected in the indications
statement to add the word
"healthcare" so that "…licensed
professional, …" changes to "…licensed
healthcare professional, …".
This difference does not significantly
affect safety and/or effectiveness. |
| Operating Temperature | 0 to 40 °C | 0 to 40 °C | Identical |
| Non-Operating Temperature | -30 °C to -70 °C | -30 °C to -70 °C | Identical |
| Non-Operating Humidity | 5 to 95% non-condensing | 5 to 95% non-condensing | Identical |
| Non-Operating pressure | 500 to 1060 hPa
Note: For comparison purposes this is
50 kPa to 106 kPa | 500 to 1060 hPa
Note: For comparison purposes this is
50 kPa to 106 kPa | Identical |
| Sterility | The SpO2 Attachment is supplied as
non-sterile and is not intended to be
sterilized. | The SpO2 Attachment is supplied as
non-sterile and is not intended to be
sterilized. | Identical |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution –
K230626 | Proposed device
Portrait Mobile Monitoring Solution – | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| | Sensor Batteries - Hardware | | |
| Device Name | Portrait Sensor Battery | | |
| Dimensions | 3.6 x 5.3 x 1.7 cm | 3.6 x 5.3 x 1.7 cm | Identical |
| Weight | 31 g | 31 g | Identical |
| | Charger - Hardware | | |
| Device Name | Portrait Bedside Charger | | |
| Input voltage and frequency | 100-240 V, 50-60 Hz (using external
power supply) | 100-240 V, 50-60 Hz (using external
power supply) | Identical |
| Power | 36 W (Output power - 3.0 A at 12 Vdc) | 36 W (Output power - 3.0 A at 12 Vdc) | Identical |
| Dimensions (exclusive of power
supply and cable) | 11.5 x 23.8 x 4.3 cm | 11.5 x 23.8 x 4.3 cm | Identical |
| Weight
(exclusive of power supply and
cable) | 412 g
Wall mount: 603 g
Table mount: 908 g | 412 g
Wall mount: 603 g
Table mount: 908 g | Identical |
| | Central/Remote Viewer | | |
| Device Name | Portrait Central Viewer Application
with Portrait Clinical Alarming Unit | | |
| Display | Required Specification for customer
supplied display:
20 in (minimum),
1920 x 1080 resolution (minimum) | Required Specification for customer
supplied display:
20 in (minimum),
1920 x 1080 resolution (minimum) | Identical |
| Operating System | Required Specification for customer
supplied PC:
Windows 10, build 10.0.17763
(minimum) | Required Specification for customer
supplied PC:
Windows 10, build 10.0.17763
(minimum) | Identical |
| Number of patients per viewer | Maximum 24 | Maximum 24 | Identical |
| Simultaneous view of numerics for
all patients on viewer | Supported on for all measured
parameters on Multiple Patient View –
SpO2%, Pulse Rate, Respiration Rate | Supported on for all measured
parameters on Multiple Patient View –
SpO2%, Pulse Rate, Respiration Rate | Identical |
| Viewing of patient waveforms | One patient at time - Supported on
single patient view | One patient at time - Supported on
single patient view | Identical |
| Viewing of patient trends | Graphical trend view supported for
one patient at time – single patient
view | Graphical trend view supported for
one patient at time – single patient
view | Identical |
| Visual/Audible alarms supported | Supported | Supported | Identical |
| | Storage and Centralized Services –
General | | |
| Device Name | Portrait Core Services | | |
| Description | The Portrait Core Services are a set of
software services that enable the
communication and interaction of the
Portrait Monitoring Solution
components and will integrate into
existing healthcare facility
infrastructure and clinical information
systems. The Portrait Core Services
provide system configuration,
administration, data storage, and
transmission of patient physiological
trends and events. The Portrait Core
Services are installed on the Portrait
non-medical device EHL (Edison Health
Link) Server. | The Portrait Core Services are a set of
software services that enable the
communication and interaction of the
Portrait Monitoring Solution
components and will integrate into
existing healthcare facility
infrastructure and clinical information
systems. The Portrait Core Services
provide system configuration,
administration, data storage, and
transmission of patient physiological
trends and events. The Portrait Core
Services are installed on the Portrait
non-medical device EHL (Edison Health
Link) Server. | Identical |
| HL7 outbound support | Supported - The Portrait Core Services
can transmit patient physiological
trends and numerics (IHE PCD DEC)
and alarm events (IHE PCD ACM)
outbound. | Supported - The Portrait Core Services
can transmit patient physiological
trends and numerics (IHE PCD DEC)
and alarm events (IHE PCD ACM)
outbound and waveforms (IHE PCD
WCM). | Equivalent
The addition of transmitting IHE PCD
WCM waveforms in addition to
physiological trends and numerics in
the predicate does not significantly
affect safety and/or effectiveness. |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution -
K230626 | Proposed device
Portrait Mobile Monitoring Solution - | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| HL7 Inbound support | Supported - The Portrait Core Services
can also receive HL7 ADT information
to admit patients to the Portrait
Monitoring Solution. | Supported - The Portrait Core Services
can also receive HL7 ADT information
to admit patients to the Portrait
Monitoring Solution. | Identical |
| | Storage and Centralized Services -
General | | |
| Server Model | HP ProLiant DL360 Gen10 | HP ProLiant DL360 Gen10 | Identical |
| | Monitored Parameters | | |
| Monitored Parameters | Oxygen saturation (SpO2)
Pulse rate (PR)
Respiration Rate (RR) | Oxygen saturation (SpO2)
Pulse rate (PR)
Respiration Rate (RR) | Identical |
| Parameters Acquisition Method | The Portrait Mobile Monitor acquires
parameter data from wireless patient
sensors over the MBAN wireless link.
The parameter electronics are
encapsulated into the respective
wireless sensors.
The sensors include:
Portrait SpO2 P-SA01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-SP01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-W01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-SE01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait RR P-RR01, Wearable
Respiration Rate Sensor (Respiration
Rate) | The Portrait HUBXB with software
Portrait HSWXB acquires parameter
data from wireless patient sensors
over the MBAN wireless link. The
parameter electronics are
encapsulated into the respective
wireless sensors.
The sensors include:
Portrait SpO2 P-SA01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-SP01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-W01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait SpO2 P-SE01, SpO2 Wearable
Pulse Oximetry Sensor (SpO2, Pulse
Rate)
Portrait RR P-RR01, Wearable
Respiration Rate Sensor (Respiration
Rate) | Identical (except for name change of
the device) |
| | Alarms | | |
| Classification / Alarm Levels | Three levels - High (red), Medium
(yellow), Low (cyan) in compliance
with IEC 60601-1-8
Informational messages (gray) also
included | Three levels - High (red), Medium
(yellow), Low (cyan) in compliance
with IEC 60601-1-8
Informational messages (gray) also
included | Identical |
| Notification | Audible and visual | Audible and visual | Identical |
| List of Physiological Alarms
supported (for parameters included
in the proposed device) | PR High
PR Low
RR High
RR Low
SpO2 High
SpO2 Low
SpO2 Critically low
Apnea | PR High
PR Low
RR High
RR Low
SpO2 High
SpO2 Low
SpO2 Critically low
Apnea | Identical |
| Technical / Equipment Alarms | Supported | Supported | Equivalent |
| | | The proposed device supports the
same Technical/Equipment alarms
with a modified SpO2 check probe
technical alarm from a single level
alarm to a 2-stage (i.e., escalating)
alarm. | This change allows for the responsible
organization flexibility in configuring
alarm priority defaults. The
configurations options in the predicate
device remain available in the
proposed device. The proposed device
provides the responsible organization
to escalate the alarm priority after a
configurable delay. The configuration
of alarm priorities and time delay are
password protected. |
| Specification | Reference Predicate Device
Portrait Mobile Monitoring Solution –
K230626 | Proposed device
Portrait Mobile Monitoring Solution – | Discussion of differences between
Portrait Mobile Monitoring Solution
and Predicate |
| | | | This difference does not significantly
affect safety and/or effectiveness. |
| | Trending | | |
| Trend Visualization | Graphical Trends only. Individual
values for each trended value are
visible at the position of the cursor. | Graphical Trends only. Individual
values for each trended value are
visible at the position of the cursor. | Identical |
| Trend Visualization Duration | Up to 4 Hours on the Portrait Mobile
Patient Monitor
Up to 24 Hours on the Portrait Central
Viewer Application | Up to 4 Hours on the Portrait Mobile
Patient Monitor
Up to 24 Hours on the Portrait Central
Viewer Application | Identical |
| Trend Smoothing | On the Portrait Central Viewer
Application, the trend data undergoes
an additional smoothing process. The
purpose of this smoothing is to
remove brief changes and normal
variations in the physiological trend
data acquired by the Portrait Mobile
Patient Monitor. | On the Portrait Central Viewer
Application, the trend data undergoes
an additional smoothing process. The
purpose of this smoothing is to
remove brief changes and normal
variations in the physiological trend
data acquired by the Portrait Mobile
Patient Monitor. | Identical |
| Event management | Physiological Events (i.e., alarms) of
medium or high priority are stored in
the Portrait Mobile Monitoring
Solution and are viewable in the Trend
display on the Portrait Central Viewer
Application. | Physiological Events (i.e., alarms) of
medium or high priority are stored in
the Portrait Mobile Monitoring
Solution and are viewable in the Trend
display on the Portrait Central Viewer
Application. | Identical |
| Trend resolution | 1-minute resolution | 1-minute resolution | Identical |
| | RESPIRATION | | |
| Measurement Method | Impedance Respiration (i.e.,
Impedance Pneumography) | Impedance Respiration (i.e.,
Impedance Pneumography) | Identical |
| Display Range | 0 to 99 breaths/min | 0 to 99 breaths/min | Identical |
| Units | Respiration Rate (RR) in breaths/min | Respiration Rate (RR) in breaths/min | Identical |
| Resolution | 1 breath/min | 1 breath/min | Identical |
| Accuracy Range | 4 to 60 breaths/min | 4 to 60 breaths/min | Identical |
| Accuracy | +/- 3 breaths/min | +/- 3 breaths/min | Identical |
| Waveforms | Impedance Respiration waveform with
automatic scaling, 6.25 mm/s sweep
speed (Portrait Mobile Patient
Monitor), 25 mm/s sweep speed
(Portrait Central Viewer Application) | Impedance Respiration waveform with
automatic scaling, 6.25 mm/s sweep
speed (Portrait HUBXB with software
Portrait HSWXB, 25 mm/s sweep
speed (Portrait Central Viewer
Application) | Identical (except for name change of
the device) |
| | PULSE OXIMETRY - SpO2 | | |
| Measurement | Arterial oxygen saturation (SpO2) | Arterial oxygen saturation (SpO2) | Identical |
| Units | Percent | Percent | Identical |
| Display Range | 0 to 100% | 0 to 100% | Identical |
| Resolution | 1% | 1% | Identical |
| Accuracy Range | 70 to 100% | 70 to 100% | Identical |
| Accuracy | SpO2 (70 to 100%)