Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™
Device Facts
| Record ID | K230626 |
|---|---|
| Device Name | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Aug 11, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence, Pediatric |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K230626 · Aug 11, 2023 | Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ | Ge Medical Systems Information Technologies, Inc. | General ward patient clinical study | The study evaluated the performance of the Portrait Mobile Monitoring Solution's dual vector impedance-based respiration rate monitoring in a general ward setting, with patients performing normal daily activities. | Respiration Rate; General Ward; Clinical Performance; Impedance-based monitoring |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Portrait Mobile Monitoring Solution Respiration Rate Performance Study; Clinical performance evaluation in general ward patients | General ward patients representative of the population requiring the device | CO2 monitoring (gold standard) | Mean absolute difference between Portrait Mobile and CO2 respiration rate |
Indications for Use
The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: · Pulse oximetry (SpO2/pulse rate) · Respiration rate (RR) Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.
Device Story
Portrait Mobile Monitoring Solution is a wireless, multi-parameter patient monitoring system for hospital use. It acquires SpO2, pulse rate, and respiration rate data via body-worn sensors (SpO2 sensors, RR electrode patch) that transmit signals to a wearable sensor battery. The battery communicates wirelessly via Medical Body Area Network (MBAN) to a handheld Portrait Mobile Patient Monitor. The monitor displays real-time numerics and waveforms on a 3.7-inch touchscreen and provides local alarms. Data is transmitted to Portrait Core Services (hosted on an Edison Health Link server) for storage and integration with hospital infrastructure. A Portrait Central Viewer Application on a PC allows clinicians to monitor multiple patients simultaneously, supported by a Clinical Alarming Unit for audible alerts. The system enables ambulatory monitoring, with data export and alarm management to assist clinical decision-making. Benefits include continuous, non-invasive monitoring for patients at risk of cardiorespiratory complications, allowing for early intervention by healthcare staff.
Clinical Evidence
Two clinical studies were conducted. The first validated the SpO2 algorithm and sensors per ISO 80601-2-61 and FDA guidance. The second evaluated the dual-vector impedance-based respiration rate (RR) monitoring in general ward patients performing normal activities (eating, walking, etc.), using CO2 monitoring as the gold standard. Performance was quantified using the mean absolute difference between the Portrait Mobile RR and the reference CO2 RR.
Technological Characteristics
System components include wearable sensors (SpO2, RR), sensor batteries, mobile monitors, bedside chargers, and central viewer software. Wireless connectivity via MBAN (2390-2400 MHz) and WLAN (802.11 a/b/g/n). Materials comply with ISO 10993-1. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Alarms per IEC 60601-1-8. Software life cycle per IEC 62304.
Indications for Use
Indicated for adult and pediatric patients (3 years and older, >10 kg) in professional healthcare facilities for continuous monitoring of SpO2, pulse rate, and respiration rate. Not for apnea monitoring, life support, or MR environments.
Regulatory Classification
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.
Predicate Devices
- Masimo Root Monitoring System (K171121)
Reference Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 11, 2023
GE Medical Systems Information Technologies, Inc. Joel Kent Director, Regulatory Affairs Strategy 9900 Innovation Drive Wauwatosa, Wisconsin 53226
# Re: K230626
Trade/Device Name: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, MSX, DRG, BZQ, DQA Dated: March 6, 2023 Received: March 7, 2023
Dear Joel Kent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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# Indications for Use
510(k) Number (if known) K230626
Device Name Portrait Mobile Monitoring Solution
#### Indications for Use (Describe)
Portrait Mobile Monitoring Solution:
The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
· Pulse oximetry (SpO2/pulse rate)
· Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not in a controlled Magnetic Resonance (MR) environment.
Portrait Central Viewer Application (Portrait CVA01):
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.
The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Core Services (Portrait CSS01):
The Portrait Core Services are a set of software services that enable the communication of the Portrait Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Monitoring Solution.
Portrait Clinical Alarming Unit (Portrait CAU01):
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.
The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
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Portrait Mobile Patient Monitor (Portrait HUB01):
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from body-worn sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The device can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.
The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor P-SA01 (Portrait SpO2 P-SA01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01):
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmit it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
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Portrait SpO2 Attachment Accessory Band (Portrait AAB01):
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.
The Portrait Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Portrait Wearable Respiration Rate Sensor (Portrait RR P-RR01):
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediativ (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the sensor battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Respiration Rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait RR Electrode Patch (Portrait RRP01):
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of respiration rate (RR) parameter. The electrode patch transfers carrier signals from the wearable respiration rate sensor and transfers impedance and biopotential signals from the patient and transmits them to the wearable respiration rate sensor.
The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait RR Electrode Patch is not in a controlled Magnetic Resonance (MR) environment.
Portrait Sensor Battery (Portrait SBT01):
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait wearable sensors and to provide wireless communication to a host device.
The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.
Portrait Bedside Charger (Portrait BCH01):
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).
The Portrait Bedside Charger is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Bedside Charger is not intended for use in a controlled Magnetic Resonance (MR) environment.
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Portrait Mobile Patient Monitor Pouch (Portrait MMP01):
The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is an optional accessory intended to enable the Mobile Patient Monitor to be carried while the patient is ambulatory.
The Portrait Mobile Patient Monitor pouch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is black and white.
GE Medical Systems Information Technologies, Inc. 9900 Innovation Drive Wauwatosa, WI 53226, USA
# 510(k) Summary
# In accordance with 21 CFR 807.92 the following summary of information is provided:
#### Owner/Contact/Date (807.92(a)(1)):
Date: August 11, 2023
GE Medical Systems Information Technologies, Inc. Owner/Submitter: 9900 Innovation Drive Wauwatosa, WI 53226, USA
- Joel Kent Primary Contact Person: Director, Regulatory Affairs Strategy GE HealthCare, Patient Care Solutions Phone: 617-851-0943 E-mail: joel.kent@ge.com
- Secondary Contact Person: William Jung Regulatory Affairs Director GE HealthCare, Monitoring Solutions Phone: 571-396-1558 E-mail: william.jung@ge.com
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# Device names (807.92(a)(2)):
| Trade Name: | Portrait Mobile Monitoring Solution consists of the following: |
|---------------------------|------------------------------------------------------------------------------|
| | Portrait™ Central Viewer Application (Portrait CVA01) |
| | Portrait™ Core Services (Portrait CSS01) |
| | Portrait™ Clinical Alarming Unit (Portrait CAU01) |
| | Portrait™ Mobile Patient Monitor (Portrait HUB01) |
| | Portrait™ Sensor Battery (Portrait SBT01) |
| | Portrait™ Bedside Charger (Portrait BCH01) |
| | Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P- |
| | SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait<br>SpO2 P-SE01) |
| | Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01) |
| | Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01) |
| | Portrait™ Wearable Respiration Rate Sensor (Portrait RR P- |
| | RR01) |
| | Portrait™ RR Electrode Patch (Portrait RRP01) |
| | |
| Common/Usual Name: | Multiparameter patient monitor (Monitor, Physiological, Patient |
| | (Without Arrhythmia Detection Or Alarms)) |
| | |
| Classification Names: | 21 CFR 870.2300 Cardiac monitor (including cardiotachometer |
| | and rate alarm |
| | 21 CFR 870.2910 Radiofrequency physiological signal |
| | transmitter and receiver |
| | 21 CFR 868.2375 monitor, breathing frequency |
| | 21 CFR 870.2700 oximeter |
| | |
| Product Code: | MWI |
| | |
| Subsequent Product Codes: | MSX |
| | DRG |
| | BZQ |
| | DOA |
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| Predicate Device(s) (807.92(a)(3)): | The primary predicate for this submission is K171121 Masimo Root Monitoring System |
|-------------------------------------|------------------------------------------------------------------------------------|
|-------------------------------------|------------------------------------------------------------------------------------|
Additional reference devices: K180472, Sotera Wireless ViSi Mobile Monitoring System K213234, CARESCAPE ONE
# Device Description (807.92(a)(4)):
The Portrait Mobile Monitoring Solution is a new wireless monitoring system for monitoring SpO2, pulse rate and respiration rate of adult and pediatric patients. The system can be used for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) within a hospital or healthcare facility. The system acquires, stores, calculates, displays, and exports patient physiological parameter data, alarms, and information. It supports pulse oximetry (SpO2/pulse rate) and respiration rate parameters. Measurement values are displayed as graphic or numeric values, like waveforms and numbers, and when applicable, also as alarm messages. This device is not an Apnea monitor (i.e., do not to rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes. Do not attempt to use this device to detect sleep apnea.
The Portrait Mobile Monitoring Solution consists of the following general categories of medical devices:
# Central Monitoring Devices:
Portrait Core Services hosted on the GE HealthCare nonmedical device Edison Health Link platform. Portrait Core Services is a set of software services that enable the communication and interaction of the system components and are capable of integrating into existing healthcare facility infrastructure and clinical information systems.
Portrait Central Viewer Application software hosted on a . Windows off-the-shelf computer. Portrait Central Viewer Application provides the ability to view patient real-time and historical data, capable of displaying data from multiple patients.
. Portrait Clinical Alarming Unit provides audible alarms at each Central Viewer.
#### Mobile Monitoring Devices:
Portrait Mobile Patient Monitor, a battery-powered, . wireless, hand-held patient monitor. The Portrait Mobile Patient Monitor is a completely wireless, hand-held device that is capable of acting as a standalone patient monitor
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including alarming, with a 3.7-inch capacitive touchscreen capable of displaying numeric data and waveforms for SpO2, Pulse Rate (PR), and Respiration Rate (RR). . Portrait Wearable SpO2 sensors for acquiring SpO2 and pulse rate data from a patient wirelessly. . Portrait Wearable Respiration Rate sensor and Portrait RR electrode patch for acquiring impedance respiration data from a patient wirelessly. . Portrait Sensor battery used for powering the wearable sensors and provide wireless communication to the Portrait Mobile Patient Monitor. . Portrait Bedside Charger for charging the Portrait Sensor Batteries and Portrait Mobile Patient Monitor (including when the Portrait Mobile Patient Monitor is in clinical use). . Portrait SpO2 Attachment accessory band which provides means to secure the SpO2 sensors to the patient's wrist. . Portrait Mobile Patient Monitor Pouch, which allows the Portrait Mobile Patient Monitor to be carried while the patient is ambulatory. Intended Use: The Intended Use of the Portrait™ Mobile Monitoring Solution (807.92(a)(5)): as a vital sign monitor is identical to the predicate primary predicate K171121 Masimo Root Monitoring System. The indications for use are described separately for each of the individual subsystems/components of the Portrait Mobile Monitoring Solution and for the system as a whole. Indications for Use are described below: Portrait™ Mobile Monitoring Solution The Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg).
Physiological parameters and waveforms supported are:
- Pulse oximetry (SpO2/pulse rate) ●
- . Respiration rate (RR)
Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious 510(k) Summary K230626 GE HealthCare Portrait Mobile Monitoring Solution
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complications.
The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
This device is not an Apnea monitor (i.e., do not rely on the device for detection or alarm for the cessation of breathing). This device should not be used for life sustaining/supporting purposes.
The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.
#### Portrait™ Central Viewer Application (Portrait CVA01)
The Portrait Central Viewer Application (Portrait CVA01) provides monitoring station capability running as an application for the Portrait Mobile Monitoring Solution on a PC platform that meets minimum system requirements. It provides the ability to view real-time data for multiple patients and historical data for a single patient including configurable visual and audible alarm notifications.
The Portrait Central Viewer Application is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
#### Portrait™ Core Services (Portrait CSS01)
The Portrait Core Services (Portrait CSS01) are a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems. The Portrait Core Services can transmit patient physiological trends and numerics (IHE PCD DEC) and alarm events (IHE PCD ACM) outbound. The Portrait Core Services can also receive HL7 ADT information to admit patients to the Portrait Mobile Monitoring Solution.
#### Portrait™ Clinical Alarming Unit (Portrait CAU01)
The Portrait Clinical Alarming Unit (Portrait CAU01) is a required accessory to the Portrait Central Viewer Application that provides audio alarming capability.
The Portrait Clinical Alarming Unit is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
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#### Portrait™ Mobile Patient Monitor (Portrait HUB01)
The Portrait Mobile Patient Monitor (Portrait HUB01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters. The Portrait Mobile Patient Monitor enables non-invasive continuous monitoring of patients by acquiring signals from Portrait wearable sensors through a Medical Body Area Network (MBAN) connection as well as displaying trends and events. The Portrait Mobile Patient Monitor can be configured to provide local audible and visual alarms and can also provide real-time, trend and event data to Portrait Core Services.
The Portrait Mobile Patient Monitor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Mobile Patient Monitor is not intended for use in a controlled Magnetic Resonance (MR) environment.
## Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
### Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) is intended for use with pediatric patients (3 years of age and older, and weighing 15 kg to 30 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry
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Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
# Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)
The Portrait Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SE01, Portrait SpO2 P-W01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of oxygen saturation (SpO2) and pulse rate (PR) parameters. The Portrait Wearable Pulse Oximetry Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Pulse Oximetry Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Pulse Oximetry Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
# Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01)
The Portrait SpO2 Attachment Accessory Band (Portrait AAB01) is intended to provide a means to secure the Portrait Wearable Pulse Oximetry Sensor with Portrait Sensor Battery to the patient's wrist.
The Portrait SpO2 Attachment Accessory Band is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
# Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01)
The Portrait Wearable Respiration Rate Sensor (Portrait P-RR01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR)
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parameter. The Portrait Wearable Respiration Rate Sensor acquires parameter data from the patient and transmits it to the Portrait Sensor Battery for communication to a host device through the Medical Body Area Network (MBAN) connection.
The Portrait Wearable Respiration rate Sensor is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Wearable Respiration Rate Sensor is not intended for use in a controlled Magnetic Resonance (MR) environment.
#### Portrait™ RR Electrode Patch (Portrait RRP01)
The Portrait RR Electrode Patch (Portrait RRP01) is intended for use with adult and pediatric patients (3 years of age and older, and weighing more than 10 kg) for continuous physiologic monitoring of the respiration rate (RR) parameter. The Portrait Electrode Patch transfers carrier signals from the Portrait Wearable Respiration Rate Sensor and transfers impedance and biopotential signals from the patient and transmits them to the Portrait Wearable Respiration Rate Sensor.
The Portrait RR Electrode Patch is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait RR Electrode Patch is not intended for use in a controlled Magnetic Resonance (MR) environment.
#### Portrait™ Sensor Battery (Portrait SBT01)
The Portrait Sensor Battery (Portrait SBT01) is intended for use as a power supply for the Portrait Wearable Sensors and to provide wireless communication to a host device.
The Portrait Sensor Battery is intended for use under the direct supervision of a licensed practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
The Portrait Sensor Battery is not intended for use in a controlled Magnetic Resonance (MR) environment.
#### Portrait™ Bedside Charger (Portrait BCH01)
The Portrait Bedside Charger (Portrait BCH01) is intended for charging the Portrait Sensor Batteries and the Portrait Mobile Patient Monitor (including while the Portrait Mobile Patient Monitor is in use).
The Portrait Bedside Charger is intended for use under the direct 510(k) Summary K230626 GE HealthCare Portrait Mobile Monitoring Solution
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| | supervision of a licensed practitioner, or by personnel trained in<br>proper use of the equipment in a professional healthcare facility. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Portrait Bedside Charger is not intended for use in a<br>controlled Magnetic Resonance (MR) environment. |
| | Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01)<br>The Portrait Mobile Patient Monitor Pouch (Portrait MMP01) is<br>an optional accessory intended to enable the Portrait Mobile<br>Patient Monitor to be carried while the patient is ambulatory. |
| | The Portrait Mobile Patient Monitor pouch is intended for use<br>under the direct supervision of a licensed practitioner, or by<br>personnel trained in proper use of the equipment in a<br>professional healthcare facility. |
| Technology (807.92(a)(6)): | The Portrait Mobile Monitoring Solution uses the same<br>fundamental technology and functionality as the primary<br>predicate primary predicate K171121 Masimo Root Monitoring<br>System. |
| | Both the Portrait Mobile Monitoring Solution and the primary<br>predicate K171121 Masimo Root Monitoring System are<br>lightweight, portable, wireless monitoring systems for<br>monitoring of patient physiological parameters in a professional<br>healthcare environment. Both have similar system topologies,<br>which include sensors that attach to the patient, small portable<br>patient monitors that can be worn or carried by the patient, a set<br>of centralized services installed on a server which is connected<br>to the healthcare facility's enterprise network, and remote<br>viewers with alarming capability that can monitor multiple<br>patients simultaneously. |
| | The main difference between the Portrait Mobile Monitoring<br>Solution and the predicate is that the Portrait Mobile Monitoring<br>Solution only supports SpO2, Pulse Rate, and Respiration Rate<br>while the predicate also supports additional optional parameters<br>The Portrait Mobile Monitoring Solution is substantially<br>equivalent to the predicate. |
| | A summary of the main changes compared to the predicate are<br>listed below in the comparison table. |
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Product Comparison versus Predicate Main features chart follows below.
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| Specification | Primary Predicate<br>Masimo Root Monitoring System and<br>Accessories (K171121) | Reference<br>Predicate Device<br>ViSi Mobile<br>Monitoring<br>System –<br>Predicate<br>(K180472) | Proposed device<br>Portrait Mobile Monitoring<br>Solution - | Discussion of differences<br>between Portrait Mobile<br>Monitoring Solution and<br>Predicates |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Vital Sign Monitor | Vital Sign Monitor | Vital Sign Monitor | Identical |
| FDA Primary<br>Product Code | MWI | MHX | MWI | Identical to primary<br>predicate |
| FDA<br>Classification<br>Regulation | 21 CFR 2300 | 21 CFR 1025 | 21 CFR 2300 | Identical to primary<br>predicate |
| Indications for<br>Use (entire<br>system) | The Masimo Root Monitoring system and<br>Accessories are indicated for use by<br>healthcare professionals for the<br>monitoring of multiple physiological<br>parameters in healthcare environments.<br>The Root Monitoring System, when used<br>with the optional ISA module, is not<br>intended to be used in road<br>ambulances. | The ViSi Mobile<br>Monitoring<br>System is<br>intended for use<br>by clinicians and<br>medically qualified<br>personnel for<br>single or multi-<br>parameter vital<br>signs monitoring<br>of adult patients<br>(18 years or<br>older).<br><br>It is indicated for<br>ECG (3 or 5 lead-<br>wire), respiration<br>rate (RESP), heart<br>rate (HR), non-<br>invasive blood<br>pressure (NIBP),<br>continuous non-<br>invasive blood<br>pressure (cNIBP),<br>non-invasive<br>monitoring of<br>functional oxygen<br>saturation of<br>arterial<br>hemoglobin<br>(SpO2), pulse rate<br>(PR), and skin<br>temperature<br>(TEMP), posture<br>tracking and<br>alarms, skin<br>temperature<br>(TEMP) and basic<br>arrhythmia<br>(Ventricular<br>Tachycardia,<br>Ventricular<br>Fibrillation,<br>Asystole, Atrial<br>Fibrillation)<br>analysis/alarm in<br>hospital-based<br>facilities;<br>including, general<br>medical- surgical<br>floors,<br>intermediate care<br>floors and | The Portrait Mobile<br>Monitoring Solution is<br>intended to acquire, store,<br>calculate, display and export<br>patient monitoring data as<br>well as provide real time<br>alarming for monitoring<br>adult and pediatric patients<br>(3 years of age and older,<br>and weighing more than 10<br>kg).<br><br>Physiological parameters<br>and waveforms supported<br>are:<br>• Pulse oximetry<br>(SpO2/pulse rate)<br>•Respiration rate (RR)<br><br>Continuous pulse oximetry<br>and respiration rate<br>monitoring may be used for<br>patients at risk of<br>cardiorespiratory and<br>infectious complications.<br><br>The Portrait Mobile<br>Monitoring Solution is<br>intended for use under the<br>direct supervision of a<br>licensed practitioner, or by<br>personnel trained in proper<br>use of the equipment in a<br>professional healthcare<br>facility.<br><br>This device is not an Apnea<br>monitor (i.e., do not rely on<br>the device for detection or<br>alarm for the cessation of<br>breathing). This device<br>should not be used for life<br>sustaining/supporting<br>purposes.<br><br>The PORTRAIT Mobile<br>Monitoring Solution is not<br>intended for use in a<br>controlled Magnetic<br>Resonance (MR)<br>environment. | Equivalent<br><br>The Portrait Mobile<br>Monitoring Solution<br>provides substantially<br>equivalent vital sign<br>monitoring parameters<br>including SpO2, Pulse Rate<br>(PR), and Respiration Rate<br>(RR) in adults and pediatrics<br>patients as indicated in the<br>primary predicate device.<br><br>While the primary predicate<br>device provides optional<br>additional parameters not<br>available in the subject<br>device and allows neonatal<br>monitoring for some<br>parameters, the monitoring<br>parameters needed are<br>based on the individual<br>monitoring needs as<br>determined by a clinician.<br>Neither the subject device<br>nor the primary predicate<br>device monitors ECG or<br>arrhythmia.<br><br>The Portrait Mobile<br>Monitoring Solution<br>provides substantially<br>equivalent vital sign<br>monitoring parameters<br>including SpO2, Pulse Rate<br>(PR), and Respiration Rate<br>(RR) compared to the<br>secondary predicate as well.<br>The secondary predicate<br>only measures in adult<br>patients and can monitor<br>ECG and other vital signs in<br>addition to those monitored<br>by the subject device.<br><br>The subject device and<br>predicate devices have<br>similar system topologies,<br>which include sensors that<br>attach to the patient, small<br>portable patient monitors<br>that can be worn or carried |
| saturation of arterial hemoglobin (SpO2), | | including, general | controlled Magnetic | similar system topologies, |
| | pulse rate, carboxyhemoglobin saturation<br>(SpCO), methemoglobin saturation | medical- surgical | Resonance (MR) | which include sensors that |
| | (SpMet), total hemoglobin concentration | floors, | environment.…
