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 O
Device Facts
| Record ID | K234130 |
|---|---|
| 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 O |
| Applicant | Ge Medical Systems Information Technologies, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Mar 20, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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 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.
Device Story
Wireless multiparameter monitoring system; acquires SpO2, pulse rate, and respiration rate via wearable sensors (pulse oximetry and impedance respiration); transmits data via MBAN to handheld mobile monitor (Portrait HUBXB) or central viewer (Portrait CVAXB). System components include wearable sensors, sensor battery, bedside charger, mobile monitor, and central viewer software. Used in professional healthcare facilities under clinician supervision. Provides real-time waveforms, numerics, and alarms. Enables continuous monitoring for patients at risk of cardiorespiratory/infectious complications. Supports clinical decision-making through real-time data display and alarm annunciation. Features include QR code patient data transfer and RTLS support.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including software verification, hardware performance, biocompatibility, human factors/usability (15 clinical/15 technical users), and cybersecurity validation.
Technological Characteristics
Wireless MBAN (2390-2400 MHz) connectivity; SpO2 (LED 600-1000 nm) and impedance respiration sensing. Handheld monitor (3.7-inch touchscreen) and PC-based central viewer. Lithium-ion battery powered. Software-based alarm management. Complies with IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, and IEC 62304. Biocompatible materials per ISO 10993-1.
Indications for Use
Indicated for continuous monitoring of SpO2, pulse rate, and respiration rate in adult and pediatric patients (≥3 years, >10 kg) in professional healthcare facilities. Not for apnea monitoring or life support. Not for use in 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
- Portrait Mobile Monitoring Solution v1.0 (K230626)
Related Devices
- K230626 — 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. · Aug 11, 2023
- K223498 — Radius VSM and Accessories · Masimo Corporation · Jun 1, 2023
- K122036 — VISI MOBILE MONITORING SYSTEM · Sotera Wireless, Inc. · Aug 15, 2012
- K133586 — VISI MOBILE MONITIORING SYSTEM · Sotera Wireless, Inc. · Dec 18, 2013
- K172586 — Vios Monitoring System Model 2050 · Vios Medical, Inc. · Jun 22, 2018
Submission Summary (Full Text)
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
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
{3}------------------------------------------------
# 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.
{4}------------------------------------------------
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.
{5}------------------------------------------------
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{7}------------------------------------------------
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
{8}------------------------------------------------
| Device names (807.92(a)(2)): | |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Portrait Mobile Monitoring Solution V1.1 consists of the following:<br>PortraitTM Central Viewer Application (Portrait CVAXB)<br>PortraitTM Core Services (Portrait CSSXB)<br>PortraitTM Clinical Alarming Unit (Portrait CAU01)<br>PortraitTM Mobile Patient Monitor Hardware (Portrait HUBXB)<br>PortraitTM Mobile Patient Monitor Software (Portrait HSWXB)<br>PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01)<br>PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01)<br>PortraitTM Wearable Pulse Oximetry Sensor (Portrait SpO2 P-W01, Portrait SpO2 P-SE01)<br>PortraitTM SpO2 Attachment Accessory Band (Portrait AAB01)<br>PortraitTM Wearable Respiration Rate Sensor (Portrait RR P-RR01)<br>PortraitTM RR Electrode Patch (Portrait RRP01)<br>PortraitTM Sensor Battery (Portrait SBT01)<br>PortraitTM Bedside Charger (Portrait BCH01)<br>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<br>21 CFR 870.2910 Radiofrequency physiological signal transmitter and receiver<br>21 CFR 868.2375 monitor, breathing frequency<br>21 CFR 870.2700 oximeter |
| Product Code: | MWI |
| Subsequent Product Codes: | MSX<br>DRG<br>BZQ<br>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.
{13}------------------------------------------------
#### 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.
{14}------------------------------------------------
#### 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.
{15}------------------------------------------------
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.
{16}------------------------------------------------
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.
{18}------------------------------------------------
- . 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.
{19}------------------------------------------------
| Specification | Reference Predicate Device<br>Portrait Mobile Monitoring Solution -<br>K230626 | Proposed device<br>Portrait Mobile Monitoring Solution - | Discussion of differences between<br>Portrait Mobile Monitoring Solution<br>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<br>Solution is intended to acquire, store,<br>calculate, display and export patient<br>monitoring data as well as provide real<br>time alarming for monitoring adult<br>and pediatric patients (3 years of age<br>and older, and weighing more than 10<br>kg).<br>Physiological parameters and<br>waveforms supported are:<br>• Pulse oximetry (SpO2/pulse<br>rate)<br>• Respiration rate (RR)<br>Continuous pulse oximetry and<br>respiration rate monitoring may be<br>used for patients at risk of<br>cardiorespiratory and infectious<br>complications.<br>The Portrait Mobile Monitoring<br>Solution is intended for use under the<br>direct supervision of a licensed<br>practitioner, or by personnel trained in<br>proper use of the equipment in a<br>professional healthcare facility.<br>This device is not an Apnea monitor<br>(i.e., do not rely on the device for<br>detection of alarm for the cessation of<br>breathing).<br>This device should not be used for life<br>sustaining/supporting purposes.<br>The PORTRAIT Mobile Monitoring<br>Solution is not intended for use in a | The Portrait Mobile Monitoring<br>Solution is intended to acquire, store,<br>calculate, display and export patient<br>monitoring data as well as provide real<br>time alarming for monitoring adult and<br>pediatric patients (3 years of age and<br>older, and weighing more than 10 kg).<br>Physiological parameters and<br>waveforms supported are:<br>• Pulse oximetry (SpO2/pulse<br>rate)<br>• Respiration rate (RR)<br>Continuous pulse oximetry and<br>respiration rate monitoring may be<br>used for patients at risk of<br>cardiorespiratory and infectious<br>complications.<br>The Portrait Mobile Monitoring<br>Solution is intended for use under the<br>direct supervision of a licensed<br>healthcare practitioner, or by<br>personnel trained in proper use of the<br>equipment in a professional healthcare<br>facility.<br>This device is not an Apnea monitor<br>(i.e., do not rely on the device for<br>detection of alarm for the cessation of<br>breathing).<br>This device should not be used for life<br>sustaining/supporting purposes.<br>The PORTRAIT Mobile Monitoring<br>Solution is not intended for use in a | Equivalent<br>A typo was corrected in the indications<br>statement to add the word<br>"healthcare" so that "…licensed<br>professional, " changes to "…licensed<br>healthcare professional, "<br>This difference does not significantly<br>affect safety and/or effectiveness. |
| | controlled Magnetic Resonance (MR)<br>environment. | controlled Magnetic Resonance (MR)<br>environment. | |
| Patient Population | Adult and pediatric patients (3 years of<br>age and older, and weighing more<br>than 10 kg). | Adult and pediatric patients (3 years of<br>age and older, and weighing more<br>than 10 kg). | Identical |
| Environments of Use | A professional healthcare facility | A professional healthcare facility | Identical |
| Location of devices in the patient<br>vicinity | In the Portrait Mobile Monitoring<br>Solution, only the sensors must be<br>located on the patient. The monitor is<br>connected wirelessly to the sensors,<br>and as such, must only be located in<br>the vicinity of the patient. However,<br>the monitor may be worn by the<br>patient using Portrait Mobile Patient<br>Monitor Pouch. The monitor is also<br>capable of being carried in one hand. | In the Portrait Mobile Monitoring<br>Solution, only the sensors must be<br>located on the patient. The monitor is<br>connected wirelessly to the sensors,<br>and as such, must only be located in<br>the vicinity of the patient. However,<br>the monitor may be worn by the<br>patient using Portrait Mobile Patient<br>Monitor Pouch. The monitor is also<br>capable of being carried in one hand.…
