The Care Team Portal is intended to support management of health conditions. It allows a clinical user to configure the collection of patient data. The Care Team Portal includes the ability to notify the patient and the clinical user when the parameters fall outside set limits and customize patient specific recommendations.

Device Description

Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices.

The Care Team Portal allows the clinical user to view and manage patient information. The functionality includes the ability to add new users and patients, ability to schedule video visits, secure in-app messaging, configure the collection of patient data leveraging care pathways survey questions, educational content and videos with customized notifications, and prioritize patients. It provides a dashboard view of the patients being monitored.

The patient portals enable the patient to provide subjective symptom or health status information that assists the care team in supporting the management of health conditions:
+Home is an option that provides the patient with software pre-loaded on a tablet that allows them to navigate through care pathways for the collection of patient data and view educational content related to their health condition.
+Go is designed for patients to download the software to their own mobile device to navigate through care pathways for the collection of patient data and delivery of educational content related to their health condition.
+Voice allows patients to answer their pathways questions and enter data using their phone.

Accessory devices can be connected to the system to allow for collection of vital signs or used independently to allow for manual input.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for an AI/machine learning medical device.

The document discusses the Vivify Health, Inc. Care Team Portal, which is a Remote Patient Monitoring System. This system is software-only and designed to help clinical users manage health conditions by configuring the collection of patient data, notifying them when parameters fall outside set limits, and customizing patient-specific recommendations.

The 510(k) summary compares the Vivify Care Team Portal to a predicate device, the Philips (Visicu) eCare Coordinator (K171029). The document states that clinical studies were not required to demonstrate substantial equivalence, and that the device was verified and validated through internal functional, system-level, and usability testing.

Therefore, none of the specific questions regarding acceptance criteria for an AI device, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance can be answered from this text. The document explicitly states: "Clinical studies were not required to demonstrate substantial equivalence of the Care Team Portal." and "Results from internal verification and validation testing established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new questions of safety and effectiveness were raised."

This suggests that the "Care Team Portal" is primarily a data management and notification system, rather than an AI-driven diagnostic or prognostic tool that would typically require the detailed performance studies you've inquired about.

Summary

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February 6, 2023

Vivify Health, Inc. % Jodi Scott Partner Hogan Lovells, US LLP 555 Thirteenth Street, NW Columbia Square Washington, District of Columbia 20004

Re: K222398

Trade/Device Name: Care Team Portal Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: January 9, 2023 Received: January 9, 2023

Dear Jodi Scott:

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.

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.

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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 (QS) 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 mediation-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.

Shruti N. Mistry -S

for

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K222398

Device Name

Care Team Portal

Indications for Use (Describe)

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

( Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. General Information

510(k) Sponsor	Vivify Health Inc.7201 Bishop Rd. Suite #E200Plano, TX 75024
Submitter	Tracey Fox, Sr. Director Regulatory Affairstracey.fox@optum.com763-330-9208
AdditionalCorrespondent	Jodi Scott, Partnerjodi.scott@hoganlovells.com303 454 2463
Date Prepared	5 August 2022

2. Device Identification

Trade Name	Care Team Portal
Common Name	Remote Patient Monitoring System
Product Code	DRG - Transmitters and Receivers, Physiological signal, Radiofrequency
Regulation Number	870.2910 - Radiofrequency physiological signal transmitter and receiver
Device Class	II

3. Predicate Information

Trade Name	eCare Coordinator
510(k) Number	K171029
Product Code	DRG - Transmitters and Receivers, Physiological signal, Radiofrequency
Regulation Number	870.2910 - Radiofrequency physiological signal transmitter and
	receiver
Device Class	II

4. Device Description

Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices.

The patient portals enable the patient to provide subjective symptom or health status information that assists the care team in supporting the management of health conditions:

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+Home is an option that provides the patient with software pre-loaded on a tablet that allows them to navigate through care pathways for the collection of patient data and view educational content related to their health condition.

+Go is designed for patients to download the software to their own mobile device to navigate through care pathways for the collection of patient data and delivery of educational content related to their health condition.

+Voice allows patients to answer their pathways questions and enter data using their phone.

Accessory devices can be connected to the system to allow for collection of vital signs or used independently to allow for manual input.

5. Indications for Use

	Vivify Care Team Portal	Philips (Visicu)eCare Coordinator K171029	Comparison
Product Code	DRG	DRG	Same
Indications forUse	The Care Team Portal isintended to supportmanagement of healthconditions. It allows a clinicaluser to configure thecollection of patient data. TheCare Team Portal includes theability to notify the patientand the clinical user when theparameters fall outside setlimits and customize patientspecific recommendations.	eCare Coordinator and itsaccessories are indicated for useby patients and by care teamsfor collecting and reviewingpatient data from patients whoare capable and willing toengage in use of this software,to transmit medical and non-medical information throughintegrated technologies.	Substantially equivalent –minor wording differences. Theindications for use of theproposed device fall withinthe intended use of thepredicate device to providepatient informationfrom the patient locationthrough networkingtechnology to a remote careteam.
FundamentalTechnology	Software Only	Software Only	Same
PatientPopulation	Home users	Home users	Same
UserInterfaces	Care Team Portal; PatientPortal	Clinical (eCC) andPatient (eCP)	Same
BiometricParameters	Blood PressureWeightBlood GlucoseOxygen SaturationTemperaturePulse Rate	Blood PressureWeightBlood GlucoseOxygen SaturationTemperaturePulse Rate	Same
AlarmFunctionality	None	None	Same

1. Substantial Equivalence

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	Vivify Care Team Portal	Philips (Visicu)eCare Coordinator K171029	Comparison
Overall Score	Health index score based onbiometric measurements,survey responses, and alerts.	Sum of weighted scores for:Measurements, surveyresponses, issues,readmission risk and dayssince discharge.	Substantially equivalent -proposed device usesbiometric measurements,survey responses, and alerts inthe equation.
Interventionrules/ Flags	Used to trigger notifications(flags) to clinician.Customizable by institution orclinician.	Used to trigger notifications(flags) to clinician. Customizableby institution or clinician.	Same
DataCollection	Wireless Bluetooth andmanual entry	Wireless Bluetooth and manualentry	Same
Pathways	Clinical users have the optionof utilizing the library ofPathways available fromVivify, they may request Vivifyto create a custom pathwayfor them, or they maycustomize a pathway andcreate patient specificrecommendations.	Used to set patient tasks,surveys and intervention rules.Customizable by institution orclinician	Substantially equivalent -proposed device allows for useof library of pathways orcustomization throughavailable questions.
Surveys	Clinical users have option tosend surveys to patients	Clinical users have option tosend surveys to patients	Same
Reports	Patient Summary report and avariety of systemadministration reportsavailable.	Hard copy patient recordreport and systemadministration reports.	Substantially equivalent -proposed device providessimilar reporting options.
Video Calls	Capability to schedule andconduct video calls withcare providers	Capability to schedule andconduct video calls withcare providers	Same
EducationalVideos	Access to patient educationvideo library	Access to pre-installededucational videos	Same

7. Performance Data

Results from internal verification and validation testing established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new questions of safety and effectiveness were raised. The Care Team Portal was designed, verified, and validated according to the company's Design Control process. Testing included detailed functional, system level and usability testing. Test results demonstrated that the Care Team Portal meets all specifications and user needs.

The subject of this submission, Care Team Portal, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing. Clinical studies were not required to demonstrate substantial equivalence of the Care Team Portal.

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8. Conclusion

Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, the Care Team Portal raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).