Care Team Portal

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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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use Submission Number (if known) K222398 Device Name Care Team Portal Indications for Use (Describe) 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. 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." {3}------------------------------------------------ # 510(k) Summary #### 1. General Information | 510(k) Sponsor | Vivify Health Inc.<br>7201 Bishop Rd. Suite #E200<br>Plano, TX 75024 | |-----------------------------|-------------------------------------------------------------------------------------| | Submitter | Tracey Fox, Sr. Director Regulatory Affairs<br>tracey.fox@optum.com<br>763-330-9208 | | Additional<br>Correspondent | Jodi Scott, Partner<br>jodi.scott@hoganlovells.com<br>303 454 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 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: {4}------------------------------------------------ +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 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. | | Vivify Care Team Portal | Philips (Visicu)<br>eCare Coordinator K171029 | Comparison | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | DRG | DRG | Same | | Indications for<br>Use | The Care Team Portal is<br>intended to support<br>management of health<br>conditions. It allows a clinical<br>user to configure the<br>collection of patient data. The<br>Care Team Portal includes the<br>ability to notify the patient<br>and the clinical user when the<br>parameters fall outside set<br>limits and customize patient<br>specific recommendations. | eCare Coordinator and its<br>accessories are indicated for use<br>by patients and by care teams<br>for collecting and reviewing<br>patient data from patients who<br>are capable and willing to<br>engage in use of this software,<br>to transmit medical and non-<br>medical information through<br>integrated technologies. | Substantially equivalent –<br>minor wording differences. The<br>indications for use of the<br>proposed device fall within<br>the intended use of the<br>predicate device to provide<br>patient information<br>from the patient location<br>through networking<br>technology to a remote care<br>team. | | Fundamental<br>Technology | Software Only | Software Only | Same | | Patient<br>Population | Home users | Home users | Same | | User<br>Interfaces | Care Team Portal; Patient<br>Portal | Clinical (eCC) and<br>Patient (eCP) | Same | | Biometric<br>Parameters | Blood Pressure<br>Weight<br>Blood Glucose<br>Oxygen Saturation<br>Temperature<br>Pulse Rate | Blood Pressure<br>Weight<br>Blood Glucose<br>Oxygen Saturation<br>Temperature<br>Pulse Rate | Same | | Alarm<br>Functionality | None | None | Same | - 6. Substantial Equivalence {5}------------------------------------------------ | | Vivify Care Team Portal | Philips (Visicu)<br>eCare Coordinator K171029 | Comparison | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Overall Score | Health index score based on<br>biometric measurements,<br>survey responses, and alerts. | Sum of weighted scores for:<br>Measurements, survey<br>responses, issues,<br>readmission risk and days<br>since discharge. | Substantially equivalent -<br>proposed device uses<br>biometric measurements,<br>survey responses, and alerts in<br>the equation. | | Intervention<br>rules/ Flags | Used to trigger notifications<br>(flags) to clinician.<br>Customizable by institution or<br>clinician. | Used to trigger notifications<br>(flags) to clinician. Customizable<br>by institution or clinician. | Same | | Data<br>Collection | Wireless Bluetooth and<br>manual entry | Wireless Bluetooth and manual<br>entry | Same | | Pathways | Clinical users have the option<br>of utilizing the library of<br>Pathways available from<br>Vivify, they may request Vivify<br>to create a custom pathway<br>for them, or they may<br>customize a pathway and<br>create patient specific<br>recommendations. | Used to set patient tasks,<br>surveys and intervention rules.<br>Customizable by institution or<br>clinician | Substantially equivalent -<br>proposed device allows for use<br>of library of pathways or<br>customization through<br>available questions. | | Surveys | Clinical users have option to<br>send surveys to patients | Clinical users have option to<br>send surveys to patients | Same | | Reports | Patient Summary report and a<br>variety of system<br>administration reports<br>available. | Hard copy patient record<br>report and system<br>administration reports. | Substantially equivalent -<br>proposed device provides<br>similar reporting options. | | Video Calls | Capability to schedule and<br>conduct video calls with<br>care providers | Capability to schedule and<br>conduct video calls with<br>care providers | Same | | Educational<br>Videos | Access to patient education<br>video library | Access to pre-installed<br>educational 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. {6}------------------------------------------------ ## 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.