(182 days)
No
The summary describes a remote patient monitoring system with features for data collection, notifications based on set limits, and customizable recommendations. There is no mention of AI, ML, or any algorithms that learn or adapt from data to perform tasks like diagnosis, prediction, or image analysis. The functionality appears to be based on pre-configured rules and thresholds.
No.
The device supports the management of health conditions by facilitating data collection, notification, and communication, but it does not directly treat or diagnose conditions.
No
Justification: This device supports the management of health conditions by allowing clinical users to configure data collection, monitor parameters, and provide recommendations. It primarily focuses on patient data management and communication rather than diagnosing conditions itself.
No
The device description explicitly states that the system includes "accessory devices" which can be connected for vital sign collection or used independently for manual input. This indicates the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "support management of health conditions" by allowing clinical users to configure data collection, notify users and patients based on parameters, and customize recommendations. This focuses on managing existing conditions and facilitating communication and data flow, not on diagnosing a disease or condition based on in vitro analysis of biological samples.
- Device Description: The description details a system for remote patient monitoring, including a portal for clinical users to view and manage patient information, patient portals for data input and educational content, and accessory devices for collecting vital signs. None of these components or their functions involve the in vitro examination of specimens derived from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic interpretation of laboratory results
The device is clearly focused on remote patient monitoring and data management for supporting the care of individuals with existing health conditions. This falls under the category of a clinical decision support or patient management system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
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)
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)
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3
510(k) Summary
1. General Information
| 510(k) Sponsor | Vivify Health Inc.
7201 Bishop Rd. Suite #E200
Plano, TX 75024 |
|-----------------------------|-------------------------------------------------------------------------------------|
| Submitter | Tracey Fox, Sr. Director Regulatory Affairs
tracey.fox@optum.com
763-330-9208 |
| Additional
Correspondent | Jodi Scott, Partner
jodi.scott@hoganlovells.com
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)
eCare Coordinator K171029 | Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DRG | DRG | Same |
| 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. | eCare Coordinator and its
accessories are indicated for use
by patients and by care teams
for collecting and reviewing
patient data from patients who
are capable and willing to
engage in use of this software,
to transmit medical and non-
medical information through
integrated technologies. | Substantially equivalent –
minor wording differences. The
indications for use of the
proposed device fall within
the intended use of the
predicate device to provide
patient information
from the patient location
through networking
technology to a remote care
team. |
| Fundamental
Technology | Software Only | Software Only | Same |
| Patient
Population | Home users | Home users | Same |
| User
Interfaces | Care Team Portal; Patient
Portal | Clinical (eCC) and
Patient (eCP) | Same |
| Biometric
Parameters | Blood Pressure
Weight
Blood Glucose
Oxygen Saturation
Temperature
Pulse Rate | Blood Pressure
Weight
Blood Glucose
Oxygen Saturation
Temperature
Pulse Rate | Same |
| Alarm
Functionality | None | None | Same |
-
- Substantial Equivalence
5
| | Vivify Care Team Portal | Philips (Visicu)
eCare Coordinator K171029 | Comparison |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Overall Score | Health index score based on
biometric measurements,
survey responses, and alerts. | Sum of weighted scores for:
Measurements, survey
responses, issues,
readmission risk and days
since discharge. | Substantially equivalent -
proposed device uses
biometric measurements,
survey responses, and alerts in
the equation. |
| Intervention
rules/ Flags | Used to trigger notifications
(flags) to clinician.
Customizable by institution or
clinician. | Used to trigger notifications
(flags) to clinician. Customizable
by institution or clinician. | Same |
| Data
Collection | Wireless Bluetooth and
manual entry | Wireless Bluetooth and manual
entry | Same |
| Pathways | Clinical users have the option
of utilizing the library of
Pathways available from
Vivify, they may request Vivify
to create a custom pathway
for them, or they may
customize a pathway and
create patient specific
recommendations. | Used to set patient tasks,
surveys and intervention rules.
Customizable by institution or
clinician | Substantially equivalent -
proposed device allows for use
of library of pathways or
customization through
available questions. |
| Surveys | Clinical users have option to
send surveys to patients | Clinical users have option to
send surveys to patients | Same |
| Reports | Patient Summary report and a
variety of system
administration reports
available. | Hard copy patient record
report and system
administration reports. | Substantially equivalent -
proposed device provides
similar reporting options. |
| Video Calls | Capability to schedule and
conduct video calls with
care providers | Capability to schedule and
conduct video calls with
care providers | Same |
| Educational
Videos | Access to patient education
video library | Access to pre-installed
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.