VitalWatch is a software user intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.

Device Description

VitalWatch is a software user interface designed to be manufacturer-installed and user-executed on a validated Relay device, which serves as a graphical user interface that displays physiological data provided by the VitalConnect wireless remote monitoring system.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the VitalWatch Software User Interface. However, it does not include detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation studies for AI/ML medical devices.

The document is a regulatory submission for a software user interface (VitalWatch) that displays physiological data collected by an existing wireless remote monitoring system (VitalConnect Platform). The core of this submission revolves around demonstrating substantial equivalence to a predicate device, not necessarily a new clinical performance study.

Therefore, many of the requested details about acceptance criteria, test set characteristics, expert involvement, and ground truth establishment are not present in this regulatory document, as it pertains to a user interface rather than an algorithm performing a diagnostic task.

Here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance (Based on provided text, limited information)

Since this submission focuses on "substantial equivalence" for a user interface, rather than a new diagnostic algorithm, explicit performance metrics and acceptance criteria for clinical efficacy (e.g., sensitivity, specificity, accuracy) are not detailed. The performance discussed is related to software verification and validation.

Acceptance Criteria Type	Acceptance Criteria (Not explicitly stated for clinical performance, only for software V&V)	Reported Device Performance
Software Verification & Validation	Adherence to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices."	"Software verification and validation testing was conducted and documentation is provided in accordance with the Guidance..."
Level of Concern	Moderate Level of Concern addressed.	"VitalWatch software has a 'Moderate' Level of Concern."
Intended Use	Device displays physiological data as a secondary, adjunct monitor; not intended to replace existing standard-of-care.	The device's functionality as a display for existing data aligns with this intended use.
Technological Characteristics	No changes to the technological characteristics of the VitalConnect Platform.	"This 510(k) does not involve any changes to the technological characteristics of the VitalConnect Platform."
Substantial Equivalence	Same intended use and technological characteristics as the predicate device.	"The VitalConnect Platform, modified to include the VitalWatch software user interface, has the same intended use and technological characteristics as the predicate device and is therefore substantially equivalent to the predicate device."

Study Details:

1. A table of acceptance criteria and the reported device performance:
- See the table above. The focus is on software quality and functional equivalence, not clinical performance metrics like diagnostic accuracy.
2. Sample size used for the test set and the data provenance:
- Not specified. The document mentions "software verification and validation testing," but it does not describe a clinical test set with patient data for performance evaluation in the context of an AI/ML algorithm. This is a user interface for displaying pre-existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Ground truth establishment by experts is typically relevant for diagnostic AI algorithms. For a user interface displaying data, the "ground truth" would be the accurate transmission and display of the physiological data collected by the established VitalConnect platform, which is presumed to be accurate from its own prior clearance (K152139).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication is used to resolve discrepancies in expert readings for diagnostic or screening tasks. This is not a diagnostic device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI-assisted diagnostic device. It is a user interface for displaying data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a user interface, part of a system where a human professional interprets the displayed data. It's not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not specified in detail. For a user interface, the "ground truth" would be the integrity and accuracy of the data displayed against the raw data from the sensors. The document relies on the prior clearance of the VitalConnect Platform and the software's functional verification.
8. The sample size for the training set:
- Not applicable. This is not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning model.

Summary:

The provided document (K170973) is a 510(k) submission for a software user interface (VitalWatch), not a new diagnostic or AI/ML algorithm. Its clearance relies on demonstrating substantial equivalence to a previously cleared predicate device (VitalConnect Platform, K152139) by showing that it has the same intended use and technological characteristics, and that software verification and validation protocols have been followed. Therefore, the details requested about clinical validation studies, expert involvement, and ground truth establishment for diagnostic performance are largely not applicable or not provided in this specific type of regulatory submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2017

VitalConnect, Inc. Kevin Potgieter Senior Manager, Regulatory Affairs 224 Airport Parkway, Suite 300 San Jose, California 95110

Re: K170973

Trade/Device Name: VitalWatch Software User Interface Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: March 31, 2017 Received: April 3, 2017

Dear Kevin Potgieter:

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. 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.

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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

M.A. Hilleman

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170973

Device Name VitalWatch Software User Interface

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 - VitalWatch™ Software User Interface

510(k) Owner's Name, Address, and Telephone Number

VitalConnect, Inc. 224 Airport Parkway, Suite 300 San Jose. CA 95110 (408) 963-4600

Contact Person

Kevin Potgieter, MS, RAC Senior Manager, Regulatory Affairs Office: (408) 963-4603 Cell: (424) 263-8484 Fax: (408) 963-2828 Email: kpotgieter@vitalconnect.com

510(k) Number: K170973

Date Prepared: 31 May 2017

Trade Name of Device: VitalWatch Software User Interface

Common or Usual Name: User Interface for Wireless Remote Monitoring System

Classification Name: 21 CFR 870.2910 - Transmitters and Receivers, Physiological Signal, Radiofrequency

Product Code: DRG

Predicate Device(s) VitalConnect Platform by VitalConnect, Inc. (K152139)

Intended Use

VitalWatch is a software user interface intended for use by healthcare professionals to display physiological data collected by the VitalConnect wireless remote monitoring system in home and healthcare settings. VitalWatch is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.

Device Description

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Technological Characteristics

This 510(k) does not involve any changes to the technological characteristics of the VitalConnect Platform.

Performance Data

Software verification and validation testing was conducted and documentation is provided in accordance with the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Applying Human Factors and Usability Engineering to Medical Devices, and Postmarket Management of Cybersecurity in Medical Devices. VitalWatch software has a "Moderate" Level of Concern.

Substantial Equivalence

The VitalConnect Platform, modified to include the VitalWatch software user interface, has the same intended use and technological characteristics as the predicate device and is therefore substantially equivalent to the predicate device.

Conclusions

The VitalConnect Platform is substantially equivalent to the predicate device. The modifications described in this 510(k) do not raise different questions of safety and effectiveness.

Topic	Predicate DeviceK152139	Modified DeviceVitalWatch
Classification	Class II	Class II
ClassificationName	Transmitters and Receivers,Physiological Signal,Radiofrequency	Transmitters and Receivers,Physiological Signal, Radiofrequency
Product Code	DRG	DRG
Trade Name	VitalConnect Platform®,HealthPatch® MD, VitalPatch®	VitalConnect Platform®,HealthPatch® MD, VitalPatch®,VitalWatchTM
PhysiologicalDataMonitored	Heart rate, electrocardiography(ECG), heart rate variability, R-Rinterval, respiratory rate, skintemperature, activity (including stepcount), and posture (body positionrelative to gravity including fall)	Heart rate, electrocardiography(ECG), heart rate variability, R-Rinterval, respiratory rate, skintemperature, activity (including stepcount), and posture (body positionrelative to gravity including fall)
Principles ofOperation	Display of data from validated Relaydevice using third-party developedGraphical User Interface andoptional transmission of data toSecure Server.	Display of data from validated Relaydevice using third-party developedGraphical User Interface, orVitalWatch, and optionaltransmission of data to Secure Server.

Summary Substantial Equivalence Table

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).