VitalWatch Software User Interface

K170973 · Vitalconnect, Inc. · DRG · Jun 2, 2017 · Cardiovascular

Device Facts

• Record ID: K170973
• Device Name: VitalWatch Software User Interface
• Applicant: Vitalconnect, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jun 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

VitalWatch is a software user interface intended for use by healthcare professionals to display physiological data collected by the VitalConnect Platform 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 Story

VitalWatch is a software user interface (UI) for the VitalConnect Platform wireless remote monitoring system. It functions as a secondary, adjunct patient monitor. The device receives physiological data—including ECG, heart rate, HRV, R-R interval, respiratory rate, skin temperature, activity, and posture—from a validated Relay device. The software displays this data to healthcare professionals in home or clinical settings. It does not replace standard-of-care monitoring. The UI allows clinicians to visualize patient status, aiding in clinical oversight. The system is designed to be manufacturer-installed and user-executed on a validated Relay device.

Clinical Evidence

Bench testing only. Software verification and validation testing were conducted in accordance with FDA guidance for software in medical devices, human factors/usability engineering, and cybersecurity.

Technological Characteristics

Software user interface for wireless remote monitoring system. Operates on a validated Relay device. Displays physiological data (ECG, heart rate, HRV, R-R interval, respiratory rate, skin temperature, activity, posture). Software level of concern: Moderate.

Indications for Use

Indicated for use by healthcare professionals to display physiological data (ECG, heart rate, HRV, R-R interval, respiratory rate, skin temperature, activity, posture) collected by the VitalConnect Platform wireless remote monitoring system in home and healthcare settings.

Regulatory Classification

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.

Predicate Devices

• VitalConnect Platform (K152139)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| <span style="font-family: Arial;">☑</span> 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 [phone]

## Contact Person

Kevin Potgieter, MS, RAC Senior Manager, Regulatory Affairs Office: [phone] Cell: [phone] Fax: [phone] Email: [e-mail]

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

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.

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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 Device<br>K152139 | Modified Device<br>VitalWatch |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II | Class II |
| Classification<br>Name | Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | Transmitters and Receivers,<br>Physiological Signal, Radiofrequency |
| Product Code | DRG | DRG |
| Trade Name | VitalConnect Platform®,<br>HealthPatch® MD, VitalPatch® | VitalConnect Platform®,<br>HealthPatch® MD, VitalPatch®,<br>VitalWatchTM |
| Physiological<br>Data<br>Monitored | Heart rate, electrocardiography<br>(ECG), heart rate variability, R-R<br>interval, respiratory rate, skin<br>temperature, activity (including step<br>count), and posture (body position<br>relative to gravity including fall) | Heart rate, electrocardiography<br>(ECG), heart rate variability, R-R<br>interval, respiratory rate, skin<br>temperature, activity (including step<br>count), and posture (body position<br>relative to gravity including fall) |
| Principles of<br>Operation | Display of data from validated Relay<br>device using third-party developed<br>Graphical User Interface and<br>optional transmission of data to<br>Secure Server. | Display of data from validated Relay<br>device using third-party developed<br>Graphical User Interface, or<br>VitalWatch, and optional<br>transmission of data to Secure Server. |

# Summary Substantial Equivalence Table