The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. This can include heart rate, electrocardiography (ECG), heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data are transmitted wirelessly from the VitalConnect Sensor for storage and analysis. The VitalConnect Platform can include the ability to notify healthcare professionals when physiological data fall outside selected parameters.

The device is intended for use on general care patients who are 18 years of age or older as a general patient monitor, to provide physiological information. The data from the VitalConnect Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

Device Description

VitalPatch is a wearable biosensor which may be used as part of the VitalConnect Platform. The device is a disposable, battery-powered, adhesive patch containing sensors used to gather patients' physiological data, which are transmitted wirelessly. The modification proposed in this 510(k) increases the wear duration for the VitalPatch wearable biosensor from 96 hours to 120 hours.

AI/ML Overview

The provided text is a 510(k) summary for a modification to the VitalPatch® VitalConnect Platform. This submission focuses on extending the wear duration of the device from 96 hours to 120 hours. As such, the detailed information typically found in a comprehensive clinical study report, like specific acceptance criteria for diagnostic performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, is not explicitly present for all physiological parameters. However, the document does list performance tests performed and the nature of the modification.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each physiological parameter (heart rate, ECG, etc.) in the context of this specific 510(k) for extended wear duration. The focus of this submission is primarily on extending the wear duration and ensuring the device continues to function as intended without raising new questions of safety or effectiveness. The performance data mentioned relates to engineering and wear-duration aspects.

Acceptance Criteria Category	Reported Device Performance (as stated in this 510(k) summary)
Wear Duration	Extended from 96 hours to 120 hours.
Electrical Safety	Passed IEC 60601-1, 3.1 Ed.
Electromagnetic Compatibility	Passed IEC 60601-1-2, 4th Ed.
Battery Performance	Internal performance testing passed.
Skin Adherence/Wear Duration	Internal performance testing passed for extended duration.
Wear Performance (Sensor Functionality)	Internal performance testing passed for extended duration.
Wireless Coexistence	Demonstrated compliance with FDA Radio Frequency Wireless Technology in Medical Devices guidance.
Firmware Verification and Validation	Complied with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Substantial Equivalence	Device remains substantially equivalent to the predicate device K152139, as the modifications do not raise different questions of safety and effectiveness.
Physiological Data Monitored	No change in the list of monitored vital signs: Heart rate, ECG, heart rate variability, R-R interval, respiratory rate, skin temperature, activity (including step count), and posture (including fall). Performance for these parameters is implicitly assumed to be maintained from the predicate device given the "no change to technological characteristics" statement.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "internal performance testing" was conducted for battery performance, skin adherence/wear duration, and wear performance (sensor functionality) in support of extending the wear duration to 120 hours. However, it does not specify the sample size for this testing.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given it was "internal performance testing" for a 510(k) for a modification (wear duration extension), it was likely prospective testing conducted by the manufacturer, Vital Connect, Inc., to validate the extended wear duration.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not provide information regarding the use of experts or their qualifications for establishing ground truth related to the performance of physiological parameters or the extended wear duration. The performance tests mentioned (electrical safety, EMC, battery, adherence, sensor functionality, firmware) typically use objective measurements against established standards or internal benchmarks rather than expert-derived ground truth in the way a diagnostic AI algorithm might.

4. Adjudication Method for the Test Set

As no "ground truth" established by experts or human readers is explicitly mentioned for the performance tests conducted, no adjudication method is described in this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted as described in this document. The submission is for a device modification (wear duration extension) of a physiological remote monitoring system, not for a diagnostic AI algorithm that typically necessitates such studies to compare human reader performance with and without AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

A standalone performance study in the context of an "algorithm only" for diagnostic purposes was not explicitly described in this 510(k) summary. The VitalConnect Platform transmits physiological data for healthcare professionals' use, and the performance tests mentioned are related to the hardware's safety, functionality, and wear duration, not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

For the specific performance tests conducted in support of this 510(k) (battery performance, skin adherence/wear duration, wear performance (sensor functionality)), the ground truth would have been established through objective measurements and engineering criteria rather than expert consensus, pathology, or outcomes data. For example, battery performance would be measured against expected discharge curves, skin adherence against defined detachment thresholds, and sensor functionality against known physical or electrical standards.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This 510(k) is for a hardware modification (extended wear duration) and not for the development or modification of an AI/ML algorithm that typically requires a training set. The "firmware verification and validation" mentioned refers to ensuring the software components function correctly for the extended duration, not to the training of a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned as part of this 510(k) submission, this information is not applicable and not provided in the document.

Summary

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November 2, 2017

Vital Connect, Inc. Kevin Potgieter Senior Manager, Regulatory Affairs 900 E. Hamilton Avenue Suite 500 Campbell, California 95008

Re: K163453

Trade/Device Name: VitalPatch® VitalConnect Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: October 12, 2017 Received: October 13, 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 of medical device-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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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. Willehemen
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) K163453

Device Name VitalPatch® VitalConnect Platform

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY - Modification to VitalPatch®

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 Direct: (408) 963-4603 (408) 963-2828 Fax: Email: kpotgieter@vitalconnect.com

510(k) Number: K163453

Date Prepared: 30 October 2017

Trade Name of Device: VitalPatch® VitalConnect Platform

Common or Usual Name: Wearable Biosensor

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

The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings.

Indications for Use

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Device Description

Technological Characteristics

This 510(k) does not involve any changes to the technological characteristics of the VitalPatch wearable biosensor.

Performance Data

The following device performance tests were performed on the VitalPatch wearable biosensor during the early design and development phase:

Test Description	Standard/Guidance Referenced
Electrical Safety Testing	IEC 60601-1, 3.1 Ed.
Electromagnetic Compatibility Testing	IEC 60601-1-2, 4th Ed.
Battery Performance Testing	N/A – internal performance testing
Skin Adherence/Wear Duration	N/A – internal performance testing
Wear Performance (Sensor Functionality)	N/A – internal performance testing
Wireless Coexistence	FDA Radio Frequency WirelessTechnology in Medical Devices

The following device performance tests were performed on the VitalPatch wearable biosensor during the commercialization phase, in support of this 510(k) submission for the extension of wear duration from 96 to 120 hours:

Test Description	Standard/Guidance Referenced
Firmware Verification and Validation	FDA Guidance for the Content ofPremarket Submissions for SoftwareContained in Medical Devices

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Substantial Equivalence

VitalPatch with the 120-hour wear duration has the same intended use, indications for use, and technological characteristics as the predicate device. Thus, VitalPatch is substantially equivalent to the predicate device.

Conclusions

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

Summary of Substantial Equivalence Table
Topic	Predicate DeviceK152139	Modified DeviceK163453
Classification	Class II21 CFR 870.2910	Class II21 CFR 870.2910
ClassificationName	Transmitters and Receivers,Physiological Signal, Radiofrequency	Transmitters and Receivers,Physiological Signal, Radiofrequency
Product Code	DRG	DRG
Trade Name	VitalPatch®	VitalPatch®
PatchConfiguration	Disposable adhesive patch containingintegrated disposable sensor module	Disposable adhesive patch containingintegrated disposable sensor module
Shelf Life	9 months	9 months
Vital SignsMonitored	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)
WearDuration	96 hours	120 hours
Principles ofOperation	Adhesive patches affixed to user'storso allowing for continuousmonitoring of wearer's physiologicaldata. Wireless transmission andstorage of data via Relay devices andoptional Secure Server.	Adhesive patches affixed to user'storso allowing for continuousmonitoring of wearer's physiologicaldata. Wireless transmission andstorage of data via Relay devices andoptional Secure Server.

Summary of 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).