The Vital Connect 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 Vital Connect Sensor for storage and analysis. The Vital Connect 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 Vital Connect 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

The Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:

Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
- a) Adhesive Patch

The Adhesive Patch is designed as a disposable self-adhesive interface to the body.

b) Sensor Module
The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library.
Relay Software Library
The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.

The Vital Connect Platform offers an optional sub-system:

. Secure Server
The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.

The Vital Connect Sensor continuously gathers physiological data from the person being monitored and then transmits encrypted data via bi-directional communication to the relay device when in range of the relay. The encrypted wireless data provided by the Sensor may be downloaded from the relay device for storage, or integrated into a Third-Party Relay Application via the APIs of the Relay Software Library. In addition, the wireless data may be transferred to the Vital Connect Secure Server where they are stored for analysis with the deployment of the server.

During normal operation, data are collected on the Vital Connect Sensor and transmitted to the Relay immediately. A continuous connection is needed between the Sensor and the Relay in order to facilitate continuous data transmission. The continuous wireless transmission of the data occurs with a delay or latency of seconds between continuous data collection and transmission. Data can be stored and downloaded from the Relay. Data can continue to be transferred to the Vital Connect Server with a server connection. If an interruption occurs between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.

AI/ML Overview

The provided text is a 510(k) summary for the Vital Connect Platform. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device. However, it does not contain specific acceptance criteria or an explicit study proving the device meets those criteria for its physiological monitoring functions (heart rate, ECG, respiratory rate, etc.) in a traditional sense.

Instead, the document focuses on:

Biocompatibility testing: Conducted according to ISO 10993-1.
Electrical safety and EMC testing: Compliance with IEC 60601 series standards and FCC CRF47 Part 15 Subpart C.
Software verification and validation: Following FDA guidance for "moderate" level of concern software.
Bench testing: In-vitro tests for shelf life, packaging, water resistance, static load, compression, and drop test.
Reliance on prior clinical testing: Stating that "Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device."

Given this, I cannot construct a table of acceptance criteria and reported device performance from the provided text for the physiological monitoring aspects. The document asserts that the device met "all acceptance criteria" during bench testing and that "safety and performance characteristics" were established through verification and validation, but it does not detail those criteria or the specific performance results for the physiological measurements.

Here's a breakdown of what can be extracted or inferred based on your request, with explicit notes on what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric Category	Acceptance Criteria (Not Explicitly Stated for Physiological Data)	Reported Device Performance (Not Explicitly Stated for Physiological Data)
Physiological Data Accuracy	Not explicitly detailed in this document. Implied adherence to performance of predicate device.	Not explicitly detailed in this document. Implied performance similar to predicate device.
Biocompatibility	ISO 10993-1 recommendations for in-vitro cytotoxicity, irritation, and sensitization.	Passed (Previously conducted testing for predicate; "still relevant").
Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-47, IEC 60601-1-2, IEC/TS 62657-2, and FCC CRF47 Part 15 Subpart C.	Complies.
Software Verification & Validation	Compliance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern software.	Conducted and documentation provided.
Bench Testing (Shelf life, Packaging, etc.)	Met "all acceptance criteria" for shelf life, packaging integrity, operation and storage conditions, water resistance, static load, compression, and drop test. (Specific acceptance values for these tests are not provided). Also, "performed similarly to the predicate device."	Met "all acceptance criteria" and "performed similarly to the predicate device." (Specific performance results are not provided).
Clinical Performance	Not explicitly detailed for the modified device; relies on predicate device's clearance.	"Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device." (No new clinical data for the modified device presented).

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): Not specified for any physiological data validation. The document states "Prior clinical testing was performed to support the clearance of the predicate device," but the sample size for that prior predicate testing is not provided. For bench testing, "in vitro bench testing" was conducted, but sample sizes for these tests are not specified.
Data Provenance: Not specified for any physiological data. The previous clinical data would be from the predicate device's clearance. The current document does not specify country of origin or whether it was retrospective/prospective for any data related to physiological performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable/Not Provided: The document does not describe a study involving expert-established ground truth for physiological measurements for the modified device nor for the predicate device's clinical testing.

4. Adjudication method for the test set

Not Applicable/Not Provided: No adjudication method is mentioned as there's no described study involving human readers or expert consensus for the physiological data.

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: No MRMC study or study demonstrating human reader improvement with AI assistance is mentioned. The device is a "wireless remote monitoring system" for continuous collection of physiological data, not an AI diagnostic aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Implied: The device is a standalone physiological data collection system (Vital Connect Sensor) that transmits data. Its performance is assessed through its ability to accurately capture and transmit these physiological parameters. However, specific standalone performance metrics (e.g., accuracy of HR measurement against a gold standard) are not detailed in this document; it relies on the "substantial equivalence" of its technology and the predicate device's prior clinical validation.

7. The type of ground truth used

Not explicitly detailed for physiological data: For biocompatibility, electrical safety, software, and bench testing, the "ground truth" is adherence to established standards and successful verification/validation. For physiological measurements, it's implied that the predicate device's clinical testing used appropriate reference methods (e.g., clinical monitoring equipment for heart rate, ECG, respiratory rate) to establish ground truth.

8. The sample size for the training set

Not Applicable/Not Provided: The document does not mention any machine learning or AI components that would require a separate training set. It describes a system for collecting and transmitting physiological data.

9. How the ground truth for the training set was established

Not Applicable/Not Provided: As no training set is mentioned, the method for establishing its ground truth is also not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 6, 2015

Vital Connect. Inc. Bonnie Wu Sr. Regulatory Manager 900 E. Hamilton Avenue, Suite 500 Campbell, California 95008

Re: K152139

Trade/Device Name: Vital Connect Platform, Healthpatch MD, VitalPatch Regulation Number: 21 CFR Regulation Name: Regulatory Class: Class II Product Code: DRG, DSI, MHX Dated: November 2, 2015 Received: November 4, 2015

Dear Bonnie Wu:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 yours.

Mitchell Stein

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) K152139

Device Name

Vital Connect Platform

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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6.0 510(k) Summary

In accordance with the provisions of the Safe Medical Device Act of 1990, Vital Connect, Inc. is providing a summary of Safety and Effectiveness information regarding the Vital Connect Platform.

6.1 Company Identification

Vital Connect, Inc. 900 E. Hamilton Ave. Suite 500 Campbell, CA 95008 Registration Number: 3010830833

6.2 Contact Person

Bonnie Wu

Sr. Manager, Regulatory Affairs

Telephone: 408-963-4620

Fax: 408-963-2828

Email: bwu@vitalconnect.com

6.3 Preparation Date

July 31, 2015

6.4 ldentification of Product and Classification

Device Trade Name: Vital Connect Platform, HealthPatch® MD, VitalPatch™ Common Name: Wireless Remote Monitoring System Classification Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Classification Panel: Cardiovascular CRF Section: 870.2910, 870.1025 Device Class: II Product Code: DRG, DSI, MHX

6.5 Predicate Device

Manufacturer: Vital Connect, Inc. Model: Vital Connect Platform 510(k) Number: K141167

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6.6 Device Description

The Vital Connect Platform is a wireless data collection system that monitors physiological data and consists of the following sub-systems:

Vital Connect Sensor (includes Adhesive Patch and Sensor Module) .
- a) Adhesive Patch

The Adhesive Patch is designed as a disposable self-adhesive interface to the body.

b) Sensor Module
The Sensor Module performs processing functions related to capture of physiologic data and also performs bi-directional communication with the Relay Software Library.
Relay Software Library
The Relay Software Library manages communication with the Vital Connect Sensor. The Relay Software Library also manages the communication with the Secure Server when the Secure Server is deployed. The Relay Software Library is installed on a relay device.

The Vital Connect Platform offers an optional sub-system:

. Secure Server
The Secure Server manages the upload, processing and storage of sensor data, as well as real-time configuration and notification communications with the Relay Software Library.

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between the Sensor and the Relay, data will be stored on the Sensor for several hours until the connection is re-established.

6.7 Indication for Use

6.8 Technology Characteristics

The intended use and technological features of the proposed Vital Connect Platform do not substantially differ from the legally marketed predicate device. The Vital Connect Platform and the predicate device have substantially equivalent intended uses and methods of operation.

6.9 Performance Data

Verification and validation activities established the safety and performance characteristics of the proposed device with respect to the predicate. The following performance data have been provided in support of the substantial equivalence determination.

6.9.1 Summary of Biocompatibility Testing

Biocompatibility testing, previously conducted, included in-vitro cytotoxicity, irritation and sensitization, according to the recommendations of ISO 10993-1:2009, Biological evaluation of medical devices – Part 1: Evaluation and testing.

6.9.2 Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Vital Connect Sensor. The device complies with the IEC 60601-1, IEC 60601-1-11, IEC 60601-1-6, IEC 60601-2-25, and IEC 60601-2-47 standards for safety, the IEC 60601-1-2 standard for EMC, IEC/TS 62657-2 and FCC CRF47 Part 15 Subpart C standards for wireless communication.

6.9.3 Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of

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Premarket Submissions for Software Contained in Medical Devices. The software for this device is determined as a "moderate" level of concern because a failure or latent flaw could lead to a minor injury to the patient through incorrect information or through the action of the care provider.

6.9.4 Bench Testing

In vitro bench testing, including shelf life, packaging integrity, operation and storage conditions, water resistance, static load, compression, and drop test were conducted to verify the modified device met all acceptance criteria and performed similarly to the predicate device.

6.9.5 Animal and Clinical Testing

Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device. The safety and effectiveness of the device associated with the product changes are demonstrated through performance testing. Thus, animal and clinical studies were not deemed necessary.

6.10 Conclusion

The proposed Vital Connect Platform is substantially equivalent in design and intended use to the predicate device. Any differences between the proposed Vital Connect Platform and the predicate device have no significant influence on safety or effectiveness as established through performance testing. Therefore, the proposed Vital Connect Platform raises no new issues of safety or effectiveness from the predicate device.

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).