The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, noninvasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

Device Description

The Vital Signs Patch (VSP in short) system is designed to monitor selected vital signs of patients in a clinical environment. The VSP system is comprised of the following components: Physical Patch, Brain - VSP Transmitter, Gateway mobile device, Clinical Backend. The Patch is attached to the patient's chest. The Brain plugs into a cradle on the Patch and is connected to the Patch with a 16-pin connector. The Brain receives the power from the Pattery; the data from the sensors are transmitted using the 16-pin connector. The Gateway includes a dedicated, medical SW application (also known as the Gateway application) designed by LifeWatch Technologies. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain. In addition, the Brain contains a 32MB Flash memory chip that can store 6-10 hours of data in case of communication failure with the Gateway. All data received from the Brain is recorded and stored on the Gateway. In addition, the Gateway can be used to view vital sign signals received from the Brain and to transmit the data to a Monitoring Center via the internet by the Wi-Fi network. The VSP is not intended for use on patients with life threatening arrhythmias; hence it is not intended for patients in the ICU. The internal LifeWatch Technologies Ltd. Part Number of the Vital Signs Patch system is CG-1101B; this model serves also as the predicate device (cleared in K132407) for this Special submission.

AI/ML Overview

The provided document is a 510(k) summary for the Vital Signs Patch (VSP) system, which is a modified version of a previously cleared device. It details product information and the modifications made, but it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative way.

The document states:
"The 510(k) summarizes the testing that was performed, the acceptance criteria and the results of the testing."
However, this summary itself does NOT provide those details. It explicitly mentions that the full 510(k) contains this information, but this extract does not. Therefore, I cannot construct a table of acceptance criteria and reported device performance from the given text.

Based on the information provided in the extract, here's what can be inferred or stated about the requested points:

A table of acceptance criteria and the reported device performance:
- Not provided in the extract. The document states that the full 510(k) summarizes this, but the extract itself only mentions that testing was performed, acceptance criteria were met, and results did not raise new safety or effectiveness issues.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the extract. The document mentions "design verification and validation testing of the modified device have been performed" but gives no details on sample size, data type, or origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided in the extract. The nature of the device (vital signs monitor) suggests that ground truth would likely come from standard, calibrated medical equipment rather than expert human interpretation in the same way an AI diagnostic tool might, but this is not explicitly stated.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the extract.
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:
- Not applicable/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic imaging tool for human readers. No mention of human readers or AI assistance in interpretation is present.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated, but implied. The device is a "continuous, non-invasive monitoring" system for various vital signs. Its primary function is to measure and record these signs. Its performance would inherently be a "standalone" measurement against a gold standard (e.g., how accurately it measures heart rate compared to an ECG machine), rather than an algorithm assisting human interpretation. However, specific details of such standalone performance or the reference standard against which it was compared are not in this excerpt.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For vital signs, the ground truth would typically be established by established, gold-standard medical measurement devices (e.g., a clinically validated ECG for heart rate, a separate temperature probe for temperature, a hospital-grade oximeter for SpO2). The document mentions "performance specifications," implying comparison to such standards, but doesn't detail them.
The sample size for the training set:
- Not provided in the extract. The document primarily concerns modifications to an existing cleared device ("Special 510(k)"), so extensive new training data might not have been central to this specific submission, but this is speculation.
How the ground truth for the training set was established:
- Not provided in the extract.

Summary

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Public Health Service

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

February 5, 2016

LifeWatch Technologies Ltd. Mr. Asher Kassel Director of RA & OA 2 Pekeris St. Rehovot, 7670202 Israel

Re: K151835

Trade/Device Name: Vital Signs Patch System Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: DSI, MHX, DOA, FLL Dated: January 5. 2016 Received: January 6, 2016

Dear Mr. Asher Kassel:

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 vours

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) K151835

Device Name Vital Signs Patch System (VSP)

Indications for Use (Describe)

· The VSP is not intended for use by persons with any type of defibrillator, external or internal (ICD); the VSP must be detached from the patient before using a defibrillator on the patient

· The VSP is not to be used in a magnetic resonance imaging (MRI) environment. The VSP device must be removed from the patient's skin before he/she undergoes MRI procedure

· The VSP is not a "life-saving" or therapeutic device; the VSP supplies vital signs data to a doctor or the purpose of diagnosis by such (or other qualified) personnel

· The VSP is not intended for use on patients with unhealed surgical incision/dressings on the thoracic or abdominal regions

· The VSP is not intended for use on patients with skin or soft tissue damage on the area where the VSP is placed (such as burns, irritation, infections, wounds, etc.)

· The VSP is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring.

Warning: The temperature function of the Vital Signs Patch measures and reports surface temper chest. Where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for LifeWatch. The logo consists of a series of curved lines in shades of green and blue, resembling a heartbeat or signal wave. To the right of the lines is the word "LifeWatch" in a dark blue, sans-serif font.

K151835 Page 1 of 3

510(k) Summary: Vital Signs Patch

Introduction

This document contains the 510(k) summary for the revised Vital Signs Patch system. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

Submitter	LifeWatch Technologies Ltd.
Address	2 Pekeris St., P.O.B. 527, Rehovot, 7610303, Israel
Contact person:	Asher KasselDirector of RA & QALifeWatch Technologies Ltd.2 Pekeris St., P.O.B. 527, Rehovot, 7610303, IsraelPhone: 972-8-948-4010 (direct)Fax: 972-8-948-4044Email: akassel@lifewatch.com
Date Prepared:	July 1, 2015
Prepared By:	Donna-Bea Tillman, Ph.D.Senior ConsultantBiologics Consulting Group, Inc.400 N. Washington St. Suite 100Alexandria, VA 22314dtillman@bcg-usa.comPhone: 410-531-6542Fax: 703-548-7457
Predicate device	Vital Signs Patch (K132407)
Trade Name:	Vital Signs Patch System
Classification:	Class II
Product Codes:	DSI - Arrhythmia Detector and AlarmMHX - Physiological Patient MonitorDQA – OximeterFLL -Clinical Electronic Thermometer
Regulations:	21 CFR 870.1025 - Arrhythmia Detector and Alarm21 CFR 870.2700 - Oximeter21 CFR 880.2910 - Clinical Electronic Thermometer
Panel:	Cardiovascular

Device Description

The Vital Signs Patch (VSP in short) system is designed to monitor selected vital signs of patients in a clinical environment.

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Image /page/5/Picture/0 description: The image shows the logo for LifeWatch. The logo consists of a series of overlapping sine waves in shades of green and blue, followed by the word "LifeWatch" in a dark blue, sans-serif font. The sine waves appear to originate from the left and converge into a peak before trailing off to the right.

Special 510(k) for Vital Sians Patch 510(k) Summarv

K151835 Page 2 of 3

The VSP system is comprised of the following components:

. Physical Patch
. Brain - VSP Transmitter
Gateway mobile device
. Clinical Backend

The Patch is attached to the patient's chest. The Brain plugs into a cradle on the Patch and is connected to the Patch with a 16-pin connector. The Brain receives the power from the Pattery; the data from the sensors are transmitted using the 16-pin connector. The Gateway includes a dedicated, medical SW application (also known as the Gateway application) designed by LifeWatch Technologies. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain.

In addition, the Brain contains a 32MB Flash memory chip that can store 6-10 hours of data in case of communication failure with the Gateway.

All data received from the Brain is recorded and stored on the Gateway. In addition, the Gateway can be used to view vital sign signals received from the Brain and to transmit the data to a Monitoring Center via the internet by the Wi-Fi network.

The VSP is not intended for use on patients with life threatening arrhythmias; hence it is not intended for patients in the ICU.

The internal LifeWatch Technologies Ltd. Part Number of the Vital Signs Patch system is CG-1101B; this model serves also as the predicate device (cleared in K132407) for this Special submission.

Device Modifications

The purpose of this Special 510(k) is a modification of the submitter's own previously cleared 510(k). The modification does not change the fundamental scientific technology or the intended use and is therefore appropriate for review as a Special 510(k).

There are two modifications being made to the VSP that are the subject of this 510(k):

1. The VSP can now interface with a Clinical Console Tablet.
1. A Patient Posture Sensor has been added.

Indications for Use

The Vital Signs Patch system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

Contraindications:

. The VSP is not intended for use by persons with any type of defibrillator, external or internal (ICD); the VSP must be detached from the patient before using a defibrillator on the patient
. The VSP is not to be used in a magnetic resonance imaging (MRI) environment. The VSP device must be removed from the patient's skin before he/she undergoes MRI procedure
. The VSP is not a "life-saving" or therapeutic device; the VSP supplies vital signs data to a doctor or technician for the purpose of diagnosis by such (or other qualified) personnel

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Image /page/6/Picture/0 description: The image shows the logo for LifeWatch. The logo consists of a series of four curved lines that resemble a heartbeat monitor. The lines are in different shades of blue and green. To the right of the lines is the word "LifeWatch" in a dark blue sans-serif font.

K151835 Page 3 of 3

The VSP is not intended for use on patients with unhealed surgical incision/dressings on the thoracic or abdominal regions
. The VSP is not intended for use on patients with skin or soft tissue damage on the area where the VSP is placed (such as burns, irritation, infections, wounds, etc.)
. The VSP is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring.

Warning: The temperature function of the Vital Signs Patch measures and reports surface temperature on the upper chest. Where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.

Performance Standards:

This 510(k) submission was written in accordance with the FDA Guidance document "Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm, October 28, 2003" and the device conforms to the applicable performance requirements contained in and referenced in this document.

Performance Testing:

A risk analysis was performed by assigning a Risk Priority Number (RPN) to each defined hazard, based on the Frequency of Occurrence (F) and the Degree of Severity (S). The result of that analysis showed that after mitigation and characterization of each remaining risk's severity, frequency and detectability, all remaining risk was ALARP (As Low as Reasonably Possible) or BA (Broadly Acceptable).

As required by the risk analysis and in accordance with design control procedures, design verification and validation testing of the modified device have been performed. The 510(k) summarizes the testing that was performed, the acceptance criteria and the results of the testing.

Substantial Equivalence:

The minor device modifications to the VSP System, as described in this 510(k), do not alter the fundamental scientific technology of the predicate device and summary level information is adequate to assess the modifications. The verification testing demonstrated that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness. Therefore the modified VSP System can be found substantially equivalent to the predicate device as cleared in K132407.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.