The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

Device Description

The V-Patch device is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The electrodes are a proprietary Intelesens design. The patient wearable monitor is named the V-Pod operates on user replaceable coin cells. The device wirelessly transmits physiological data relating to ECG and heart rate to a receiving station - the V-Cell via a wireless ANT connection.

The V-Cell interfaces to the Internet via GPRS allowing for web-based analysis by a clinician on the Canberra System. There are also on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias and a patient activated event button. The cardiac arrhythmias detected are:

. Bradyarrhythmia
. Ventricular Tachycardia
. Supraventricular Tachycardia
Ventricular Fibrillation .
. Atrial Flutter
. Atrial Fibrillation
l st degree Heart Block .
. 2nd degree Heart Block
. 3rd degree Heart Block

AI/ML Overview

The provided text describes the V-Patch System, a physiological patient monitor, and its 510(k) submission. However, it does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria beyond general statements of compliance with standards.

The document states:

"The V-Patch System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market."
It lists tests performed: Hardware Verification, Compliance with IEC 60601-1, Compliance with IEC 60601-1-2, System Validation, Electrode Validation Summary inclusive of AAMI EC12 compliance, Compliance with AAMI EC 57, Electrode Storage test, and AAMI ANSI EC38.
"The V-Patch has equivalent specifications of performance as the predicate."

Without access to the "relevant test plans/reports" mentioned, specific numerical acceptance criteria and reported device performance are not available in this summary.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided 510(k) summary.

Based on the provided text, I can extract the following information, but many requested details are missing:

A table of acceptance criteria and the reported device performance:
- Information Missing: The document states the device was tested for compliance with various standards (IEC 60601-1, IEC 60601-1-2, AAMI EC12, AAMI EC57, AAMI ANSI EC38) and underwent Hardware Verification, System Validation, and Electrode Storage tests. However, the specific numerical acceptance criteria for these tests and the reported device performance against those criteria are not detailed in this summary. It only states "Compliance with AAMI EC 57" for example, not the specific metrics within EC 57 that were met and by what margin.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information Missing: The document does not specify the sample size used for any test sets or the provenance of the data (e.g., country of origin, retrospective/prospective nature).
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):
- Information Missing: The document makes no mention of experts or the establishment of ground truth for specific test sets. The device has "on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias," implying an automated detection process, but no human expert review process for evaluation is described in the provided summary.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information Missing: No adjudication method is described, as there's no mention of human expert review.
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:
- Information Missing: No MRMC study is mentioned. The device's purpose is to "monitor and transmit ECG data to a web based host application for display or analysis by a clinician" and to "automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This implies a potential assistance role, but no study on the effectiveness of human readers with vs. without AI assistance is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partial Information: The document states, "The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event." This confirms the existence of a standalone algorithm for arrhythmia detection. The "Compliance with AAMI EC 57" suggests evaluation of rhythm and ST-segment measurement algorithms, which would typically involve standalone performance assessment. However, specific performance metrics for this standalone algorithm are not listed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Information Missing: The specific type of ground truth used for evaluating the arrhythmia detection algorithm is not stated. AAMI EC57 involves established arrhythmia databases and methods for performance evaluation against known truth, but the details of how that truth was established for the specific data used by Intelesens are not in this summary.
The sample size for the training set:
- Information Missing: No information about a training set or its sample size is provided.
How the ground truth for the training set was established:
- Information Missing: As no training set information is provided, how its ground truth was established is also not mentioned.

Summary

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510(k) Summary December 3, 2013 Page I of 3

K131000 Page 1 of 3

Date Prepared	December 3, 2013	JAN - 8 2014
Official Contact:	Patricia PepperRegulatory Affairs OfficerIntelesens Ltd.4 Heron RoadBelfast BT3 9LE UKTel - 44 (0) 845 5838 6243Fax - 44 (0) 845 5838 6241
Proprietary or Trade Name:	V-Patch System
Common/Usual Name:	Physiological Patient Monitor
Classification Name:	Arrhythmia detector and alarm (including ST-segmentmeasurement and alarm)DSI, Class II, CFR 870.1025
Predicate Device:	K100155Biomedical SystemsTruVue

Device Description:

. Bradyarrhythmia
. Ventricular Tachycardia
. Supraventricular Tachycardia
Ventricular Fibrillation .
. Atrial Flutter
. Atrial Fibrillation
l st degree Heart Block .
. 2nd degree Heart Block
. 3rd degree Heart Block

Nomenclature:

The V-Patch System is composed of the V-Pod, V-Cell and Canberra display as described above.

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510(k) Summary December 3, 2013 Page 2 of 3

Indications for Use:

The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or nonambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation.

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

Patient Population:

Adult

Environment of Use:

Healthcare or home environment

Contraindications:

Not to be used on patients where real time monitoring is required Not to be used on patients with a pacemaker or ICD

Technology:

The V-Patch System is an electronic device that contains software. It conforms to the applicable performance requirements contained in and referenced in this 510(k). The V-Patch System conforms to the following standards:

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety, . 1988; Amendment 1, 1991-11, Amendment 2, 1995 (VS300)
. IEC 60601-1-2. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004)).
. AAMI / ANSI EC12:2000/(R) 2005, Disposable ECG electrodes.
. AAMI / ANSI EC57:1998/(R) 2008, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
. AAMI / ANSI EC38:2007, Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems

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510(k) Summary December 3, 2013 Page 3 of 3

Summary of Performance Data

The V-Patch System has been tested in accordance with the relevant test plans/reports included with this 510(k) submission using the production equivalent units prior to release to market. Testing includes:

. Hardware Verification
Compliance with IEC 60601-1 .
Compliance with IEC 60601-1-2 .
. System Validation
Electrode Validation Summary inclusive of AAMI EC12 compliance .
. Compliance with AAMI EC 57
Electrode Storage test
. AAMI ANSI EC38

Risk analyses identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Intelesens' product development procedure. Intelesens' Quality System conforms to 21CFR820 and is certified by SGS UK Itd., to ISO9001:2008 and ISO13485:2003.

Substantial Equivalence

Indications -

The indications for use are equivalent.

Prescriptive - The V-Patch and predicate are both prescription devices.

Design and Technology - The V-Patch and predicate have equivalent design features and technology

Performance and Specifications - The V-Patch has equivalent specifications of performance as the predicate.

Patient Population -

The V-Patch and predicate are indicated for adults

Environment of Use - V-Patch also includes home

Differences -There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns.

Substantial Equivalence Conclusion-

It is Intelesens' opinion that the V-Patch Monitoring System is substantially equivalent to the predicate device, and is safe and effective.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human form or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 8, 2014

Intelesens Limited % Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134

Re: K131000

Trade/Device Name: V-patch system Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor Regulatory Class: Class II Product Code: DSI Dated: December 4, 2013 Received: December 5, 2013

Dear Paul Dryden:

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

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Page 2 - Paul Dryden

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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.

Owen P. Faris -S

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 Statement

K131000 Page 1 of 1

510(k) Number:

(To be assigned)

Device Name:

Intelesens V-Patch System

Indications for Use:

The re-usable device is intended to be used with a single use electrode on the patient for up to seven days.

Prescription Use X (Part 21 CFR 801 Subpart D) or

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by
Owen P. Faris -S
Date: 2014.01.08
16:07:12-05'00'

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.