V-PATCH SYSTEM

K131000 · Intelesens Limited · DSI · Jan 8, 2014 · Cardiovascular

Device Facts

• Record ID: K131000
• Device Name: V-PATCH SYSTEM
• Applicant: Intelesens Limited
• Product Code: DSI · Cardiovascular
• Decision Date: Jan 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended 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 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 Story

V-Patch System is a wearable, battery-operated monitor (V-Pod) using proprietary electrodes to capture ECG and heart rate data. Data transmits wirelessly via ANT to a V-Cell receiver, which relays information via GPRS to a web-based Canberra System for clinician review. On-board algorithms continuously monitor for nine specific cardiac arrhythmias; device also features a patient-activated event button for on-demand recording. Used in home or clinical environments to support routine observations; enables remote monitoring of patients otherwise unobserved. Clinicians access data via web interface to inform clinical decision-making and patient management. Benefits include continuous cardiac surveillance and timely detection of symptomatic or asymptomatic arrhythmia events.

Clinical Evidence

Bench testing only. Verification included hardware testing, system validation, and electrode validation per AAMI EC12. Algorithm performance validated per AAMI/ANSI EC57. Compliance with IEC 60601-1, IEC 60601-1-2, and AAMI/ANSI EC38 confirmed.

Technological Characteristics

Wearable electronic monitor; proprietary disposable electrodes (AAMI/ANSI EC12 compliant). Wireless ANT transmission to V-Cell; GPRS connectivity to cloud. Powered by user-replaceable coin cells. Conforms to IEC 60601-1, IEC 60601-1-2, and AAMI/ANSI EC38. Software-based arrhythmia detection.

Indications for Use

Indicated for adult patients, ambulatory or non-ambulatory, in healthcare or home settings for ECG monitoring. Contraindicated for patients requiring real-time monitoring or those with pacemakers or ICDs.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Biomedical Systems TruVue (K100155)

Submission Summary (Full Text)

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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 Pepper<br>Regulatory Affairs Officer<br>Intelesens Ltd.<br>4 Heron Road<br>Belfast BT3 9LE UK<br>Tel - 44 (0) 845 5838 6243<br>Fax - 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-segment<br>measurement and alarm)<br>DSI, Class II, CFR 870.1025 | |
| Predicate Device: | K100155<br>Biomedical Systems<br>TruVue | |

### 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

# 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.

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.

## 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 [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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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 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.

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'