CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR

K110499 · Card Guard Scientific Survival , Ltd. · DSI · Apr 6, 2011 · Cardiovascular

Device Facts

• Record ID: K110499
• Device Name: CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DSI · Cardiovascular
• Decision Date: Apr 6, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

Device Story

The CG-6108 ACT-3L is a chest-worn ECG monitor for home use. It acquires ECG signals via a 4-electrode harness and transmits them via Bluetooth to a mobile computing device (e.g., cell phone). A proprietary application on the mobile device processes the signal using an arrhythmia detection algorithm. Upon detection of an event (Atrial Fibrillation, Tachycardia, Bradycardia, or Pause) or manual patient trigger, the device transmits data via cellular link or landline to a remote Monitoring Center. Medical professionals at the center analyze the data to inform clinical decision-making. The device allows for monitoring of patients with Implanted Cardioverter Defibrillators (ICD) under specific precautions. The system benefits patients by providing continuous cardiac surveillance and rapid transmission of symptomatic events for physician review.

Clinical Evidence

No clinical data. Bench testing only. Testing included ACT-3L High Voltage Pulse Test (ENTR-0112) and ACT-3L EMC Dipole Antenna Test (ENTR-0113) to support labeling changes regarding ICD compatibility.

Technological Characteristics

Chest-worn sensor with 4 electrodes, 3.6V AA battery, Bluetooth transceiver, and buzzer. Mobile device interface. Conforms to ANSI/AAMI EC57:1998, ANSI/AAMI EC38:1998, ISO 14971:2007, IEC 60601-1 (2nd ed), IEC 60601-1-2, IEC 60601-1-4, IEC 62304:2006, and ISO 15223:2000.

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia. Used for continuous ECG monitoring, automated arrhythmia detection, and manual alarm triggering with transtelephonic data transmission to a monitoring center for professional evaluation.

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

• Unmodified version of CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (K101703)

Submission Summary (Full Text)

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APR - 6 2911

# 510(k) Summary: Modified CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

Introduction

This document contains the 510(k) summary for the modified CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector. The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

| Submitter | Card Guard Scientific Survival Ltd., | |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Establishment<br>Registration<br>Number | 9681879 | |
| Address | 2 Pekeris St., P.O.B. 527, Rehovot, 76100, Israel | |
| Contact person: | Asher Kassel, Director of RA & QA, Card Guard Scientific Survival Ltd. | |
| Phone: | 972-8-9484010<br>(direct) | Fax: [phone] |
| E-mail: | [e-mail] | |
| Date Prepared: | February 18, 2011 | |
| Predicate device | Unmodified version of CG-6108 ACT-3L Continuous ECG Monitor and<br>Arrhythmia Detector, cleared in K101703 on July 13, 2010. | |
| Trade Name: | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector | |
| Classification: | Detector and alarm, arrhythmia /Transmitters and receivers,<br>electrocardiograph, telephone | |
| Product Code: | DSI, DXH | |
| Regulation No: | 870.1025, 870.2920 | |
| Class: | II | |

# Device Description

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for selftesting by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a buzzer.

The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application.

When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.

The Patient and Physician manuals are being modified to change a warning to allow the use of the ACT-3L on patients with an Implanted Cardioverter Defibrillator (ICD) if specific precautions are observed.

# Indications for Use

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the

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Image /page/1/Picture/1 description: The image shows the words "CARD GUARD" in bold, black letters. Underneath the words is a thin, black line. Below the line are the words "Scientific Survival LTD" in a smaller font. To the right of the words is a line graph with a sharp peak.

Special 510(k) for CG-6108 ACT-3L Continuous ECG monitor and Arrhythmia Detector Section 7: 510(k) Summary

recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

### Summary of the Technological Characteristics / Principles of Operation

The technological characteristics and principles of operation of the modified device are the same as the predicate device. The chest-worn ECG sensor transmits signals via Bluetooth to the handheld device equipped with the Medical Application, which incorporates an algorithm for detection of cardiac events: Atrial Fibrillation, Tachycardia, Bradycardia and Pause. A detected artifact triggers transmission of the signal to the Monitoring Center for analysis.

### Non-clinical performance data for the CG-6108 ACT-3L

In order to support the labeling change the following testing has been performed:

- ACT-3L High Voltage Pulse Test, Card Guard document # ENTR-0112 .
- ACT-3L EMC Dipole Antenna Test, Card Guard document # ENTR-0113 .

#### 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. In addition, this submission was prepared in accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11 2005". The design of the CG-6108 ACT-3L conforms to the following voluntary standards:

- ANSI/AAMI EC57:1998 (R) 2008: Testing and reporting performance results of cardiac rhythm . and ST segment measurement algorithms (Cardiovascular)
- ANSI/AAMI EC38:1998 Medical electrical equipment Part 2-47: Particular requirements . for the safety, including essential performance, of ambulatory electrocardiographic systems (Cardiovascular)
- . ISO 14971:2007: Medical devices - application of risk management to medical devices (General)
- IEC 60601-1:1988, 2nd edition, Part 1, plus A1:1991 and A2:1995: Medical electrical . equipment; Part 1: General requirements for safety
- IEC 60601-1-2: 2001, plus A1:2004, Part 1: Medical electrical equipment, Part 1-2: General . requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
- . IEC 60601-1-4:2000, Medical electrical equipment - Part 1:General requirements for safety; Part 1-4: Collateral standard: Programmable electrical medical systems
- IEC 62304:2006: Medical device software Software life cycle processes .
- . ISO 15223:2000: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements

#### Substantial Equivalence:

The modified CG-6108 ACT-3L device is substantially equivalent with respect to the indications for use, technological characteristics and performance characteristics to the identified legally marketed predicate device.

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

Card Guard Scientific Survival Ltd c/o Mr. Asher Kassel Vice President of Operations 2 Pekeris St. Rehovot, 76100 Israel

APR - 6 2011

Re: K110499

Trade/Device Name: CG-6108-3L Continuous ECG Monitor and Arrhythmia Detector Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia detection or alarms (including ST-segment measurement and alarm)

Regulatory Class: Class II Product Code: DSI and DXH Dated: February 18, 2011 Received: February 22, 2011

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 – Mr. Asher Kassel

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

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): _ K 1/0499

Device Name: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector

# Indications for Use:

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of Cardiovascular Devices |

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