CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR

K081257 · Card Guard Scientific Survival , Ltd. · DSI · May 29, 2008 · Cardiovascular

Device Facts

• Record ID: K081257
• Device Name: CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DSI · Cardiovascular
• Decision Date: May 29, 2008
• 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 Arthythmia Detector is intended for use by palients 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 transtele-phonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

Device Story

System comprises chest-worn 3-lead ECG sensor and handheld device (PDA/Smartphone/PC) running proprietary medical application. Sensor acquires ECG signals via electrodes; transmits via Bluetooth to handheld unit. Handheld unit utilizes dual memory loop configuration for pre/post-event recording. Arrhythmia detection algorithm monitors ECG; triggers automatic alarm upon event detection; patient can also manually trigger alarm. Handheld device transmits recorded ECG data to remote Monitoring Center via cellular link or landline. Monitoring Center staff analyze data; provide results to medical practitioner for clinical decision-making. Enables remote cardiac monitoring for patients with transient symptoms; facilitates timely professional intervention.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by verification, validation, and testing (VV&T) documentation, including adherence to ANSI/AAMI EC57:1998 for cardiac rhythm and ST segment measurement algorithms and ANSI/AAMI EC38:1998 for ambulatory ECG.

Technological Characteristics

Chest-worn 3-lead ECG sensor with ASIC and Bluetooth transceiver. Handheld device (PDA/Smartphone/PC) with proprietary application. Dual memory loop configuration for signal processing. Connectivity via Bluetooth (sensor-to-handheld) and cellular/landline (handheld-to-center). Complies with IEC 60601-1, IEC 60601-2-27, and EN 60601-1-2 (EMC).

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia. Used for continuous ECG monitoring, arrhythmia detection, and transmission of data 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

• Card Guard's CG-6108 Continuous ECG Monitor And Arrhythmia Detector (K071995)
• Card Guard's CG-6550 Personal ECG Transmitter (K990478)

Submission Summary (Full Text)

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P1/2

# MAY 2 9 2008

**CARD. GUARD.**

## CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector 510(k) Summary of Safety and Effectiveness

- IEC 60601-2-27 2005 Medical electrical equipment Part 2: Particular requirements for the safety of ● electrocardiographic monitoring equipment
- EN 475: Medical devices Electrically-generated alarm signals ; April 1995 .
- EN 980: Graphical symbols for use in the labeling of medical devices; August 2003 .
- EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the e manufacturer with medical devices; April 1998
- EN ISO 9001: Quality management systems Requirements; December 2000 ●
- EN ISO 13485: Quality systems Medical devices; August 2000 .
- EN 1SO 14971: Medical devices -- application of risk management to medical devices; March 2001 .
- EN ISO 10993 Biological evaluation of medical devices Part 1; Evaluation and testing; Dec. 1997 .
- EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Sept. 2002 ●
- EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral Std: EMC; requirements and tests; 2007 ●
- EN 60601-1-4+A1 2000: Medical electrical equipment; Part 1: 4. Collateral Std: Programmable electric � medical systems;

### Indications for Use, Intended Use

The CG-6108 ACT-3L Continuous ECG Monitor and Arthythmia Detector is intended for use by palients 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 transtele-phonically to a monitoring center. The monitoring center provides the ECG data to the medical practitioner for evaluation.

#### Principles of operation

The chest-worn ECG sensor transmits signals via Bluetooth to the handheld device equipped with the Medical Application, which incorporates an algorithm specially developed for detection of AF events. A detected artifact triggers transmission of the Signal to the CG Monitoring Center for analysis.

## Substantially Equivalent Devices

The clearance for the CG-6108 ACT-3L is sought on the grounds of its claimed substantial equivalence (SE) to the following predicate devices:

- Card Guard's CG-6108 Continuous ECG Monitor And Arrhythmia Detector K071995 for being the 1. parent model
- Card Guard's CG-6550 Personal ECG Transmitter K990478 for the 3 leads/3 channel design. 2.

#### Conclusions

All Verification, Validation and Testing (VV&T) documents - although not included in this dossier, constitute a part of the device DMR and are available upon request

The Truthful and Accurate Statement complies with 21 CFR 807.87(j).

We trust that the submitted information will enable the reviewer to process the material promptly. The time factor is crucial for Card Guard's commercial interests.

This dossier contains one paper copy of the 510(k) submission together with an electronic copy that is an exact duplicate of the paper copy.

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| Submitter | Card Guard Scientific Survival Ltd., |
|-----------------|---------------------------------------------------------------|
| Address | 2 Pekeris St. P.O.B. 527 Rehovot 76100, Israel |
| Contact: | Alex Gonorovsky, RA Manager |
| Phone: | 972-8-9484019 Fax: [phone] |
| E-mail: | [e-mail] |
| Device | |
| Trade Name: | CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector |
| Classification: | detector and alarm, arrhythmia |
| Product Code: | DSI DXH |
| Regulation No: | 870.1025 |
| Class: | II |

## Device Definition

The CG-6108 ACT-3L is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. It comprises a chest-worn ECG sensor and a handheld device with a proprietary application, configured to process and transmit the ECG recordings.

The chest-worn unit has 3 electrodes on a harness and it houses a battery, an ASIC and a Bluetooth transceiver for the acquisition, recording, and transmission of the ECG signal.

The ECG signals are transmitted via Bluetooth to the handheld device. When an event is detected it is wirelessly transmitted to the CG Monitoring Center for professional analysis. The handheld device is equipped with shared memory used to received from the sensor and to allow preand post processing options through the use of this memory in a dual memory loop configuration, both running in parallel. One loop is auto-triggered, with programmable that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled to provide the physician with more information, when requested by the CG Monitoring Center.

The handheld device automatically transmits the recorded ECG, via cellular link, to the Monitoring Center. When cellular service is unavailable the patient can transmit via landline telephone.

#### Medical Application

The Application is designed for wireless mobile platforms, e.g. PDA, SmartPhone and for static platforms, such as PC. It is used to receive from the CG-6108 the test results and other medical data, to process and save these test results, and synchronize data and test results with the CG Medical Center. The Application is a part of a personal medical system solution. It performs the following activities:

- 1. Receives medical test inputs from the external accessories
- Collects medical test data and other related information as defined for each test 2.
- Accesses historical test and related data stored on the device 3.
- Transmits medical test data and other information to Center for professional evaluation/backup র্ধ
- క్. Receives data from Center
- Enables configuring GPRS data connection (based on mobile phone GPRS/CDMA capabilities), ర్. changing user name and password.

## Referenced Standards

- Arrhythmia Detector and Alarm Guidance for Industry and FDA Staff Class II Special Controls Guidance
- ANSVAAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment � Measurement Algorithms
- ANSI/AAMI EC38:1998 Ambulatory Electrocardiograph �

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2008

Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Manager, Regulatory Affairs 2 Pekeris St. P.O. Box 527 Rehovot 76101 ISRAEL

Re: K081257

CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Dctector Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: DSI Dated: March 26, 2008 Received: May 2, 2008

Dear Mr. Gonorovsky:

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. Alex Gonorovsky

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 cquivalence 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 [phone]. 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,

B. Sommermeyer 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): Ko81257

## 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 181 (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blummmmor

(ion sign-om)
Division of Cardiovascular Devices
510(k) Number Korld57

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(Posted November 13, 2003)