CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR

K071995 · Card Guard Scientific Survival , Ltd. · DSI · Dec 18, 2007 · Cardiovascular

Device Facts

• Record ID: K071995
• Device Name: CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DSI · Cardiovascular
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2

Intended Use

The CG-6108 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 a one lead 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

System comprises chest-worn 3-electrode ECG sensor and handheld device (PDA/Smartphone/PC) with proprietary application. Sensor acquires/records ECG via ASIC and transmits via Bluetooth to handheld unit. Handheld unit uses dual memory loop: auto-triggered loop (programmable thresholds) and remotely controlled loop. Device transmits ECG data via cellular or landline to remote Monitoring Center. Medical professionals at Center evaluate data to inform clinical decisions. Enables patient self-testing at home; provides physician with continuous or event-based ECG recordings to diagnose transient cardiac symptoms.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance validated against recognized standards including ANSI/AAMI EC57:1998 for cardiac rhythm and ST segment measurement algorithms, and IEC 60601-2-27 for safety of electrocardiographic monitoring equipment.

Technological Characteristics

Chest-worn 3-electrode sensor; ASIC-based signal acquisition; Bluetooth connectivity to handheld; cellular/landline transmission. Handheld application runs on mobile (PDA/Smartphone) or static (PC) platforms. Complies with IEC 60601-1, IEC 60601-1-2, and ANSI/AAMI EC38:1998. Software includes arrhythmia detection algorithm.

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia. Intended for continuous one-lead ECG monitoring, automated arrhythmia alarm generation, and manual patient-triggered alarm recording 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 CG-6108 Arrhythmia ECG Event Recorder (K060911)
• Cardiac Telecom Corp Heartlink, Model II (K982803)

Submission Summary (Full Text)

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| | CG-6108 Continuous ECG Monitor and Arrhythmia Detector<br>510(k) Summary of Safety and Effectiveness | |
|-----------------|------------------------------------------------------------------------------------------------------|--------------------|
| 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 Continuous ECG Monitor and Arrhythmia Detector | |
| Classification: | detector and alarm, arrhythmia | |
| Product Code: | DSI | |
| Regulation No: | 870.1025 | |
| Class: | II | |

#### 1. Definition

The CG-6108 Continuous ECG Monitor and Arrhythmia Detector system 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 includes 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 record the signal received from the sensor and to allow pre- and 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 thresholds that starts recording based on specific rhythms detected or manually activated by the patient. The second, and longer, recording loop is controlled remotely 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.

#### 2. Medical Application

The Application is designed for wireless mobile platforms, e.g. PDA, SmartPhone and for static platforms, i.e., 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 Medical Center. The Application is a part of a personal medical system solution. The Medical Application performs the following activities:

- 1. Receives medical test inputs from the external accessories
- 2. Collects medical test data and other related information as defined for each test
- Accesses historical test and related data stored on the device 3.
- 4. Transmits medical test data and additional information to Center for professional evaluation/backup
- న్. Receives data from Center
- Enables configuring GPRS data connection (based on mobile phone GPRS/CDMA capabilities), 6. changing user name and password.

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## 3. Referenced Standards

No performance standards have been developed under Section 514 of the Federal Food, Drug and Cosmetic Art for wireless ECG event recording devices. Following are reference standards:

- Arthythmia Detector and Alarm Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: (1) October 28, 2003
- ANSVAAMI-EC 57:1998, Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement (2) Algorithms
- (3) ANSI/AAMI EC38:1998 Ambulatory Electrocardiograph
- IEC 60601-2-27 2005 Medical electrical equipment Part 2: Particular requirements for the safety of (4) electrocardiographic monitoring equipment
- EN 475: Medical devices Electrically-generated alarm signals ; April 1995 (5)
- EN 980: Graphical symbols for use in the labeling of medical devices; August 2003 (6)
- EN 1041: Terminology, Symbols and Information provided with Medical Devices; Information supplied by the (7) manufacturer with medical devices; April 1998
- EN ISO 9001: Ouality management systems Requirements: December 2000 (8)
- EN ISO 13485: Quality systems Medical devices; August 2000 (9)
- (10) EN ISO 14971: Medical devices application of risk management to medical devices; March 2001
- (11) EN ISO 10993 Biological evaluation of medical devices Part 1: Evaluation and testing: Dec. 1997
- (12) EN 60601-1: Medical electrical equipment; Part 1: General requirements for safety; Sept. 2002
- (13) EN 60601-1-2: Medical electrical equipment; Part 1: 2. Collateral Std: EMC; requirements and tests; 2001
- (14) EN 60601-1-4: Medical electrical equipment; Part 1: 4. Collateral Std: Programmable electric medical systems; 2001

### 4. Indications For Use

The CG-6108 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 a one lead 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.

#### 5. Principles of operation

The CG-6108 system comprises a chest-worn ECG sensor with 3 electrodes and a handheld device with a Medical Application, used to process and transmit the ECG recordings. The battery powered chest-worn unit has an ASIC and a transceiver for acquisition, recording, and transmission of the ECG signal. The ECG signals are transmitted via Bluetooth to the handheld device equipped with the Medical Application, which incorporates an algorithm for AF detection. A detected event triggers transmission of the signal to the CG Monitoring Center for analysis.

### 6. Substantial Equivalence

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

- 1. Card Guard's CG-6108 Arrhythmia ECG Event Recorder K060911 for the complete physical identity and the identity of the intended use and technical specifications. The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is physically identical to the CG-6108 ECG Event Recorder K060911.
- Cardiac Telecom Corp's Heartlink, Model II K982803 for Product Code DSI (Reg. Number 2. 870.1025).

K071995

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

## 7. Conclusions

The CG-6108 device constitutes a safe and reliable means for self-testing by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is at least as safe, effective, and reliable as the cleared predicate devices.

K071995

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2007

Card Guard Scientific Survival, Inc. c/o Mr. Gregory Levine Arnold & Porter, LLP 555 12 St NW Washington DC 20004

Re: K071995

Trade/Device Name: Card Guard CG-6108 Continuous ECG Monitor and Arrhythmia Detector Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm) Regulatory Class: II (special controls) Product Code: DSI, DXH Dated: October 26, 2007 Received: October 26, 2007

Dear Mr. Levine:

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. Gregory Levine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Bhimlima fr

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): Ko71995

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

Indications for Use:

The CG-6108 Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device continuously monitors a one lead 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)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. hummer

(Division/Sign-Off)
Division of Cardiovascular Devices
510(k) Number K071995

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(Posted November 13, 2003)