MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)

K963725 · Card Guard , Ltd. · DXH · Sep 10, 1997 · Cardiovascular

Device Facts

• Record ID: K963725
• Device Name: MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
• Applicant: Card Guard , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

This device intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device is not intended for the simultaneous recording and transmitting of the patient's ECG signals.

Device Story

Personal ECG transmitter; captures cardiac electrical activity; intended for patients with transient symptoms suggestive of arrhythmia. Device records ECG signals for subsequent transmission; does not perform simultaneous recording and transmission. Used by patients in home or ambulatory settings; data transmitted to remote monitoring facility or physician for clinical review. Output assists healthcare providers in diagnosing cardiac rhythm abnormalities; facilitates timely clinical intervention for symptomatic patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Personal ECG transmitter; portable form factor; electronic signal acquisition; intended for non-simultaneous transmission of ECG data.

Indications for Use

Indicated for patients experiencing transient symptoms suggestive of cardiac arrhythmia. Not for simultaneous recording and transmission of ECG signals.

Regulatory Classification

Identification

A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

# SEP 10 1997

Mr. Leonid Trachtenberg
Card Guard Scientific Survival Ltd.
12 Hachoma Street
Rishon Le Zion
ISRAEL

Re: K963725
Model CG-2206 Personal Electrocardiogram Transmitter
Regulatory Class: II (two)
Product Code: 74 DXH
Dated: June 8, 1997
Received: June 12, 1997

Dear Mr. Trachtenberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Leonid Trachtenberg

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular,
Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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TOTAL P. 02

Card Guard Ltd

Page 1 of 1.

S10(k) Number: K963725

Device Name: Card Guard Model CG-2206
Personal Electrocardiogram Transmitter.

## Indication For Use:

This device intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.

The device is not intended for the simultaneous recording and transmitting of the patient's ECG signals.

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

Concurrence of CDRH, Of-ce of Device Evaluation (ODE)

A. A. C. D.

Prescription Use ☑ (Pcr 21 CI;R 801..109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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