CARD GUARD, MODEL CG-7100

K964836 · Card Guard Scientific Survival , Ltd. · DXH · Jul 28, 1997 · Cardiovascular

Device Facts

• Record ID: K964836
• Device Name: CARD GUARD, MODEL CG-7100
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement. The CG-7100 is suggested to record and transmit ECG’s to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.

Device Story

Patient-activated cardiac event monitor; records non-standard 12-lead ECG data in internal memory; transmits stored ECG signals via telephone to physician office, hospital, or cardiac monitoring center. Used by ambulatory patients to capture transient symptoms; physician reviews transmitted data to assess cardiac morphology. Not intended for diagnostic comparison with standard 12-lead ECGs. Facilitates remote monitoring of cardiac events.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Personal ECG transmitter; memory storage; transtelephonic transmission capability; non-standard 12-lead ECG acquisition.

Indications for Use

Indicated for ambulatory patients requiring cardiac monitoring for evaluation of transient symptoms and gross cardiac morphology changes. Prescription use only.

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

JUL 28 1997

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

Re: K964836
Model CG-7100 12 Lead ECG Personal Transmitter
Regulatory Class: II (two)
Product Code: 74 DXH
Dated: July 17, 1997
Received: July 24, 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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CARD GUARD
Scientific Survival Ltd.

510(k) Number: K964836

Device Name: Card Guard Model CG-7100
Personal Electrocardiogram Transmitter.

## Indication For Use:

The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms.
The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center.
This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement.

The CG-7100 is suggested to record and transmit ECG’s to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


Prescription Use ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)