TELEMEDICINE 2000

K991307 · Card Guard Scientific Survival , Ltd. · DXH · Jun 14, 1999 · Cardiovascular

Device Facts

• Record ID: K991307
• Device Name: TELEMEDICINE 2000
• Applicant: Card Guard Scientific Survival , Ltd.
• Product Code: DXH · Cardiovascular
• Decision Date: Jun 14, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of ECG parameters of cardiac patients.

Device Story

Telemedicine 2000 functions as a receiving center for transtelephonic ECG monitoring. It receives ECG signals transmitted from remote patient locations; processes and displays these signals for clinical review. Used by healthcare professionals in clinical settings to monitor cardiac patients. Output allows clinicians to assess cardiac rhythm and parameters, facilitating remote patient management and clinical decision-making.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of device specifications and intended use.

Technological Characteristics

Receiving center for transtelephonic ECG signals. System facilitates remote monitoring of cardiac parameters. Technical details regarding specific materials, connectivity standards, or software architecture are not provided in the source document.

Indications for Use

Indicated for cardiac patients requiring transtelephonic monitoring of ECG parameters.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 4 1999

Mr. Leonid Trachtenberg, Chief Enqineer Card Guard Scientific Survival, Ltd. 2 Pereris Street, Science Park REHOVOT, ISRAEL

Re: K991307 Telemedicine 2000 Regulatory Class: II (two) Product Code: DXH Dated: May 13, 1999 Received: May 18, 1999

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 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). 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 Requlations, 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

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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.

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, ² Misbranding by reference to premarket notification? (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

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

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Special 510(k) Number: K99)307

Device Name: Telemedicine 2000, the Telemedicine Receiving Center

. Indication For Use:

.

The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of ECG parameters of cardiac patients.

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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)

KaKelle

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Deyice 510(k) Number