(93 days)
This device is intended to assist doctors in checking implanted pacing systems of ambulatory patients. The device transmits the patient's ECG signals, including ambulatory pulse width code, to the remote receiving station via the telephone line.
Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter
I am sorry, but the provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a medical device (Pacemaker Data Transmitter, Model CG-4000) and primarily focuses on regulatory approval based on substantial equivalence to a predicate device.
The letter does not include:
- A table of acceptance criteria and reported device performance.
- Details about specific studies, sample sizes for test or training sets, data provenance, or ground truth establishment.
- Information on expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
Therefore, I cannot extract the requested information from this document.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
DEC - 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leonid Trachtenberq Chief Enqineer Card Guard Scientific Survival, Ltd. 2 Pekeris Street P.O.B. 527 Rehovot 76100 ISRAEL
Re : K983026 Pacemaker Data (PMD®) Transmitter, Model CG-4000 Regulatory Class: II (two) Product Code: 74 DXH Dated: November 15, 1998 Received: November 16, 1998
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 aqainst 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 requlatory 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. Trachtenberg
This letter will allow you to beqin 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, 2Misbranding by reference to premarket notification? (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter
Indications For Use:
This device is intended to assist doctors in checking implanted pacing systems of ambulatory patients. The device transmits the patient's ECG signals, including ambulatory pulse width code, to the remote receiving station via the telephone line.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K983026 |
Prescription Use_ X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
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.(b)
Classification. Class II (performance standards).