(33 days)
The device is intended for receiving the signal, transmitted by the Card Guard personal transtelephonic transmitters and transferring the signal to PC equipped with the TM2000 Receiving program or compatible.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "CG-3250 TM MiniReceiver." It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
However, the provided text does not contain specific information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets.
The document is purely a regulatory clearance notice and does not elaborate on the technical performance or testing methodology of the device beyond stating its intended use.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the study that proves the device meets those criteria based on the information provided.
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with the profiles overlapping each other. The image is black and white.
AUG 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival, Ltd. 2 Pekeris Street. Science Park Rehovot ISRAEL
Re: K012187
Trade Name: CG-3250 TM MiniReceiver Regulation Number: 21 CFR 870.2920 Regulatory Class: II (two) Product Code: 74 DXH Dated: July 26, 2001 Received: July 30, 2001
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 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
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Page 2 - Mr. Leonid Trachtenberg
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 Itsponse to your promation nouncears 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 noutheation. The I Drivening as fication 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 additionally 607.10 for mi mi mo and advertising on the promotion and advertising of your device, (2017) 594-1010. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding 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 mionination on your responsibility the number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Souda Tille
ames E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CARD GUARD
Scientific Survival LTD
The device is intended for receiving the signal, transmitted by the Card Guard personal transtelephonic transmitters and transferring the signal to PC equipped with the TM2000 Receiving program or compatible.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K01287
§ 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).