(56 days)
CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a device called "ECG Minimonitor, Model CG-5000." This type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.
510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical trials or detailed performance studies that would be necessary to define acceptance criteria and prove adherence for an AI/ML medical device.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications: Not available.
- Adjudication method: Not available.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not available.
- If a standalone performance (algorithm only) study was done: Not available.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document primarily states that the device is "substantially equivalent" to legally marketed predicate devices and outlines its "Indications For Use": "CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis."
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 ОСТ
Mr. Leonid Trachtenberg Chief Engineer Card Guard Scientific Survival Ltd. 2 Pekeris Street, P.O.B. 527 Rehovot 76100 ISRAEL
K992696 Re: ECG Minimonitor, Model CG-5000 Regulatory Class: II (two) Product Code: 74 DXH Dated: August 26, 1999 Received: August 30, 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 requlations 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 (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, "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 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,
Sincerely yours,
Thomas J. Callehan
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
Page 1 of 1
510(k) Number: K992696
Device Name: Card Guard Model CG-5000 ECG MiniMonitor
Indications For Use:
CG-5000 ECG MiniMonitor is a medical device intended for recording, display, output to the electrocardiograph recorder, and, optionally, transtelephonic transmission of the ECG signal for the purpose of cardiac conditions analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Omer L. Goode for DBT
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K992696
Prescription Use OR (Per 21 CFR 801.109)
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).