(93 days)
Not Found
Not Found
No
The summary describes a device that transmits ECG signals for remote monitoring, but there is no mention of AI or ML being used for analysis or interpretation of these signals.
No.
The device assists doctors in checking implanted pacing systems by transmitting ECG signals; it does not directly treat or diagnose a medical condition.
Yes
The device transmits ECG signals to assist doctors in checking implanted pacing systems, which is a diagnostic activity.
No
The device description explicitly mentions a "Pacemaker Data (PMD®) Transmitter," which is a hardware component used to transmit ECG signals. The summary does not indicate that the device is solely software running on a general-purpose computing platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description states the device transmits the patient's ECG signals to a remote station. ECG signals are electrical signals from the heart, not samples taken from the body for analysis.
- Intended Use: The intended use is to assist doctors in checking implanted pacing systems and transmitting ECG signals, which is a monitoring and data transmission function, not an in vitro diagnostic test.
Therefore, the Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
74 DXH
Device Description
Card Guard Model CG-4000 Pacemaker Data (PMD®) Transmitter is a device that transmits the patient's ECG signals, including ambulatory pulse width code, to a remote receiving station via the telephone line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctors
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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)