(241 days)
The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement.
The CG-7100 is suggested to record and transmit ECG's to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.
Card Guard Model CG-7100 Personal Electrocardiogram Transmitter.
Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the provided document. Here's why:
The document is an FDA 510(k) clearance letter for the Card Guard Model CG-7100 Personal Electrocardiogram Transmitter. This letter approves the device for marketing based on a determination of substantial equivalence to a predicate device.
Key Point: An FDA 510(k) clearance letter typically does not contain the detailed acceptance criteria or the full study report that led to the substantial equivalence determination. Instead, it references the 510(k) submission (K964836 in this case) which would contain that information.
The document indicates that the device transmits "non-standard 12 leads electrocardiogram (ECG)" and explicitly states: "This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement." This statement is a crucial part of its intended use and suggests its primary role is for monitoring changes rather than formal diagnostic interpretation based on standard ECG criteria.
Therefore, I cannot extract the specific information you requested without access to the actual 510(k) submission (K964836) itself.
What this document does provide is:
- Device Name: Card Guard Model CG-7100 Personal Electrocardiogram Transmitter.
- Regulatory Class: II
- Product Code: 74 DXH
- Indications For Use: A patient-activated cardiac event monitor for evaluation of transient symptoms. It allows recording and transmission of non-standard 12-lead ECGs to physicians for monitoring gross cardiac morphology changes in ambulatory patients. Crucially, it emphasizes that this non-standard ECG should not be used for diagnostics in comparison to a standard 12-lead ECG.
- Date of Clearance: July 28, 1997
To answer your specific questions, you would need to access the original 510(k) submission, K964836, which would contain the detailed technical specifications, validation studies, and performance data.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
JUL 2 8 1997
Mr. Leonid Trachtenberg Card Guard Scientific Survival Ltd. 12 Hachoma Street -- ----Rishon Le Zion, Israel
Re: K964836 Model CG-7100 12 Lead ECG Personal Transmitter Regulatory Class: II (two) Product Code: 74 DXH Dated: July 17, 1997 Received: July 24, 1997
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 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 Wedical 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 requiatory 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.
{1}------------------------------------------------
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. For a
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" (21 CFR 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/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
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image contains the logo for Card Guard Scientific Survival Ltd. The logo features a stylized electrocardiogram (ECG) waveform inside a square grid on the left. To the right of the waveform, the text "CARD GUARD" is written in bold, uppercase letters. Below "CARD GUARD", the text "Scientific Survival Ltd." is written in a smaller, regular font.
510(k) Number : K964836
Device Name: Card Guard Model CG-7100 Personal Electrocardiogram Transmitter.
Indication For Use:
The CG-7100 Personal Electrocardiogram Telephone Transmitter is a patient activated cardiac event monitor for evaluation of transient symptoms. The CG-7100 allows a patient to record non-standard 12 leads electrocardiogram (ECG) in device memory and transmit the stored data to transtelephonic receiver located in physician office, hospital or cardiac monitoring center. This non-standard 12 leads electrocardiogram(ECG), which is measured with CG-7100, should not be used for diagnostics in comparison to the standard 12 lead ECG obtained at standard electrode placement.
The CG-7100 is suggested to record and transmit ECG's to physicians for use in monitoring gross cardiac morphology changes in ambulatory patients for whom physicians, in their judgment, believe cardiac monitoring is appropriate.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. R
(Division Sign-C Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use V (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).