(415 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms in medical devices.
No.
The device is described as a "Personal Electrocardiogram Transmitter" intended for patients experiencing symptoms that "may suggest cardiac arrhythmias." However, it explicitly states it is "not intended for the simultaneous recording and transmitting of the patient's ECG signals," which is essential for diagnosis or therapy. Its function appears to be limited to transmitting, not actively treating or diagnosing, symptoms related to a condition.
No
The device is described as a "Personal Electrocardiogram Transmitter" intended for patients experiencing transient symptoms that "may suggest cardiac arrhythmia," but it explicitly states it is "not intended for the simultaneous recording and transmitting of the patient's ECG signals." This suggests it's for transmitting information, but doesn't explicitly state it performs analysis or diagnosis itself. While the information it transmits might be used for diagnosis, the device itself is described as a transmitter, not a diagnostic tool per se.
No
The device description explicitly states "Personal Electrocardiogram Transmitter," which implies a hardware component for acquiring ECG signals. The summary does not indicate it is solely software.
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 Description: The description states the device is a "Personal Electrocardiogram Transmitter." An electrocardiogram (ECG) measures the electrical activity of the heart directly from the body surface, not from a sample taken from the body.
- Intended Use: The intended use describes monitoring for cardiac arrhythmia based on transient symptoms, which aligns with the function of an ECG device.
Therefore, since the device works by measuring electrical signals directly from the patient's body and not by analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This device intended for use by patients who experience transient symptoms that , may suggest cardiac arrythmia.
Product codes
74 DXH
Device Description
Card Guard Model CG-2206 Personal Electrocardiogram Transmitter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 1 0 1997
Mr. Leonid Trachtenberg Card Guard Scientific Survival Ltd. 12 Hachoma Street Rishon Le Zion ISRAEL
Re: K963725 Model CG-2206 Personal Electrocardiogram Transmitter Regulatory Class: II (two) Product Code: 74 DXH Dated: June 8, 1997 Received: June 12, 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 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.
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.
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. Callahon
Thomas 6. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1.
. Card Guard Ltd
. 510(k) Number : K963725
Device Name: Card Guard Model CG-2206 Personal Electrocardiogram Transmitter.
. Indication For Use:
This device intended for use by patients who experience transient symptoms that , may suggest cardiac arrythmia.
. The device is not intended for the simultaneous recording and transmitting of the . patient's ECG signals.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Of-ce of Device Evaluation (ODE)
A.A. Cidd.
OR
Prescription Use
(Per 21 CI;R 801..109)
Over-The-Counter Use_
(Optional Format 1-2-96)