(66 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description is not available to provide further clues.
No
The device is described as a "Telemedicine Receiving Center intended for supporting transtelephonic monitoring" of parameters like ECG and Spirometry. Monitoring devices gather information and do not directly treat or cure a disease or condition, which is the function of a therapeutic device.
Yes
The device supports monitoring of ECG and spirometric parameters, which are used to assess a patient's health status, indicating a diagnostic function.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended use describes receiving parameters, which could be done by software, but the summary doesn't explicitly state the device is solely software.
Based on the provided information, the Telemedicine 2000 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.
- Telemedicine 2000's function: The Telemedicine 2000 is described as a "Telemedicine Receiving Center intended for supporting transtelephonic monitoring of Electrocardiographic (ECG) and Spirometric parameters".
- Nature of ECG and Spirometry: ECG and Spirometry are in vivo measurements. They involve monitoring physiological signals directly from the patient's body (electrical activity of the heart and lung function, respectively), not analyzing samples taken from the body.
Therefore, the Telemedicine 2000 falls under the category of devices that monitor physiological parameters directly from the patient, which are not considered IVDs.
N/A
Intended Use / Indications for Use
The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of Electrocardiographic (ECG) and Spirometric parameters of cardiac patients.
Product codes
74 DXH
Device Description
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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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with flowing lines, possibly representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 30 1999
Mr. Leonid Trachtenberg Card Guard Scientific Survival Ltd. 2 Pekeris Street, P.O.B. 527 Rehovot 76100 ISRAEL
K992164 Re: Card Guard Telemedicine 2000 Regulatory Class: II (two) Product Code: 74 DXH Dated: August 4, 1999 Received: August 9, 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 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 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
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/dsma/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
CARD GUARD
Scientific Survival LTD
Page 1 of 1
Special 510(k) Number:
Device Name: Telemedicine 2000, the Telemedicine Receiving Center
Indication For Use: .
The Telemedicine 2000 is a Telemedicine Receiving Center intended for supporting transtelephonic monitoring of Electrocardiographic (ECG) and Spirometric parameters of cardiac patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
……
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _