(107 days)
Not Found
Not Found
Unknown
The summary mentions an "ECG interpretation program" which could potentially use AI/ML, but the provided text does not explicitly state this or provide details about the program's technology.
No.
The device is used for recording and interpreting ECGs, which are diagnostic functions, not therapeutic interventions.
Yes
The device is used to record and automatically interpret ECGs, which are used to assess a patient's cardiac health, thus serving as a diagnostic tool.
No
The description explicitly states the device "maybe used to record and store standard 12 lead Electrocardiograms (ECG)". Recording ECGs requires hardware (electrodes, amplifier, etc.), indicating it is not a software-only device.
Based on the provided information, the Cardiovit CS-200 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record and store electrocardiograms (ECG) from patients. This is a measurement of electrical activity within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Nature of ECG: ECG is a physiological measurement, not a diagnostic test performed on a biological sample in vitro (outside the living organism).
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, reagents, or other components typically associated with IVD devices.
Therefore, the Cardiovit CS-200 falls under the category of a medical device used for physiological monitoring and recording, not an IVD.
N/A
Intended Use / Indications for Use
The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.
Product codes
74 LOS
Device Description
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Mentions image processing
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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
Not Found
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
N/A
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a person embracing or supporting another, representing the department's mission of protecting and promoting the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Markus Maritz Schiller America, Inc. 3002 Dow Avenue JUN 25 1997 Building 138 Tustin, California 92780
Re: K970879 · Cardiovit CS-200 Regulatory Class: III (three) Product Code: 74 LOS Dated: June 5, 1997 Received: June 9, 1997
Dear Mr. Maritz:
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 aqainst misbrandinq 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. 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. Markus Maritz
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) 594-4646. 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 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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Page l of l
5 1 O(k) Number (if known): K970879
Cardiovit CS-200 Davice Nama:
Indications For Use:
The Cardiovit CS-200 device maybe used to record and store standard 12 lead Electrocardiograms (ECG) at patients resting or exercising. Resting ECG's are automatically measured and interpreted by the optionally available Schiller ECG interpretation program.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K970879 |
Prescription Use V (Per 21 CFR 801.109)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)