(207 days)
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No
The summary describes a system for monitoring and storing physiological data (ECGs, NIBPs) and patient information. There is no mention of AI, ML, or any related concepts like image processing, training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The functionality described is data acquisition, storage, and retrieval.
No
The device monitors heart rhythms and reports ECGs, NIBPs, and patient demographic information. It is designed for monitoring and data management, not for treating a disease or condition.
Yes
The device monitors heart rhythms and reports ECGs, rhythm conditions, and NIBPs, which are all diagnostic measurements.
No
The description mentions "ECGs, rhythm conditions, ECG printouts, BCG measurements, NIBPs". These are typically generated by hardware devices (ECG machines, NIBP monitors). The "Cardio-Card Management System II" appears to be a system that manages data from these hardware devices, rather than being a software-only device that acquires the data itself.
Based on the provided information, the Cardio-Card system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Cardio-Card system directly monitors physiological signals from the patient's body (heart rhythms, ECGs, NIBPs). It is a device that interacts with the patient directly, not with a sample taken from the patient.
Therefore, the Cardio-Card system falls under the category of a medical device that performs physiological monitoring and data management, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.
Product codes
74 DXN
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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(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 stylized eagle or bird-like symbol with three curved lines representing the wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger E. Nasiff President Nasiff Associates, Inc. P.O. Box 88 Brewerton, NY 13029
FEB 2 0 1998
Re : K972795 Cardio-Card Management System II II (Two) Requlatory Class: Product Code: 74 DXN Dated: November 21, 1997 ………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… Received: November 24, 1997
Dear Mr. Nasiff:
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, Druq, 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 obliqation 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. Roger E. Nasiff
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 requlation 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. Callahal Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page I of 1
发生 - 2017-04-04
510(k) Number (if known): 长972795
Device Name: Cardio-Card Management System II
Indications For Use:
. ·
The Cardio-Card system monitors heart mythms and reports ECGs, thythm conditions, ECG printouts, BCG measurements, NIBPs and patient demographic information (e.g. patient name, ssn, physician name, address, physician notes, test notes). The system stores the patient's data to computers for later easy retrieval from its database. The computers can be networked to allow sharing of the information also. Studies can be typical short 12-sec ECG strips and NIBPs or very long term studies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
[Signature]
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | ||
|---|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(Optional Format 1-2-96)