(167 days)
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Not Found
No
The summary describes an "interpretation program" that analyzes ECG data and reports findings, but it does not explicitly mention or provide details about the use of AI, ML, deep learning, or any related technologies. The description of the analysis is generic and could be based on rule-based algorithms or other traditional methods. Furthermore, the lack of information regarding training/test sets and performance metrics commonly associated with AI/ML models supports this conclusion.
No
The device analyzes and reports ECG data to assist physicians in diagnosis; it does not directly treat or provide therapy to the patient.
Yes
The device analyzes ECG data and reports abnormal and normal ECGs and possible classifications of abnormalities, which directly aids in identifying or determining the presence of a disease or condition.
Unknown
The summary describes a software program that analyzes ECG data but does not explicitly state that the device is only software. It mentions an "ECG acquisition device" which implies a hardware component is involved in the overall system, even if the submitted device is just the interpretive software. Without a clear statement that the submission is solely for the software component and does not include any hardware, it's impossible to definitively classify it as a software-only medical device based on this summary alone.
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 function: The Cardio-Card interpretation program analyzes and reports on ECG data. ECG data is a measurement of the electrical activity of the heart, obtained through electrodes placed on the body. It is not a sample taken from the body.
- Intended Use: The intended use describes the analysis of ECG data to assist in interpreting potential heart problems. This is a diagnostic aid based on physiological measurements, not on the analysis of biological samples.
Therefore, the Cardio-Card interpretation program falls under the category of a medical device that analyzes physiological signals, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.
It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.
It is intended to be used on the adult patient population.
Product codes
74 LOS
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
ECG data
Anatomical Site
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Indicated Patient Age Range
adult patient population
Intended User / Care Setting
used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.
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): 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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N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing right, with three curved lines above them that resemble wings or feathers.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2000
Roger E. Nasiff, Ph.D. Nasiff Associates, Inc. P.O. Box 88 Brewerton, NY 13029
Re: K993616 Cardio-Card Interpretation System I Requlatory Class: III (three) Product Code: 74 LOS Dated: February 2, 2000 Received: February 4, 2000
Dear Dr. 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 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 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation 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 - Roger E. Nasiff, Ph.D.
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,
ficmJA wutermhe r for,
James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Page 1 of 1
510(k) Number (if known):
Device Name: Cardio-Card Interpretive System I
Indications For Use:
The Cardio-Card interpretation program analyzes and reports abnormal and normal ECGs and possible classifications of what kind of abnormals may have been detected from ECG data sent to it. The ECG statements reported assist the user in knowing what problems may exist in the ECG. These statements are to be overread by a Physician trained in the art of ECG interpretation as no automated analysis is completely reliable.
It is intended to be used by or on the order of a physician or similarly qualified health care professional in any environmental setting that the ECG acquisition device is suitable for. These environments include hospitals, physician offices, and clinical settings.
It is intended to be used on the adult patient population.
(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 __