(120 days)
The MOVIEW is a software device vicently , print and save cardia. In the same income studio refrieve refrieve, display, profit and into in a mage studio cathelerization faboration and to view these real-Time mode PC images on Cu
The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis.
The provided document is a 510(k) premarket notification for a medical image communication and storage device (MDVIEW-MEDCON's DICOM Viewer). It does not contain typical acceptance criteria or a detailed study proving device performance in the way modern AI/ML medical devices would.
This document is from 1997, a time before the widespread use of AI/ML in medical devices, and it concerns a Picture Archiving and Communication System (PACS) device. For such devices, "performance" relates to their ability to accurately display, store, and retrieve medical images, ensuring image integrity and compatibility with standards like DICOM. The review process for such devices would focus on demonstrating technical functionality and equivalence to existing devices rather than a detailed clinical performance study with statistical endpoints.
Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, and ground truth establishment, as they apply to clinical performance of an AI/ML algorithm, are not applicable or available in this document.
However, I can extract the relevant information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device: The device must demonstrate substantial equivalence in its intended use for retrieving, displaying, printing, and saving cardiac catheterization laboratory image studies. | The MDVIEW is "substantially equivalent to The CRS 2000 subsystem of the Kodak Science Digital Image System." The differences between MDVIEW and the predicate device "raise no new issues of safety or effectiveness." |
| Image Integrity: The device must handle "loss free images" from cardiac catheterization laboratories. | The device is designed to handle "loss free images" recorded on CD-R in conformance with the DICOM standard, providing a "valuable tool for diagnostic review and analysis." |
| Standard Conformance: Compatibility with established medical imaging standards. | Digital imaging is recorded on CD-R "in conformance with the DICOM standard." |
| Platform Compatibility & Real-time Viewing: Ability to view images on a PC computer in real-time. | The device is intended "to view these images on a PC computer in real time mode." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document does not describe a clinical performance study with a test set of patient data to evaluate diagnostic accuracy. The assessment focuses on technical and functional equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No ground truth establishment for a test set is mentioned, as there was no clinical performance study in the context of an AI/ML diagnostic aid.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a PACS viewer, not an AI diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is a PACS viewer, not an algorithm. Standalone performance as understood for AI/ML algorithms is not relevant to this device's regulatory review.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. The concept of "ground truth" for a diagnostic outcome is not relevant to a PACS device's functional equivalence review. The "truth" in this context refers to the accurate display and storage of the original, unadulterated medical images.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No training set or ground truth establishment is described.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH" is arranged in a semi-circular fashion around the left side of the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDCON LTD. c/o Dr. Eli M. Orbach International Regulatory Consultants POB 6718, Erfrat 90435 ISRAEL
Re: K971181 MDVIEW (PACS) Medical Image Communication and Storage Device (Cardiac Device Accessory) Dated: July 14, 1997 Received: July 16, 1997 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI
JUL 2 9 1997
Dear Dr. Orbach:
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 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 requirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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,
h.J.Liau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SUMMARY OF SAFETY AND EFFECTIVENESS 5.
9 1997
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
Submitter: Medcon Ltd. Kiryat Atidim, P.O. Box 518164 Tel Aviv 615811srael Tel: +972.3 6487702, Fax: +972. 3 6482310
Name of the Device: The MDVIEW-MEDCON's DICOM Viewer
Predicate Devices: The MDVIEW is substantially equivalent to The CRS 2000 subsystem of the Kodak Science Digital Image System. ...
Description of the Device: The MDVIEW is a software device intended to retrieve, display, print and save cardiac catheterization laboratory image studies from CD-R media, and to view these images on a PC computer in real time mode. Digital imaging from the cardiac catheterization laboratory is recorded on the CD-R in conformance with the DICOM standard. These loss free images provide physicians with a valuable tool for diagnostic review and analysis. The differences between the MDVIEW and the predicate device raise no new issues of safety or effectiveness.
24 March, 1997
y
Mr.Uzi Blumensohn, General Manager
Date
Image /page/1/Picture/10 description: The image shows the logo for Medcon Ltd. The logo is black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "TELEMEDICINE TECHNOLOGY" in a smaller font. The logo is simple and professional, and it conveys the company's focus on telemedicine technology.
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ MOVIEW - MEDION'S DICOM INEWER Indications For Use: The MOVIEW is a software device vicently , print and save cardia.
In the same income studio refrieve refrieve, display, profit and into in a mage studio cathelerization faboration and to view these real-Time mode PC ડ images on Cu
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971181
Luy
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.