(80 days)
The Barco Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The Coronis 2MP device is a digital image display system
The Barco Coronis 2MP device consists of components to provide high resolution visualization of digital images.
The provided text is a 510(k) summary for the Barco Coronis 2MP Medical Flat Panel Display System, which is an image display system. The document does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the way typically expected for an AI/algorithm-based medical device.
This document describes a medical display system (hardware), not an AI algorithm. Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications for ground truth, MRMC studies, standalone algorithm performance, and ground truth establishment) are not applicable or would not be found in such a submission for a display device.
However, I can extract the information that is present and indicate where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The submission acts as a declaration that the Barco Coronis 2MP Medical Flat Panel Display System is "substantially equivalent" to a legally marketed predicate device (Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System (K013922)). For a display system, acceptance criteria are generally related to display characteristics (resolution, brightness, contrast, uniformity, viewing angle, stability, calibration capabilities, etc.) and compliance with relevant medical display standards (e.g., DICOM Part 14, AAPM TG18). These specific technical performance metrics are not detailed in the provided 510(k) summary. The summary focuses on the device's intended use and classification.
The "reported device performance" is implicitly that it meets the requirements for substantial equivalence to the predicate device for displaying and viewing digital images for review by trained medical practitioners. Specific numerical performance values are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a display system, not an algorithm being tested on a clinical image dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a display system. "Ground truth" in the context of image interpretation by experts is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a display system, and it is not an AI-assisted device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable. This is a display system, not an algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable.
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510(K) SUMMARY
DEC 2 3 2002
メロ23322
| Manufacturer: | Barco NV BarcoviewTheodoor Sevenslaan 1068500 KortrijkBelgium |
|---|---|
| Submitted By: | Ferguson MedicalConsultant to Barco NV |
| Contact Information: | Phone: +32(0) 56 23 32 11FAX: +32(0) 56 23 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Image display system, medical imageworkstation, image monitor/display, and others |
| Proprietary Name: | Barco Coronis 2MP Medical Flat Panel DisplaySystem |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems Coronis 3MP MedicalFlat Panel Display System (K013922) |
| Device Description: | The Coronis 2MP device is a digital imagedisplay system |
| Intended Use: | The Barco Coronis 2MP Medical Flat PanelDisplay System is intended to be used indisplaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The Barco Coronis 2MP device consists ofcomponents to provide high resolutionvisualization of digital images. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be slightly distressed.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barco NV BARCOVIEW % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K023322 Trade/Device Name: Coronis 2MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 21, 2002 Received: October 4, 2002
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Nancy C. Grigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): KO23
Device Name: Coronis 2MP Medical Flat Panel Display System
Indications For Use:
The Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ghris A. Lezman
(Division Sign-Off) Division of Reproductive, Abdominal, KOZ 3322 and Radiological Devices 510(k) Number _
Prescription Use XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use _
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).