(135 days)
The Coronis 5MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images, including digital mammography, for review by trained medical practitioners.
The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
The Coronis 5MP device is a digital image display system
The Coronis 5MP device consists of components to provide high resolution visualization of digital images.
This document is a 510(k) summary for the Barco Coronis 5MP Medical Flat Panel Display System, a digital image display system intended for viewing digital images, including digital mammography.
1. Table of Acceptance Criteria and the Reported Device Performance:
The provided document does not contain a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics for an AI device. Instead, it describes a medical device (a display system) and seeks substantial equivalence to existing devices. The "performance" being assessed here is the device's ability to display images adequately for medical review, and the acceptance is based on meeting the regulatory requirements for such a display system.
However, based on the context of a 510(k) for a display system, the implicit acceptance criteria would revolve around the display's ability to accurately and sufficiently present medical images, particularly for mammography. This would typically involve:
| Acceptance Criteria (Implied for a Medical Display) | Reported Device Performance (Implied from Substantial Equivalence Claim) |
|---|---|
| Resolution (e.g., 5 Megapixels) | Coronis 5MP (implies meeting 5 Megapixel performance) |
| Brightness/Luminance | Comparable to predicate devices (K013922, K040443) |
| Contrast Ratio | Comparable to predicate devices (K013922, K040443) |
| Uniformity | Comparable to predicate devices (K013922, K040443) |
| DICOM compliance | Implicit for a medical display system |
| Intended Use (displaying digital images including mammography for trained practitioners) | Device is marketed for this explicit intended use. |
2. Sample size used for the test set and the data provenance:
- No specific test set or data provenance is mentioned. This document is a regulatory submission for a display device, not a study evaluating an AI algorithm's diagnostic performance on a dataset of patient images. The evaluation is focused on the characteristics of the display itself and its equivalence to other legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this is a display device, there's no "ground truth" establishment in the context of diagnosing cases. The evaluation focuses on technical specifications of the display and its suitability for medical image review.
4. Adjudication method for the test set:
- Not applicable. No test set requiring expert adjudication is mentioned for this device.
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 document pertains to a medical display system, not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a display system, not an algorithm.
7. The type of ground truth used:
- Not applicable. No ground truth in the context of diagnostic accuracy is used for evaluating this display system. The "ground truth" for a display would refer to objective technical specifications and performance against industry standards.
8. The sample size for the training set:
- Not applicable. This document does not describe the development or training of an AI algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe the development or training of an AI algorithm.
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DEC 3 0 2004
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510(K) SUMMARY
| 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: | Coronis 5MP Medical Flat Panel Display System |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 5MP Medical Flat Panel Display System(K013922), Dome CX Digital Flat Panel DisplaySystem, Model C5i (K040443) and others |
| Device Description: | The Coronis 5MP device is a digital imagedisplay system |
| Intended Use: | The Coronis 5MP Medical Flat Panel DisplaySystem is intended to be used in displayingand viewing digital images, including digitalmammography, for review by trained medicalpractitioners. |
| Technological Characteristics: | The Coronis 5MP device consists ofcomponents to provide high resolutionvisualization of digital images. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2004
Barco NV Barcoview c/o Mr. Frank Ferguson Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
K042221 Device Name: Coronis 5MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulatory Class: Class II Product Code: LLZ Dated: December 14, 2004 Received: December 16, 2004
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 (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 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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This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrb/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
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): K042221
Device Name: Coronis 5MP Medical Flat Panel Display System
Indications For Use:
The Coronis 5MP Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images, including digital mammography, 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)
Nancy C. Brogdon
Prescription Use _ ్ల (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).