(62 days)
The Barco Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The Coronis 3MP 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 3MP device is a digital image display system
The Barco Coronis 3MP device consists of components to provide high resolution visualization of digital images.
The provided text does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria. The document is a 510(k) summary for the Barco Coronis 3MP Medical Flat Panel Display System, a device intended for displaying and viewing digital medical images. It primarily focuses on demonstrating substantial equivalence to a predicate device (Barco NV Display Systems MeDis 5MP2 Dual-Head Medical Diagnostic Display System, K001753).
The text does not provide the following information:
- A table of acceptance criteria and the reported device performance: This level of detail about technical performance metrics and their comparison is absent.
- Sample size used for the test set and the data provenance: There is no mention of a test set, data provenance, or any clinical or technical study outcomes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As no test set is discussed, this information is not present.
- Adjudication method for the test set: No test set is described, so no adjudication method is mentioned.
- 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: This device is a display system, not an AI or diagnostic algorithm, so an MRMC study with AI assistance is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a display system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed as there is no diagnostic algorithm or study evaluated.
- The sample size for the training set: No training set is applicable or mentioned for a display system.
- How the ground truth for the training set was established: Not applicable.
The document mainly states the device's intended use, classification, and asserts substantial equivalence to a predicate device based on its technological characteristics (high-resolution visualization of digital images). Device performance is implied to be similar to the predicate device, which would have undergone its own clearance process, but specific performance metrics for the Coronis 3MP are not detailed in this summary.
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Ko 13922
510(K) SUMMARY
:
JAN 2 8 2002
| Manufacturer: | Barco NV Display SystemsTheodoor 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 3MP Medical Flat Panel DisplaySystem |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco NV Display Systems MeDis 5MP2 Dual-Head Medical Diagnostic Display System(K001753) |
| Device Description: | The Coronis 3MP device is a digital imagedisplay system |
| Intended Use: | The Barco Coronis 3MP Medical Flat PanelDisplay System is intended to be used indisplaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The Barco Coronis 3MP device consists ofcomponents to provide high resolutionvisualization of digital images. |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized birds in flight, arranged in a layered formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2002
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 Re: K013922 Trade/Device Name: Coronis 3MP Medical Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications system Regulatory Class: II Product Code: 90 LLZ Dated: October 15, 2001 Received: November 27, 2001
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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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. 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): Ko / 3927
Device Name: Coronis 3MP Medical Flat Panel Display System
Indications For Use:
The Coronis 3MP 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)
David A. Sygnor
(Division Sign-Off)
(Division Sign-Om)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012922
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).