(75 days)
The Coronis 2MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Color Coronis 2MP is a digital image display system. The Color Coronis 2MP device consists of components to provide high resolution visualization of digital images.
The provided text describes a 510(k) premarket notification for the "Color Coronis 2MP Medical Flat Panel Display System". This document is a regulatory approval letter and summary, not a study report detailing performance against acceptance criteria. Therefore, most of the requested information regarding performance, sample sizes, expert qualifications, and study methodologies is not present in the provided text.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
The document does not specify quantitative acceptance criteria or report specific performance metrics for the device. Instead, it focuses on the device's substantial equivalence to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
Not specified in the provided text. The document refers to a "study" implicitly through the 510(k) process, but details of any specific clinical or technical test set are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not specified in the provided text.
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. The device is a medical display system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
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 (expert consensus, pathology, outcomes data, etc.):
Not specified or applicable in the provided context for a display system.
8. The sample size for the training set:
Not applicable. As a display system, it does not typically involve a "training set" in the context of machine learning or diagnostic algorithms.
9. How the ground truth for the training set was established:
Not applicable for the reasons mentioned above.
In summary, the provided document is a regulatory approval for a medical display system based on substantial equivalence, not a detailed technical or clinical study report. Therefore, it does not contain the information requested regarding acceptance criteria, study methodologies, or performance metrics.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top. Inside the circle is an abstract image of an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
Re: K040365
Trade/Device Name: Color Coronis 2MP Medical Flat Panel Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: February 1, 2004 Received: February 13, 2004
Dear Mr. Ferguson:
This letter corrects our substantially equivalent letter of April 28, 2004, regarding a typographical error. The word "Color" was omitted from the trade name and has since been corrected.
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, Dr to 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 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
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Page 2 - Mr. Ferguson
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.
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, primits 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 (301) 594-4654. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html
Sincerely yours,
David R. Ingram
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): K040365
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 (excluding 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)
David A. Sgouris
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040365
Prescription Use _ XX (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
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APR 2 8 2004
510(K) SUMMARY
Ferguson Medical
Consultant to Barco NV
Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74
System, image processing
Manufacturer:
Barco NV Barcoview Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Submitted By:
Contact Information:
Classification Name:
Common/Usual Name:
Proprietary Name:
Classification Number:
Substantial Equivalence:
Device Description:
Intended Use:
Technological Characteristics:
Medical flat panel grayscale display, monitor, display and others
Color Coronis 2MP
21 CFR 892.2050/Procode 90ШZ
Coronis 3MP Medical Flat Panel Display System (K013922)
Color Coronis 2MP is a digital image display system
The Color Coronis 2MP device is intended to be used in displaying and viewing digital images for review by trained medical practitioners
The Barcoview Color Coronis 2MP device consists of components to provide high resolution visualization of digital images
§ 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).