(80 days)
The MFCD 2320 Medical Flat Color Display is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The MFCD 2320 is a diagnostic display. The MFCD 2320 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This submission describes a medical flat color display (MFCD 2320) and not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML performance metrics cannot be found in the provided text. The document is a 510(k) summary for a display device, focusing on its substantial equivalence to a predicate device, and not on algorithmic performance or clinical study outcomes involving AI.
However, based on the information provided, here's what can be extracted and inferred about the device and regulatory process:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain specific acceptance criteria or detailed performance data for the MFCD 2320 in the way one would describe an AI/ML device. For display devices, acceptance criteria would typically relate to technical specifications like resolution, brightness, contrast, color reproduction, stability, viewing angle, and conformity to display standards (e.g., DICOM Part 14). The document states the device is "a high resolution monitor with electronic capabilities for evaluation of high resolution medical images."
Since no specific performance metrics are given, a table cannot be constructed. The regulatory decision is based on substantial equivalence to a predicate device (MFCD 120, K000294), implying that the MFCD 2320 meets similar, if not improved, technical specifications and performance as its predicate.
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 hardware display device, not an AI/ML algorithm that processes data. Therefore, there is no "test set" of medical images or data provenance in the context of an AI/ML study.
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. As noted above, this is a display device, not an AI/ML algorithm requiring ground truth annotation for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a display device, not an AI/ML algorithm with a test set that requires expert adjudication.
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 device, and the submission is not for an AI/ML device, so an MRMC comparative effectiveness study involving AI assistance would not have been performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This is a display device, not an AI/ML algorithm requiring ground truth.
8. The sample size for the training set
Not applicable. This is a display device, not an AI/ML algorithm that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is a display device, not an AI/ML algorithm.
Summary of Device and Regulatory Context (from the provided text):
The MFCD 2320 is a medical flat color display intended for "displaying and viewing digital images for review by trained medical practitioners" (excluding digital mammography images). The regulatory submission (K040158) is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to an already legally marketed predicate device (MFCD 120, K000294). This means that the FDA determined the new device has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness. The approval allows the manufacturer to market the device under general controls, and possibly special controls if it were a Class II device.
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KO40158
APR 1 2 2004
:
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 23 374 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Medical flat panel color display, monitor,display and others |
| Proprietary Name: | MFCD 2320 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | MFCD 120 (K000294) |
| Device Description: | The MFCD 2320 is a diagnostic display |
| Intended Use: | The MFCD 2320 device is intended to be usedin displaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The MFCD 2320 device is a high resolutionmonitor with electronic capabilities forevaluation of high resolution medical images. |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2004
BARCO NV BARCOVIEW % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111
Re: K040158 Trade/Device Name: MFCD 2320 Medical Flat Color Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: January 10, 2004 Received: January 23, 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 10 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 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brydon
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): K040158
Device Name: MFCD 2320 Medical Flat Color Display
Indications For Use:
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ XX = (Per 21 CFR 801.109)
OR
Over-The» Counter Use ________________________________________________________________________________________________________________________________________________________
David A. Ingram
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
§ 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).