(174 days)
The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.
The MGD 521M device is a digital image display system, image monitor/display, and others workstation, image processing
This document describes the 510(k) summary for the Barco MGD 521M, a 5-megapixel diagnostic display intended for displaying and viewing digital mammography images. The submission asserts substantial equivalence to the Barco NV Display Systems MGD 521 (K980541).
Acceptance Criteria and Device Performance:
The document does not explicitly state quantitative acceptance criteria or a detailed "device performance" section in the traditional sense of a clinical or technical study outcome. Instead, the acceptance criteria for the Barco MGD 521M appear to be defined by its conformity to the specifications required by digital mammography system manufacturers and the functional equivalence to its predicate device.
The "reported device performance" in this context is the statement that the device is a "high resolution monitor with electronic capabilities for evaluation of high resolution digital images." The focus is on meeting the technical characteristics required for displaying such images accurately for review by trained medical practitioners.
The critical acceptance criterion is implicit: the Barco MGD 521M must meet the criteria specified by the manufacturer of the digital mammography system with which it is intended to be used. Furthermore, its performance must be "substantially equivalent" to the predicate device, the Barco NV Display Systems MGD 521 (K980541).
| Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|
| Resolution | 5 Megapixel diagnostic display (Implies high resolution capability suitable for digital mammography) |
| Purpose | Intended for displaying and viewing digital images for review and analysis by trained medical practitioners. |
| Mammography Use | Specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer. |
| Technical | High resolution monitor with electronic capabilities for evaluation of high resolution digital images. |
| Equivalence | Substantially equivalent to the Barco NV Display Systems MGD 521 (K980541) |
Study Information (Based on the provided text):
The provided 510(k) summary and FDA letter do not describe a specific clinical study or technical validation study with detailed methodology, sample sizes, or ground truth establishment relevant to performance metrics like sensitivity, specificity, or reader agreement. This type of submission (for a display monitor) typically focuses on technical specifications, safety, and substantial equivalence to a previously cleared predicate device, rather than a clinical trial assessing diagnostic accuracy of the display itself.
Therefore, many of the requested items cannot be directly answered from the given text.
- Sample size used for the test set and the data provenance: Not applicable/Not provided. The document does not describe a test set or clinical data used to evaluate diagnostic performance. The criteria refer to the display's technical capability to show images, not to interpret them.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No test set requiring expert ground truth establishment is mentioned for this device.
- Adjudication method for the test set: Not applicable/Not provided.
- 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 device is a display monitor, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware display device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided. This device is a display monitor and does not use a training set in the context of machine learning.
- How the ground truth for the training set was established: Not applicable/Not provided.
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medical
image
. JUN - 2 2004
510(K) SUMMARY
- Manufacturer: Barco NV Barcoview Theodoor Sevenslaan 106 8500 Kortrijk Belgium
Ferguson Medical Submitted By: Consultant to Barco NV
Phone: +32(0) 56 23 32 11 Contact Information: FAX: +32(0) 56 23 3 74
System, image processing Classification Name:
Common/Usual Name:
Proprietary Name:
Classification Number:
Substantial Equivalence:
Device Description:
Intended Use:
21 CFR 892.2050/Procode 90LLZ
Barco MGD 521M
Image
Barco NV Display Systems MGD 521 5 Megapixel Diagnostic Display (K980541)
workstation, image monitor/display, and others
display system,
The MGD 521M device is a digital image display
The Barco MGD 521M device is intended to be used in displaying and viewing digital images for review by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system
The Barco MGD 521M is a high resolution Technological Characteristics: with electronic capabilities monitor for evaluation of high resolution 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE #931 ALBUQUERQUE NM 87111
Re: K033859 Trade/Device Name: MGD 521M Digital Mammography Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: May 16, 2004 Received: May 20, 2004
Dear Mr. Ferguson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your we your be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the 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). and Oosmetic Free (120) the the device, subject to the general controls provisions of the Act. The I ou may, there or ovisions 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 that I Drivel 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. Boyden
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): K033859
Device Name: MGD 521M
Indications For Use:
The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ XX ... (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
David R. Legram
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 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).