(200 days)
The MGD 2621L device is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
The MGD 2621L Medical Grayscale 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 MGD 2621L is a diagnostic display
The MGD 2621L device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This document is a 510(k) summary for a medical grayscale display (MGD 2621L). It is for a display device, not an AI/ML algorithm or diagnostic device that makes clinical assessments. Therefore, the questions related to acceptance criteria for algorithm performance, sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth are not applicable.
The submission focuses on establishing substantial equivalence to a predicate device (Barco MGD 221) based on technical characteristics and intended use.
Here's the relevant information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" in the sense of performance metrics (sensitivity, specificity, etc.) for a diagnostic algorithm. Instead, it refers to substantial equivalence to a predicate device, which implies the device meets similar performance and safety standards.
| Characteristic | MGD 2621L (Proposed Device) | MGD 221 (Predicate Device, K000293) | Basis for Equivalence |
|---|---|---|---|
| Intended Use | Displaying and viewing digital images for review by trained medical practitioners (excluding digital mammography). | Displaying and viewing digital images for review by trained medical practitioners. | Similar (implicit) |
| Technological Characteristics | High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | Diagnostic Display (Implicitly high resolution) | Similar (implicit) |
| Classification Name | System, image processing | System, image processing | Identical |
| Common/Usual Name | Medical flat panel grayscale display, monitor, display | Medical flat panel grayscale display, monitor, display | Similar |
| Proprietary Name | MGD 2621L | MGD 221 | Different (Model) |
| Classification Number | 21 CFR 892.2050 / Procode 90LLZ | 21 CFR 892.2050 / Procode 90LLZ | Identical |
2. Sample size used for the test set and the data provenance: Not applicable. This is a display device, not an algorithm being tested on a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is a display device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a display device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. This is a display device.
8. The sample size for the training set: Not applicable. This is a display device.
9. How the ground truth for the training set was established: Not applicable. This is a display device.
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APR 1 6 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: | Medical flat panel grayscale display, monitor,display and others |
| Proprietary Name: | MGD 2621L |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Barco MGD 221 2 Megapixel Diagnostic Display(K000293) |
| Device Description: | The MGD 2621L is a diagnostic display |
| Intended Use: | The MGD 2621L device is intended to be usedin displaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The MGD 2621L device is a high resolutionmonitor with electronic capabilities forevaluation of high resolution medical images. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2004
BARCO NV BARCOVIEW % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111
Re: K033103 Trade/Device Name: MGD 2621L Medical Grayscale Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: July 14, 2003 Received: January 26, 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 anproval 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 adultcration.
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. 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): K033103
Device Name: MGD 2621L
Indications For Use:
The MGD 2621L Medical Grayscale 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.
please do not writte 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 A. Slyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 5 ! O(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).