(207 days)
The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD 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 MFGD 1318 is a diagnostic display. The MFGD 1318 device is a high resolution monitor with electronic capabilities for evaluation of high resolution medical images.
This 510(k) premarket notification (K033005) is for a medical display device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.
The submission focuses on establishing substantial equivalence to a predicate device (Coronis 1MP Medical Flat Panel Display System, K023340) based on technological characteristics and intended use. The "acceptance criteria" here refer to the performance specifications of the display hardware, and "study" refers to tests and comparisons demonstrating these specifications are met and are equivalent to the predicate.
Here's the information that can be extracted, and where the requested AI/ML specific information is not applicable (N/A):
- Table of acceptance criteria and the reported device performance
| Criteria | MFGD 1318 Performance | Basis for Acceptance |
|---|---|---|
| Intended Use | Displaying and viewing digital images (excluding digital mammography) for review by trained medical practitioners. | Substantially equivalent to predicate device (K023340) which has the same intended use for medical practitioners. |
| Technological Characteristics | High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | Substantially equivalent to predicate device (K023340) as both are 1 Megapixel Grayscale LCD Displays for medical imaging. Specific technical display parameters (resolution, brightness, contrast, etc.) would have been detailed in the full 510(k) submission, but are not provided in this summary. |
| Display Type | 18 Inch 1 Megapixel Grayscale LCD Display | Matches the display type and resolution category of the predicate device. |
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Sample size used for the test set and the data provenance
- Sample size for test set: N/A (as this is a hardware device, not an AI/ML algorithm evaluated on a dataset of medical images).
- Data provenance: N/A
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (no ground truth established in the context of an AI/ML algorithm's performance on medical images).
-
Adjudication method for the test set
- N/A
-
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
- N/A (This is not an AI-assisted device). The evaluation here is about the technical performance of a display, not its impact on human reader performance with AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A (This is a display device, not a standalone algorithm).
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The type of ground truth used
- N/A. The "ground truth" for a display device would relate to its physical characteristics meeting industry standards and safety regulations, not a medical diagnosis dataset.
-
The sample size for the training set
- N/A.
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How the ground truth for the training set was established
- N/A.
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APR 1 9 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 3 74 |
| Classification Name: | System, image processing |
| Common/Usual Name: | Medical flat panel grayscale display, monitor,display and others |
| Proprietary Name: | MFGD 1318 |
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ |
| Substantial Equivalence: | Coronis 1MP Medical Flat Panel Display System(K023340) |
| Device Description: | The MFGD 1318 is a diagnostic display |
| Intended Use: | The MFGD 1318 device is intended to be usedin displaying and viewing digital images forreview by trained medical practitioners. |
| Technological Characteristics: | The MFGD 1318 device is a high resolutionmonitor with electronic capabilities forevaluation of high resolution medical 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 features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle figure in the center.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2004
Barco NV Barcoview c/o Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, #931 ALBUQUERQUE NM 87111
Re: K033005
Trade/Device Namc: MFGD 1318 18 Inch 1 Megapixel Grayscale LCD 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 We nave reviews your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreament date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do froos mat have been 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 cither 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 r rouse of a nove 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (scctions 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) i his lefter will anow you to ocgainmanteang your antial equivalence of your device to a legally premarket notincation. The PDA momg or easing 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 If you desire specific advice for your dones to to.
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 Additionally, for questions on the president on the regulation entitled, "Misbranding Office of Compliance at (301) 57 - 1057.97) you may obtain. Other general by relerence to premarked notimoditors (r the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octorss http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincercly 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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Page 1 of 1
510(k) Number (If known): K033005
Device Name: MFGD 1318
Indications For Use:
The MFGD 1318 18 Inch 1 Megapixel Grayscale LCD 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 write below this line - continue on another page if needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Emil G. Syverson
(Divison Sign-Off) Distrion of Reproductive, Abdorninal, anu Radiologica. Devices KO33005 510(k) Number ________
Prescription Use __ XX (Per 21 CFR 801.109)
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________
OR
§ 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).