(80 days)
The Nio 5MP Medical Grayscale Display System 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 Nio 5MP device is a digital image display system. The Barco Nio 5MP device consists of components to provide high resolution visualization of digital images.
This is a 510(k) premarket notification for a medical device: Barco Nio 5MP Medical Grayscale Display System. As such, the submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics typically seen for novel diagnostic algorithms.
Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given text. A 510(k) submission for a display system typically focuses on meeting technical specifications (e.g., luminance, contrast, resolution, DICOM conformance) rather than clinical performance metrics like sensitivity or specificity for a diagnostic task. The document states that the device provides "high resolution visualization of digital images," implying it meets general display standards, but no specific performance criteria or a table are presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. Since this is a display system, a "test set" in the context of diagnostic accuracy studies (like those for AI algorithms) is not applicable. The evaluation for a display system would involve technical performance tests and possibly human factor usability assessments, but not a dataset of medical images for diagnostic performance evaluation of the display itself.
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)
This information is not provided. As explained above, the concept of "ground truth" for diagnostic accuracy is not relevant for a medical display system in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Not applicable for a display system.
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
This information is not provided. MRMC studies are used for evaluating diagnostic performance, often for AI algorithms or new imaging modalities. This device is a display system, not an AI diagnostic tool, so such a study would not be performed for its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. Not applicable, as this is a display system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. Not applicable for a display system.
8. The sample size for the training set
This information is not provided. Not applicable, as this is a display system, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not provided. Not applicable, as this is a display system, not an AI algorithm.
Summary of what is available from the document:
The provided document is a 510(k) Summary for a medical display system. Its primary purpose is to demonstrate substantial equivalence to an already legally marketed predicate device (Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System, K013922).
- Device Description: The Nio 5MP device is a digital image display system consisting of components to provide high-resolution visualization of digital images.
- Intended Use: "The Barco Nio 5MP Display System is intended to be used in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners."
- Basis for Clearance: The FDA's decision to clear the device is based on its determination of "substantial equivalence" to the predicate device, meaning it has the same intended use and similar technological characteristics, or different characteristics that do not raise different questions of safety and effectiveness. The document itself does not contain detailed studies with acceptance criteria for clinical performance but implies that the device meets technical standards necessary for medical image review.
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MAR 2 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: | Image display system, medical imageworkstation, image monitor/display, and others | ||
| Proprietary Name: | Barco Nio 5MP | ||
| Classification Number: | 21 CFR 892.2050/Procode 90LLZ | ||
| Substantial Equivalence: | Barco NV Display Systems Coronis 3MP MedicalFlat Panel Display System (K013922) | ||
| Device Description: | The Nio 5MP device is a digital image displaysystem | ||
| Intended Use: | The Barco Nio 5MP Display System is intendedto be used in displaying and viewing digitalimages for review by trained medicalpractitioners. | ||
| Technological Characteristics: | The Barco Nio 5MP device consists ofcomponents to provide high resolutionvisualization of digital images. |
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus has a staff with two snakes winding around it, topped by a pair of wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2004
Barco NV Barcoview % Mr. Frank Ferguson Official Correspondent Ferguson Medical 12200 Academy Road NE, # 931 ALBUQUERQUE NM 87111
Re: K040040 Trade/Device Name: Nio 5MP Medical Grayscale Display System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 7, 2003 Received: January 9, 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 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. 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): K040040
Device Name: Nio 5MP Medical Grayscale Display System
Indications For Use:
The Nio 5MP Medical Grayscale Display System 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)
| Prescription Use | XX | OR | Over-The- Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | |||
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, and Radiological Devices | |||
| 510(k) Number | K040040 |
§ 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).