(15 days)
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display may be used in dental applications.
The MDNC-3421 is a derivative of the MDNC-3321. The modifications are:
✓ PLD panel instead of NLT panel
✓ Change in packaging (smaller size)
✓ Updated firmware
✓ Change in type of material from steel to aluminum (inside metal housing)
✓ For the dental radiology market, this display will be marketed with the screen in landscape orientation
Here's an analysis of the acceptance criteria and study information based on the provided document:
This document is a 510(k) premarket notification for a medical display system, which often focuses on demonstrating substantial equivalence to a predicate device rather than extensive clinical studies for novel technologies.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/CADe devices. Instead, it demonstrates substantial equivalence by comparing the new device (MDNC-3421) to a predicate device (MDNC-3321) based on technical specifications and performance testing. The "reported device performance" is implicitly shown by the new device meeting or exceeding the specifications of the predicate device and showing no new safety or performance issues.
| Acceptance Criteria (Inferred) | Reported Device Performance (MDNC-3421) |
|---|---|
| Technological Characteristics (Similar to Predicate): | |
| Screen technology | TFT AM Color LCD IPS |
| Active screen size (diagonal) | 540 mm (21.3") |
| Active screen size (H x V) | 433 x 325 mm (17.0 x 12.8") |
| Aspect ratio (H:V) | 4:3 |
| Resolution | 3MP (2048 x 1536) |
| Pixel pitch | 0.2155 mm |
| Color imaging | Yes |
| Gray imaging | Yes |
| Viewing angle (H, V) | 176° |
| Uniform Luminance Technology (ULT) | Yes |
| Per Pixel Uniformity (PPU) | No |
| Ambient Light Compensation (ALC) | No |
| Backlight Output Stabilization (BLOS) | Yes |
| Maximum luminance | 800 cd/m² |
| DICOM calibrated luminance (ULT off) | 400 cd/m² |
| Contrast ratio (typical) | 1400:1 |
| Response time (Tr + Tf) | 40 ms |
| Video input signals | DVID Dual Link, DisplayPort |
| USB ports | 1 upstream (endpoint), 2 downstream |
| USB standard | 2.0 |
| Power consumption (nominal) | 50W |
| Power save mode | Yes |
| Dimensions with stand (W x H x D) | Portrait: 378 x 528 |
| Dimensions w/o stand (W x H x D) | Portrait: 378 x 491 x 84 mm, Landscape: 491 x 378 x 84 mm |
| Net weight with stand | 12.8 kg |
| Intended use | Displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. |
| Performance (Demonstrated Equivalence/Superiority for Modifications): | |
| PLD panel instead of NLT panel | PPVR (Product Producibility Validation Report) confirms performance. |
| Change in packaging (smaller size) | Environmental tests confirm performance. |
| Updated firmware | Firmware tests confirm performance. |
| Change in type of material from steel to aluminum (inside metal housing) | Environmental tests confirm performance. |
| Marketing in landscape/portrait orientation | Clinical study (mentioned, but details not provided in this excerpt). |
| Electrical Safety | IEC 60601-1 compliant |
| EMC | IEC 60601-1-2 compliant |
| Overall Conclusion: | Device has similar or superior characteristics compared to the predicate and did not reveal new issues of safety and performance. |
2. Sample size used for the test set and the data provenance
The document primarily describes bench testing and, for one specific aspect, mentions a "Clinical study."
- Bench Tests (for hardware/firmware changes, safety, and EMC): No specific sample sizes (e.g., number of displays tested) are provided for tests like PPVR, Environmental tests, Firmware tests, Electrical Safety (IEC 60601-1), and EMC (IEC 60601-1-2). These are typically engineering validation tests. The provenance is internal to the manufacturer's testing process.
- Clinical Study (for landscape/portrait orientation marketing): A "Clinical study" is mentioned for validating the marketing of the display in landscape/portrait orientation. However, no details are provided regarding the sample size, data provenance (e.g., country of origin, retrospective/prospective nature), or the methodology of this study. This suggests it was likely a usability or preference study relevant to display orientation, rather than a clinical trial assessing diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the core of the submission relies on demonstrating substantial equivalence through technical specifications and bench testing, rather than a diagnostic performance study, the establishment of "ground truth" by medical experts is not a primary focus here. The clinical study mentioned is too briefly described to extract this information.
4. Adjudication method for the test set
This information is not provided in the document. As noted above, the predominant testing described is bench testing, where adjudication by medical experts isn't applicable in the same way as in a diagnostic study.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not described or implied in this document. This device is a medical display system, not an AI/CADe diagnostic algorithm. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study of an algorithm was not done. This device is a display monitor, not an algorithm.
7. The type of ground truth used
For the bench tests, the "ground truth" consists of engineering specifications, industry standards (e.g., DICOM, IEC 60601-1), and established performance metrics (e.g., luminance, contrast ratio, response time). These are not expert consensus, pathology, or outcomes data. For the mentioned "clinical study," the type of ground truth is not specified due to the lack of detail.
8. The sample size for the training set
This information is not applicable as this device is a medical display system, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
{0}------------------------------------------------
Image /page/0/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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Barco NV % Ms. Helena Soenen Regulatory Affairs Officer President Kennedypark 35 Kortriik 8500 BELGIUM
Re: K170837
Trade/Device Name: Nio Color 3MP (MDNC-3421) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 15, 2017 Received: March 21, 2017
Dear Ms. Soenen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K170837
Device Name Nio Color 3MP (MDNC-3421)
Indications for Use (Describe)
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The display may be used in dental applications.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| 510(k) Summary (in accordance with 21 CFR 807.92) | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM | ||||||||||||||||||||||||||||||
| 2. Contact person | Helena SoenenRegulatory Affairs Officer | ||||||||||||||||||||||||||||||
| 3. Date of submission | 15 March 2017 | ||||||||||||||||||||||||||||||
| 4. Device information | Trade name/model: Nio Color 3MP (MDNC-3421)Common name: MDNC-3421Classification name: System, image processing, RadiologicalClassification code: PGYRegulation number: 892.2050 | ||||||||||||||||||||||||||||||
| 5. Predicate device | Nio Color 3MP (MDNC-3321) cleared under 510(K) K131295 | ||||||||||||||||||||||||||||||
| 6. Device description | The MDNC-3421 is a derivative of the MDNC-3321. The modifications are:✓ PLD panel instead of NLT panel✓ Change in packaging (smaller size)✓ Updated firmware✓ Change in type of material from steel to aluminum (inside metal housing)✓ For the dental radiology market, this display will be marketed with the screen in landscape orientation | ||||||||||||||||||||||||||||||
| 7. Intended Use of the Device | The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. | ||||||||||||||||||||||||||||||
| 8. Comparison of technological characteristics | Specification MDNC-3421 MDNC-3321 Screen technology TFT AM Color LCD IPS TFT AM Color LCD IPS Active screen size (diagonal) 540 mm (21.3") 540 mm (21.3") Active screen size (H x V) 433 x 325 mm (17.0 x 12.8") 433 x 325 mm (17.0 x 12.8") Aspect ratio (H:V) 4:3 4:3 Resolution 3MP (2048 x 1536) 3MP (2048 x 1536) Pixel pitch 0.2155 mm 0.2155 mm Color imaging Yes Yes Gray imaging Yes Yes Viewing angle (H, V) 176° 176° |
BARCO
{4}------------------------------------------------
| Uniform LuminanceTechnology (ULT) | Yes | Yes |
|---|---|---|
| Per Pixel Uniformity (PPU) | No | No |
| Ambient Light Compensation(ALC) | No | No |
| Backlight Output Stabilization(BLOS) | Yes | Yes |
| Maximum luminance | 800 cd/m² | 800 cd/m² |
| DICOM calibrated luminance(ULT off) | 400 cd/m² | 400 cd/m² |
| Contrast ratio (typical) | 1400:1 | 1400:1 |
| Response time (Tr + Tf) | 40 ms | 40 ms |
| Video input signals | DVID Dual Link, DisplayPort | DVID Dual Link, DisplayPort |
| USB ports | 1 upstream (endpoint), 2 downstream | 1 upstream (endpoint), 2 downstream |
| USB standard | 2.0 | 2.0 |
| Power consumption (nominal) | 50W | 50W |
| Power save mode | Yes | Yes |
| Dimensions with stand (W x H x D) | Portrait: 378 x 528 | Portrait: 378 x 528 |
| Dimensions w/o stand (W x H x D) | Portrait: 378 x 491 x 84 mmLandscape: 491 x 378 x 84 mm | Portrait: 378 x 491 x 84 mmLandscape: 491 x 378 x 84 mm |
| Net weight with stand | 12.8 kg | 12.8 kg |
| Intended use | The Nio Color 3MP LEDMedical Flat Panel DisplaySystem is intended to be usedfor displaying and viewingdigital images (excludingdigital mammography) forreview and analysis by trainedmedical practitioners. | The Nio Color 3MP LEDMedical Flat Panel DisplaySystem is intended to be usedfor displaying and viewingdigital images (excludingdigital mammography) forreview and analysis by trainedmedical practitioners. |
| 9. PerformanceThe bench tests mentioned below were performed to validate the device characteristicsthat differ from the predicate device:testing | ||
| Modification to device | Test performed | |
| PLD panel instead of NLT panel | PPVR (Product Producibility ValidationReport) | |
| Change in packaging (smaller size) | Environmental tests | |
| Updated firmware | Firmware tests | |
| Change in type of material from steel toaluminum (inside metal housing) | Environmental tests | |
| For the dental radiology market, thisdisplay will be marketed with the screen | Clinical study | |
| in landscape orientation and for generalradiology, this display will be marketed inportrait orientation. | ||
| Additional tests performed: Electrical Safety test (IEC 60601-1), EMC test (IEC 60601-1-2) | ||
| The tests showed that the device has similar or superior characteristics compared to thepredicate device and did not reveal new issues of safety and performance. | ||
| Animal testing has not been performed. | ||
| 10. Conclusion | The Nio Color 3MP was found to be substantially equivalent to the predicate device, dueto the following reasons:a) Device and predicate device have the same intended useb) The technological characteristics differences from the predicate device do notaffect safety or effectivenessc) Bench testing showed that the device has similar or superior characteristicscompared to the predicate device and did not reveal new issues of safety andperformance. |
BARCO
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The "R" and "C" in "BARCO" are stylized, with the top right of the "R" and the top left of the "C" forming a connected shape.
§ 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).