(26 days)
Not Found
No
The document describes a medical display device and its technical specifications, focusing on image display and performance characteristics. There is no mention of AI or ML being used for image analysis, processing, or any other function within the device.
No
The device is a medical computer display for diagnostic imaging, which is a diagnostic tool, not a therapeutic one.
Yes
Explanation: The device is intended for "review, analysis, and diagnosis by trained medical practitioners" in displaying digital images, including mammography and breast tomosynthesis. This explicitly states its role in the diagnostic process.
No
The device description explicitly states it is a medical computer display with integrated hardware components like an LCD panel, LED backlight, internal mechanics chassis, electronics, sensors, and power supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a medical computer display. Its function is to display digital images for review, analysis, and diagnosis. It does not perform any tests on biological samples.
- Intended Use: The intended use is for displaying images for medical practitioners to interpret. This is a display function, not a diagnostic test performed on a sample.
Therefore, while this device is a medical device used in the diagnostic process, it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The MDNC-12130 (Nio Fusion 12MP) is a medical computer display designed for both PACS and breast imaging applications. It consists of a 30.9" 12 mega-pixel (4200x2800 resolution) LCD panel with integrated LED backlight. The panel is integrated into the display housing body with an internal mechanics chassis structure, that also integrates the electronics, sensors and power supply. The display module is supported by a display stand. Internal sensors and controllers measure, control and stabilize the device. SoftGlow Lights are integrated as an ancillary function for user comfort and can be lit to illuminate the desk and to create some ambient lighting in the reading room.
The 31" 12MP (4200x2800 resolution) MDNC-12130 display can be compared to a dual-head, 2 x 21″ 5.8 MP (2100x2800 resolution) MDNC-6121 display system.
The MDNC-12130 is a derivative of the MDNC-6121. The modified display is effectively identical to the predicate device except for the following changes:
31" 12 mega-pixel (4200x2800 resolution) LCD panel, compared to 2 x 21inch 5.8 MP LCD panel of a dual-head MDNC-6121 display system New housing, display stand and internal mechanics, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display
✓ Change in electronics board, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display; including:
✓ Integration of the power supply adaptor into the device, compared to an external power adapter for MDNC-6121
✓ Updated firmware, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display
✓ Change in packaging, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display
✓ Addition of SoftGlow Task Light and Wall Light ancillary function for user comfort
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images, standard and multiframe digital mammography, breast tomosynthesis applications
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The technological characteristics discussed above show that the device MDNC-12130 has similar technological characteristics as the predicate device MDNC-6121 and do not reveal new issues of safety and performance.
The below performance bench tests are performed and corresponding results reported for the modified device MDNC-12130 in comparison to the predicate device MDNC-6121, as per the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued on October 2, 2017:
Spatial resolution – MTF Pixel defects, Artifacts Temporal Response Maximum and Minimum Luminance, Luminance response Conformance to DICOM GSDF Angular Dependency of Luminance Luminance uniformity Stability of Luminance and Chromacity over Time and Operating Temperature Spatial Noise – NPS Reflection coefficient - Display Reflectance with Specular, Diffuse & Haze coefficients Veiling glare or small-spot contrast Color tracking, Gray tracking
The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance. Additionally, the modified device MDNC-12130 is compliant to EMC and Safety standards.
No animal testing or clinical testing has been performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
November 10, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk. W-VL 8500 BELGIUM
Re: K203106
Trade/Device Name: Nio Fusion 12MP (MDNC-12130) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: October 8, 2020 Received: October 15, 2020
Dear Ms. Vandecandelaere:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203106
Device Name Nio Fusion 12 MP (MDNC-12130)
Indications for Use (Describe)
The display is intended to be used in displaying digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis 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) |
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 required to respond to, a collection of information unless it displays a currently valid OMB number."
3
BARCO
| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---|---|
| 1. Company | Barco N.V. |
| Healthcare Division | |
| 35 President Kennedypark | |
| B-8500 Kortrijk | |
| BELGIUM | |
| 2. Contact person | Julie Vandecandelaere |
| Regulatory Affairs Officer | |
| Tel: +32 (0)56 26 13 19 | |
| julie.vandecandelaere@barco.com | |
| 3. Date of submission | 08 October 2020 |
| 4. Device information | Trade name/model: Nio Fusion 12MP (MDNC-12130) |
| Common name: MDNC-12130 | |
| Classification name: System, image processing, Radiological | |
| Classification code: PGY | |
| Regulation number: 892.2050 | |
| 5. Predicate device | Nio Color 5.8MP (MDNC-6121) cleared under 510(K) K170476. |
| 6. Device description | The MDNC-12130 (Nio Fusion 12MP) is a medical computer display designed for both |
| PACS and breast imaging applications. | |
| It consists of a 30.9" 12 mega-pixel (4200x2800 resolution) LCD panel with integrated | |
| LED backlight. | |
| The panel is integrated into the display housing body with an internal mechanics chassis | |
| structure, that also integrates the electronics, sensors and power supply. The display | |
| module is supported by a display stand. | |
| Internal sensors and controllers measure, control and stabilize the device. | |
| SoftGlow Lights are integrated as an ancillary function for user comfort and can be lit to | |
| illuminate the desk and to create some ambient lighting in the reading room. |
The 31" 12MP (4200x2800 resolution) MDNC-12130 display can be compared to a dual-
head, 2 x 21″ 5.8 MP (2100x2800 resolution) MDNC-6121 display system.
The MDNC-12130 is a derivative of the MDNC-6121.
The modified display is effectively identical to the predicate device except for the
following changes:
31" 12 mega-pixel (4200x2800 resolution) LCD panel, compared to 2 x 21inch
5.8 MP LCD panel of a dual-head MDNC-6121 display system New housing, display stand and internal mechanics, with similar functionality and
design principle compared to MDNC-6121 or any other Barco diagnostic display |
4
| ✓ Change in electronics board, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display; including: | |||
|---|---|---|---|
| ✓ Integration of the power supply adaptor into the device, compared to an external power adapter for MDNC-6121 | |||
| ✓ Updated firmware, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display | |||
| ✓ Change in packaging, with similar functionality and design principle compared to MDNC-6121 or any other Barco diagnostic display | |||
| ✓ Addition of SoftGlow Task Light and Wall Light ancillary function for user comfort | |||
| 7. Intended Use of | |||
| the Device | The display is intended to be used in displaying and viewing digital images, including standard and multiframe digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications. |
Note: There are no changes to the indications for use statement from that of the unmodified device. | | |
| 8. Comparison of
technological
characteristics | Item | Predicate Device
(K170476) | Device for which listing is
sought |
| | Device name | Nio Color 5.8MP (MDNC-6121) | Nio Fusion 12MP (MDNC-12130) |
| | Display Technology | | |
| | | a-Si TFT active matrix LCD
with LED backlight | a-Si TFT active matrix LCD with
LED backlight |
| | Screen size | | |
| | Active screen size
(diagonal) | 541 mm (21.3") | 784 mm (30.9") |
| | Active screen size
(HxV) | 324.45 x 432.6 mm (12.77" x
17") | 653 x 435 mm (25.7 x 17.1") |
| | Aspect ratio (H: V) | 3:4 for each display in portrait
mode, 3:2 overall for dual
head system | 3:2 |
| | Resolution | 5.8 MP (2100 x 2800 pixels) | Native 12MP (4200 x 2800
pixels)
Configurable to 2 x 5.8MP (2100
x 2800 pixels) |
| | Optical characteristics | | |
| | Maximum
luminance (panel
typical) | 1000 Cd/m² | 1200 Cd/m² |
| DICOM calibrated
luminance | 600 Cd/m² | 600 Cd/m² | |
| Contrast ratio
(panel typical) | 1400:1 | 1500:1 | |
| Frame rate and refresh rate | | | |
| Frame rate | 60 Hz (60 frames per second) | 60 Hz (60 frames per second) | |
| Response time
((Tr + Tf)/2)
(typical)
Gray-to-gray | 12.5 ms | 10 ms | |
| Pixel array, pitch, subpixel pattern, pixel aperture ratio | | | |
| Pixel array | 0.1545 x 0.1545 mm RGB pixel | 0.1554 x 0.1554 mm RGB pixel | |
| Pixel pitch | 0.1545 mm | 0.1554 mm | |
| DPI (dots per
inch) | 164 | 164 | |
| Subpixel pattern | 0.0515 x 0.1554 mm x 3
(RGB) | 0.0518 x 0.1554 mm x 3 (RGB) | |
| Pixel aperture
ratio | 53.6% | 56.5% | |
| Display Interface | | | |
| Video input
signals | DVI-D Dual Link (2x)
DisplayPort (2x) | 2 x DisplayPort 1.2 | |
| Ambient light sensing | | | |
| Ambient Light
Sensor | Yes | Yes | |
| Luminance calibration tools | | | |
| Front sensor | Yes | Yes | |
| Luminance
calibration and
stabilization | Integrated Front sensor with
luminance stabilization
firmware | Integrated Front sensor with
luminance stabilization firmware | |
| | QAWeb quality control
software (external) | QAWeb quality control software (external) | |
| Quality-control procedures | | | |
| QA software | QAWeb | QAWeb | |
| 9. Performance
testing | The technological characteristics discussed above show that the device MDNC-12130 has similar technological characteristics as the predicate device MDNC-6121 and do not reveal new issues of safety and performance. | | |
| | The below performance bench tests are performed and corresponding results reported for the modified device MDNC-12130 in comparison to the predicate device MDNC-6121, as | | |
| | per the instructions in "Guidance for Industry and FDA Staff: Display Devices for
Diagnostic Radiology", issued on October 2, 2017: | | |
| | Spatial resolution – MTF Pixel defects, Artifacts Temporal Response Maximum and Minimum Luminance, Luminance response Conformance to DICOM GSDF Angular Dependency of Luminance Luminance uniformity Stability of Luminance and Chromacity over Time and Operating Temperature Spatial Noise – NPS Reflection coefficient - Display Reflectance with Specular, Diffuse & Haze coefficients Veiling glare or small-spot contrast Color tracking, Gray tracking | | |
| | The tests showed that the device has similar characteristics compared to the predicate
device and did not reveal new issues of safety and performance.
Additionally, the modified device MDNC-12130 is compliant to EMC and Safety standards. | | |
| | No animal testing or clinical testing has been performed. | | |
| 10. Conclusion | The Nio Fusion 12MP (MDNC-12130) was found to be substantially equivalent to the
predicate device MDNC-6121, due to the following reasons:
a) Device and predicate device have the same intended use
b) The technological characteristics differences from the predicate device do not affect
safety or effectiveness
c) Bench testing showed that the device has similar characteristics compared to the
predicate device and did not reveal new issues of safety and performance. | | |
Image /page/4/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in BARCO has a unique design, with a circle and two small lines extending from it.
5
Image /page/5/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in "BARCO" has a small circle inside it with a line extending from the top, resembling a stylized target or a technical symbol.
6
Image /page/6/Picture/2 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in "BARCO" is stylized with a circle and two horizontal lines extending from either side.
ENABLING BRIGHT OUTCOMES