(9 days)
The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel 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 Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display system for reviewing medical images. It consists of an LCD display (MDCC-4230), an optional high-resolution display controller board and QA software. The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant. The display uses LED backlight technology.
The provided document is a 510(k) summary for the Barco Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System, which is a display device, not an AI/ML medical device. Therefore, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or provided within this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Coronis Fusion 4MP DL, MDCC-4130) by comparing technological characteristics and presenting bench test results related to safety and performance.
Here's a breakdown of the available information relevant to acceptance criteria and device performance:
1. Table of Acceptance Criteria (implicitly, comparison to predicate) and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance but rather demonstrates equivalence to a predicate device based on similar or superior characteristics as shown in a table comparing specifications and the results of bench testing.
| Characteristic | Predicate Device (MDCC-4130) Value | Subject Device (MDCC-4230) Value | Performance Description / Test Result |
|---|---|---|---|
| General | |||
| Screen technology | TFT AM LCD Dual Domain IPS Pro | TFT AM LCD Dual Domain IPS Pro | Same |
| Active screen size (diagonal) | 756 mm (29.8") | 756 mm (29.8") | Same |
| Active screen size (H x V) | 641.28 x 400.8 mm (25.2 x 15.8") | 641.28 x 400.8 mm (25.2 x 15.8") | Same |
| Aspect ratio (H:V) | 16:10 | 16:10 | Same |
| Resolution | 4MP (2560 x 1600) | 4MP (2560 x 1600) | Same |
| Pixel pitch | 0.2505 mm | 0.2505 mm | Same |
| Color imaging | Yes | Yes | Same |
| Gray imaging | No | No | Same |
| Viewing angle (H, V) | 178° | 178° | Same |
| Uniform Luminance Technology (ULT) | Yes | Yes | Same |
| Ambient Light Compensation (ALC) | Yes | Yes | Same |
| Backlight Output Stabilization (BLOS) | Yes | Yes | Same |
| I-Guard | Yes | Yes | Same |
| DICOM calibrated luminance (ULT off) | 500 cd/m² | 500 cd/m² | Same |
| Response time (Tr + Tf) | 20 ms | 20 ms | Same |
| Scanning frequency (H; V) | 30-150 kHz; 15-80 Hz | 30-150 kHz; 15-80 Hz | Same |
| Video input signals | DVI-D Dual Link | DVI-D Dual Link / DisplayPort 1.1 | Improvement: Added DisplayPort 1.1 |
| USB ports | 1 upstream (endpoint), 3 downstream (USB 1.0) | 1 upstream (endpoint), 3 downstream (USB 2.0) | Improvement: Upgraded to USB 2.0 |
| Power requirements (nominal) | 100-240V | 100-240V | Same |
| Power save mode | Yes | Yes | Same |
| Differences/Improvements | |||
| Backlight technology | CCFL | LED | Improvement: LED backlight instead of CCFL. Tested via DICOM calibration and Luminance Uniformity tests. |
| Per Pixel Uniformity (PPU) | No (per zone uniformity) | Yes | Improvement: Per Pixel Uniformity. Tested via Luminance Uniformity tests. |
| Maximum luminance | 950 cd/m² | 720 cd/m² | Different, but considered acceptable within the context of medical imaging display standards and DICOM calibration targets. |
| Contrast ratio (typical) | 1100:1 | 1000:1 | Different, but considered acceptable. |
| Power consumption (nominal) | 135W | 105W | Improvement: Lower power consumption. |
| Net weight with stand | 28.1 kg | 21.5 kg | Improvement: Lighter. |
| Net weight w/o stand | 21.6 kg | 15 kg | Improvement: Lighter. |
| Firmware | Specific to MDCC-4130 | New (different platform) | Firmware tests performed. |
| Front filter material | Unspecified | Different material | Impact test in IEC 60601-1 tests. |
| Sheet metal parts material | Unspecified | Other material | Shock and Vibration tests in Environmental test report. |
| Electrical Safety | Conformed to standards | Conforms to IEC 60601-1 | Additional test performed: Electrical Safety test (IEC 60601-1). |
| EMC | Conformed to standards | Conforms to IEC 60601-1-2 | Additional test performed: EMC test (IEC 60601-1-2). |
The conclusion states: "The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance."
The questions about sample size, ground truth, experts, adjudication, and MRMC studies are not applicable to this type of device (a medical display monitor) and therefore are not found in the provided document. The device is evaluated based on its physical and technical specifications, and its ability to meet relevant performance and safety standards, rather than its interpretive output on medical images. No animal or clinical testing was performed.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
Barco NV % Mr. Lieven De Wandel Regulatory Affairs Officer 35 President Kennedypark 8500 Kortriik BELGIUM
Re: K143157
Trade/Device Name: Coronis Fusion 4MP LED Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 21, 2014 Received: November 3, 2014
Dear Mr. De Wandel:
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.
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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.
Robert A. Ochs
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
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Indications for Use
510(k) Number (if known) K143157
Device Name Coronis Fusion 4MP LED (MDCC-4230)
Indications for Use (Describe)
The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel 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.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary (in accordance with 21 CFR 807.92) | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM | |||||||||||||||||||||||||||
| 2. Contactperson | Lieven De WandelRegulatory Affairs Officer | |||||||||||||||||||||||||||
| 3. Date ofsubmission | October 21, 2014 | |||||||||||||||||||||||||||
| 4. Deviceinformation | Trade name/model: Coronis Fusion 4MP LED (MDCC-4230)Common name: 4MP color LCD displayClassification name: System, image processing, RadiologicalClassification code: PGYRegulation number: 892.2050 | |||||||||||||||||||||||||||
| 5. Predicatedevice | Coronis Fusion 4MP DL (MDCC-4130) cleared under 510(K) K111989 | |||||||||||||||||||||||||||
| 6. Devicedescription | The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD displaysystem for reviewing medical images. It consists of an LCD display (MDCC-4230), anoptional high-resolution display controller board and QA software.The display controller board is installed in a PACS workstation computer, connected to thedisplay. The QA software helps to make and keep the displays DICOM compliant.The display uses LED backlight technology. | |||||||||||||||||||||||||||
| 7. Intended Useof the Device | The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System isintended to be used as a tool in displaying and viewing digital images (excluding digitalmammography) for review and analysis by trained medical practitioners. | |||||||||||||||||||||||||||
| 8. Comparisonof technologicalcharacteristics | Specification MDCC-4130 MDCC-4230 Screen technology TFT AM LCD Dual Domain IPS Pro TFT AM LCD Dual Domain IPS Pro Active screen size (diagonal) 756 mm (29.8") 756 mm (29.8") Active screen size (H x V) 641.28 x 400.8 mm(25.2 x 15.8") 641.28 x 400.8 mm(25.2 x 15.8") Aspect ratio (H:V) 16:10 16:10 Resolution 4MP (2560 x 1600) 4MP (2560 x 1600) Pixel pitch 0.2505 mm 0.2505 mm Color imaging Yes Yes Gray imaging No No |
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BARCO
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| Viewing angle (H, V) | 178° | ||||||
|---|---|---|---|---|---|---|---|
| Uniform Luminance Technology (ULT) | Yes | Yes | |||||
| Per Pixel Uniformity (PPU) | No | Yes | |||||
| Ambient Light Compensation (ALC) | Yes | Yes | |||||
| Backlight Output Stabilization (BLOS) | Yes | Yes | |||||
| I-Guard | Yes | Yes | |||||
| Maximum luminance | 950 cd/m² | 720 cd/m² | |||||
| DICOM calibrated luminance (ULT off) | 500 cd/m² | 500 cd/m² | |||||
| Contrast ratio (typical) | 1100:1 | 1000:1 | |||||
| Response time (Tr + Tf) | 20 ms | 20 ms | |||||
| Scanning frequency (H; V) | 30-150 kHz; 15-80 Hz | 30-150 kHz; 15-80 Hz | |||||
| Video input signals | DVI-D Dual Link | DVI-D Dual Link /DisplayPort 1.1 | |||||
| 1 upstream (endpoint), | 1 upstream (endpoint), | ||||||
| USB ports | 3 downstream | 3 downstream | |||||
| USB standard | 1.0 | 2.0 | |||||
| Power requirements (nominal) | 100-240V | 100-240V | |||||
| Power consumption (nominal) | 135W | 105W | |||||
| Power save mode | Yes | Yes | |||||
| Net weight with stand | 28.1 kg | 21.5 kg | |||||
| Net weight w/o stand | 21.6 kg | 15 kg | |||||
| Modification to device | Test performed | ||||||
| LED backlight instead of CCFL | DICOM calibration and LuminanceUniformity tests | ||||||
| Different platform (including firmware) | Firmware tests | ||||||
| Additional DisplayPort video input | Firmware tests | ||||||
| Uniformity correction: Per pixel uniformity(vs per zone unif. on predicate device) | Luminance Uniformity tests | ||||||
| Other material of front filter | lmpact test in IEC 60601-1 tests | ||||||
| Other material for sheet metal parts | Shock and Vibration tests inEnvironmental test report | ||||||
| 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 or clinical testing have not been performed. | |||||||
| 10. Conclusion | The Coronis Fusion 4MP LED (MDCC-4230) was found to be substantially equivalent to |
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| the predicate device, due to the following reasons: |
|---|
| a) Device and predicate device have the same intended useb) The technological characteristics differences from the predicate device do not affect safety or effectivenessc) Bench testing showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance. |
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§ 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).