(58 days)
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.
The MDCC-6530 is a derivative of the MDCC-6230.
✓ Updated Liquid Crystal Display technology, providing a higher Contrast Ratio
✓ New housing, display stand and internal mechanics
✓ Change in electronics board, including integration of the power supply adaptor into the device
✓ Updated firmware
✓ New packaging
The MDCC-4430 only differs from MDCC-6530 in having a 4MP panel instead of a 6MP panel.
The Intuitive Workflow Tools package includes some software tools that are intended to support the intended use of the diagnostic displays by performing image enhancement.
The provided text is a 510(k) Summary for Barco NV's Coronis Fusion displays (MDCC-6530, MDCC-4430) and Intuitive Workflow Tools (IWT). The document focuses on demonstrating substantial equivalence to a predicate device (Coronis Fusion 6MP, MDCC-6230).
Based on the provided information, here's an analysis of the acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes specific modifications to the devices (Coronis Fusion MDCC-6530 and MDCC-4430) compared to the predicate, and how performance was assessed for these changes. The acceptance criteria essentially boil down to "PASS" for various tests, indicating that the new devices perform comparably or better than the predicate and meet established safety/performance standards.
| Modification to Device | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Update to LCD panel (higher Contrast Ratio, max output Luminance) | Bench Test Equivalence report | PASS (showed similar characteristics) | PASS |
| Change in housing and display stand | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Change in internal mechanics | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Change in electronics board | Environmental tests | PASS | PASS |
| Electrical Safety tests | PASS | PASS | |
| EMC tests | PASS | PASS | |
| Updated firmware | Firmware tests | PASS | PASS |
| Change in packaging | Environmental tests | PASS | PASS |
| Internal power supply instead of external power supply | Electrical Safety tests | PASS | PASS |
2. Sample Size for the Test Set and Data Provenance:
The document does not specify a sample size for any clinical test set. Instead, it relies on bench tests and technical comparisons to demonstrate substantial equivalence. The data provenance is implied to be from internal testing by Barco NV, related to the manufacturing and design of the devices. There is no information about country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The concept of "experts" to establish ground truth is not applicable in this submission as it's primarily a technical and performance comparison against a predicate device, not a clinical study requiring expert interpretation of medical images. The "ground truth" here is the performance and safety characteristics as defined by relevant industry standards and the predicate device's established performance.
4. Adjudication Method for the Test Set:
An adjudication method like 2+1 or 3+1 is not applicable as there was no clinical study involving human readers and interpretations that would require such a method for discrepancies.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed and is not mentioned in the document. The submission focuses on demonstrating substantial equivalence of the display hardware and software tools, not on evaluating the clinical effectiveness of AI assistance in improving human reader performance.
6. Standalone (Algorithm Only) Performance:
The document does not provide information about standalone (algorithm-only) performance. The "Intuitive Workflow Tools" are described as "accessories for image enhancement in diagnostic displays," implying they work with human-in-the-loop, but no specific performance metrics are given for the tools themselves in a standalone capacity. The main devices are displays, which inherently require a human for interpretation.
7. Type of Ground Truth Used:
The "ground truth" for the acceptance criteria and performance evaluation is based on:
- Technical specifications and performance characteristics of the predicate device (MDCC-6230).
- Compliance with relevant standards (implied by the "PASS" criteria for Electrical Safety, EMC, Environmental tests).
- Bench test results demonstrating that the new devices' characteristics are "similar" to the predicate and do not introduce new safety or performance issues.
There's no mention of expert consensus, pathology, or outcomes data being used as ground truth for this particular submission.
8. Sample Size for the Training Set:
The document does not mention a training set specific to the devices or the Intuitive Workflow Tools. Since this is a hardware and basic software accessory submission for image display/enhancement rather than a complex AI algorithm for diagnosis, the concept of a "training set" in the context of machine learning is not directly applicable or discussed here.
9. How the Ground Truth for the Training Set Was Established:
As no training set is discussed, the method for establishing its ground truth is not applicable/provided.
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Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 6, 2019
Barco NV % Ms. Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 8500 Kortrijk W-VL BELGIUM
Re: K191845
Trade/Device Name: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 5, 2019 Received: July 10, 2019
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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
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Indications for Use
510(k) Number (if known)
K191845
Device Name MDCC-6530 MDCC-4430 Intuitive Workflow Tools (IWT)
Indications for Use (Describe)
The display is intended to be used for 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)
X 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."
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Indications for Use
510(k) Number (if known)
Device Name MDCC-4430
Indications for Use (Describe)
The display is intended to be used for 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 |
| | 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."
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Indications for Use
510(k) Number (if known)
Device Name Intuitive Workflow Tools
Indications for Use (Describe)
The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.
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."
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| 510(k) Summary (in accordance with 21 CFR 807.92) | K191845 | |||
|---|---|---|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM | |||
| 2. Contact person | Julie VandecandelaereRegulatory Affairs OfficerTel: +32 (0)56 26 13 19julie.vandecandelaere@barco.com | |||
| 3. Date ofsubmission | 05 July 2019 | |||
| 4. Deviceinformation | Trade name/model: | Coronis Fusion 6MP (MDCC-6530)Coronis Fusion 4MP (MDCC-4430)Intuitive Workflow Tools (IWT) | ||
| Common name: | MDCC-6530MDCC-4430Intuitive Workflow Tools (IWT) | |||
| Classification name:Classification code:Regulation number: | System, image processing, RadiologicalPGY892.2050 | |||
| 5. Predicatedevice | Coronis Fusion 6MP (MDCC-6230) cleared under 510(K) K130103 | |||
| 6. Devicedescription | The MDCC-6530 is a derivative of the MDCC-6230.✓ Updated Liquid Crystal Display technology, providing a higher Contrast Ratio✓ New housing, display stand and internal mechanics✓ Change in electronics board, including integration of the power supply adaptor into the device✓ Updated firmware✓ New packaging | |||
| 7. Intended Use ofthe Device | The MDCC-4430 only differs from MDCC-6530 in having a 4MP panel instead of a 6MP panel.The Intuitive Workflow Tools package includes some software tools that are intended to support the intended use of the diagnostic displays by performing image enhancement.The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.Note: There are no changes to the indications for use statement from that of the | |||
| unmodified device.The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays. | ||||
| 8. Comparison oftechnologicalcharacteristics | Item | Predicate Device(K130103) | Device for whichlisting is sought | |
| Device name | Coronis Fusion 6MP(MDCC-6230) | Coronis Fusion 6MP(MDCC-6530) | Coronis Fusion 4MP(MDCC-4430) | |
| Screentechnology | TFT AM Color LCDDual Domain IPS-Pro | IPS | IPS | |
| Active screensize (diagonal) | 772 mm (30.4") | 772 mm (30.4") | 772 mm (30.4") | |
| Active screensize (HxV) | 654 x 409 mm (25.8 x16.1") | 654 x 409 mm (25.8 x16.1") | 655 x 410 mm (25.8 x16.1") | |
| Aspect ratio(H:V) | 16:10 | 16:10 | 16:10 | |
| Resolution | Native 6MP (3280 x2048 pixels)Configurable to 2 x3MP+ (1640 x 2048pixels)Configurable to 2 x3MP (1536 x 2048pixels) | Native 6MP (3280 x2048 pixels)Configurable to 2 x3MP+ (1640 x 2048pixels)Configurable to 2 x3MP (1536 x 2048pixels) | Native 4MP (2560 x1600 pixels)Configurable to 2 x2MP+ (1280 x 1600pixels)Configurable to 2 x2MP (1200 x 1600pixels) | |
| Pixel pitch | 0.1995 mm | 0.1995 mm | 0.256 mm | |
| Color imaging | Yes | Yes | Yes | |
| Gray imaging | Yes | Yes | Yes | |
| Bit depth | 30 bit | 30 bit | 30 bit | |
| Viewing angle(H, V) | 178° | 178° | 178° | |
| UniformityCorrection | ULT | ULT - Color PPU | ULT - Color PPU | |
| Ambient LightPresets | Yes, reading roomselection | Yes, reading roomselection | Yes, reading roomselection | |
| Ambient LightSensor | Yes | Yes | Yes | |
| Front sensor | Yes, I-Guard | Yes, I-Guard | Yes, I-Guard | |
| Maximumluminance(panel typical) | 720 Cd/m² | 1050 Cd/m² | 1050 cd/m² | |
| DICOMcalibratedluminance | 500 Cd/m² | 600 Cd/m² | 600 cd/m² | |
| Contrast ratio(panel typical) | 1000:1 | 2000:1 | 2000:1 | |
| Responsetime (paneltypical data [1])Tr,typ | 9 ms | 20 ms | 20 ms | |
| T f,typ | 9 ms | 16 ms | 16 ms | |
| Housing color | Black / SilverDVI-D Dual Link (2x),DisplayPort (2x) | Black / White2 x DP1.2 | Black / White2 x DP1.2 | |
| Video outputsignals | N/A | 1 x DP (MST) | 1 x DP (MST) | |
| USB ports | 1x USB 2.0 upstream(endpoint)3x USB 2.0downstream | 1x USB 2.0 upstream(endpoint)2x USB 2.0downstream1x USB 2.0downstream withhigh-power chargingfunctionality | 1x USB 2.0 upstream(endpoint)2x USB 2.0downstream1x USB 2.0downstream withhigh-power chargingfunctionality | |
| Power rating | 100-240V | 100-240 Vac, 50/60Hz, 3.6-1.6 A | 100-240 Vac, 50/60Hz, 3.6-1.6 A | |
| Powerconsumption | 125W | 110 W (nominal) @calibrated luminanceof 600 cd/m²< 0.5 W (hibernate)< 0.5 W (standby) | 110 W (nominal) @calibrated luminanceof 600 cd/m²< 0.5 W (hibernate)< 0.5 W (standby) | |
| Dimensionswith stand (Wx H x D) | 731 x 580~676 x 265mm | 714 x 524~624 x 240mm | 714 x 524~624 x 240mm | |
| Dimensionswithout stand(W x H x D) | 731 x 485 x 141 mm | 714 x 478 x 74 mm | 714 x 478 x 74 mm | |
| Dimensionspackaged (Wx H x D) | 869 x 764 x 400 mm | 800 x 650 x 300 mm | 800 x 650 x 300 mm | |
| Net weightwith stand | 26.5 kg | 17.7 kg | 17.7 kg | |
| Net weightwithout stand | 20 kg | 13.1 kg | 13.1 kg | |
| Net weightpackaged | 36.5 kg | 22.3 kg (withoutoptional accessories) | 22.3 kg (withoutoptional accessories) | |
| Tilt | -5° to +25° | -5° to +25° | -5° to +25° | |
| Swivel | -45° to +45° | -30° to +30° | -30° to +30° | |
| Pivot | N/A | N/A | N/A | |
| Heightadjustmentrange | 96 mm | 100 mm | 100 mm | |
| Mountingstandard | VESA (100 mm) | VESA (100 mm) | VESA (100 mm) | |
| Screenprotection | Protective, anti-reflective glass cover | Protective, anti-reflective glass cover | Protective, anti-reflective glass cover | |
| Recommended modalities | CT, MR, US, DR, CR,NM, Film | All digital images,except digitalmammography. | All digital images,except digitalmammography. | |
| Suppliedaccessories | User GuideQuick InstallationSheetDocumentation disc | User GuideDocumentation disc | User GuideDocumentation disc | |
| System discVideo cablesMains cablesUSB cableExternal powersupply | Video cablesMains cablesUSB cable | Video cablesMains cablesUSB cable | ||
| Optionalaccessories | Graphics board | Graphics boardTouch pad | Graphics boardTouch pad | |
| QA software | QAWeb | QAWeb | QAWeb | |
| Warranty | 5 years | 5 years, including40,000 hoursbacklight warranty | 5 years, including40,000 hoursbacklight warranty | |
| Operatingtemperature | 0 °C to 35 °C (15 °Cto 30 °C within specs) | 0 °C to 35 °C (15 °Cto 30 °C within specs) | 0 °C to 35 °C (15 °Cto 30 °C within specs) | |
| Storagetemperature | -20 °C to 60 °C | -20 °C to 60 °C | -20 °C to 60 °C | |
| Operatinghumidity | 8 % to 80 % (non-condensing) | 20 % to 85 % (non-condensing) | 20 % to 85 % (non-condensing) | |
| Storagehumidity | 5 % to 95 % (non-condensing) | 20 % to 85 % (non-condensing) | 20 % to 85 % (non-condensing) | |
| Minimumoperatingpressure | 3000 m | 70 kPa | 70 kPa | |
| Storagepressure | N/A | 50 to 106 kPa | 50 to 106 kPa | |
| Note [1] Response time: the stated values are the values as specified in the datasheet ofthe LCD module by the LCD manufacturer and are defined as the transitions betweenblack (0%) and white (100%) luminance value:More detailed measurement results for other luminance value transitions are available inthe Bench Test Equivalence report. | ||||
| 9. Performancetesting | The bench tests mentioned below were performed to validate the device characteristicsthat differ from the predicate device: | |||
| Modification to device | Test performed | Criteria | ||
| Update to the LCD panel,providing a higherContrast Ratio andmaximum outputLuminance | Bench TestEquivalence report | PASS | ||
| Change in housing anddisplay stand | Environmental testsElectrical Safety testsEMC tests | PASSPASSPASS | ||
| Change in internalmechanics | Environmental testsElectrical Safety testsEMC tests | PASSPASSPASS | ||
| Change in electronicsboard | Environmental testsElectrical Safety testsEMC tests | PASSPASSPASS | ||
| Updated firmware | Firmware tests | PASS | ||
| Change in packaging | Environmental tests | PASS | ||
| Internal power supplyinstead of external powersupply | Electrical Safety tests | PASS | ||
| The tests showed that the device has similar characteristics compared to the predicatedevice and did not reveal new issues of safety and performance.Animal testing has not been performed. | ||||
| 10. Conclusion | The Coronis Fusion 6MP and 4MP were found to be substantially equivalent to the predicatedevice, 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 affectsafety or effectivenessc) Bench testing showed that the device has similar characteristics compared to thepredicate device and did not reveal new issues of safety and performance. |
BARCO
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ENABLING BRIGHT OUTCOMES
Image /page/6/Picture/3 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 attached to the upper right side, giving it a stylized appearance.
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ENABLING BRIGHT OUTCOMES
BARCO
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BARCO
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Image /page/9/Picture/2 description: The image features the text "ENABLING BRIGHT OUTCOMES" in red font on the left side. To the right, there is a red rectangle containing the word "BARCO" in white font. The logo is simple and modern, with a focus on the company name and a tagline that emphasizes positive results.
§ 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).