(58 days)
Not Found
No
The document describes updates to hardware (LCD, housing, electronics) and firmware for a medical display and image enhancement software. There is no mention of AI, ML, or related concepts like training data, test data, or performance metrics typically associated with AI/ML algorithms. The "Intuitive Workflow Tools" are described as image enhancement accessories, which is a broad term that doesn't necessarily imply AI/ML.
No.
The device is a display for viewing digital images and includes image enhancement tools for diagnostic displays, not for direct therapeutic use.
Yes
The "Intended Use / Indications for Use" states that the display is for "viewing digital images... for review and analysis by trained medical practitioners" and that "Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays." This directly indicates its use in a diagnostic setting.
No
The device description explicitly mentions hardware components such as a Liquid Crystal Display, housing, display stand, internal mechanics, and electronics board. While it includes software tools for image enhancement, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for displaying and viewing digital images for review and analysis by trained medical practitioners. This is a function related to medical imaging, not the analysis of biological samples or specimens in vitro.
- Device Description: The device is a display and associated software tools for image enhancement. It does not involve reagents, calibrators, controls, or other components typically associated with IVD devices.
- Lack of IVD Characteristics: The description does not mention any activities related to testing biological samples, diagnosing conditions based on in vitro analysis, or providing results derived from such analysis.
The device falls under the category of medical imaging display systems, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes
PGY
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
All digital images, except digital mammography.
Anatomical Site
Not Found
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
The bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device:
Study Type: Bench Test
Sample Size: Not Specified
Key results:
Modification to device: Update to the LCD panel, providing a higher Contrast Ratio and maximum output Luminance. Test performed: Bench Test Equivalence report. Criteria: PASS.
Modification to device: Change in housing and display stand. Test performed: Environmental tests, Electrical Safety tests, EMC tests. Criteria: PASS, PASS, PASS.
Modification to device: Change in internal mechanics. Test performed: Environmental tests, Electrical Safety tests, EMC tests. Criteria: PASS, PASS, PASS.
Modification to device: Change in electronics board. Test performed: Environmental tests, Electrical Safety tests, EMC tests. Criteria: PASS, PASS, PASS.
Modification to device: Updated firmware. Test performed: Firmware tests. Criteria: PASS.
Modification to device: Change in packaging. Test performed: Environmental tests. Criteria: PASS.
Modification to device: Internal power supply instead of external power supply. Test performed: Electrical Safety tests. Criteria: PASS.
The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance.
Animal testing has not been performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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."
3
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."
4
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."
5
| 510(k) Summary (in accordance with 21 CFR 807.92) | K191845 | |||
|---|---|---|---|---|
| 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 | 05 July 2019 | |||
| 4. Device | ||||
| information | Trade name/model: | Coronis Fusion 6MP (MDCC-6530) | ||
| Coronis Fusion 4MP (MDCC-4430) | ||||
| Intuitive Workflow Tools (IWT) | ||||
| Common name: | MDCC-6530 | |||
| MDCC-4430 | ||||
| Intuitive Workflow Tools (IWT) | ||||
| Classification name: | ||||
| Classification code: | ||||
| Regulation number: | System, image processing, Radiological | |||
| PGY | ||||
| 892.2050 | ||||
| 5. Predicate | ||||
| device | Coronis Fusion 6MP (MDCC-6230) cleared under 510(K) K130103 | |||
| 6. Device | ||||
| description | 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 of | ||||
| the 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 of | ||||
| technological | ||||
| characteristics | Item | Predicate Device | ||
| (K130103) | Device for which | |||
| listing is sought | ||||
| Device name | Coronis Fusion 6MP | |||
| (MDCC-6230) | Coronis Fusion 6MP | |||
| (MDCC-6530) | Coronis Fusion 4MP | |||
| (MDCC-4430) | ||||
| Screen | ||||
| technology | TFT AM Color LCD | |||
| Dual Domain IPS-Pro | IPS | IPS | ||
| Active screen | ||||
| size (diagonal) | 772 mm (30.4") | 772 mm (30.4") | 772 mm (30.4") | |
| Active screen | ||||
| size (HxV) | 654 x 409 mm (25.8 x | |||
| 16.1") | 654 x 409 mm (25.8 x | |||
| 16.1") | 655 x 410 mm (25.8 x | |||
| 16.1") | ||||
| Aspect ratio | ||||
| (H:V) | 16:10 | 16:10 | 16:10 | |
| Resolution | Native 6MP (3280 x | |||
| 2048 pixels) | ||||
| Configurable to 2 x | ||||
| 3MP+ (1640 x 2048 | ||||
| pixels) | ||||
| Configurable to 2 x | ||||
| 3MP (1536 x 2048 | ||||
| pixels) | Native 6MP (3280 x | |||
| 2048 pixels) | ||||
| Configurable to 2 x | ||||
| 3MP+ (1640 x 2048 | ||||
| pixels) | ||||
| Configurable to 2 x | ||||
| 3MP (1536 x 2048 | ||||
| pixels) | Native 4MP (2560 x | |||
| 1600 pixels) | ||||
| Configurable to 2 x | ||||
| 2MP+ (1280 x 1600 | ||||
| pixels) | ||||
| Configurable to 2 x | ||||
| 2MP (1200 x 1600 | ||||
| pixels) | ||||
| 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° | |
| Uniformity | ||||
| Correction | ULT | ULT - Color PPU | ULT - Color PPU | |
| Ambient Light | ||||
| Presets | Yes, reading room | |||
| selection | Yes, reading room | |||
| selection | Yes, reading room | |||
| selection | ||||
| Ambient Light | ||||
| Sensor | Yes | Yes | Yes | |
| Front sensor | Yes, I-Guard | Yes, I-Guard | Yes, I-Guard | |
| Maximum | ||||
| luminance | ||||
| (panel typical) | 720 Cd/m² | 1050 Cd/m² | 1050 cd/m² | |
| DICOM | ||||
| calibrated | ||||
| luminance | 500 Cd/m² | 600 Cd/m² | 600 cd/m² | |
| Contrast ratio | ||||
| (panel typical) | 1000:1 | 2000:1 | 2000:1 | |
| Response | ||||
| time (panel | ||||
| typical data [1]) | ||||
| Tr,typ | 9 ms | 20 ms | 20 ms | |
| T f,typ | 9 ms | 16 ms | 16 ms | |
| Housing color | Black / Silver | |||
| DVI-D Dual Link (2x), | ||||
| DisplayPort (2x) | Black / White | |||
| 2 x DP1.2 | Black / White | |||
| 2 x DP1.2 | ||||
| Video output | ||||
| signals | N/A | 1 x DP (MST) | 1 x DP (MST) | |
| USB ports | 1x USB 2.0 upstream | |||
| (endpoint) | ||||
| 3x USB 2.0 | ||||
| downstream | 1x USB 2.0 upstream | |||
| (endpoint) | ||||
| 2x USB 2.0 | ||||
| downstream | ||||
| 1x USB 2.0 | ||||
| downstream with | ||||
| high-power charging | ||||
| functionality | 1x USB 2.0 upstream | |||
| (endpoint) | ||||
| 2x USB 2.0 | ||||
| downstream | ||||
| 1x USB 2.0 | ||||
| downstream with | ||||
| high-power charging | ||||
| functionality | ||||
| Power rating | 100-240V | 100-240 Vac, 50/60 | ||
| Hz, 3.6-1.6 A | 100-240 Vac, 50/60 | |||
| Hz, 3.6-1.6 A | ||||
| Power | ||||
| consumption | 125W | 110 W (nominal) @ | ||
| calibrated luminance | ||||
| of 600 cd/m² |