Coronis OneLook

{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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Barco NV Ms. Julie Vandecandelaere Regulatory Officer President Kennedypark 35 Kortrijk, 8500 BELGIUM Re: K242008 Trade/Device Name: Coronis OneLook Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: July 10, 2024 Received: July 10, 2024 August 2, 2024 Dear Ms. Julie 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pm.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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and {1}------------------------------------------------ production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-report-medicaldevice-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuingeducation/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-devices/deviceadvice-comprehensive-regulatory-assistance/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. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K242008 Device Name Coronis OneLook ### Indications for Use (Describe) 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 especially designed for breast tomosynthesis (3D mammography) applications, breast MRI and breast US. It is especially designed for CT and ultrasound including vascular and gynaecological US. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ | 510(k) Summary | Prepared on: 2024-07-26 | |----------------|-------------------------| | Details | | ## Contact Details 21 CFR 807.92(a)(1) Applicant Name Barco NV # K242008 {4}------------------------------------------------ Prepared on: 2024-07-26 21 CFR 807.92(a)(1) | Applicant Name | Barco NV | | |------------------------------------|----------------------------------------------------------|---------------------| | Applicant Address | President Kennedypark 35 Kortrijk 8500 Belgium | | | Applicant Contact Telephone | +32497377770 | | | Applicant Contact | Ms. Julie Vandecandelaere | | | Applicant Contact Email | julie.vandecandelaere@barco.com | | | Device Name | | 21 CFR 807.92(a)(2) | | Device Trade Name | Coronis OneLook | | | Common Name | Medical image management and processing system | | | Classification Name | Display, Diagnostic Radiology | | | Regulation Number | 892.2050 | | | Product Code(s) | PGY | | | Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K151505 | Coronis Uniti | PGY | | Device Descrintion Summary | 21 CER 807 92/2 VAN | | The Coronis OneLook® (MDMC-32133) is a medical computer display designed for general radiology, mammography and tomosynthesis applications. The device can also be used for home reading in radiology. The display is a high-resolution LCD monitor with improved technical chat are important for accurate medical image review: high luminance, good luminance ratio and luminance ratio and luminance stability. The medical display comes with special image-enhancing technologies to ensure consistent brightne of the display, noise-free images (=good luminance uniformity), ergonomic reading and automated compliance with DICOM and other medical image quality standards and guidelines. These technologies help the radiologist to make a swift and accurate diagnosis. The displays can be used optionally with the downloadable QAWeb Enterprise software, listed under D332294 as a class 1 device with product code LHO. QAWeb Enterprise is a calibration software that is intended as a quality assurance software for the displays. QAWeb Enterprise software helps to keep the display DICOM compliant. The display can be used optionally with the downloadable Intuitive Workflow Tools, cleared in K191845 as a class 2 device with product code PGY. The Intuitive Workflow Tools are accessories for image enhancement on diagnostic displays: - SpotView: The Barco SpotView display feature allows focusing on a region of interest in an image by boosting the display's backlight such that the maximum luminance in provided inside the region of interest. SpotView also enables focused observation during reading by dimming images outside the region of increasing the contrast in this region. Also magnification and inversion of pixels are possible with SpotView. -AAM – Application Appearance Manager: This workflow tool allows you to set the luminance as well as the color space for each application that is on the workstation. There are often multiple windows open on a screen, but not all of them need the hightness {5}------------------------------------------------ These applications are addressed by the general term 'Intuitive Workflow Tools'. The integration of the Intuitive Workflow Tools with the displays have been de-risked, verified and validated to ensure that they do not affect the safety and effectiveness of the displays. The display can be used with or without the Barco MXRT display controller boards. The display controller board is installed in a PACS workstation computer, connected to the display can optionally be used with a touchpad, which is a controlling device (e.g. like a mouse or trackball) that makes it easier to work with diagnostic images and to use the IWTs. ## 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 especially designed for breast tomosynthesis (3D mamnography) applications, breast MRI and breast US. It is especially designed including vascular and gynaecological US. ## Indications for Use Comparison The indications for use are the same. ## Technological Comparison Modifications between MDMC-32133 and MDMC-12133 The modifications are: • 32 mega-pixel (6848 x 4560 resolution) LCD panel, compared to 12 mega-pixel (4200 x 2800 resolution) LCD panel of a Uniti o 1200 Nit Calibrated light output compared to 1000 Nit in a Uniti • Updated power supply with similar functionality and design principle compared to Uniti or any other Barco diagnovic display v New internal electronics processing boards from the latest generation, with similar functionality and design principle compared to Uniti or any other Barco diagnostic display v New firmware on the MDMC-32133, with similar functionality and design principle compared to Uniti or any other Barco diagnostic display • Updated housing, display stand and internal mechanity and design principle compared to Uniti or any other Barco diagnostic display • Change in packaging, with similar functionality and design principle compared to Uniti or any other Barco diagnostic display • Because of the evolution towards more reading in radiology, we will rephrase the intended usage environment description in the intended use document to make it clear and correct for all use cases • Small update in the intended user description in the intended use document The below performance bench tests are performed and corresponding results reported for the modified device MDMC-32133 in comparison to the already cleared device MDMC-12133 as per the Physical Laboratory Testing in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022: • Spatial resolution – MTF • Pixel defects (Maximum counts, allowed defect types, and locations) - Artifacts - Temporal Response - Luminance (maximum, minimum, achievable and recommended) - Luminance response - · Conformance to DICOM GSDF - · Angular Dependency of Luminance - Luminance uniformity or Mura test (Luminance & Chromaticity Uniformity) - · RMS (image variance) for multiple video levels - Stability of luminance and chromaticity response with temperature and time of operation or on-time - Spatial noise - Reflection coefficient Display Reflectance incl. Specular and Diffuse coefficients - Veiling glare or small-spot contrast - Color tracking (primary colors and color gamut) - · Gray tracking (gray shaded and color gamut) 21 CFR 807.92(a)(6) 21 CFR 807.92(a)(5) {6}------------------------------------------------ The tests showed that the MDMC-32133 has similar characteristics compared to already cleared device MDMC-12133 and did not reveal new issues of safety and performance. Additionally, the MDMC-32133 is compliant to EMC and Safety standards, the environmental tests (climate, mechanical and software tests passed. No animal testing or clinical testing has been performed. Conclusion As a conclusion we can state that the device MDMC-32133 is found to be substantially equivalent to the predicate device MDMC-12133, because: - The indications for use are the same as the predicate device - The technological characteristics discussed above do not raise questions of safety and effectiveness - The bench tests show that the display characteristics are equivalent to those of the predicate device ### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) The below performance bench tests are performed and corresponding results reported for the modified device MDMC-32133 in comparison to the already cleared device MDMC-12133 as per the Physical Laboratory Testing in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology", issued in 2022: - Spatial resolution MTF - Pixel defects (Maximum counts, allowed defect types, and locations) - Artifacts - Temporal Response - · Luminance (maximum, minimum, achievable and recommended) - Luminance response - · Conformance to DICOM GSDF - · Angular Dependency of Luminance - Luminance uniformity or Mura test (Luminance & Chromaticity Uniformity) - · RMS (image variance) for multiple video levels - Stability of luminance and chromaticity response with temperature and time of operation or on-time - Spatial noise - Reflection coefficient Display Reflectance incl. Specular and Diffuse coefficients - · Veiling glare or small-spot contrast - Color tracking (primary colors and color gamut) - Gray tracking (gray shaded and color gamut) The tests showed that the MDMC-32133 has similar characteristics compared to already cleared device MDMC-12133 and did not reveal new issues of safety and performance. Additionally, the MDMC-32133 is compliant to EMC and Safety standards, the environmental tests (climate, mechanical and software tests passed. No animal testing or clinical testing has been performed. Conclusion As a conclusion we can state that the device MDMC-32133 is found to be substantially equivalent to the predicate device MDMC-12133, because: - The indications for use are the same as the predicate device - The technological characteristics discussed above do not raise questions of safety and effectiveness - The bench tests show that the display characteristics are equivalent to those of the predicate device