Elements Viewer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. January 23, 2020 Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 81829 Munich, De GERMANY Re: K191014 Trade/Device Name: Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2019 Received: December 26, 2019 Dear Chiara Cunico: 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 medical devices and radiation-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) K191014 Device Name Viewer Indications for Use (Describe) Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (Multiplanar reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images. Type of Use (Select one or both, as applicable) | <div><span style="font-size:100%;"></span>Prescription Use (Part 21 CFR 801 Subpart D)</div> | |----------------------------------------------------------------------------------------------| | <div>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 VIEWER # IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92 | General Information | | | | |----------------------|---------------------------------------------------------------|--|--| | Manufacturer | Brainlab AG, Olof-Palme-Straße 9, 81829 Munich, Germany | | | | Establishment Reg. # | 8043933 | | | | Device name: | Viewer | | | | Trade name: | Elements Viewer | | | | Common name | DICOM Viewer | | | | Classification name: | Picture archiving and communications system (21 CFR 892.2050) | | | | Review Panel | Radiology | | | | Product Code: | LLZ | | | | Device Class: | Class II | | | | Predicate Device: | K153653 DICOM Viewer | | | | Reference Device | K172418 OpenSight | | | | Date of preparation | 23 September 2019 | | | | Contact Information | | |-----------------------------------|----------------------------------------| | Primary contact person | Alternate contact person | | Chiara Cunico | Regulatory Affairs Brainlab | | Manager RA | phone: +49 89 99 15 68 0 | | phone: +49 89 99 15 68 1738 | fax: +49 89 99 15 68 5033 | | Email: Chiara.cunico@brainlab.com | Email: regulatory.affairs@brainlab.com | #### Intended use: Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (Multiplanar reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images. {4}------------------------------------------------ #### Device description Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles. These are the operating principles: - On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard. - - On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface. - - -On Mixed Reality qlasses the interaction is performed with a dedicated pointing device. The subject device provides or integrates the following frequently used functions: - -Select medical images and other healthcare data to be displayed - -Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views) - Change view layout (e.g. maximize / minimize views, close / open / reorder views) - - Manipulate views (e.g. scroll, zoom, pan, change windowing) - - Perform measurements (e.g. distance or angle measurements) - - -Place annotations at points of interests #### Changes to Predicate Device Convenience function have been added for view and object selection. Magic Leap Mixed reality glasses have been added to the Subject Device as additional means of display. The Mixed Reality views are started from within the desktop version of Viewer. The view selection is done on the desktop, the views are cloned into the virtual space of Mixed Reality. The 2D views are shown on a 2D view pane in Mixed Reality. The 3D views are placed as virtual objects in to the real world. | | Cleared device<br>feature/specification<br>DICOM Viewer (K153653) | Modified device<br>feature/specification<br>Viewer 5.0 | Substantial<br>Equivalent | |-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------| | HW Environment | Server based, for viewing via<br>HTML5 client or RDP on<br>individual client computer | Server and local installation, ,<br>for viewing via HTML5 client<br>or RDP, or local execution on<br>individual client computer | yes | | Data inputs | DICOM | | yes | | Viewing Data | • Skin<br>• Bone<br>• Skin/Bone<br>• Vessels<br>• Bone/Vessels<br>• Skin/Vessels<br>• Skin/Bone/Vessels<br>• Maximum Intensity Projection (MIP)<br>• Digital Reconstructed Radiograph (DRR) | | yes | | | Cleared device<br>feature/specification<br>DICOM Viewer (K153653) | Modified device<br>feature/specification<br>Viewer 5.0 | Substantial<br>Equivalent | | Measurement | Distance in slice sets<br>•<br>Diameter<br>•<br>Angle<br>• | Distance in slice sets<br>and X-ray images<br>•<br>Diameter<br>•<br>Angle (incl. open<br>angle) | yes | | "Smart View" | Individual selectable visibility<br>of objects (tumor, fibers etc.) | Individual selectable visibility<br>of objects (tumor, fibers etc.)<br>Additional view: with a slider<br>it is possible to change<br>visibility of objects. | yes | | View Layouts | Manual selection of<br>appropriate view. | Manual selection of<br>appropriate view.<br>Additional: Cranial, Spine<br>and Angio layouts load views<br>in the presence of certain<br>modalities in the Subject<br>Device. | yes | | Probe's Eye View<br>(available in Mixed<br>Reality) | Align crop box to any desired<br>direction for the display of<br>MPR perpendicular and<br>parallel (inline) to the given<br>direction. | Align crop box to any desired<br>direction for the display of<br>MPR perpendicular and<br>parallel (inline) to the given<br>direction.<br>In Mixed Reality the user can<br>point in a desired direction and<br>view MPR perpendicular and<br>parallel (inline) to the given<br>direction. | yes | #### Technological Characteristics of the Subject Device in comparison to the Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ Technological Characteristics of the Subject Device in comparison to the Reference Device: | | Cleared device<br>feature/specification<br>OpenSight K172418 | Modified device<br>feature/specification<br>Viewer 5.0 | Substantial<br>Equivalent | |------------------------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------| | Supported Mixed<br>Reality Device | Microsoft HoloLens | Magic Leap One | yes | | Supported device<br>electrical medical<br>device according to<br>IEC 60601-1 | No | No | yes | | Mixed Reality | 2D slices and MPRs<br>3D Views | 2D slices and MPRs<br>3D Views | yes | | Registration to<br>patient | yes | no | No, this is not part of<br>the Subject Device.<br>Equivalence is not<br>claimed | #### Verification summary: Verification of communication and cybersecurity between Viewer and Magic Leap Mixed Reality glasses has been tested. All interactive testing of user interface have successfully passed. ## Validation summary: The validation comprises usability tests which ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria. As conclusion, the nonclinical and clinical tests (discussed above) demonstrate that the device is as safe, as effective, and performs as well as the predicate device. | Test | Test Method Summary | Results | |----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | User interface | Interactive testing of user interface | All tests passed | | DICOM compatibility | Interactive testing with companywide test data, which are<br>identical for consecutive version of the SW | All tests passed | | Views | Interactive testing of user interface | All tests passed | | Unit test /Automatic tests | Automated or semi-automated cucumber tests or unit<br>tests are written on the applicable level for new<br>functionalities of the Viewer in respect to previous<br>versions. Exiting tests have to pass. | All tests passed | {7}------------------------------------------------ | Test | Test Method Summary | Results | |------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Integration test | Interactive testing on various platforms and combination<br>with other products following test protocols, combined<br>with explorative testing. | All tests passed | | | The software is developed with daily builds, which are<br>explanatively tested. | | #### Substantial equivalence The comparison of the Viewer with the predicate device shows that the Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification activities ensure that the design specifications are met and that the Viewer does not introduce new issues concerning safety and effectiveness. Hence the Viewer is substantial equivalent to the predicate device.