Vitrea Advanced Visualization, Version 7.6

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The image is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 5, 2017 Vital Images, Inc. % Ms. Katie Ryan Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414 Re: K172855 Trade/Device Name: Vitrea Advanced Visualization, Version 7.6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 19, 2017 Received: September 20, 2017 Dear Ms. Ryan: 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. {1}------------------------------------------------ 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. Michael D. O'Hara For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K172855 Device Name Vitrea Advanced Visualization, Version 7.6 Indications for Use (Describe) Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. | 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><span style="font-size:100%;">☐</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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered. ## 510K Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c). | Basis for the<br>Submission: | Vital Images, Inc. hereby submits this special 510(k) to provide a<br>notification submission for proposed software changes in the already<br>510(k) cleared Vitrea Advanced Visualization software (K150258) | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN, 55343-4414 | | Establishment<br>Registration: | 2134213 | | Contact Person: | Katie Ryan<br>Sr. Regulatory Affairs Specialist<br>Phone: 952-487-9793<br>Fax: 952-487-9510<br>E-mail: kryan@vitalimages.com<br>Alternate Contact Person:<br>Vince Swenson<br>Sr. Director of Quality and Regulatory<br>Phone: 952-487-9548<br>Fax: 952-487-9510<br>E-mail: vswenson@vitalimages.com | | 510(k) Type: | Special | | Summary Date: | October 4, 2017 | | Device Trade Name: | Vitrea Advanced Visualization, Version 7.6 | | Device Common<br>Name/ Regulatory<br>Description: | Radiological Image Processing Software | | Device Classification<br>Name: | System, Image Processing, Radiological | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | | Regulatory<br>Classification: | Class II | | Device Panel: | Radiology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered. #### Predicate Device(s): | Predicate Device | Manufacturer | FDA 510(k) Number | |--------------------------------------------------------------|----------------------------------------------------------------------------|-------------------| | Vitrea®, Version 7.0<br>Medical Image Processing<br>Software | Vital Images, Inc.<br>5850 Opus Parkway, Suite 300<br>Minnetonka, MN 55343 | K150258 | #### Device Description: The Vitrea Advanced Visualization software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The Vitrea Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: - Retrieve image data over the network via DICOM ● - Display of images in dedicated protocols which are automatically adapted based on exam ● type - . Select images for closer examination from a gallery of 2D or 3D views - Interactively manipulate an image in real-time to visualize anatomy and pathology ● - Annotate, measure, and record selected views ● - Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device - Retrieve reports that are archived on a Web server #### Intended Use / Indications for Use: Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. #### Intended for Disease / Condition / Patient Population: Vitrea Advanced Visualization is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Therefore, intended disease, conditions, or patient population information is not applicable. #### Key Changes from last 510k clearance K150258 The following list contains the key changes since the last 510k. These changes were made to improve user experience, performance and regulatory compliance: - . Improvements to the Study List and data launching workflows - Enhancements to export and save to media workflows ● - Reporting enhancements for printing ● - Support for STL file generation and exporting (output anatomical model is not for diagnostic use) - Improved efficiency and performance of data handling - Licensing enhancements - High resolution monitor support ● 009 510(k) Summary {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The word is horizontally aligned and appears to be a logo or brand name. - System Health and Performance monitoring tool ● - Enhancements to PACS integrations and workflows ● - . Support for upgrades - Display of the UDI for Vitrea Advanced Visualization . - . Addition of Vitrea Extend and Vitrea Enterprise deployments ## Substantial Equivalence Comparison: ### Regulatory Comparison: | | Subject Device | Predicate Device | | |---------------------|-------------------------------------------------|----------------------------------------------|--------------------------------| | Characteristic | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Classification Name | System, Image<br>Processing,<br>Radiological | System, Image<br>Processing,<br>Radiological | Same | | Regulatory Number | 892.2050 | 892.2050 | Same | | Product Code | LLZ | LLZ | Same | | Classification | Class II | Class II | Same | | Review Panel | Radiology | Radiology | Same | | Decision Date | Under Review | March 5, 2015 | Predicate device<br>is cleared | #### Indications for Use Comparison with Predicate Device: | | Subject Device | Predicate Device | | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Criteria | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0 (K150258) | Comparison | | Indications for<br>Use | Vitrea is a medical<br>diagnostic system that<br>allows the processing,<br>review, analysis,<br>communication and media<br>interchange of multi-<br>dimensional digital images<br>acquired from a variety of<br>imaging devices. Vitrea is<br>not meant for primary image<br>interpretation in<br>mammography. | Vitrea is a medical<br>diagnostic system that<br>allows the processing,<br>review, analysis,<br>communication and media<br>interchange of multi-<br>dimensional digital images<br>acquired from a variety of<br>imaging devices. Vitrea is<br>not meant for primary<br>image interpretation in<br>mammography. | Same | | Intended Users | Qualified healthcare<br>professionals including, but<br>not restricted to, radiologists,<br>non-radiology specialists, | Qualified healthcare<br>professionals including, but<br>not restricted to,<br>radiologists, non-radiology | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are slightly blurred, giving them a soft appearance. | Criteria | Subject Device | Predicate Device | Comparison | |----------|-------------------------------------------------|-----------------------------------------------|------------| | | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0 (K150258) | | | | physicians and<br>technologists. | specialists, physicians and<br>technologists. | | ### Similarities in Technology with Predicate Device: | | Subject Device | Predicate Device | | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-----------------------------------------------------------------|------------| | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | General Features: | | | | | Selection and loading a patient study<br>Component: AppShell / Vitrea Client<br>and Study List | Yes | Yes | Same | | Selection of protocol and preset for<br>patient study<br>Component: Gallery Window | Yes | Yes | Same | | Visualization and analysis of patient<br>study<br>Component: Viewer Window | Yes | Yes | Same | | Allows access to the visual, analysis,<br>and batch pages<br>Component: Viewer Window | Yes | Yes | Same | | Segment, trim, sculpt, perform<br>measurements, and change display<br>settings<br>Component: Viewer Window | Yes | Yes | Same | | Record images, batches of images, and<br>movies for physician reporting<br>Component: Viewer Window | Yes | Yes | Same | | Software Functionality | Subject Device<br>Vitrea Advanced<br>Visualization<br>Version 7.6 | Predicate Device<br>Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Creation of a report for the patient<br>study) data publishing and archiving<br>Component: Report Window | Yes | Yes | Same | | Review of report for any patient<br>study<br>Component: Report Window | Yes | Yes | Same | | Help on Vitrea software<br>Component: Help Window | Yes | Yes | Same | | DICOM Compliance and Data<br>Management | Yes | Yes | Same | | Data Security and HIPAA<br>Compliance | Yes | Yes | Same | | Multi-vendor scanner compatibility | Yes | Yes | Same | | Integrated 2D and 3D visualization<br>measurements | Yes | Yes | Same | | Interactive navigation in 3D | Yes | Yes | Same | | Large data set capability, including<br>the ability to render multi-detector<br>computed tomography (MDCT) data | Yes | Yes | Same | | Multiple User Workstation<br>Deployment | Yes | Yes | Same | | Multi-modality Support | Yes | Yes | Same | | Vitrea Advanced Visualization Basic Clinical Toolset: | | | | | Retrieve image data over the network | Yes | Yes | Same | | Display images that are automatically<br>adapted to exam type via dedicated<br>protocols | Yes | Yes | Same | | Select images for closer examination<br>from a gallery of up to six 2D or 3D<br>views | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Interactively manipulate an image in<br>real-time to visualize anatomy and<br>pathology | Yes | Yes | Same | | Annotate, tag, measure, and record<br>selected views | Yes | Yes | Same | | Output selected views to standard film<br>or paper printers, or post a report to an<br>Intranet | Yes | Yes | Same | | Study List: | | | | | Automatic reading and display of<br>demographic and scanner information<br>including Patient, ID, Date, Time,<br>Series, Modality, Exam Type,<br>Thickness/Spacing, and the number of<br>images in the series | Yes | Yes | Same | | Each patient entry can include multiple<br>series of image data | Yes | Yes | Same | | Fully sortable listing of all studies<br>present on the system to optimize data<br>searching and selection for users, along<br>with user-specific filters | Yes | Yes | Same | | Preview of an image of the selected<br>series to ensure its applicability | Yes | Yes | Same | | Customization of the layout of study list<br>to each user's personal preference | Yes | Yes | Same | | Series thumbnail display indicating<br>available series | Yes | Yes | Same | | Display of selected images, series, or<br>entire study and loading of multiple<br>series or studies for simultaneous<br>analysis and review | Yes | Yes | Same | | Direct launch into 2D or 3D workflow for<br>a study or series | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Display image findings and reports in<br>the Evidence Manager | Yes | Yes | Same | | Retrieve reports that are archived on a<br>Web server | Yes | Yes | Same | | Gallery Window: | | | | | Unique clinical protocols based on<br>anatomy, workflow, and image type | Yes | Yes | Same | | Automatic pre-selection of clinical<br>protocol of images to exam type, as<br>indicated in the DICOM header fields | Yes | Yes | Same | | Easy selection of independent 2D and<br>3D views of selected image data for<br>review, optimized and rendered based<br>on the clinical protocol | Yes | Yes | Same | | Ability to return to the Gallery window at<br>any time to select other views, or to<br>select alternative protocols | Yes | Yes | Same | | Customized presets that can be created<br>in the Viewer window for display and<br>selection in the Gallery window (one<br>custom preset for each view available<br>for any of the protocols) | Yes | Yes | Same | | Viewer Window: | | | | | A choice of four 2D review and four 3D<br>display formats, as well as a 2D "All<br>Exams" comparative viewer that allows<br>the user to display up to nine series on<br>the screen at once | Yes | Yes | Same | | Pick tabs in both 2D comparative and 2D<br>montage formats, allowing the user to<br>change the orientation of the image<br>views and the order of the series<br>displayed in comparative viewing | Yes | Yes | Same | | Simultaneous view of 3D volume-<br>rendered projections and correlated | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | multi-planar reformatted projections<br>(MPRs) | | | | | Orthogonal, Oblique, Double Oblique,<br>and Curved MPRs | Yes | Yes | Same | | Cross-reference lines (Crosshairs) to<br>identify and correlate point of interest in<br>all 2D and 3D views | Yes | Yes | Same | | Ability to navigate, scroll, pan, cine,<br>zoom, rotate, flip, invert interactively that<br>lets the user select, edit, measure,<br>annotate, and record the optimum 2D<br>and 3D views for diagnosis and reporting | Yes | Yes | Same | | Navigation through or around the 3D<br>view selected (Fly-around, Fly-through,<br>Point-of-interest) | Yes | Yes | Same | | Adjustment of window/level on screen<br>interactively | Yes | Yes | Same | | Adjustment of a broad range of imaging<br>controls and displays such as rendering<br>(Normal, Min/Max Intensity Projections),<br>brightness, contrast, shading,<br>transparency, and color | Yes | Yes | Same | | Image segmentation using any of<br>several segmentation methods<br>(trimming, freehand/box sculpting, semi-<br>automated vessel inclusion/bone<br>removal based on threshold and<br>connectivity) | Yes | Yes | Same | | Variable size slab reformat and<br>rendering | Yes | Yes | Same | | Annotation of the images with<br>embedded 3D arrows and text | Yes | Yes | Same | | Distance measurements using ruler and<br>area and volume measurements using<br>ellipse or freehand ROI | Yes | Yes | Same | | Keyboard shortcuts for many functions | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Creation of custom visualization presets<br>to appear in the Gallery Tab | Yes | Yes | Same | | Recording of selected views<br>(snapshots) for report generation and to<br>allow return to the same view at a later<br>time to continue the work done<br>previously; ability to record a multi-<br>volume snapshot for cases when<br>multiple series or volumes have been<br>loaded simultaneously | Yes | Yes | Same | | Batch creation functionality that allows<br>2D, 3D, or 3D fly through batched<br>images or movies to print or be sent to<br>the report page | Yes | Yes | Same | | Report Application: | | | | | configuration<br>Report<br>in<br>various<br>reporting displays | Yes | Yes | Same | | Report header that includes user<br>configurable information such as<br>Institution Name, Patient ID, Patient<br>Name, Referring Physician, Reading<br>Physician, Exam Type, Modality, Scan<br>Date, and Scan Time | Yes | Yes | Same | | Inclusion or deletion of patient and<br>hospital information for filming purposes | Yes | Yes | Same | | Slide Tray containing snapshots,<br>batches, and movies saved in the<br>Viewer window | Yes | Yes | Same | | Movie preview | Yes | Yes | Same | | Electronic posting of reports to a Web<br>server | Yes | Yes | Same | | | Subject Device | Predicate Device | | | Software Functionality | Vitrea Advanced<br>Visualization<br>Version 7.6 | Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Printing of the report on DICOM or<br>Postscript® format printers, exporting to<br>a DICOM image archive, posting on<br>Vitrea software's web server, recording<br>on a CD or a DVD, or exporting to a MS<br>Word document with a defined template | Yes | Yes | Same | | Evidence Manager: | | | | | Allows the user to view published Image<br>/ batch finding reports and related digital<br>movies | Yes | Yes | Same | | Snapshot restoration | Yes | Yes | Same | | Help Window: | | | | | Provides on-line help manual, quick<br>reference and index in HTML format or<br>as PDF documents | Yes | Yes | Same | | DICOM Data Management: | | | | | DICOM conformance | Yes | Yes | Same | | DICOM Storage as SCU & SCP<br>(receive and push) | Yes | Yes | Same | | DICOM query/retrieve SCU (pulling<br>images from other DICOM devices) | Yes | Yes | Same | | DICOM query/retrieve SCP (can serve<br>images to other vendor workstations) | Yes | Yes | Same | | DICOM Connection Management | Yes | Yes | Same | | Save & Send images in DICOM | Yes | Yes | Same | | Data Security and HIPAA Compliance: | | | | | Software Functionality | Subject Device<br>Vitrea Advanced<br>Visualization<br>Version 7.6 | Predicate Device<br>Vitrea Software<br>Version 7.0<br>(K150258) | Comparison | | Software can de-identify patient data,<br>removing patient name and information<br>from the image | Yes | Yes | Same | | Software controls workstation access<br>and reporting security | Yes | Yes | Same | | Authentication and access controls<br>require users to enter a confidential<br>password to view both patient studies<br>and reports | Yes | Yes | Same | | Secured access (NT or domain -Login) | Yes | Yes | Same | | User group preference and access<br>control | Yes | Yes | Same | | Vitrea Advanced Visualization Components: | | | | | CPU-Based Rendering Engine | Yes | Yes | Same | | Vitrea Information Management<br>System (VIMS) | Yes | Yes | Same | | Medical Imaging Network Transport<br>(MINT) | Yes | Yes | Same | | Vitrea Services Platform (VSP) | Yes | Yes | Same | {7}------------------------------------------------ # ViTAL {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "ViTAL" in a bold, sans-serif font. The letters are black, except for the dot on the "i", which is red. The letters are evenly spaced and aligned horizontally. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The letters are evenly spaced and the word is centered in the image. The background is white. {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The letters are slightly blurred, giving the image a soft focus. {11}------------------------------------------------ # Vil {12}------------------------------------------------ {13}------------------------------------------------ # ViTAL {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered. ## Summary of Non-Clinical Tests: The changes to the Vitrea Advanced Visualization software were designed, developed, and tested according to written procedures that included risk management. Software verification testing was completed to ensure the new features operate according to defined requirements. The following design control measures were applied to the development of the Vitrea Advanced Visualization software: - Risk Management ● - Requirements Reviews ● - Code Designs ● - Code Development Testing ● - Code Reviews ● - Design Reviews ● - . Verification of the software ### Risk Management: Each risk pertaining to the modifications to the Vitrea Advanced Visualization software has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole is extremely low. Considering all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature. During the design review, the following conclusions were reached: - The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together - . All risks have been reduced as low as possible - The overall residual risk for the software product is deemed acceptable ● ## Verification: The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly. ## Summary of Clinical Tests: The subject of this 510(k) notification, Vitrea Advanced Visualization software, did not require clinical studies to support safety and effectiveness of the software. ## Cyber and Information Security: The Vitrea Advanced Visualization software follows internal documentation which includes information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. 009 510(k) Summary {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white. Internal documentation covers the following: - 1. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including: - A specific list of all cybersecurity risks that were considered in the design of your device: - . A specific list and justification for all cybersecurity controls that were established for vour device. - 2. A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered; - A summary describing the plan for providing validated software updates and patches as ဒေ needed throughout the lifecycle of the medical device to continue to assure its safety and effectiveness. The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity. - 4. A summary describing controls that are in place to assure that the medical device software will maintain its integrity (e.g. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and - Device instructions for use and product specifications related to recommended 5. cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall). ## Performance Standards: The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features. The Vitrea Advanced Visualization software complies with the following voluntary recognized consensus standards: | Standard No. | Standards<br>Organization | Standard Title | Version | Date | |-------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------| | PS 3.1- 3.20 (2011)<br>(Recognition<br>Number 12-238) | NEMA | Digital Imaging and<br>Communications in Medicine<br>(DICOM) Set (Radiology) | 3 | 03/16/2012 | | ISO 14971:2007<br>(Recognition<br>Number 5-70) | AAMI / ANSI<br>/ ISO | Medical Devices -<br>Applications of Risk<br>Management to Medical<br>Devices | 2007 | 03/16/2012 | | IEC 62304:2006<br>(Recognition<br>Number 13-32) | AAMI / ANSI<br>/ IEC | Medical Device Software -<br>Software Life Cycle<br>Processes (Software /<br>Informatics) | 2006 | 08/20/2012 | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered. ## Substantial Equivalence Analysis Conclusion: Vital Images believes the Vitrea Advanced Visualization software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Vitrea (K150258). Furthermore, the verification and validation testing performed demonstrates the subject device is as safe and effective as the predicate device and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the enhancements in the Vitrea Advanced Visualization software do not alter the fundamental scientific technology, safety or intended use of the device. Each change was evaluated for the impact to the safety and effectiveness of the software. It was concluded that the changes do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification and validation tests demonstrate the safety and efficacy of the subject device. Based on the comparison provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.