VITREAADVANCED

{0}------------------------------------------------ # KIBI213 # 510(k) Summary This 510(k) summary is submitted in accordance with the requirements by section 807.92.(c) | Submitter: | Vital Images, Inc.<br>5850 Opus Parkway<br>Suite 300<br>Minnetonka, MN 55343-4414 | | | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--|-----|--------| | Establishment<br>Registration: | 2134213 | | NOV | 2 2012 | | Contact Person: | Ian Nemerov<br>Vice President, General Counsel & Secretary<br>Phone: 952-487-9622<br>Fax: 952-487-9510<br>E-mail: inemerov@vitalimages.com | | | | | 510(k) Type: | Traditional 510(k) | | | | | Summary Date: | October 5,2012 | | | | | Device Name | | | | | | Trade Name: | VitreaAdvanced | | | | | Common Name: | Picture Archiving and Communications System | | | | | Classification Name: | System, Image Processing, Radiological (21 C.F.R. 892.2050,LLZ) | | | | : #### Predicate Devices: | Subject Functions | Predicate Devices | | | |--------------------------------|----------------------------------------------------------------------|--------------------------------------------|---------------| | | Manufacturer | Trade Name | 510(k) Number | | Advanced Image Post-processing | Vital Images, Inc., | Vitrea®, Version 4.0 | K071331 | | Vitrea® CT Body Perfusion | Toshiba America Medical System, Inc., | CSBP-001A Body Perfusion System | K090504 | | Vitrea® CT Liver Analysis | MeVis - Center for Medical Diagnostic Systems and Visualization GmbH | MeVis LiverAnalyser / LiverViewer Software | K051528 | | | MEDIAN Technologies | LMS-Liver | K071241 | | | Vital Images, Inc | Vitrea® 4DCT | K072821 | | Vitrea® CT Brain Perfusion | Siemens Medical Solutions, Inc. | syngo® Volume Perfusion-CT Neuro | K073238 | {1}------------------------------------------------ #### Device Description: VitreaAdvanced is a package of noninvasive post-processing software applications for the Vitrea software platform. The system is a software only medical device to be installed on common IT hardware. VitreaAdvanced leverages existing Vitrea® functionality for the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides multi-dimensional visualization of digital images to aid medical professionals in their analysis of analomy and pathology. VitreaAdvanced can be used with a variety of cleared Vitrea based software applications. VitreaAdvanced uses the Vitreas system user interface to follow typical clinical workflow patterns and process, review, and analyze digital images, including: - Receive DICOM image data from a variety of sources . - Display images using dedicated protocols adapted to exam types . - Select images for closer examination from collection of 2D. 3D or 4D views . - Interactively manipulate an image in real-time to visualize anatomy and pathology ● - Annotate, tag, measure, and record selected views . - . Output selected views to compatible devices and publishing tools (e.g. printers, DICOM devices, etc.) In addition, VitreaAdvanced includes three Vitrea® applications: Vitrea CT Body Perfusion is noninvasive post-processing software that has been designed to assess dynamic (time lapsed collections) CT volume scans and provide data related to the volume sets. It displays blood flow parametric maps for single-input and dual-input workflows. Vitrea® CT Liver Analysis is noninvasive post-processing software that displays CT image data. It processes image data to segment liver structures and evaluate resection surfaces as well as volumes. Vitreas CT Liver Analysis provides automatic registration and composite views of mulliple series, optimized screen layouts and measurement tools. It also generates standardized reports for WHO and RECIST protocols and for percentage change tumor response values. Vitrea®CT Brain Perfusion is noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data. It displays time density curves, perfusion characteristics in parametric and summary maps, as well as regions of interest and mirrored regions. #### Intended Use / Indications for Use: VitreaAdvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. VitreaAdvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitreao based software applications. In addition, VitreaAdvanced includes three Vitrea® applications: Vitrea CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring. {2}------------------------------------------------ Vitrea CT Liver Analysis is a noninvasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels segmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the fesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy. Vitrea CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored regions, as well as the visual inspection of time densily curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT). #### Comparison with Predicate Devices: VitreaAdvanced is a package of noninvasive post-processing software applications for the Vitrea software platform. It leverages the basic functionality and technology of the existing 510(k) cleared Vitrea software platform. VitreaAdvanced includes advance applications that extend the functionality of the platform for specific uses. The specific uses are substantially equivalent to the cleared uses of existing post-processing software applications available on other platforms. Also, the software applications use similar technology as existing post-processing software applications. | Vitrea® CT<br>Body<br>Perfusion<br>(Submission<br>Subject). | Description | Toshiba CSBP-001A<br>Body Perfusion<br>System (K090504) | Explanation of Differences | |-------------------------------------------------------------|-----------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | Analysis Model | Maximum slope (Fick<br>principal) | Includes | The subject and predicate<br>both implement Maximum-<br>slope.<br>The predicate implements<br>additional models:<br>Compartment model and<br>Patlak Plot. | #### Vitrea® CT Body Perfusion: {3}------------------------------------------------ | Vitrea® CT<br>Body<br>Perfusion<br>(Submission<br>Subject) | Description | Toshiba CSBP-001A<br>Body Perfusion<br>System (K090504) | Explanation of Differences | |------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Parameters | Blood flow | Includes | The subject and predicate<br>both display blood flow<br>parameters.<br>The predicate includes<br>additional parameters: Blood<br>volume, MTT, HAF (PI),<br>equivalent blood volume<br>using the additional analysis<br>models. | | Functions | Single input, dual<br>input, map display and<br>ROI measurement | Same | None | # Vitrea® CT Liver Analysis: | Vitrea® CT<br>Liver Analysis<br>(Submission<br>Subject) | Description | MeVis Liver<br>Analyser /<br>LiverViewer<br>Software<br>(K051528) | Median LMS-<br>Liver<br>(K071241) | Explanation of<br>Differences. | |---------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Analysis Model | Rigid and deformable<br>registration,<br>Segmentation and<br>region growing | Same | Same | None | | Parameters | Basic measurements,<br>volume, resection<br>plane, RECIST, WHO<br>and comparisons | Partial<br>(volumes,<br>resection<br>planes and<br>comparisons) | Partial<br>(RECIST,<br>WHO and<br>comparisons) | MeVis provides<br>basic<br>measurements<br>for volumes,<br>resection planes<br>and comparisons.<br>LMS-Liver<br>provides RECIST<br>and WHO<br>measurements<br>and comparison. | {4}------------------------------------------------ | Vitrea® CT<br>Liver Analysis<br>(Submission<br>Subject) | Description | MeVis Liver -<br>Analyser /<br>LiverViewer<br>Software<br>(K051528) | Median LMS-<br>Liver .<br>(K071241) : | Explanation of<br>Differences | |---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Functions | Segment: organs,<br>tumors and<br>intrahepatic vessels.<br>Resection planning<br>tool (defines vascular<br>territories), multi-phase<br>fusion and<br>standardized reports | Partial<br>(segmentation,<br>resection<br>planning and<br>multi-phase<br>fusion) | Partial<br>(standardized<br>reports) | MeVis provides<br>segmentation,<br>resection<br>planning and<br>multi-phase<br>fusion.<br>LMS-Liver<br>provides<br>standardized<br>reports. | Vitrea® CT Liver Analysis: | Vitrea® CT<br>Brain<br>Perfusion<br>(Submission<br>Subject) | Description | Vitrea® 4DCT<br>(K072821) | Siemens syngo®<br>Volume<br>Perfusion –<br>CT Neuro<br>(K073238) | Explanation of<br>Differences | |-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Analysis Model | Deconvolution | Same | Includes | syngo® Volume<br>Perfusion-CT<br>Neuro uses both<br>deconvolution<br>and maximum<br>slope. | | Parameters | Cerebral blood flow<br>(CBF), cerebral blood<br>volume (CBV), local<br>bolus timing (i.e., delay<br>of tissue response,<br>time to peak), and<br>mean transit time (MTT) | Same | Includes | syngo® Volume<br>Perfusion-CT<br>Neuro has<br>all the<br>parameters and<br>vascular<br>permeability | {5}------------------------------------------------ | Vitrea® CT<br>Brain<br>Perfusion<br>(Submission<br>Subject) | Description | Vitrea® 4DCT.<br>(K072821) | Siemens syngo®<br>Volume<br>Perfusion -<br>CT Neuro<br>(K073238) | Explanation of<br>'Differences' | |-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functions | Display regions of<br>interest, mirrored<br>regions, time density<br>curves and perfusion<br>characteristics in<br>parametric and<br>summary maps | Partial | Same | 4DCT does not<br>include summary<br>maps (maps that<br>combine<br>parameters).<br>syngo®<br>Volume<br>Perfusion- CT<br>Neuro includes<br>maps that<br>combine<br>parameters. | #### Summary of Non-Clinical Tests: VitreaAdvanced was designed, developed, and tested according to written procedures that included applying risk management. Testing included verification, and evaluation of previously acquired medical images. The following quality assurance measures were applied to the development of VitreaAdvanced: - Risk analysis . - . Requirements reviews - . Design reviews - Performance testing (Verification) . - Safety testing (Verification) . - Simulated use testing (Validation) . #### Software Testing: The primary focus of the Verification and Validation team during development was producing, reviewing and execuling manual and automated test cases to ensure the product conformed to new and previously defined specifications and also to ensure that risks were properly mitigated during testing. The Requirement Traceability Matrix (RTM) provides a mapping between requirements, risks, test cases, and shows related test results. The RTM confirms that there was a test case authored and executed for all requirements and any applicable risks. In addition, the Verification and Validation Team demonstrated clinical features to several Radiologists and 3D Technologists to gather feedback and formal acceptance. #### Manual Tests: Manual tests cases were executed to verify and validate the CT Body Perfusion, CT Liver Analysis and CT Brain Perfusion applications, and to determine the impact of any changes. All manual tests and steps were executed to prove the product conformed to specifications and to mitigate risks. {6}------------------------------------------------ #### Verification: The software verification team had a primary goal of assuring that software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM. #### Automated Integration Level Build Verification Tests (BVT): Automated integration level Build Verification Tests (BVT) were developed to exercise mainstream functionality and provide an assessment of the stability of the VitreaAdvanced software. Automated software rendering tests were used to verify correctness of images generated by the rendering engine. Automated algorithm smoke tests and automated algorithm regression tests were executed. Automated performance tests were used to verify that response times and throughput were acceptable. Automated regressions tests were used to verify correctness of measurements, orientation markers, and other core features of VitreaAdvanced. #### Validation: The software validation team had a primary goal of assuring that software conforms to user needs and intended uses. The result of the validation team's efforts was evidence, produced by workflow testing, that system requirements and features were implemented, reviewed and met. #### Internal Validation: The software validation team provided internal validation of VitreaAdvanced. Internal validation included internal beta testing and internal user acceptance testing. #### External Validation: #### Vitrea® CT Body Perfusion During external validation of CT Body Perfusion of VitreaAdvanced, an external cardiologist confirmed that the CT Body Perfusion application's deformable (non-rigid) registration for dynamically scanned organs produces similar results to what is available on the scanner console. It was also confirmed that it takes the same amount of time or less to complete registration. The results of the qualitative analysis (visual verification), performed as part of validation, support the feedback received from the cardiologist during external validation regarding the visual similarity of images produced by the VitreaAdvanced registration to the registration applied at the scanner. In addition, a cardiologist also confirmed the measurements produced were clinically acceptable and that the software was ready for general release. Based on the results of the qualitative analysis, and feedback gathered during external validation, the CT Body Perfusion application has passed validation. #### Vitrea® CT Liver Analysis During external validation of CT Liver Analysis application of VitreaAdvanced, two external 3D Technicians evaluated the functionality, usability and performance of the CT Liver Analysis application. Based on their evaluation, the software passed external validation. #### Vitrea® CT Brain Perfusion During external validation of CT Brain Perfusion of VitreaAdvanced, an external radiologist evaluated the functionality and performance of the summary map feature and the correlation of each summary map with his interpretation of that summary map's associated perfusion maps. He confirmed that the software has met the intended use and effectively provides a summary image of the data displayed in the perfusion maps as well as when used in conjunction with the perfusion maps, the summary map enables the user to characterize the brain tissue and communicate their findings. {7}------------------------------------------------ #### Summary of Clinical Tests: The subject of this traditional 510(k) notification, VitreaAdvanced, did not require clinical studies to support safety and effectiveness of the software. #### Cyber and Information Security: #### . Confidentiality Vitrea platform relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine. - . Integrity Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields. #### . Availability Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained. #### . Accountability Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user. #### Measurement Accuracy: Measurements and orientations in VitreaAdvanced were verified using various imaging phantoms. These imaging phantoms contain markers at known positions, distances, and angles from one another. The known positions, distances, and angles were used as input into expected results for verification tests that verified the spatial accuracy of image rendering of 2D and 3D images, the accuracy of distance, angular measurement, and navigational tools, as well as the accuracy of orientation markers within VitreaAdvanced. #### Performance Standard: No applicable mandatory performance standards or special controls exist for this device. However, the software is designed to meet NEMA PS 3.1 - 3.18 Digital Imaging and Communications in Medicine (DICOM) standard. #### Conclusion: The testing reported in this 510(k) establishes that VitreaAdvanced is substantial equivalent to the predicate devices and is safe and effective for its intended use. {8}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002 Mr. Daniel Biank Regulatory Affairs Manager Vital Images, Inc. 5850 Opus Parkway, Suite 300 Minnetonka, MN 55343 Re: K121213 Trade/Device Name: VitreaAdvanced Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 5, 2012 Received: October 9, 2012 #### Dear Mr. Biank: We have reviewed vour 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of 2 2012 NOV {9}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K121213 Device Name: VitreaAdvanced #### Indications for Use: VitreaAdvanced is a medical diagnostic system for the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. VitreaAdvanced is not meant for primary image interpretation in mammography. It can be used with a variety of cleared Vitrea® based software applications. In addition, VitreaAdvanced includes three Vitrea applications: Vitrea® CT Body Perfusion is a noninvasive post-processing application designed to evaluate perfusion of organs and tumors. The software can calculate perfusion characteristics from dynamic CT image data acquired after the injection of contrast media. The software also allows the separate calculation of the arterial and venous components of perfusion in organs. It supports evaluation of regions of interest and the visual inspection of time density curves. When used by a trained and qualified physician a potential application is to differentiate blood flow between normal and diseased tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring. Vitrea® CT Liver Analysis is a noninyasive post-processing application designed to evaluate liver tumors and plan for liver surgery. It displays images for analysis and preoperative liver surgery planning, such as organ segmentation, tumor segmentation and intrahepatic vessels seqmentation, as well as the approximation of vascular territories. It supports preoperative evaluation of specific surgery strategies by allowing the user to interactively define virtual resections splitting the liver. It also allows the user to evaluate safety-margins around lesions and to identify affected vascular branches and territories. Vitrea® CT Liver Analysis also provides automatic registration of multiple series and measurement tools for characterization and follow-up of the lesions. When used by a trained and qualified physician a potential application is to assist in the assessment of tumor response to therapy. Vitrea CT Brain Perfusion is a noninvasive post-processing application designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of tissue response, time to peak), and mean transit time (MTT) from dynamic CT image data acquired after the injection of contrast media. The package also allows the calculation of regions of interest and mirrored reqions, as well as the visual inspection of time density curves. Vitrea® CT Brain Perfusion supports the physician in visualizing the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for both CBF and CBV and higher for time to peak and MTT). Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) Michael D'Auria, CR Invision of Radiotogical Hea 510(k) K121213