Velocity

{0}------------------------------------------------ February 15, 2018 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304 Re: K173636 Trade/Device Name: Velocity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 22, 2017 Received: November 24, 2017 Dear Mr. Coronado: 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. 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 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}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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) ## K173636 Device Name Velocity #### Indications for Use (Describe) Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography. Type of Use (Select one or both, as applicable) [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Premarket Notification [510(k)] Summary ## Velocity 4.0 The following information is provided following the format of 21 CFR 807.92(c). | Submitter's Name: | Varian | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 3100 Hansen Way E-110 | | | Palo Alto, CA 94304 | | | | | | Contact Name: Peter J. Coronado | | | Phone: 650.424.6320 | | | Fax: 650.646.9200 | | | | | | Date: February 6, 2018 | | Proprietary Name: | Velocity | | Classification Name: | Image Processing System, Radiology | | | 21 CFR 892.2050, Class II | | | Product Code: LLZ | | | | | Common/Usual Name: | Picture Archiving and Communication System (Medical Imaging Software) | | Predicate Devices: | Primary predicate: Velocity AI – K081076 | | | Secondary predicate: MIM Y90 Dosimetry - K172218 | | Device Description: | Velocity is a software application providing relevant tools for Radiotherapy | | | professionals to use while creating treatment plans. | | | The Velocity device is a Picture Archiving and Communication System (medical imaging<br>software). Velocity provides medical image processing designed to facilitate the | | | oncology or other clinical specialty work flow by allowing the comparison of medical | | | imaging data from different modalities, points in time, and / or scanning protocols. The | | | product provides users with the means to display, co-register and analyze medical | | | images from multiple modalities including PET, SPECT, CT, RT Dose and MR; draw | | | Regions of Interest (ROI), calculate and report relative differences in pixel intensities, | | | Standardized Uptake Value (SUV) or other values within those regions; and import / | | | export results to/from commercially available radiation treatment planning systems<br>and PACS devices. Co-registration includes deformable registration technology that can | | | be applied to DICOM data including diagnostic and planning image volumes, | | | structures, dose, and automatic anatomical atlas-based segmentation tools. | | | | | | Velocity is used as a stand-alone application on recommended Off-The-Shelf (OTS) | | | computers supplied by the company or by the end-user. | | Intended Use Statement | Velocity is a software package that provides the physicians a means for comparison of | | | medical data including imaging data that is DICOM compliant. | | | It allows the display, annotation, volume operation, volume rendering, registration, | | | and fusion of medical images as an aid during use by diagnostic radiology, oncology, | | | radiation therapy planning and other medical specialties. Velocity is not intended for | | | mammography. | | Indications for Use | Velocity is a software package that provides the physicians a means for comparison of | | Statement | medical data including imaging data that is DICOM compliant. | | | It allows the display, annotation, volume operation, volume rendering, registration, | | | and fusion of medical images as an aid during use by diagnostic radiology, oncology, | | | radiation therapy planning and other medical specialties. Velocity is not intended for | | | mammography. | {4}------------------------------------------------ ## Technological Characteristics: | VELOCITY 4.0 - DEVICE COMPARISON TABLE | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FEATURE AND/OR SPECIFICATION OF<br>NEW/MODIFIED DEVICE | VELOCITYAIS v2.0<br>K081076 | VELOCITY 4.0 | | Indications for Use/Intended Use | VelocityAIS (VelocityAl) is a stand-<br>alone software product that<br>provides the physician a means<br>for comparison of medical imaging<br>data from multiple DICOM<br>conformant imaging modality<br>sources. It allows the display,<br>annotating, volume rendering,<br>registration and fusing of medical<br>images as an aid during use by<br>diagnostic radiology, oncology,<br>radiation therapy planning and<br>other medical specialties.<br>VelocityAIS (VelocityAI) is not<br>intended for mammography<br>diagnosis. | Velocity is a software package that<br>provides the physicians a means<br>for comparison of medical data<br>including imaging data that is<br>DICOM compliant.<br>It allows the display, annotation,<br>volume operation, volume<br>rendering, registration, and fusion<br>of medical images as an aid during<br>use by diagnostic radiology,<br>oncology, radiation therapy<br>planning and other medical<br>specialties.<br>Velocity is not intended for<br>mammography diagnosis. | | General Usage/ Performance Features | | | | Image Study Importation | Yes<br>DICOM, PET/SPECT/CT/MRI<br>Dose | Yes<br>DICOM, PET/SPECT/CT/MRI<br>Dose<br>Query/Retrieve automation added<br>in 4.0 | | Image Structure Import, Save & Export<br>to Treatment Planning Systems | Yes | Yes | | Volume rendering | Yes | Yes<br>4D Cine Volume support in 4.0.0 | | Advanced Visualization and Navigation<br>Features | Yes | Yes<br>multi-volume view support in 4.0 | | Volume Operations | No | Yes | | Diagnostic Image registration | Yes | Yes | | Image Fusion | Yes | Yes | | Anatomical and Functional Images | Anatomical and Functional Images | | | ROI & Contouring | Yes | Yes | | Manual Contouring Tools | Yes | Yes | | Image Analysis | Yes | Yes | | Plan Review of imported plans or<br>created dose composites | No | Yes | | Oncology workflow automation | No | Yes | | Image/ROI Export to DICOM RT | Yes | Yes | | Secure login and data storage | Yes | Yes | | Operating System Platform | Microsoft Windows XP 32 bit<br>only/Windows 7, Vista | Microsoft Windows 7 & 10 (64 bit<br>only)/ Windows Server 2008R2<br>(Citrix), 2012R2, 2016 | | | MAC OSX 10.6 | MAC OS 10.12 Sierra, macOS 10.13<br>High Sierra | | Multimodality DICOM Import | | | | Import and display DICOM CT, MR, DS,<br>PET, RTS, RTP | Yes | Yes | | Advanced Visualization & Navigation | | | | General image viewer with view layout<br>selection and toolbars | Yes | Yes | | Volume Operations | | | | User scaling of image volumes | No | Yes | | Biological Effective Dose (BED) Scaling | No | Yes | | Y-90 Microsphere Dosimetry - | No | Yes | | conversion of SPECT to DS | | | | Automated Image-based Registration | | | | Manual registration editing | Yes | Yes | | Auto Rigid Registration | Yes | Yes | | Deformable Registration | Yes | Yes | | Inverse deformable registration | No | Yes | | Structure Guided deformable | No | Yes | | Segmentation (Manual Contouring Tools and Atlas Segmentation) | | | | Manual Contouring tools | Yes | Yes | | Atlas Auto-Segmentation | Yes | Yes | | Image analysis with volumetric graphs | | | | Histograms and Voxel Assessment<br>graphs | Yes | Yes | | DVH statistics display | Yes | Yes | | Plan Review | | | | Storage and display of DICOM RT Plans | No | Yes | | Lesion volume tracking by associating<br>structure with name tag | No | Yes | | Navigator Semi-Automated Workflows | | | | Semi-automatic workflows to assist<br>with common clinical image<br>registration & analysis tasks | No | Yes | | Adaptive Navigators to assist in offline<br>dose review: includes workflows to<br>create adaptive CT based on CBCT<br>registration, copy plan to adaptive CT,<br>and compare dose. | No | Yes | | Security | | | | Logging of database activity | No | Yes | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ MIM Y90 Dosimetry (K172218) was determined to be a predicate for the RapidSphere SPECT Microsphere Dosimetry feature. Both features: - are intended for post-treatment absorbed dose calculation and evaluation - are compatible with Y90 PET and SPECT image types - and use the Local deposition model for dose calculation. ## Performance Data: ## Software Verification and Validation Testing Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern. Clinical Tests No clinical tests have been included in this pre-market submission. ## Conclusions The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Velocity device performs as intended. Varian therefore considers Velocity 4.0 to be safe and effective and to perform at least as well as the predicate device.