vRad PACS with Mammography

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized caduceus with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 25, 2016 Virtual Radiologic Corporation % Ms. Melinda Sewell Quality and Regulatory Compliance Manager 11995 Singletree Lane, Suite 500 EDEN PRAIRIE MN 55344 Re: K162145 Trade/Device Name: vRad PACS with Mammography Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2016 Received: October 11, 2016 Dear Ms. Sewell: 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) K162145 #### Device Name vRad PACS with Mammography #### Indications for Use (Describe) The vRad PACS with Mammography software is used with general purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf g minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, Xray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOMcompliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer. vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA. | 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}------------------------------------------------ ### 510(k) Summary for vRad PACS with Mammography ### Applicant: Virtual Radiologic Corporation 11995 Singletree Lane, Suite 500 Eden Prairie, MN 55344 | Establishment Registration | | |----------------------------|--------------| | Number: | 3007795813 | | Telephone: | 952.595.1100 | | Fax: | 952.942.3361 | Company Contact: Melinda Sewell, Quality and Regulatory Compliance Manager Date Prepared: October 7, 2016 ### Device Name and Classification: | Proprietary Name: | vRad PACS with Mammography | |------------------------|----------------------------------------------------| | Device Common Name: | Picture Archiving and Communications System (PACS) | | Classification Name: | System, Image Processing, Radiological | | Product Code: | LLZ | | Regulation Number: | 21 CFR 892.2050 | | Device Classification: | Class II | | Review Panel: | Radiology | ### Predicate Device: FujiFilm Medical Systems, Synapse Workstation Software Version 3.3.0, K112439 ### Device Description: vRad PACS with Mammography is a device which consists solely of software that allows electronic transmission of radiological patient images from one location to another. The device is capable of accepting, storing, digitally {4}------------------------------------------------ processing, and displaying medical images for the purposes of providing digital diagnostic image interpretation services by trained radiologists on PC workstations. The software provides functions for performing operations related to manipulation, enhancement, compression, and quantification of medical images. vRad PACS with Mammography is a modified version of vRad PACS (K090649) that will now allow display of presentation-quality digital mammography images. # Indications for Use: The vRad PACS with Mammography software is used with general-purpose computing hardware which meets or exceeds minimum specifications. vRad PACS with Mammography is intended to receive, transmit, store, and display images for clinical purposes and is comprised of three components: Viewer, Storage, and Cache. The vRad PACS Viewer component is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with vRad PACS Storage component. The vRad PACS Viewer is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The vRad PACS Viewer can process medical images from DICOM modalities such as X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM-compliant modalities. The vRad Storage component is intended to handle the DICOM protocol and store images as DICOM files to a location where they can be read by vRad PACS Cache and transmitted to radiologists' workstations for viewing by the vRad PACS Viewer. vRad PACS with Mammography may be used for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM "For Presentation" format and displayed on a monitor that meets technical specifications reviewed and cleared by FDA. # Substantial Equivalence Comparison: Virtual Radiologic believes vRad PACS with Mammography is substantially equivalent to Synapse Workstation. | Characteristic | vRad PACS with<br>Mammography | Synapse Workstation<br>(K112439) | |---------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The vRad PACS with<br>Mammography software is<br>intended for use with<br>general purpose | FujiFilm Synapse<br>Workstation Software is<br>intended for installation on<br>an off-the-shelf PC | | Characteristic | vRad PACS with<br>Mammography | Synapse Workstation<br>(K112439) | | | computing hardware which<br>meets or exceeds<br>minimum specifications.<br>vRad PACS with<br>Mammography is intended<br>to receive, transmit, store<br>and display images for<br>clinical purposes and is<br>comprised of three<br>components: Viewer,<br>Storage, and Cache. The<br>vRad PACS Viewer<br>component is intended for<br>installation on an off-the-<br>shelf PC meeting or<br>exceeding minimum<br>specifications and<br>networked with the vRad<br>PACS Storage component.<br>The vRad PACS Viewer is<br>intended to serve as the<br>primary user interface for<br>the processing of medical<br>images for presentation on<br>displays appropriate to the<br>medical task being<br>performed. The vRad<br>PACS Viewer can process<br>medical images from<br>DICOM modalities such as<br>X-ray radiography, X-ray<br>computed tomography,<br>magnetic resonance<br>imaging, ultrasound,<br>nuclear medicine, and<br>images from other DICOM-<br>compliant modalities. The<br>vRad Storage component<br>is intended to handle the<br>DICOM protocol and store<br>images as DICOM files to<br>a location where they can<br>be read by vRad PACS<br>Cache and transmitted to<br>radiologists' workstations<br>for viewing by the vRad<br>PACS Viewer. | meeting or exceeding<br>minimum specifications<br>and networked with Fuji<br>Synapse PACS. The Fuji<br>Synapse Workstation is<br>intended to serve as the<br>primary user interface for<br>the processing of medical<br>images for presentation<br>on displays appropriate to<br>the medical task being<br>performed. The Synapse<br>Workstation can process<br>medical images from the<br>following modality types:<br>plane X-ray radiography,<br>X-ray computed<br>tomography, magnetic<br>resonance imaging,<br>ultrasound, nuclear<br>medicine and images from<br>other DICOM compliant<br>modalities.<br>The Synapse Workstation<br>may be used to process<br>DICOM MG "For<br>Processing" images and<br>also for the display,<br>manipulation, and<br>interpretation of lossless<br>compressed or non-<br>compressed<br>mammography images<br>that have been received<br>in the DICOM For<br>Presentation format and<br>displayed on FDA cleared,<br>DICOM compatible<br>displays for<br>mammography. | | Characteristic | vRad PACS with<br>Mammography | Synapse Workstation<br>(K112439) | | | vRad PACS with<br>Mammography may be<br>used for the display,<br>manipulation, and<br>interpretation of lossless<br>compressed or non-<br>compressed<br>mammography images<br>that have been received<br>in the DICOM" For<br>Presentation" format<br>and displayed on an<br>FDA-approved monitor<br>that meets technical<br>specifications reviewed<br>and accepted by FDA. | | | Display of Digital<br>Mammography<br>Images | Yes | Yes | | On-demand access<br>to database and<br>images | Yes | Yes | | Viewing study lists | Yes | Yes | | Decompression for<br>compressed images<br>before display | Yes | Yes | | Display images | Yes | Yes | | Viewing reports | Yes | Yes | | Hanging protocol | Yes | Yes | | Spine labeling | Yes | Yes | | Reference line<br>display | Yes | Yes | | Key images<br>identification | Yes | Yes | | Link multiple series | Yes | Yes | | Measurement tools | Yes | Yes | | Annotation tools | Yes | Yes | | Standard image<br>manipulation tools<br>(Window width/level,<br>zoom, pan, etc) | Yes | Yes | | Characteristic | vRad PACS with<br>Mammography | Synapse Workstation<br>(K112439) | | FCR IPSS for Fuji-CR<br>images | No (proprietary to<br>Fuijfilm) | Yes | | CT IPSS for CT<br>images | No (proprietary to<br>Fuijfilm) | Yes | # Functional Comparison: {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ # Technical Comparison: | Characteristic | vRad PACS with<br>Mammography | Synapse Workstation<br>(K112439) | |-----------------------------------|-------------------------------|----------------------------------| | Product<br>availability | Software only | Software only | | Operating<br>Systems | Windows 7 | Windows 2000/XP | | Web Browser | Internet Explorer | Internet Explorer | | Image and Data<br>Processing | Client Side | Client Side | | Technology<br>Platform (Client) | Windows .Net | Windows Active-X | | Technology<br>Platform (Server) | Windows Server | Windows Server | | Programming<br>Languages (Client) | C++, C# .Net | C++, Active-X | # Safety Information vRad PACS with Mammography introduces no new safety or efficacy issues other than those already identified with the cleared vRad PACS (K090649). The results of the hazard analysis combined with the appropriate mitigations taken indicate that the device is of moderate concern, as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The vRad PACS with Mammography labeling contains instructions for use and necessary cautions, warnings, and notes to provide the safe and effective use of the device. # Testing Information vRad PACS with Mammography tested successfully with reference to its product requirements, as well as design verification and validation document and traceability matrix document. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of the {8}------------------------------------------------ vRad PACS with Mammography software, which is found to be as safe and effective as the predicate device. Testing involved system-level functionality test, component testing, verification testing, integration testing, usability testing, labeling testing, as well as the testing for risk mitigations associated with the risk management process. Pass/fail criteria were based on the requirements and intended use of the product. Test result results showed that all tests successfully passed. # Performance Standards: The subject device is in compliance with the following standards: - NEMA PS 3.1 3.20 (2016) Digital Imaging and Communications in ● Medicine (DICOM) Set - IEC 62304 Ed. 1.1 (2015) Medical Device Software Software Life Cycle ● Processes - ISO 14971 2nd Ed. (2007) Medical Devices Application Of Risk ● Management To Medical Devices - ISO 16142-1, 1st Ed. (2016) Medical Devices Recognized essential . principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards. This 510(k) submission was prepared in consideration of the following quidance documents: - Guidance for the Submission of Premarket Notifications for Medical Image . Management Devices (2000) - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014) - Applying Human Factors and Usability Engineering to Medical Devices ● (2016) - Display Accessories for Full-Field Digital Mammography Systems -Premarket Notification (510(k)) Submissions (2008) - . Guidance for Off the Shelf Software Used in Medical Devices (1999) # Conclusion The predicate device was cleared based on non-clinical supportive information. The comparison of features, technical characteristics, devices hazards, and verification and validation testing demonstrate that the subject device is as safe {9}------------------------------------------------ and effective as the predicate device currently marketed for the same intended use. In conclusion, the subject device, vRad PACS with Mammography does not introduce any new significant potential safety risks and is substantially equivalent to the predicate device in terms of performance, safety and effectiveness.