Visaris Avanse

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 8, 2015 VISARIS d.o.o. Belgrade % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K150725 Trade/Device Name: Visaris Avanse® Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ Dated: May 12, 2015 Received: May 14, 2015 Dear Mr. Kamm: 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, Robert A Ochs Robert Ochs. Ph.D. Acting 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) K150725 Device Name Visaris Avanse® #### Indications for Use (Describe) The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors. 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}------------------------------------------------ #### 1. Administrative Information #### Reason for Submission: #### 510(k) Notification for Visaris Avanse®, a new device #### Submitter: | Address: | VISARIS d.o.o. Belgrade<br>Batajnički drum 10 deo 1b<br>11080 Zemun<br>SERBIA | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission contact person:<br>Contact telephone:<br>Contact e-mail:<br>Date prepared:<br>Common device name:<br>Classification:<br>Regulation #s.:<br>Product codes: | Mr. Milan Ratković<br>+381 11 2017 631<br>mratkovic@visaris.com<br>May 12, 2015<br>Stationary X-Ray System (accessory)<br>Class II<br>21 CFR 892.1680 and 21 CFR 892.2050<br>KPR and LLZ | | Substantially equivalent device: | | | Device Name(s): | dicomPACS® 5.2 - dicomPACS DX-R® 1.6 | | Manufacturer: | Oehm & Rehbein GmbH | | Product Code: | LLZ | | Regulation Number: | 21 CFR 892.2050 | | Common Product Name: | Radiological Image Processing System | | 510(k) Number: | K091364 | ## 2. Device description: 21 CFR 807 92 (a) (4) Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements. ## 3. Indications for Use: 21 CFR 807 92 (a) (5) The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse® supports printing to DICOM compatible printers. Within a network environment Visaris Avanse® may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse® has a modular {4}------------------------------------------------ system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse® also provides a user interface for generator control and image acquisition of medical images DR detectors. Not intended for mammography. ## 4. Technological characteristics: 21 CFR 807 92 (a) (6) Visaris Avanse/PACS ® has a modular system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. The software has been validated for compatibility with digital panels previously cleared by FDA and has been validated for control compatibility with the following list of generators: | Manufacturer | Product Name | |------------------------|----------------| | Sedecal, Spain | All models | | Claymount, Switzerland | Clayrad Series | | Spellman, Germany | HFe Series | | EMD, Canada | All models | | CPI, Canada | Indico100, CMP | The image formats used are: DICOM, TIFF, BMP, PNG, JPEG, RAW (new) Image Compression: Visaris Avanse/PACS use the following compression methods within the DICOM standard: - JPEG Baseline (Process 1): Lossy JPEG 8 Bit Image Compression . - JPEG Extended (Process 2 & 4): Lossy JPEG 12 Bit Image Compression (Process 4 . only) - JPEG Extended (Process 3 & 5) ● - JPEG Spectral Selection. Non-Hierarchical (Process 6 & 8) ● - JPEG Lossless, Non-Hierarchical (Process 14) ● - JPEG Lossless, Non-Hierarchical, First-Order Prediction (Process 14 [Selection Value . 11) - JPEG-LS Lossless Image Compression - JPEG-LS Lossy (Near-Lossless) Image Compression ● - JPEG 2000 Image Compression (Lossless Only) - JPEG 2000 Image Compression ● These compression methods are defined in the DICOM standard. Support of them is optional. The modules are: - 1. Avanse® DR image acquisition module - 2. X-ray Generator Control Module - 3. Minet Server internal communication module - 4. CDViewer module - 5. RIS Interface module - 6. Avanse® DR service shell module - 7. VisarisPACS database module - 8. Worklist Server module - 9. Dics Burn server module {5}------------------------------------------------ 10. Worklist generator module - 11. Diagon DICOM image viewer module The interfaces are: - 1. DR flat panel - 2. X-ray generator - 3. HTTP - 4. DICOM Store (SCP) - 5. DICOM Send (SCU) - 6. DCIOM Print (SCU) - 7. Worklist Query (SCP) #### 5. Non clinical testing The complete Visaris Avanse® PACS system configuration has been assessed and tested at the factory and has passed all in-house criteria. The Verification and Validation plan was design to evaluate all input and output functions, and actions performed by Visaris Avanse® PACS software in each operation mode and followed the process documented in the Validation Test Plan. Validation testing indicate that as required by risk analysis, designated individuals performed all verification and validation activities and that the result demonstrated that the predetermine acceptance criteria were met. If the device is installed by Visaris, installation and integration verification tests are conduct against acceptance criteria prior to release to client. #### 6. Clinical testing Clinical images were obtained using each of the declared compatible digital panels. The images were evaluated by a board certified radiologist and were found to be of excellent diagnostic quality. ## 7. Substantial Equivalence Discussion The Visaris Avanse® has the same essential indications for use as the predicate and uses the same kind of platform (Windows PC) to perform its functions. The same kind of software validation and panel testing has been performed. It is DICOM compatible like the predicate and handles jpeq images like the predicate. | dicomPACS®5.2 and dicomPACS DX-R<br>K091364, Oehm und Rehbein GmbH<br>(Predicate Device) | VISARIS AVANSE®<br>(New Device)<br>[Equivalence Level] | Equivalence Justification | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design | | | | Overall software architecture:<br>A front-end + back-end architecture.<br>Front-end includes user interface realised<br>through „stand-alone" user applications.<br>Back-end includes image and metadata<br>databases and background services that<br>operate on them. Front and back end are<br>linked through DICOM standard protocol<br>communication. DICOM communication<br>realised trough service provider-client<br>model, back end provides the service and<br>front end is its client. | Overall software architecture:<br>A front-end + back-end architecture.<br>Front-end includes user interface realised<br>through „stand-alone" user applications.<br>Back-end includes image and metadata<br>databases and background services that<br>operate on them. Front and back end are<br>linked through DICOM standard protocol<br>communication. DICOM communication<br>realised trough service provider-client<br>model, back end provides the service and<br>front end is its client.<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | | dicomPACS®5.2 and dicomPACS DX-R<br>K091364, Oehm und Rehbein GmbH | VISARIS AVANSE®<br>(New Device) | Equivalence Justification | | (Predicate Device)<br>Software architecture back end:<br>Integrated database of image, examination<br>and patient data linking acquired image files<br>on the file system (local or network storage).<br>Windows services (background processes<br>with no user interface) handle data transfer<br>to and from database and ensure database<br>integrity. | [Equivalence Level]<br>Software architecture back end<br>Integrated database of image, examination<br>and patient data linking acquired image files<br>on the file system (local or network storage).<br>Windows services (background processes<br>with no user interface) handle data transfer<br>to and from database and ensure database<br>integrity.<br>[EQUIVALENT] | None required.<br>They are<br>EQUIVALENT. | | Software architecture front end:<br>Front end is realised throught several static<br>windows (win32) applications implementing<br>main user interface functionality including<br>image acquisition, exam scheduling and<br>image review.<br>Only one application entity active on the<br>user interface at any time.<br>Win32 applications implement<br>DICOM<br>communication clients to communicate<br>with services in the back-end and external<br>DICOM services. | Software architecture front end:<br>Front end is realised throught several static<br>windows (win32) applications implementing<br>main user interface functionality including<br>image acquisition, exam scheduling and<br>image review.<br>Only one application entity active on the<br>user interface at any time.<br>Win32 applications implement DICOM<br>communication clients to communicate<br>with services in the back-end and external<br>DICOM services.<br>Exam scheduling user interface is also<br>realised through web based interface.<br>[PRACTICALLY EQUIVALENT] | Web interface architecture<br>is used to collect user input,<br>but not process it. Main<br>processing functionality is<br>still performed in the back<br>end and the web interface<br>is implemented on a win32<br>process within a browser. | | Communication to external components:<br>Realised through each<br>component's<br>proprietary communication protocol using<br>standard interface/data exchange protocols<br>(such as RS232 or TCP-IP). Connections to<br>components managed locally on the main<br>system PC through component proprietary<br>software (SDK) interfaces implemented in<br>dynamicly linked libratries (dlls).<br>Communication from main system software<br>realised through direct calls to exposed<br>functions of the SDK contained within the<br>dlls. Data transfer realised through common<br>memory access. | Communication to external components:<br>Realised through each<br>component's<br>proprietary communication protocol using<br>standard interface/data exchange protocols<br>(such as RS232 or TCP-IP). Connections to<br>components managed locally on the main<br>system PC through component proprietary<br>software (SDK) interfaces implemented in<br>dynamicly linked libratries (dlls).<br>Communication from main system software<br>realised through direct calls to exposed<br>functions of the SDK contained within the<br>dlls. Data transfer realised through common<br>memory access.<br>[EQUIVALENT] | None required.<br>They are<br>EQUIVALENT. | | dicomPACS®5.2 and dicomPACS DX-R<br>K091364, Oehm und Rehbein GmbH<br>(Predicate Device) | VISARIS AVANSE®<br>(New Device)<br>[Equivalence Level] | Equivalence Justification | | User Interface design<br>Multiple application enetites with related<br>but separate user interface to cover<br>different workflow aspects (DR/CR<br>acquisition and patient entry, database<br>search, image viewing, examination<br>scheduling).<br>User interface is graphical with clear display<br>of acquired or retreived images and system<br>information on the screen as well as data<br>entry fields.<br>Action commands are input by the user as<br>mouse clicks on command buttons, menus,<br>results lists and data entry fields.<br>Textual data input is handled through<br>keyboard/touchscreen keyboard input. | User Interface design<br>Multiple application enetites with related<br>but separate user interface to cover<br>different workflow aspects (DR/CR<br>acquisition and patient entry, database<br>search, image viewing, examination<br>scheduling).<br>User interface is graphical with clear display<br>of acquired or retreived images and system<br>information on the screen as well as data<br>entry fields.<br>Action commands are input by the user as<br>mouse clicks on command buttons, menus,<br>results lists and data entry fields.<br>Textual data input is handled through<br>keyboard/touchscreen keyboard input.<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | | Development Platform:<br>Main development platform Microsoft<br>Windows development platform (.NET<br>Technologies: ADO.NET Entity Framework,<br>LINQ, ADO.NET, XML, ODATA Protocol,<br>Native: ODBC, ADO, MSDASQL, Database:<br>SQL Serever Database Engine, SQL Server<br>Integration Services SSIS, SQL Server<br>Reporting Services SSRS). | Development Platform:<br>Main development platform Microsoft<br>Windows development platform (.NET<br>Technologies: ADO.NET Entity Framework,<br>LINQ, ADO.NET, XML, ODATA Protocol,<br>Native: ODBC, ADO, MSDASQL, Database:<br>SQL Serever Database Engine, SQL Server<br>Integration Services SSIS, SQL Server<br>Reporting Services SSRS). Android mobile<br>platform used for UI extension to mobile<br>devices.<br>[PRACTICALLY EQUIVALENT] | Main development platform<br>is equivalent. Android<br>platform is additionally used<br>on Visaris Avanse only to<br>collect user actions from<br>mobile devices. System<br>actions are not processed<br>on this platform, rather on<br>the same main platform as<br>predicate device.<br>Functionality verified. | | PC Platform | PC Platform | | | Common Personal Computer (PC) platform,<br>static or mobile (laptop, tablet). | Common Personal Computer (PC) platform,<br>static or mobile (laptop, tablet).<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | | Material | Material | | | Software only product, no material<br>included. | Software only product, no material<br>included.<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | | Chemical Composition | Chemical Composition | | | Software only product, no chemical<br>composition. | Software only product, no chemical<br>composition.<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | | Energy Source | Energy Source | | | Software only product, no energy source<br>included. | Software only product, no energy source<br>included.<br>[EQUIVALENT] | None required. They are<br>EQUIVALENT. | ## Substantial Equivalence Table {6}------------------------------------------------ {7}------------------------------------------------ 8. Substantial Equivalence Conclusion: After analyzing software validation, risk analysis, and clinical images, it is the conclusion of VISARIS d.o.o. Belgrade Inc that the VISARIS AVANSE® is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.