MAMMOGRAPHY VIEWER SMV658

{0}------------------------------------------------ FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(k) # 5. 510(k) Summary ## Date Prepared: September 10, 2013 #### Submitter's Information: FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: (301) 251-1092 Fax: (203) 602-3785 Contact: Jyh-Shyan Lin OCT 2 5 2013 ## Device Trade Name: ASPIRE Bellus / Mammography Viewer SMV658 #### Device Common Name: Medical Image Processing and Analysis Software ### Regulation Number: 21 CFR 892.2050 #### Device Classification: Class II ## Device Classification Name : Picture Archiving and Communications System (PACS) #### Pane I: Radiology #### Product Code : LLZ #### Date Received: TBD #### Decision Date: TBD #### Decision: TBD {1}------------------------------------------------ ## FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(K) ## Predicate Device: - . MammoWorkstation (K081630), Image Diagnostic International GmbH ## Description of the Device FUJIFILM's Mammography Viewer SMV658 (V3.0) system receives mammography images directly from FUJIFILM's digital mammography acquisition systems using DICOM protocol and PACS via network. These images are displayed on mammography diagnostic monitors for doctors' review. The SMV658 system works as mammography workstation depending on its configuration (monitors) and license information (software key). The system provides visualization and image enhancement tools (such as image review, measurement, postprocessing, film printing, displaying mammography CAD results, and image manipulation) to assist the radiologists' review of mammography images for diagnostic and screening purposes. ## Indication for Use ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. · To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation. ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines. ## Technological Characteristics The proposed Mammography Viewer SMV658 and the predicate device, MammoWorkstation (K081630), are medical application software running on Windows operating system installed on commercial general-purpose Windows-compatible computers. These devices are connected to mammography systems with DICOM standard and retrieve image data via network communications. These devices provide image visualization, enhancement, and manipulation tools for mammography images with various user interfaces and measurement tools for analysis of rendered images. Both the Mammography Viewer SMV658 and the predicate devices support the workflows, UI, and reporting functions for supporting the radiologists' review of mammography images for screening and diagnosis purposes. Mammography Viewer SMV658 introduces no new safety or efficacy issues other than those already indentified with the predicate device. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." {2}------------------------------------------------ FUJIFILM Medical Systems U.S.A., Inc. SMV658 V3.0 510(k) ## Testing Mammography Viewer SMV658 is tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities establish the performance, functionality, and reliability characteristics of the Mammography Viewer SMV658 software, which is found to be safe and effective and substantially equivalent to the currently cleared predicate devices. Testing involved system level functionality test, segmentation accuracy test, measurement accuracy test, interfacing test, usability test, serviceability test, labeling test, as well as the test for risk mitigation method analyzed and implemented in the risk management process. In addition, we conducted the bench performance testing using actual clinical images to help demonstrate that the proposed device achieved the expected accuracy performance. Pass/Fail criteria were based on the requirements and intended use of the product. Test results showed that all tests successfully passed. ## Conclusion This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the bird symbol. Public Health Service Foud and Drug Administration 10903 New Hampshire Avenue Document Control Center - WObo6-Gods Silver Spring, MD 20993-0002 October 25. 2013 FUJIFILM Medical System U.S.A., Inc. % Jyh-Shyan Lin, Ph.D. Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue STAMFORD CT 06902 Re: K132188 Trade/Device Name: Mammography viewer SMV658/ASPIRE Bellus Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ. Dated: October 2, 2013 Received: October 4, 2013 Dear Dr. Lin: 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 10 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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRFI 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. {4}------------------------------------------------ Page 2 - Dr. Lin If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) 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/McdicalDevices/Safey/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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. ரொ Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K132188 Device Name: ASPIRE Bellus/ Mammography Viewer SMV658 Indications for Use: ASPIRE Bellus is intended to receive digital mammography images and to display these images on monitors for radiologists' review for diagnostic and screening purposes. To assist radiologists, ASPIRE Bellus provides functions such as image review, measurement, post-processing, film printing, displaying mammography CAD results, and image manipulation. ASPIRE Bellus does not accept lossy compressed mammographic images, which should not be used for primary diagnostic interpretation. Display monitors connected to ASPIRE Bellus for diagnostic interpretation of mammographic images must be cleared for use in digital mammography. All images sent to or imported into the ASPIRE Bellus must conform to regulatory requirements. Image quality must conform to applicable quality guidelines. Prescription Use メ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) \$\sin(x)\$ (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health > 510(k) == K132188 Page 1 of _I