SOMATOM Perspective

{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 a human figure, represented by three overlapping profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2016 Siemens Medical Solutions USA, Inc. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway Malvern, Pennsylvania 19355 Re: K151765 Trade/Device Name: Somatom Perspective Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-ray System Regulatory Class: Class II Product Code: JAK Dated: June 19, 2015 Received: June 30, 2015 Dear Kimberly Mangum: 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 devicerelated 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/ResourcesforYou/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.'Hara For Robert Ochs. PhD Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. Image /page/2/Picture/3 description: The image shows the 510(k) number, if known, which is K151765. The text is in a clear, sans-serif font, making it easily readable. The number is likely associated with a medical device or product seeking FDA approval. The text is aligned to the left and is the primary focus of the image. Device Name SOMATOM Perspective ### Indications for Use (Describe) The Siemens SOMATOM Perspective system is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Itemporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation. The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.) Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a large, sans-serif font. The color of the text is a light teal. The text is horizontally oriented and appears to be a logo or brand name. # 510(K) SUMMARY FOR SOMATOM PERSPECTIVE SYSTEMS Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: October 30, 2015 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. #### 1. General Information: # Importer/Distributor Establishment: Registration Number: 2240869 Siemens Medical Solutions, Inc. 40 Liberty Boulevard Mail code: 65-1A Malvern, PA 19355 ## Manufacturing Facility (1): SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425 # Manufacturing Facility (2): Siemens AG Medical Solutions. Business Unit CR Siemensstrasse 1 DE-91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Kimberlv Manqum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, 65-1A Malvern, PA 19355-1406 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com {4}------------------------------------------------ | 3. Device Name and Classification<br>Product Name:<br>Propriety Trade Name:<br>Classification Name:<br>Classification Panel:<br>CFR Section:<br>Device Class:<br>Product Code: | SOMATOM Perspective<br>SOMATOM Perspective (with syngo® CT VC30-<br>easyIQ version)<br>Computed Tomography X-ray System<br>Radiology<br>21 CFR §892.1750<br>Class II<br>JAK | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Legally Marketed Primary Predicate Device:<br>Product Name:<br>Propriety Trade Name:<br>Classification Name:<br>Classification Panel:<br>CFR Section:<br>Device Class:<br>Product Code:<br>510(k) #: | SOMATOM Perspective<br>SOMATOM Perspective<br>Computed Tomography X-ray System<br>Radiology<br>21 CFR §892.1750<br>Class II<br>JAK<br>K113287 | | Legally Marketed Primary Predicate Device:<br>Product Name:<br>Propriety Trade Name:<br>Classification Name:<br>Classification Panel:<br>CFR Section:<br>Device Class:<br>Product Code:<br>510(k) Number: | SOMATOM Perspective (16 and 32 slice<br>configuration)<br>SOMATOM Perspective<br>Computed Tomography X-ray System<br>Radiology<br>21 CFR §892.1750<br>Class II<br>JAK<br>K133590 | | Legally Marketed Secondary Predicate Device:<br>Product Name:<br>Propriety Trade Name:<br>Classification Name:<br>Classification Panel:<br>CFR Section:<br>Device Class:<br>Product Code:<br>510(k)#: | SOMATOM Definition Edge<br>SOMATOM Definition Edge<br>Computed Tomography X-ray System<br>Radiology<br>21 CFR §892.1750<br>Class II<br>JAK<br>K143401 | #### Substantial Equivalence: 4. Siemens SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version is substantially equivalent to the following medical devices in commercial distribution as listed in commercial distribution. {5}------------------------------------------------ ### Table 1 Predicate Devices | Predicate Device Name and<br>Manufacturer | 510(k)<br>number | Clearance Date | |---------------------------------------------------------------------------------------|------------------|----------------| | Primary Predicate Device:<br>Siemens SOMATOM Perspective with<br>SOMARIS/5 VC10 | K113287 | 05/23/2012 | | Primary Predicate Device:<br>Siemens SOMATOM Perspective 16&32<br>with SOMARIS/5 VC28 | K133590 | 04/30/2014 | | Secondary Predicate Device:<br>Siemens SOMATOM Definition Edge with<br>SOMARIS/7 VA48 | K143401 | 04/06/2015 | #### Device Description: 5. The Siemens SOMATOM Perspective is a Computed Tomography X- ray System which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols. 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel(FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept. 12) Temporal-MIP. 13) TrueD-4D viewer, 14) Adaptive Signal Boost Improvement, 15) FAST 3D Align, 16) Dual Spiral Dual Energy, 17) FAST DE Results (for Mono-energetic), 18) Tube Protection, 19) Modified Patient Table. #### Indications for Use 6. The Siemens SOMATOM Perspective system is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images {6}------------------------------------------------ compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation. The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes; the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.) - Summary of Technical Characteristics of the Subject Device as 7. Compared with the Predicate Device: SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. Both the subiect device and predicate devices are computed tomography scanners that support various visualization and evaluation tools. The intended use and fundamental scientific technology remain unchanged from the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices. Table 2 below provides a comparison of the primary features of the subject device in comparison to the predicate device. | | Predicate Device Comparable Feature | | |----------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------| | Subject Device Feature | SOMATOM Perspective<br>K133287 and K133590 | SOMATOM Definition<br>Edge (K143401) | | New Software version<br>syngo® CT VC30-easyIQ<br>version | System scanner<br>software syngo® CT<br>2012A and syngo® CT<br>VC28 | System scanner<br>software syngo® CT<br>VA48 | | iMAR iterative<br>reconstruction technique | N/A | iMAR supported as an<br>optional iterative<br>reconstruction<br>technique | | Temporal MIP (T-MIP) | N/A | Temporal MIP (T-MIP) | | FAST 3D Align | N/A | FAST 3D Align | | FAST DE Results for mono-<br>energetic | N/A | FAST DE Results for<br>mono-energetic | Table 2 Predicate Device Comparison #### 8. Nonclinical Testing: SOMATOM Perspective configured with software version syngo® CT VC30easylQ version is designed to fulfill the requirements of the following standards: - . IEC 60601-2-44: Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography - Ed. 3.1 - IEC 61223-3-5: Evaluation and routine testing Evaluation and routine . testing in medical imaging departments - Part 3-5: Acceptance tests - {7}------------------------------------------------ Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1 - NEMA XR-25: Computed Tomography Dose Check ● - . IEC 61223-2-6: Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment - NEMA PS 3.1 - 3.14: Digital Imaging and Communications in Medicine DICOM) Set - IEC 62304 Ed. 1.0: Medical device software software life cycle ● processes - IEC 60601-1: Medical electrical equipment - Part 1: General requirements for Safety, 2005 - . IEC 60601-1-3: 2008. Medical electrical equipment - Part 11-3: General requirements for radiation protection in diagnostic X-ray equipment - IEC 60601-1-6 : 2010; Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability - ISO 14971: Medical devices Application of risk management to . medical devices - NEMA XR-29: Standard Attributes on CT Equipment Related to Dose ● Optimization and Management - NEMA XR-26: Access Controls for Computed Tomography-● Identification, Interlocks, and Logs - IEC/ISO 10918: Information Technology - Digital Compression and of Continuous-Tone Still Images: Requirements and Coding Guidelines [Including: Technical Corrigendum (2005)] This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests were conducted for the SOMATOM Perspective configured with software version SOMARIS/5 VC30 synqo® CT VC30-easylQ version during product development. The modifications described in this Premarket Notification were supported with verification/validation and performance testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. # Software Verification and Validation Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. {8}------------------------------------------------ # Summary Performance tests were conducted to test the functionality of the SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. #### 9. General Safety and Effectiveness Concerns: The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical. mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards. # 10. Conclusion as to Substantial Equivalence: The SOMATOM Perspective configured with software version SOMARIS/5 VC30 synqo® CT VC30-easylQ version has the same intended use and comparable indication for use as the predicate devices. The technological characteristics such as image acquisition, operating platform, and image manipulation are similar to the predicate devices. The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the SOMATOM Perspective (K113287) and SOMATOM Perspective 16&32 (K133590) are adequate for the intended use. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use.