SOMATOM PERSPECTIVE

{0}------------------------------------------------ ### 510(K) SUMMARY FOR SOMATOM Pserspective Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: March 11, 2014 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: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Establishment Registration Number: 2240869 ### Manufacturing Site: SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD. 278 Zhou Zhu Rd Shanghai, CHINA 201318 Establishment Registration Number: 3003202425 #### Contact Person: 2. Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA - 51 Valley Stream Parkway D02 -- -- --Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com #### Device Name and Classification 3. SOMATOM Perspective Product Name: SOMATOM Perspective Propriety Trade Name: Computed Tomography X-ray System Classification Name: Radiology Classification Panel: CFR Section: 21 CFR §892.1750 {1}------------------------------------------------ Device Class: Product Code: Class II 901AK Legally Marketed Predicate Devices SOMATOM Perspective Trade Name: K113287 510(k)#: May 23, 2012 Clearance Date: Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology Classification Regulation: 21 CFR § 892.1750 Device Class: ll Product Code: 90JAK SOMATOM Emotion 16 Trade Name: 510(k)#: K050297 March 01, 2005 Clearance Date: Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: Product Code: 90JAK ### 4. Substantial Equivalence: Siemens SOMATOM Perspective 16 and 32 slice configurations are substantially equivalent to the following medical devices in commercial distribution: | Predicate Device Name | FDA Clearance<br>Number | FDA Clearance Date | | |-----------------------|-------------------------|--------------------|--| | SOMATOM Perspective | K113287 | May 23, 2012 | | | SOMATOM Emotion 16 | K050297 | March 01, 2005 | | ### 5. Device Description: The SOMATOM Perspective 16 and 32 slice configurations are whole body Xray Computed Tomography Systems. The SOMATOM Perspective 16 and 32 slice configurations produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors. 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, syngo® {2}------------------------------------------------ CT VC28 (SOMARIS/5 VC28) supports several new features which support more economical and energy efficient scanner operation. ### 6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device: The SOMATOM Perspective 16 and 32 slice configurations are comparable in Indications for Use, material, functionality, technology, energy source, and are considered substantially equivalent to the predicate devices SOMATOM Perspective (K113287, clearance date May 23, 2012) and the SOMATOM Emotion 16 (K050297, clearance date March 01, 2005). The SOMATOM Perspective 16 and 32 slice configurations are intended to produce whole body 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. The imaging components (tube, collimator, detector, and DAS) are the same as the predicate devices. The SOMATOM Perspective 16 and 32 slice configurations include the following new system features designed to allow more efficient system use: - eCockpit Software bundle designed to support more efficient . system use - eStart Software option designed to extend the tube life by pre-. warming the tube before a scan - eSleep Software option designed to save energy by stopping the . gantry rotation during scan breaks Additionally, the SOMATOM Perspective 16 and 32 slice configurations support the following acquisition method: - Source Dual Energy Acquisition Scanning and Single . reconstruction of two spiral scans with different tube voltages (Dual Eneray) The intended use and fundamental scientific technology are similar to the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices. {3}------------------------------------------------ ### 7. Nonclinical Testing: Nonomical Footing. The SOMATOM Perspective 16 and 32 slice configurations are designed to fulfill the requirements of following standards: | Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization | |-----------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------| | 5-40 | General | Medical devices -<br>Application of risk<br>management to<br>medical devices | 14971 Second<br>Edition 2007-<br>03-01 | 08/20/2012 | ISO | | 13-8 | Software | Medical device<br>software - Software life<br>cycle processes | 62304 First<br>edition 2006-05 | 08/20/2012 | IEC | | 5-41 | General | Medical electrical<br>equipment - Part 1-4:<br>General requirements for<br>safety - Collateral<br>standard: Programmable<br>electrical medical<br>systems, edition 1.1 | 60601-1-4: 2000<br>Consol.Ed 1.1 | 09/08/2009 | IEC | | 12-218 | Radiology | Digital Imaging and<br>Communications in<br>Medicine (DICOM) | PS 3.1 - 3.18<br>(2008) | 2008 | NEMA | | 12-222 | Radiology | Evaluation and routine<br>testing in medical imaging<br>departments - Part 3-5:<br>Acceptance tests -<br>Imaging performance of<br>computed tomography X-<br>ray equipment | 61223-3-5 First<br>edition 2004-08 | 03/18/2011 | IEC | | 12-226 | Radiology | Evaluation and routine<br>testing in medical<br>imaging departments -<br>Part 2-6: Constancy<br>tests - Imaging<br>performance of<br>computed tomography<br>X-ray equipment | 61223-2-6<br>Second Edition<br>2006-11 | 02/28/2011 | IEC | | 12-250 | Radiology | Medical electrical<br>equipment - Part 2-44:<br>Particular requirements<br>for the safety of X-ray<br>equipment for computed<br>tomography - Ed. 3.0 | 60601-2-44<br>(2009): | 09/09/2008 | IEC | | 12-225 | Radiology | Computed<br>Tomography Dose | XR-25 | 03/18/2011 | NEMA | {4}------------------------------------------------ This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Perspective 16 and 32 slice configurations during product development. The modifications described in this Premarket Notification were supported with verification and validation 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 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. EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed. ### 8. Indications for Use: 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 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.) {5}------------------------------------------------ ### 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 In summary, Siemens is of the opinion that the SOMATOM Perspective 16 and 32 slice configurations do not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices. {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines. Public Health Service Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 30, 2014 Siemens Medical Solutions USA, Inc. Kimberly Mangum 51 Valley Stream Pkwy. MALVERN PA 19355 Re: K133590/S002 Trade/Device Name: SOMATOM Perspective Regulation Number: 21 CFR 892.1750 Regulation Name: System, X-Ray, Tomography, Computed Regulatory Class: II Product Code: JAK Dated: March 25, 2014 Received: March 31, 2014 Dear Ms. Mangum: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave love 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 The general controls provisions or actice, labeling, and prohibitions against misbranding and of devices, good manandering practice 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), if your device is classified to additional controls. Existing major regulations affecting your device can be it inay of subject to additions, 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 r lease of advised that I Dris issuance or or device complies with other requirements of the Act that I DA has made a ceterimiations administered by other Federal agencies. You must of any I cochar statutios the registenents, including, but not limited to: registration and listing (21 Comply with an the Fer 8 requirement 801); medical device reporting (reporting of medical CrK Patt 607), labeling (21 OFR 803); good manufacturing practice requirements as sets as sets device-related adverse events) (21 OF R Part 820); and if applicable, the electronic fordin in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 80 ), please If you desire specific advice 10. your as not on the more of its toll-free number (800) 638 2041 {7}------------------------------------------------ ### Page 2-Ms. Mangum 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" (21CFR 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/Resourcesfor You/Industry/default.htm. Sincerely yours. Smh7) for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics · and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. ### Indications for Use 510(k) Number (if known) K133590 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 r no wonesmission 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 postprocessing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Itemive Temporal Resolution I or causiae might, while is at opinist of cardiat CT images compared to convenional cardiae 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. The intel planes the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simulaneous translation of the patient.) 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) PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Smh7) FORM FDA 3881 (9/13) PSC Publishing Services (J01) 443-4740 EP