DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
March 28, 2016
Siemens Medical Solutions USA, Inc. Ə0V.LPEHUOy Mangum Technical Specialist, Regulatory Submissions 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K151749 Trade/Device Name: SOMATOM Scope/Scope Power Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 7, 2016 Received: March 9, 2016
Dear Ms. Mangum:
This letter corrects our substantially equivalent letter of March 18, 2016.
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 Page 2 – Ms. Kimberly Mangum
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.
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, sMisbranding by reference to premarket notifications (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs, Ph.D.
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure Special 510(k) Submission: SOMATOM Scope CT systems
K151749
Siemens Medical Solutions USA, Inc.
510(k) for SOMATOM Scope CT System 510(K) SUMMARY FOR SOMATOM SCOPE 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
Siemens AG Medical Solutions Business Unit CR Siemensstrasse 1 DE—91301 Forchheim, Germany Establishment Registration Number: 3004977335
2. Contact Person: Kimberly Mangum 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 3. Device Name and Classification Product Name: SOMATOM Scope Propriety Trade Name: SOMATOM Scope (with syngo® CT VC30- easyIQ version) Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK
Device Name and Classification
Product Name: SOMATOM Scope Power Propriety Trade Name: SOMATOM Scope Power (with syngo® CT VC30- easyIQ version) Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK
Legally Marketed Primary Predicate Device:
Product Name: SOMATOM Scope/Scope Power Propriety Trade Name: SOMATOM Scope/Scope Power Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK 510(k) #: K140912
Legally Marketed Secondary Predicate Device:
Product Name: SOMATOM Definition Edge Propriety Trade Name: SOMATOM Definition Edge Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK 510(k)#: K143401
4. Substantial Equivalence: Siemens SOMATOM Scope/Scope Power with software version SOMARIS/5 VC30 syngo® CT VC30-easyIQ version is substantially equivalent to the following medical devices in commercial distribution. Table 1 Predicate Devices Predicate Device Name and 510(k) Clearance Date Manufacturer number Primary Predicate Device: K140912 09/15/2014 Siemens SOMATOM Scope/Scope Power with SOMARIS/5 VC28 Secondary Predicate Device: K143401 04/06/2015 Siemens SOMATOM Definition Edge with SOMARIS/7 VA48
5. Device Description: The Siemens SOMATOM Scope/Scope Power are Computed Tomography X- ray Systems which feature a continuously rotating tube-detector system and function 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 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) RTP Enhancement 15) Adaptive Signal Boost Improvement, 16) FAST 3D Align, 17) Dual Spiral Dual Energy, 18) FAST DE Results (for Mono-energetic), 19) Tube Protection, 20) SAFIRE, 21) Modified Patient Table 22) Interleaved Volume Reconstruction (IVR)
6. Indications for Use
The SOMATOM Scope systems are 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.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and xray tube, and the simultaneous translation of the patient.)
7. Summary of Technical Characteristics of the Subject Device as
Compared with the Predicate Device: SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easyIQ version do not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. Both the subject 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.
Table 2 Predicate Device Comparison
Predicate Device Comparable Feature Subject Device Subject Device Primary Predicate SOMATOM Scope/Scope SOMATOM Feature Device Power Definition Edge SOMATOM Scope/Scope (K143401) Power Localized language Localized language support of N/A N/A support of scan protocols scan protocols Easy UI Improvement Easy UI Improvement Easy UI Easy UI iMAR iMAR N/A iMAR Study Split Study Split Improvement Study Split Improvement Study Split Improvement FAST kV FAST kV N/A N/A e-Sleep Improvement e-Sleep Improvement e-Sleep N/A syngo.via client syngo.via client N/A syngo.via client FAST Positioning FAST Positioning N/A N/A Online help based on Online help based on Online help Online help available knowledge gateway knowledge gateway available FAST Wizard FAST Wizard N/A N/A New software field New software field update N/A N/A update concept concept Temporal MIP (t- Temporal MIP (t-MIP) Temporal MIP (t-MIP) N/A MIP) True-D-4D True-D-4D Viewer True-D-4D Viewer N/A Viewer RTP Enhancement RTP enhancement RTP supported RTP supported Adaptive Signal Boost Adaptive Signal Boost Improvement (SDF Improvement (SDF Adaptive Signal Boost N/A Improvement) Improvement) FAST 3D Align FAST 3D Align N/A FAST 3D Align Dual Spiral Dual Dual Spiral Dual Energy Dual Spiral Dual Energy N/A Energy FAST 3D Results FAST 3D Results for FAST 3D Results for Mono- N/A for Mono- Mono-Energetic Energetic Energetic SAFIRE SAFIRE N/A SAFIRE Modified Patient Table Modified Patient Table Normal table load N/A Tube Protection Tube Protection N/A N/A Interleaved Volume Interleaved Volume N/A N/A Reconstruction (IVR) Reconstruction (IVR)
8. Nonclinical Testing: SOMATOM Scope/Scope Power configured with software version syngo® CT VC30-easyIQ 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 – 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 – 3.20 (2011): 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 60601-1-6 : 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 Coding of Continuous-Tone Still Images: Requirements and Guidelines [Including: Technical Corrigendum (2005)] 60601-1-2 (2007): Medial Electrical Equipment – Part 1-2: General requirements for basic safety and essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30- easyIQ 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.
Summary Performance tests were conducted to test the functionality of the SOMATOM Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easyIQ 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 Scope/Scope Power configured with software version SOMARIS/5 VC30 syngo® CT VC30-easyIQ 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 Scope/Scope Power (K140912) is 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.
