SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence

K173630 · Siemens Medical Solutions USA, Inc. · JAK · Mar 30, 2018 · Radiology

Device Facts

Record IDK173630
Device NameSOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
ApplicantSiemens Medical Solutions USA, Inc.
Product CodeJAK · Radiology
Decision DateMar 30, 2018
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1750
Device ClassClass 2

Intended Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Story

SOMATOM CT scanner systems (single or dual source) utilize continuously rotating tube-detector systems to acquire x-ray transmission data; computer reconstruction generates cross-sectional DICOM images. Operated by trained staff in clinical settings; output used by physicians for diagnosis, treatment planning, and radiation therapy. Software version SOMARIS/7 syngo CT VB10 provides patient/data management, scan control, and image reconstruction. New features include 3D camera-assisted patient positioning, tin filtration, and DirectDensity reconstruction (HU-like scaling proportional to electron density). System supports iterative reconstruction (ADMIRE, SAFIRE, iMAR). Benefits include enhanced workflow, improved positioning, and optimized radiation therapy planning. Cybersecurity controls protect data integrity and access.

Clinical Evidence

Bench testing only. Verification and validation testing included phantom tests, integration, and functional testing. Conformance to standards (ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, DICOM 3.1-3.20, IEC 60601 series) demonstrated. No clinical trial data presented.

Technological Characteristics

Whole-body CT scanner; single or dual source; rotating tube-detector. Materials/energy source unchanged from predicates. Features: Stellar detector technology, tin filtration, 3D camera interface, gantry touch panels. Software: SOMARIS/7 syngo CT VB10 (Windows-based). Connectivity: DICOM 3.0 compliant, teamplay support. Iterative reconstruction: ADMIRE, SAFIRE, iMAR. Cybersecurity: unauthorized access prevention, data encryption/authentication.

Indications for Use

Indicated for generation and processing of cross-sectional patient images via computer reconstruction of x-ray transmission data. Used by trained physicians for diagnosis and by trained staff for diagnosis, treatment preparation, and radiation therapy planning. Includes low-dose lung cancer screening for high-risk populations as defined by professional medical societies.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Siemens Medical Solutions USA, Inc. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd. Malvern, Pennsylvania 19355 March 30, 2018 ## Re: K173630 Trade/Device Name: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+. SOMATOM Confidence Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 28, 2018 Received: March 14, 2018 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 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); {1}------------------------------------------------ ## Page 2 - Kimberly Mangum and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Definition AS/AS+ #### Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) | <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | |-------------------------------------------------------------| | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> | #### 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 {3}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Definition AS Open #### Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> 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 {4}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Confidence #### Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 {5}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Drive Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) | <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |--------------------------------------------------------------------------------------------------------------------------------| | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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 {6}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Definition Edge #### Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | 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. 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 {7}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Definition Flash #### Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------| | | <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="font-family: Arial, sans-serif;">☐</span> 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 {8}------------------------------------------------ 510(k) Number (if known) K173630 Device Name SOMATOM Force Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations * * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The color of the text is a light blue or teal. The letters are evenly spaced and appear to be a logo or brand name. #### 510(K) SUMMARY FOR ### SOMATOM CT SCANNER SYSTEMS - SOFTWARE VERSION SOMARIS/7 syngo CT VB10 Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 29, 2018 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. #### I. Submitter Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 #### Location of Manufacturing Site (1) Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335 #### Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425 #### Contact Person: Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com #### II. Device Name and Classification Product Name: SOMATOM Force Trade Name: SOMATOM Force Classification Name: Computed Tomography X-ray System Secondary Classification Name: Picture Archiving and Communications System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Secondary CFR Section: 21CFR §892.2050 Device Class: Class II Product Code: JAK {10}------------------------------------------------ # SIEMENS - Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: Product Name: Trade Name: Classification Name: Secondary Classification Name: Classification Panel: CFR Section: Secondary CFR Section: Device Class: Product Code: SOMATOM Definition Flash SOMATOM Definition Flash Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK SOMATOM Drive SOMATOM Drive Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK SOMATOM Definition Edge SOMATOM Definition Edge Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK SOMATOM Definition AS/AS+ SOMATOM Definition AS/AS+ Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK SOMATOM Definition AS Open SOMATOM Definition AS Open Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK SOMATOM Definition Confidence SOMATOM Definition Confidence Computed Tomography X-ray System Picture Archiving and Communications System Radiology 21 CFR §892.1750 21CFR §892.2050 Class II JAK {11}------------------------------------------------ # SIEMEN ## III. Predicate Device Primary Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: SOMATOM Computed Tomography System Family Scanners K142955 November 24, 2015 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK This predicate has not been subject to a design-related recall #### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: ### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: ### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: ### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: ### SOMATOM Drive K161196 August 24, 2016 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process #### SOMATOM Definition Edge K143401 April 6, 2015 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process SOMATOM Force K133589 April 17, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process SOMATOM Definition Flash K143416 April 16, 2015 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process {12}------------------------------------------------ #### Predicate Device: Trade Name: SOMATOM Definition AS/AS+ 510(k) Number: K143400 Clearance Date: April 8, 2015 Computed Tomography X-ray System Classification Name: Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK Recall Information: All applicable recalls are considered and addressed as part of the design control process #### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: SOMATOM Definition AS Open K143409 March 26, 2015 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process #### Predicate Device: Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: SOMATOM Confidence K162302 December 16, 2016 Computed Tomography X-ray System Radiology 21 CFR § 892.1750 Class II JAK All applicable recalls are considered and addressed as part of the design control process ## IV. Device Description Siemens intends to market a new software version, SOMARIS/7 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems: ### Dual Source CT Systems: - SOMATOM Force ● - SOMATOM Drive ● - . SOMATOM Flash ### Single Source CT Systems: - SOMATOM Definition AS/AS+ ● - SOMATOM Definition AS Open ● - . SOMATOM Definition Edge - SOMATOM Confidence The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB10 are Computed Tomography X-ray Systems which feature one (single source) or two (dual source) continuously rotating tube-detector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation and therapy planning support (including, but not limited to, Brachytherapy, Particle including Proton {13}------------------------------------------------ # SIEMEN Therapy, External Beam Radiation Therapy, Surgery). The computer system delivered with the CT scanner is able to run optional post processing applications. The platform software for the SOMATOM CT Scanner Systems, SOMARIS/7 syngo CT VB10, is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The subject devices with software version SOMARIS/7 syngo CT VB10 will support the following modifications in comparison with the predicate devices: #### Modified Indications for Use Statement 1) #### 2) New/Modified Hardware - Table 1: Overview of Hardware modifications supported by software SOMARIS/7 syngo ● CT VB10 #### Software version SOMARIS/7 syngo CT VB10 3) - Table 2: Overview Software modifications of Dual Source CT System Scanner with ● syngo CT VB10 - . Table 3: Overview Software modifications of Single Source CT System Scanner with syngo CT VB10 - 4) Update 510(k) Information - Provided as Appendix H ● #### Table 1: Hardware Modifications Supported by software SOMARIS/7 syngo VB10 | # | SOMATOM CT<br>System Scanner with | Subject Devices<br>(Dual Source) | | Subject Devices<br>(Single Source) | | | |---|-----------------------------------------------------|----------------------------------|------------------|----------------------------------------|--------------------------------------|-----------------------| | | SOMARIS/7 syngo<br>CT VB10<br>hardware properties | SOMATOM<br>Force<br>SOMATOM | SOMATOM<br>Flash | SOMATOM<br>Definition Edge:<br>SOMATOM | SOMATOM<br>Definition AS:<br>SOMATOM | SOMATOM<br>Confidence | | | Drive | | | Definition AS+ | Definition AS Open | | | | 3D Camera (in<br>combination with<br>Touch Display) | New | N/A | N/A | N/A | New | | 2 | Extended Radiotherapy<br>Functions | Modified | N/A | Modified | Modified | Modified | | 3 | Tin Filter / Tin Filter<br>Technologie | Unmodified | Enabled | Enabled | N/A | N/A | Table 2: Overview Software modifications of Dual Source CT System Scanner with software version SOMARIS/7 syngo CT VB10 | # | SOMATOM CT System Scanner<br>with | Subject Devices<br>(Dual Source) | | | |----|---------------------------------------------|----------------------------------|---------------|---------------| | | SOMARIS/7 syngo CT VB10<br>property | SOMATOM Force | SOMATOM Drive | SOMATOM Flash | | 1 | HD FoV | Modified | Modified | Modified | | 2 | kV and Filter Independent CaScore | Modified | Modified | Modified | | 3 | FAST Topo | Modified | Modified | Modified | | 4 | FAST Phase | Modified | Modified | Modified | | 5 | IT Hardening | Enabled | Unmodified | Enabled | | 6 | teamplay | Enabled | Unmodified | Enabled | | 7 | syngo RRWP | Enabled | Unmodified | Unmodified | | 8 | iMAR | Enabled | Unmodified | Unmodified | | 9 | DirectDensity™ | Enabled | Enabled | Enabled | | 10 | Respiratory Motion Management | N/A | Modified | Modified | | 11 | FAST 4D | N/A | Modified | Modified | | 12 | Adaptive 4D Spiral (Sliding Gantry<br>Mode) | N/A | N/A | N/A | | 13 | Extended Radiotherapy Functions | Modified | Modified | N/A | | 14 | FAST Integrated Workflow | New | New | N/A | | 15 | FAST ECG Check | Enabled | Unmodified | N/A | {14}------------------------------------------------ Table 3: Overview Software modifications of Single Source CT System Scanner with syngo CT VB10 | # | SOMATOM CT System<br>Scanner with<br>SOMARIS/7 syngo CT<br>VB10<br>property | Subject Devices<br>(Single Source) | SOMATOM<br>Definition Edge | SOMATOM<br>Definition AS/AS+ | SOMATOM<br>Definition AS Open | SOMATOM<br>Confidence | |----|-----------------------------------------------------------------------------|------------------------------------|----------------------------|------------------------------|-------------------------------|-----------------------| | 1 | HD FoV | | Modified | Modified | Modified | Modified | | 2 | kV and Filter Independent<br>CaScore | | Modified | Modified | Modified | Modified | | 3 | FAST Topo | | Modified | Modified | Modified | Modified | | 4 | FAST Phase | | Modified | Modified | Modified | Modified | | 5 | IT Hardening | | Enabled | Enabled | Enabled | Unmodified | | 6 | teamplay | | Enabled | Enabled | Enabled | Unmodified | | 7 | syngo RRWP | | Unmodified | Unmodified | Unmodified | Unmodified | | 8 | iMAR | | Unmodified | Unmodified | Unmodified | Unmodified | | 9 | DirectDensity™ | | Enabled | Enabled | Enabled | Unmodified | | 10 | Respiratory Motion<br>Management | | Modified | Modified | Modified | Modified | | 11 | FAST 4D | | Modified | Modified | Modified | Modified | | 12 | Adaptive 4D Spiral<br>(Sliding Gantry Mode) | | Modified | Modified | Modified | Modified | | 13 | Extended Radiotherapy<br>Functions | | Modified | Modified | Modified | Modified | | 14 | FAST Integrated<br>Workflow | | N/A | N/A | N/A | New | | 15 | FAST ECG Check | | N/A | N/A | N/A | Enabled | A comparison of these modifications with respect to the predicate devices is provided the "Comparison of Technological Characteristics with the Predicate Device" section below. Software version SOMARIS/7 syngo CT VB10 and the corresponding supported hardware will be offered as an optional upgrade for the applicable existing SOMATOM CT Systems. ### V. Indications for Use This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. * *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### VI. Comparison of Technological Characteristics with the Predicate Device The SOMATOM CT Scanner Systems with VB10 Software provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software and hardware components of these scanners have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices. The hardware components of the subject devices have been modified to include features like 3D Camera Interface for topo positioning, tin filter, redesign of Interventional Module (IVM), gantry touch panels (GPA) user interface, modified gantry mechanics, patient tables, and a Stellar Technology detector. Software version SOMARIS/7 syngo CT VB10 supports software features that are designed to support a new Software Platform including all new and modified features. The applicable features are depending on the SOMATOM CT Scanner Systems technological characteristics and are provided as optional features for updating the installed base and are designed features for the subject devices: SOMATOM Force, SOMATOM Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM {15}------------------------------------------------ # SIEMEN Confidence which supporting the technological characteristics as Hardware precondition for its intended software usage. The intended use and fundamental scientific technology for the SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence remains unchanged from the predicate devices. #### At a high level, the subject and predicate devices are based on the following same technological elements: - . Scanner Principle- Whole body X-Ray Computed Tomography Scanner - System Acquisition Continuously rotating tube detector system ● - Iterative Reconstruction Support of various iterative reconstruction methods ● - Workplaces - Support of workplaces that include reconstruction and image evaluation software - Patient table - . Patient table foot switch for movement - . Tin filtration technology - Stellar detector technology ● #### The following technological differences exist between the subject device and predicate devices: - Software version SOMARIS/7 syngo CT VB10 ● - Support of additional cybersecurity features ● - Support of interfaces to access 3D Camera operation for fast patient positioning workflow - DirectDensity™ Reconstruction, which provides CT images with an HU-like scaling that is . nearly proportional to relative electron density - . Extended Radiotherapy Functions to support hardware and software interface options for RT A tabular summary of the unmodified subject and predicate device comparable properties is provided in Table 4below: | Hardware Property | Subject and Predicate Device<br>(Dual Source Systems) | | | Subject and Predicate Device<br>(Single Source Systems) | | | | |---------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------|-----------------------|-------------------------------| | | SOMATOM<br>Force | SOMATOM<br>Flash | SOMATOM<br>Drive | SOMATOM<br>Definition Edge | SOMATOM<br>Definition AS/AS+ | SOMATOM<br>Confidence | SOMATOM<br>Definition AS Open | | Scan mode | single source, dual source, dual energy | | | single source, dual energy | | | | | High voltage<br>generator | 120kW* | 100kW/100kW | | | 100kW | | 80kW* | | Detector | 2 x 57,6 mm | 2 x 38.4 mm | | 38,4mm<br>(128 slice conf.) | 19,2mm<br>(20/40/64<br>slice conf.)<br>38,4mm<br>(128 slice<br>conf.) | 19,2 mm | | | Tube | Vectron | STRATON MX P | STRATON MX Sigma | STRATON MX P | | | | | kV Steps | 70kV,<br>80kV,<br>90kV,<br>100kV,<br>110 kV,<br>120 kV,<br>130 kV,<br>140 kV,<br>150 kV | 70kV,<br>80kV,<br>100kV,<br>120kV,<br>140kV | 70kV,<br>80kV,<br>90kV,<br>100kV,<br>110kV,<br>120kV,<br>130kV,<br>140kV | 70kV,<br>80kV,<br>100kV,<br>120kV,<br>140kV | | | | Table 4: Unmodified hardware properties valid for the subject device and predicate device *(optional 100kW) {16}------------------------------------------------ # SIEMENS The tabular summary of the software and hardware differences between the subject devices with software version SOMARIS/7 syngo CT VB10 and the predicate devices are listed in Table 5 - Table 8 below. Table 5: Device Software Comparison for Subject (Single Source CT System Scanner) and Predicate Devices | | Subject Device<br>(Single Source) | | Predicate Device<br>(Single Source) | | |----------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------| | Software<br>Property | SOMATOM<br>Definition Edge<br>SOMATOM<br>Definition AS/AS+,<br>SOMATOM<br>Definition AS Open,<br>SOMATOM<br>Confidence | SOMATOM Definition<br>Edge<br>SOMATOM<br>Definition AS/AS+, | SOMATOM<br>Definition AS Open | SOMATOM<br>Confidence | | | syngo CT VB10 | (K143400)<br>and<br>(K143401) | (K143409) | (K162302) | | Operating<br>System | Windows based<br>SOMARIS/7 syngo CT<br>VB10 | Windows based<br>SOMARIS/7 syngo CT<br>VA48A | Windows based<br>SOMARIS/7 syngo<br>CT VA48A | Windows based<br>SOMARIS/7 syngo CT<br>VA62A | | | syngo AWP | syngo AWP | syngo AWP | syngo AWP | | | optional second operating<br>console - syngo RRWP** | CTWP | CTWP | RRWP | | | i-control & interventional<br>module (redesign) | i-control &<br>interventional module | i-control &<br>interventional module | i-control &<br>interventional module | | Software | Image Reconstruction | Image Reconstruction | Image Reconstruction | Image Reconstruction | | | IT Hardening | IT features supported<br>that protect against<br>cybersecurity attacks | IT features supported<br>that protect against<br>cybersecurity attacks | IT Hardening | | | teamplay | support of availability of<br>scan protocols form<br>other systems | support of availability of<br>scan protocols form<br>other systems | teamplay | | Iterative | ADMIRE | ADMIRE | ADMIRE | ADMIRE | | Reconstructio | SAFIRE | SAFIRE | SAFIRE | SAFIRE | | n Methods | iMAR | iMAR | iMAR | iMAR | | Sliding<br>Gantry | Sliding Gantry<br>configuration syngo CT<br>VB10 | Sliding Gantry<br>configuration syngo CT<br>VA48A | Sliding Gantry<br>configuration syngo<br>CT VA48A | Sliding Gantry<br>configuration syngo<br>CT VA62A | Table 6: Device Software Comparison for Subject (Dual Source CT System Scanner) and Predicate Devices | | Subject Device<br>(Dual Source) | Predicate Device<br>(Dual Source) | | | |----------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------| | Software<br>Property | SOMATOM<br>Force<br>SOMATOM<br>Drive<br>SOMATOM<br>Definition Flash | SOMATOM<br>Force | SOMATOM<br>Definition Flash | SOMATOM<br>Drive | | | syngo CT VB10 | K133589 | K143416 | K161196 | | Operating<br>System | Windows based<br>SOMARIS/7 syngo CT<br>VB10 | Windows based<br>SOMARIS/7 syngo CT<br>VA50A | Windows based<br>SOMARIS/7 syngo CT<br>VA48A | Windows based<br>SOMARIS/7 syngo CT<br>VA62A | | Software | AWP | syngo AWP | syngo AWP | AWP | | | optional second<br>operating console (syngo<br>RRWP) | N/A | CTWP | optional second<br>operating console<br>(syngo RRWP) | | | optional i-control IVM<br>module (HW- redesign) | optional i-control IVM<br>module | optional i-control IVM<br>module | optional i-control IVM<br>module | | | Image Reconstruction | Image Reconstruction | Image Reconstruction | Image Reconstruction | | | IT Hardening | IT features supported<br>that protect against<br>cybersecurity attacks | IT features supported<br>that protect against<br>cybersecurity attacks | IT Hardening | | | teamplay | support of availability of<br>scan protocols form<br>other systems | support of availability of<br>scan protocols form<br>other systems | teamplay | | Iterative<br>Reconstruction<br>Methods | ADMIRE<br>SAFIRE<br>iMAR | ADMIRE<br>SAFIRE | ADMIRE<br>SAFIRE<br>iMAR | ADMIRE<br>SAFIRE<br>iMAR | {17}------------------------------------------------ | | | Subject Devices<br>(Single Source CT Scanner) | | Predicate Devices<br>(Single Source CT Scanner) | | |--------------------------------------|--------------------------|----------------------------------------------------------------|------------------------------------------|-------------------------------------------------|------------------------------------------------------------------------------------| | Hardware<br>Property | | SOMATOM<br>Definition Edge,<br>(syngo CT VB10) | SOMATOM<br>Confidence<br>(syngo CT VB10) | SOMATOM<br>Confidence<br>(K162302) | SOMATOM<br>Definition AS/AS+,<br>SOMATOM<br>Definition AS Open,<br>(syngo CT VB10) | | Selective<br>Photon Shield | Tin Filter<br>Technology | N/A | N/A | N/A | N/A | | workflow for<br>topogram<br>scanning | conventional<br>workflow | auto positioning<br>for topo scan<br>supported by 3D<br>Camera | conventional<br>workflow | conventional<br>workflow | conventional<br>workflow | | Touch<br>Display | N/A | on both sides of<br>the gantry | N/A | N/A | on both sides of<br>the gantry | Table 7: Device Hardware Comparison for Subject (Single Source CT System Scanner) and Predicate Devices Table 8: Device Hardware Comparison for Subject (Dual Source CT System Scanner) and Predicate Devices | | Subject Device<br>(Dual Source CT Scanner) | | Predicate Devices<br>(Dual Source CT Scanner) | | | |--------------------------------------|-------------------------------------------------------------|------------------------------------------------|-----------------------------------------------|----------------------------------------|-----------------------------| | Hardware<br>Property | SOMATOM Force:<br>SOMATOM Drive<br>(syngo CT VB10) | SOMATOM<br>Definition Flash<br>(syngo CT VB10) | SOMATOM<br>Force<br>K133589 | SOMATOM<br>Definition Flash<br>K143416 | SOMATOM<br>Drive<br>K161196 | | Selective Photon<br>Shield | Tin Filter<br>Technology | Tin Filter<br>Technology | Tin Filter<br>Technology | N/A | Tin Filter<br>Technology | | workflow for<br>topogram<br>scanning | auto positioning for<br>topo scan supported<br>by 3D Camera | conventional<br>workflow | conventional<br>workflow | conventional<br>workflow | conventional<br>workflow | | Touch Display | both sides of the<br>gantry | N/A | N/A | N/A | both sides of the<br>gantry | Any differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject devices, the SOMATOM CT Scanner Systems, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices. ## VII. Performance Data #### Non Clinical Testing Non-clinical test (integration and functional) including phantom tests were conducted for the SOMATOM CT Scanner Systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: ISO 14791, NEMA XR-29, IEC 61223-2-6, IEC 61223-3-5, IEC 62304, NEMA XR-25, and DICOM 3.1-3.20. Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: IEC 60601-1, 60601-2-44, and 60601-1-2. Completed Form FDA 3654 are provided within this submission. #### 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. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing {18}------------------------------------------------ supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence. Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission in Appendix E. #### Summarv The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence. #### General Safety and Effectiveness Concerns The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related Risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the Risk Management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards. #### VIII. Conclusions The predicate devices were cleared based on the results of non-clinical testing including verification and validation, phantom tests, and supportive literature. The subject device is also tested using the same methods as used for the predicate devices. The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject device SOMATOM CT Scanner Systems should perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM CT Scanner Systems perform comparably to the predicate devices currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the SOMATOM CT Scanner Systems testing supports a finding of substantial equivalence.
Innolitics
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