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

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc % Ms. Maria Ebio Sr. Director, Regulatory Affairs 40 Liberty Blvd. MALVERN PA 19355 June 27, 2019. # Re: K190578 Trade/Device Name: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition 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: May 15, 2019 Received: May 16, 2019 Dear Ms. Ebio: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known) K190578 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) | |-------------------------------------------------| |-------------------------------------------------| X 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 {3}------------------------------------------------ 510(k) Number (if known) K190578 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 {4}------------------------------------------------ 510(k) Number (if known) K190578 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*)|X 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 {5}------------------------------------------------ 510(k) Number (if known) K190578 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 {6}------------------------------------------------ 510(k) Number (if known) K190578 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) | | |-------------------------------------------------|--| | | | X 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) K190578 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) | |-------------------------------------------------| |-------------------------------------------------| X 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 {8}------------------------------------------------ 510(k) Number (if known) K190578 Device Name SOMATOM Edge Plus 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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 {9}------------------------------------------------ 510(k) Number (if known) K190578 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| |X 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 {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. #### 510(K) SUMMARY K190578 FOR ## SOMATOM CT SCANNER SYSTEMS-SOFTWARE VERSION SOMARIS/7 syngo CT VB20 Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: February 28, 2019 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: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: SOMATOM Force SOMATOM Force Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots. Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: Product Name: Trade Name: Classification Name: Classification Panel: Regulation Number: Device Class: Product Code: #### SOMATOM Definition Flash SOMATOM Definition Flash Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Drive SOMATOM Drive Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Definition Edge SOMATOM Definition Edge Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Definition AS/AS+ SOMATOM Definition AS/AS+ Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Definition AS Open SOMATOM Definition AS Open Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Confidence SOMATOM Confidence Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK SOMATOM Edge Plus SOMATOM Edge Plus Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II JAK {12}------------------------------------------------ # III. Predicate Device ## Primary Predicate Device: | Trade Name: | SOMATOM CT Scanner Systems | |-----------------------|---------------------------------------------------------------------------------| | 510(k) Number: | K173630 | | Clearance Date: | March 30, 2018 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | All predicate device recalls have been considered in the subject device design. | #### Predicate Device: | Trade Name: | SOMATOM Edge Plus | |-----------------------|------------------------------------------------| | 510(k) Number: | K173607 | | Clearance Date: | March 21, 2018 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | There are currently no recalls for this device | # IV. Device Description Siemens intends to market a new software version, SOMARIS/7 syngo CT VB20 for the following SOMATOM Computed Tomography (CT) Scanner Systems: ## Dual Source CT Systems: - SOMATOM Force - SOMATOM Drive - . SOMATOM Definition Flash ## Single Source CT Systems: - SOMATOM Definition AS/AS+ ● - SOMATOM Definition AS Open ● - SOMATOM Definition Edge - SOMATOM Confidence ● - . SOMATOM Edge Plus The subject device SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB20 are Computed Tomography X-ray Systems which feature one (single source) or two (dual source) continuously rotating tubedetector system and function according to the fan beam principle. The SOMATOM CT Scanner Systems with Software SOMARIS/7 syngo CT VB20 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 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 VB20, is a commandbased 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 VB20 will support the following modifications in comparison with the predicate devices: ## 1) New/Modified Hardware - Table 1: Overview of Hardware modifications supported by software SOMARIS/7 syngo CT ● VB20 {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. #### 2) Software version SOMARIS/7 syngo CT VB20 - Table 2: Overview Software modifications of Single Source CT System Scanner with syngo CT ● VB20 - . Table 3: Overview Software modifications of Dual Source CT System Scanner with syngo CT VB20 #### 3) Update 510(k) Information - Provided as Appendix H . | Table 1: Hardware Modifications Supported by software SOMARIS/7 syngo VB20 | | | | | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------| | # | SOMATOM CT System<br>Scanner with<br>SOMARIS/7 syngo CT<br>VB20<br>hardware properties | Subject Devices<br>(Single Source Systems) | Subject Devices<br>(Dual Source Systems) | | | | | SOMATOM Definition AS/AS+; SOMATOM Definition AS Open; | SOMATOM Definition Edge SOMATOM Confidence SOMATOM Edge Plus | SOMATOM Force SOMATOM Definition Flash SOMATOM Drive | | 1 | Stellar Detector (HW) | Unmodified | Unmodified | Modified | # Table 1: Hardware Modifications Supported by software SQMARIS/7 syngo VB20 | | Table 2: Overview Software Modifications of Single Source CT System Scanner with syngo CT VB20 | | | | | |----|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------|----------------------------------------------|--| | | | | | | | | | | | Single Source Subject Devices | | | | # | SOMATOM CT System Scanner<br>with<br>SOMARIS/7 syngo CT VB20<br>property | • SOMATOM<br>Definition<br>AS/AS+;<br>• SOMATOM<br>Definition AS<br>Open | SOMATOM<br>Definition Edge | • SOMATOM Confidence;<br>• SOMATOM Edge Plus | | | 1 | Enhanced FAST DE Results | Modified | Modified | Modified | | | 2 | Precision Matrix | N/A | N/A | N/A | | | 3 | DirectBreathhold™ | New | New | New | | | 4 | IT Hardening | Modified | Modified | Modified | | | 5 | HD FoV (modification 4.0) | Modified | Modified | Modified | | | 6 | Extended i-Control Function | Enabled | Enabled | Enabled | | | 7 | Respiratory Scan Post-processing | Modified | Modified | Modified | | | 8 | Data Role Settings | Enabled | Enabled | Enabled | | | 9 | Stellar Detector (Firmware) | N/A | Modified | Modified | | | 10 | DirectDensity™<br>(showing relative<br>mass density) | Modified | Modified | Modified | | | 11 | FAST 3D Camera | N/A | N/A | Modified | | | 12 | Support of Additional Dual Spiral<br>Dual Energy Protocols | New | New | New | | | 13 | Modified User Interface Display | Modified | Modified | Modified | | | | | | | | Table 3: Overview Software modifications of Dual Source CT System Scanner with syngo CT VB20 | | |--|--|--|--|--|----------------------------------------------------------------------------------------------|--| |--|--|--|--|--|----------------------------------------------------------------------------------------------|--| | # | SOMATOM CT System Scanner<br>with | Subject Devices<br>(Dual Source) | | | |----|------------------------------------------------------------|----------------------------------|---------------|-----------------------------| | | SOMARIS/7 syngo CT VB20<br>property | SOMATOM Force | SOMATOM Drive | SOMATOM Definition<br>Flash | | 1 | Enhanced FAST DE Results | Modified | Modified | Modified | | 2 | Precision Matrix | Modified | N/A | N/A | | 3 | DirectBreathhold™ | N/A | New | New | | 4 | IT Hardening | Modified | Modified | Modified | | 5 | HD FoV (modification 4.0) | Unmodified | Modified | Modified | | 6 | Extended i-Control Function | Enabled | Enabled | Enabled | | 7 | Respiratory Scan Post-processing | N/A | Modified | Modified | | 8 | Data Role Settings | Enabled | Enabled | Enabled | | 9 | Stellar Detector (Firmware) | N/A | Modified | N/A | | 10 | DirectDensity™ (showing relative<br>mass density) | Modified | Modified | Modified | | 11 | FAST 3D Camera | Modified | Modified | N/A | | 12 | Support of Additional Dual Spiral<br>Dual Energy Protocols | N/A | N/A | N/A | | 13 | Modified User Interface Display | Modified | Modified | Modified | {14}------------------------------------------------ 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 VB20 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 VB20 Software provide the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features 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 support a modified Stellar Technology detector. Software version SOMARIS/7 syngo CT VB20 supports software features that are designed as Software Platform update 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 Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence, SOMATOM Edge Plus 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 Edge, SOMATOM Definition AS/AS+, SOMATOM AS Open, SOMATOM Confidence, SOMATOM Edge Plus 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 VB20 ● - . Support of additional cybersecurity features - . Precision Matrix function - Respiratory Scan - Functions - . i-Control Functions - DirectDensity™ (showing relative mass density) . {15}------------------------------------------------ A tabular summary of the unmodified subject and predicate device comparable hardware properties is provided in Table 4 and Table 5 below: Table 4: Unmodified hardware properties valid for the subject device and predicate device | | Subject and Predicate Device<br>(Single Source Systems) | | | | | |-------------------------------------|---------------------------------------------------------|-------------------------------|-----------------------------------------------------------------|-----------------------|----------------------------------| | Hardware Property | SOMATOM<br>Edge Plus | SOMATOM<br>Definition<br>Edge | SOMATOM<br>Definition AS/AS+ | SOMATOM<br>Confidence | SOMATOM<br>Definition AS<br>Open | | Scan mode | single source, dual energy | | | | | | High voltage generator | 100kW | | | | 80kW | | Detector | 38.4mm (128 slice conf.) | | 19.2mm (20/40/64<br>slice conf.)<br>38.4mm (128 slice<br>conf.) | | 19.2mm | | Detector<br>Performance Technologie | Stellar | | | | | | Tube | STRATON<br>MX Sigma | STRATON MX P | | | | | kV Steps | | 70kV,80kV,100kV, 120kV, 140kV | | | | | | Subject and Predicate Device<br>(Dual Source Systems) | | | |-------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|--------------------------------------------------------------------------| | Hardware Property | SOMATOM<br>Force | SOMATOM Definition<br>Flash | SOMATOM<br>Drive | | Scan mode | single source, dual source, dual energy | | | | High voltage generator | 120kW/120kW | 100kW/100kW | 100kW/100kW | | Detector | 2 x 57.6mm | 2 x 38.4mm | 2 x 38.4mm | | Detector<br>Performance Technologie | Stellar | | | | Tube | Vectron | STRATON MX P | STRATON MX Sigma | | kV Steps | 70kV,<br>80kV,<br>90kV, 100kV,<br>110 kV,<br>120 kV,<br>130 kV,<br>140 kV,<br>150 kV | 70kV,<br>80kV, 100kV,<br>120kV,<br>140kV | 70kV,<br>80kV,<br>90kV,<br>100kV,<br>110kV,<br>120kV,<br>130kV,<br>140kV | The tabular summary of the software and hardware differences between the subject devices with software version SOMARIS/7 syngo CT VB20 and the predicate devices are listed in Table 6 - Table 7 below (in gray shaded sections). Table 6: Device Hardware Comparison for Subject (Single Source CT System Scanner) and Predicate Devices | # | hardware properties | Subject Devices<br>(syngo CT VB20) | Predicate Device<br>(K173630 / K173607) | |----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | 1 | Stellar Detector<br>(HW) | Dual Source:<br>• SOMATOM Force,<br>• SOMATOM Definition Flash | • Siemens SOMATOM CT<br>Scanner System | | | | Single Source<br>• SOMATOM Definition<br>AS/AS+<br>• SOMATOM Definition AS<br>Open | • SOMATOM Edge Plus | | | | Dual Source:<br>• SOMATOM Drive | | | | | Single Source:<br>• SOMATOM Definition Edge,<br>• SOMATOM Confidence<br>• SOMATOM Edge Plus | | | | | Stellar Detector based on<br>Sillian classic technologie<br>supported | Stellar Detector based on<br>Sillian M technologie<br>supported | | | Subject Device | Predicate Device | | | Properties software | Dual Source:<br>• SOMATOM Force,<br>• SOMATOM Drive,<br>• SOMATOM Definition Flash<br>Single Source:<br>• SOMATOM Definition Edge,<br>• SOMATOM Definition AS/AS+<br>• SOMATOM Definition AS Open,<br>• SOMATOM Confidence<br>• SOMATOM Edge Plus<br>(syngo CT VB20) | • Siemens SOMATOM CT Scanner System (K173630)<br>• SOMATOM Edge Plus (K173607)<br>(K173630 / K173607) | | | | Windows based | Windows based | | | Operating System | SOMARIS/7 syngo CT VB20 | SOMARIS/7 syngo CT VB10A | | | Acquisition<br>Workplace | syngo Acquisition Workplace (AWP)<br>optional 2nd console syngo RRWP<br>syngo Viewing, syngo Filming and syngo<br>Archiving & Networking<br>Image Reconstruction | syngo Acquisition Workplace (AWP)<br>optional 2nd console syngo RRWP<br>syngo Viewing, syngo Filming and syngo Archiving<br>& Networking<br>Image Reconstruction | | | Stellar Detector | Stellar detector firmware supported for<br>subject device stellar detector re-design<br>(no redesign for SOMATOM Force,<br>Definition Flash and Definition AS<br>Systems) | Stellar detector firmware supported for predicate<br>device stellar detector design | | | Teamplay | Support teamplay Protocols | Support teamplay Protocols | | | Protocols<br>(Single Source CT<br>Scanner Systems) | Support of :<br>• Dual Spiral Dual Energy Protocols<br>• Protocols for Radiation Therapy Planning<br>• Dual Spiral Dual Energy Protocols<br>for radiation therapy planning<br>• Protocols that allow triggering of<br>breath hold scanning from external<br>device. | Support of :<br>• Dual Spiral Dual Energy Protocols<br>• Protocols for Radiation Therapy Planning | | | Protocols<br>(Dual Source CT<br>Scanner Systems) | Support of :<br>• Protocols for Radiation Therapy Planning<br>• Protocols that allow triggering of<br>breath hold scanning from external<br>device. | Support of :<br>• Protocols for Radiation Therapy Planning | | | Cybersecurity | IT Hardening (improved) | IT Hardening | | | HD FoV | HD FoV (modification 4.0) | HD FoV 3.0 | | | Option for Patient<br>Instructions. | Support Automatic Patient Instruction<br>(API) Interface. | Support Automatic Patient Instruction (API)<br>Interface. | | | FAST CARE | FAST, CARE Features supported | FAST, CARE Features supported | | | FAST DE Results | FAST DE Results with enhanced dialog<br>box for individual image post-processing<br>parameter settings and labeling | FAST DE Results | | | FAST Integrated<br>Workflow* | FAST Integrated Workflow steps<br>supported:<br>• FAST Isocentering<br>• FAST Range<br>• FAST Direction<br>*(full workflow only in combination with<br>FAST 3D Camera) | FAST Integrated Workflow steps supported:<br>• FAST Isocentering<br>• FAST Range<br>• FAST Direction<br>*(full workflow only in combination with FAST 3D<br>Camera) | | | FAST 3D Camera | FAST 3D Camera supported which<br>provides more accurate proposals for | FAST 3D Camera supported which provides<br>proposals for patient positioning and patient outline. | | | | Subject Device | Predicate Device | | | | Dual Source:<br>• SOMATOM Force,<br>• SOMATOM Drive,<br>• SOMATOM Definition Flash | • Siemens SOMATOM CT Scanner System<br>(K173630)<br>• SOMATOM Edge Plus (K173607) | | | Properties software | Single Source:<br>• SOMATOM Definition Edge,<br>• SOMATOM Definition AS/AS+<br>• SOMATOM Definition AS Open,<br>• SOMATOM Confidence<br>• SOMATOM Edge Plus | | | | | (syngo CT VB20) | (K173630 / K173607) | | | | patient positioning and patient outline. | | | | | DirectDensityTM | DirectDensityTM | | | DirectDensityTM | (including electron density and mass<br>density) | (including electron density) | | | Respiratory Scan<br>Post-Processing | Respiratory Scan Post-Processing<br>Including automated transfer of t-MaxIP<br>& t-MinIP series to DICOM node. | Respiratory Scan Post-Processing<br>Manual function for transferring t-MaxIP & t-MinIP<br>series to DICOM node. | | | | Precision Matrix resolution<br>support image matrix sizes of 768x768<br>pixels and 1024x1024 pixel (auto mode<br>supported) | Matrix resolution 512x512<br>(auto mode not supported) | | | Precision Matrix<br>(SOMATOM Force<br>only) | | | | | | DirectBreathholdTM (automated trigger<br>supported)<br>(not for SOMATOM Force) | Respiratory Motion Management support breath<br>hold triggered spiral scans with manual breath hold<br>triggered examinations. | | | breath-hold technique | | | | | Extended i-Control<br>Function | i-Control Function<br>(IVM support all key function's) | i-Control Function of 1st<br>(limited IVM key functions set) | | | Software | Support Auto Tasking card UI - with<br>interactive settings of syngo.via Data Role | Support Auto Tasking card UI - showing selected<br>syngo.via Data Role | | | | • Software Update: Smart Remote<br>Service (SRS) or Anytime Software<br>energy saving techniques in UI<br>supported<br>• improved user doc | • Software Update: Smart Remote Service (SRS)<br>• limited energy saving techniques | | | User Interface | | | | | Iterative<br>Reconstruction<br>Methods | • ADMIRE<br>• SAFIRE<br>• iMAR | • ADMIRE<br>• SAFIRE<br>• iMAR | | {16}------------------------------------------------ Table 7: Software Comparison for Subject Devices (Single Source CT Scanner System) and Predicate Devices {17}------------------------------------------------ Image /page/17/Picture/0 description: The image contains the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. 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. Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the SOMATOM CT Scanner Systems in accordance with the following standards: 60601-2-44, and 60601-1-2. A list of recognized and general consensus standards considered for the subject devices is provided as Table 9 below. {18}------------------------------------------------ # Healt | Table 8: Recognized Consensus Standards | | | | | |-----------------------------------------|-----------------------|----------------------------------------|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of<br>Recognition | Recognition<br>Number | Standard<br>Developing<br>Organization | Standard<br>Designation<br>Number and Date | Title of Standard | | 06/27/2016 | 12-300 | NEMA | PS 3.1 - 3.20 (2016) | Digital Imaging And Communications In<br>Medicine (DICOM) Set | | 03/14/2011 | 12-225 | NEMA | XR-25 | Computed Tomography Dose Check | | 01/27/2015 | 12-287 | NEMA | XR-28 2013 | Supplemental Requirements For User Information<br>And System Function Related To Dose In CT | | 6/27/2016 | 5-40 | ANSI AAMI ISO | 14971:2007/(R)2010<br>(Corrected 4 October<br>2007) | Medical Devices - Applications Of Risk<br>Management To Medical Devices | | | | ISO | 14971 Second Edition<br>2007-03-01 | Medical Devices - Applications Of Risk<br>Management To Medical Devices | | 01/14/2019 | 13-79 | IEC | 62304 Edition 1.1<br>2015-06<br>CONSOLIDATED<br>VERSION | Medical Device Software - Software Life Cycle<br>Processes | | 07/09/2014 | 19-4 | ANSI AAMI | ES60601-<br>1:2005/(R)2012 And<br>A1:2012, | C1:2009/(R)2012 And A2:2010/(R)2012<br>(Consolidated Text) Medical Electrical Equipment<br>- Part 1: General Requirements For Basic Safety<br>And Essential Performance (IEC 60601-1:2005,<br>MOD) | | 09/17/2018 | 19-8 | ANSI AAMI IEC | 60601-1-2:2014 | Medical Electrical Equipment -- Part 1-2: General<br>Requirements For Basic Safety And Essential<br>Performance -- Collateral Standard:<br>Electromagnetic Disturbances -- Requirements<br>And Tests*<br>*Existing SOMATOM Definition Flash systems<br>conform to ANSI AAMI IEC 60601-1-2:2007.<br>SOMATOM Definition Flash is no longer being<br>manufactured or being delivered ex-factory.<br>Software version SOMARIS/7 syngo CT VB20<br>supports updates of legacy SOMATOM Definition<br>Flash scanner systems. | | 7212/23/2016 | 5-114 | ANSI AAMI IEC | 62366-1:2015 | Medical Devices - Part 1: Application Of<br>Usability Engineering To Medical Devices | | 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.0<br>2007-03 | Safety Of Laser Products - Part 1: Equipment<br>Classification, And Requirements [Including:<br>Technical Corrigendum 1 (2008), Interpretation<br>Sheet 1 (2007), Interpretation Sheet 2 (2007)] | | 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition<br>3.2: 2016 | Medical Electrical Equipment - Part 2-44:<br>Particular Requirements For The Basic Safety<br>And Essential Performance Of X-Ray Equipment<br>For Computed Tomography | | 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition 2.1<br>2013-04 | Medical Electrical Equipment - Part 1-3: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Standard: Radiation<br>Protection In Diagnostic X-Ray Equipment | | 06/27/2016 | 5-89 | IEC | 60601-1-6 Edition 3.1<br>2013-10 | Medical Electrical Equipment - Part 1-6: General<br>Requirements For Basic Safety And Essential<br>Performance - Collateral Stan…