syngo.CT Extended Functionality

{0}------------------------------------------------ July 13, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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. % Monsuru Bello Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932 ## Re: K221727 Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 13, 2022 Received: June 14, 2022 ## Dear Monsuru Bello: 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 mediation-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, Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team OHT 8B: Division of Radiological Imaging Devices and Electronic Products Office of Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K221727 Device Name syngo.CT Extended Functionality ## Indications for Use (Describe) syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo. CT Extended Functionality software package and the interconnected CT Scanner system. Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis. | Type of Use (Select <i>one</i> or <i>both</i> , 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary K221727 #### Identification of the Submitter l. Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869 ## Manufacturing Site Siemens Healthcare GmbH Siemensstr 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335 ## Submitter Contact Person: Submitter Contact Person: Monsuru K Bello Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (202) 856-6099 Email: Monsuru.bello@siemens-healthineers.com ## Alternate Contact: Alaine Medio Regulatory Affairs Manager Siemens Medical Solutions, Inc. USA (MI) 810 Innovation Drive Knoxville, TN 37932 Phone: +1 (865) 206-0337 Email: alaine.medio@siemens-healthineers.com #### II. Device Name and Classification | Product Name: | syngo.CT Extended Functionality | |-----------------------|----------------------------------| | Propriety Trade Name: | syngo.CT Extended Functionality | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | {4}------------------------------------------------ Image /page/4/Picture/1 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 words is a graphic of orange dots in a pattern. #### Predicate Devices III. ## Predicate Device | Trade Name: | syngo.CT Extended Functionality | |-----------------------|----------------------------------| | 510(k) Number: | K214019 | | Clearance Date: | 01/20/2022 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | #### Device Description IV. syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions. Advanced visualizations and measurements are listed as follows. The subject device in the current software version SOMARIS/8 VB70 has been extended/modified as follows: - Support of the extension "Average" - Modifications to the extension "Vessel" - Modifications to the extension "Interactive Spectral Imaging" - Modifications to the extension "Oncology" - "Trauma" Extension – No changes - "Osteo" Extension - No changes - "Neuro DSA" Extension – No changes - "ROI HU Threshold" Extension – No changes - . "Dual Energy" Extension – No changes - "Endoscopic Viewing" Extension - No changes - . "Pulmonary Density" Extension – No changes - . "General" (Extension Independent Features) – No changes #### Indications for Use V. syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system. Resulting images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. ### Comparison of Technological Characteristics with the Predicate Device VI. The differences and similarities between the above referenced predicate device are listed at a highlevel in the following table: | Feature | Subject Device | Predicate Device | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | syngo.CT Extended Functionality<br>(SOMARIS/8 VB70) | syngo.CT Extended Functionality<br>(SOMARIS/8 VB60) | | 1. Average | The extension offers the possibility to<br>average on a pixel-by-pixel basis of two<br>different DICOM images. The "Average"<br>functionality can be used on individual<br>frames of the same series, or for frames<br>belonging to different series. The tool<br>saves a DICOM image as result series. This<br>extension does not introduce any new<br>clinical algorithms or features. | N/A | | 2. Vessel Extension | The user can perform a vascular<br>evaluation supporting the following main<br>functionalities:<br>• Measuring vessels<br>• Creating DICOM snapshots or result<br>series for documenting findings<br>• Working on images that are acquired<br>with CT or MR scanner systems<br>constituting one or more volumes of<br>vascular structures<br>Modification:<br>Improved quality of the bone removal<br>algorithm for the head & neck region.<br>Segmentation of the bones use a deep<br>learning algorithm instead of a<br>traditional image processing. | The user can perform a vascular<br>evaluation supporting the following main<br>functionalities:<br>• Measuring vessels<br>• Creating DICOM snapshots or result<br>series for documenting findings<br>• Working on images that are acquired<br>with CT or MR scanner systems<br>constituting one or more volumes of<br>vascular structures | | 3. Interactive Spectral<br>Imaging | Display different representations of Dual<br>Energy data.<br>Modifications:<br>Support of circular and elliptic ROIs. In<br>VB70 version the measurement tool<br>supports all others ROIs (ROI Circle (incl.<br>elliptic) / ROI Freehand / ROI Auto<br>Contour / ROI Polygonal). | Display different representations of Dual<br>Energy data. | | 4. Oncology | The oncology extension offers tools for<br>localization and evaluation of nodules.<br>Modifications:<br>With SOMARIS/8 VB70, the spectral<br>information displayed for circular ROIs<br>was extended to arbitrarily shaped ROIs. | The oncology extension offers tools for<br>localization and evaluation of nodules. | The remaining functions in syngo.CT Extended Functionality remain unchanged compared to the predicate version. - Trauma- displays of sorted large number of reconstruction series into body region specific layouts. - Osteo Extension - Evaluation of Bone Mineral Density (BMD) values (mg CA-HA/ml). - Neuro DSA Extension - Selective bone removal from a CT angiography dataset {6}------------------------------------------------ # Healthinee - ROI HU Threshold Extension Evaluation of HU Value distributions - Dual Energy Extension – Simultaneous evaluation for low and high kV dual energy images - Endoscopic Viewing Extension – Interactive fly through tubular structures that are filled by either low-intensity or high-intensity material - . Pulmonary Density – Segmentation of opacity regions inside the lung using an Al algorithm. The core modification of the subject device as compared to its predicate device (syngo.CT Extended Functionality (SOMARIS/8 VB60)) are the modifications shown in the table above. ### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. ## Non-Clinical Testing This submission contains performance tests (Non-clinical test reports) to demonstrate continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted for syngo.CT Extended Functionality during product development. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. ## Risk Analysis The risk analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Siemens hereby certifies that syngo.CT Extended Functionality will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce: | Recognition<br>Number | Product<br>Area | Title of Standard | Date of<br>Recognition | Standards<br>Development<br>Organization | |-----------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------| | 12-300 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set; PS 3.1 - 3.20 | 06/27/2016 | NEMA | | 13-79 | Software | Medical Device Software –Software Life Cycle<br>Processes; 62304:2006 (1st Edition)/A1:2016 | 01/14/2019 | AAMI, ANSI, IEC | | 5-125 | Software/<br>Informatics | Medical devices – Application of risk<br>management to medical devices; 14971 Third<br>Edition 2019-12 | 12/23/2019 | ISO | | 5-129 | General I<br>(QS/RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>IEC 62366-1:2016 | 07/06/2020 | ANSI, AAMI, IEC | | 5-117 | General I<br>(QS/RM) | Medical devices - Symbols to be used with<br>medical device labels, labelling, and<br>information to be supplied - Part 1: General<br>requirements 15223-1:2016 | 8/21/2017 | ISO | {7}------------------------------------------------ Image /page/7/Picture/2 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. ## VIII. Conclusion syngo.CT Extended Functionality has the same intended use and same indications for use as the predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate device. For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Extended Functionality to be as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices.