syngo.CT Extended Functionality

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September 20, 2019 Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932 Re: K192402 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: August 29, 2019 Received: September 3, 2019 Dear Alaine Medio: 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. 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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, 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K192402 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. Result 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 one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|--| | <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | | | <div> <span style="font-size: 10pt;">☐ 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 "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 FOR SYNGO.CT EXTENDED FUNCTIONALITY Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: September 18, 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 Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335 ### Contact Person Alaine Medio Regulatory Affairs Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865)206-0337 Fax: (865) 218-3019 Email: alaine-medio(@siemens-healthineers.com #### Alternate Contact : Tabitha Estes ### II. Device Name and Classification | Product 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}------------------------------------------------ # III. Predicate Device #### Primary Predicate Device: | Trade Name: | syngo.CT Clinical Extensions | |-----------------------|------------------------------------------------| | 510(k) Number: | K173625 | | Clearance Date: | 03/08/2018 | | Classification Name: | System, X-Ray, Tomography, Computed | | Classification Panel: | Radiology | | CFR Section: | 21 CFR § 892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | There are currently no recalls for this device | #### Secondary Predicate Device: | Trade Name: | syngo.CT Dual Energy | |-----------------------|------------------------------------------------| | 510(k) Number: | K150757 | | Clearance Date: | 08/11/2015 | | Classification Name: | System, Image Processing, Radiological | | Classification Panel: | Radiology | | CFR Section: | 21 CFR § 892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | There are currently no recalls for this device | # IV. Device Description 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. In addition, the table below shows which extensions has been changed in the current software version SOMARIS/8 VB40. | No | Extension | No | Extension | |----|--------------------------------------|----|-------------------------------| | 1 | Interactive Spectral Imaging (new) | 5 | Neuro DSA (unmodified) | | 2 | Vascular/Vessel Extension (modified) | 6 | ROI HU Threshold (unmodified) | | 3 | Oncology Extension (modified) | 7 | Dual Energy (unmodified) | | 4 | Osteo (unmodified) | 8 | Endoscopic View (unmodified) | syngo.CT Extended Functionality is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Clinical Extensions (K173625) and includes the following modifications in comparison to the primary predicate device: - Support of Interactive Spectral Imaging a. - Vascular Extension modification: b. - i. 2D Filter Type Support - ii. Multiphase Support in Vessel Layout - Oncology Extension modification: C. - i. Support of MR Data - General: Multiphase support for merged 4D series d. {5}------------------------------------------------ # V. Indications for Use 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. Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis. # VI. Comparison of Technological Characteristics with the Predicate Device The indications for use for the syngo.CT Extended Functionality are identical to the predications for Use (see Table 2). The only difference is the renaming of the feature from syngo.CT Clinical Extensions to syngo.CT Extended Functionality. The intended use of this product is identical to the predicates. | Subject Device | Predicate Device (K173625) | Comparison Result | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | syngo.CT Extended Functionality | syngo.CT Clinical Extensions | Identical with the exception<br>of the name of the product. | | syngo.CT Extended Functionality is<br>intended to provide advanced visualization<br>tools to prepare and process medical<br>images for diagnostic purpose. The<br>software package is designed to support<br>technicians and physicians in qualitative<br>and quantitative measurements and in the<br>analysis of clinical data that was acquired<br>and reconstructed by Computed<br>Tomography (CT) scanners, and possibly<br>other medical imaging modalities (e.g. MR<br>scanners).<br>An interface shall enable the connection<br>between the syngo.CT Extended<br>Functionality software package and the<br>interconnected CT Scanner system.<br>Result images created with the syngo.CT<br>Extended Functionality software package<br>can be used to assist trained technicians or<br>physicians in diagnosis. | syngo.CT Clinical Extensions is intended<br>to provide advanced visualization tools to<br>prepare and process medical images for<br>diagnostic purpose. The software package<br>is designed to support technicians and<br>physicians in qualitative and quantitative<br>measurements and in the analysis of<br>clinical data that was acquired and<br>reconstructed by Computed Tomography<br>(CT) scanners, and possibly other medical<br>imaging modalities (e.g. MR scanners).<br>An interface shall enable the connection<br>between the syngo.CT Clinical<br>Extensions software package and the<br>interconnected CT Scanner system.<br>Result images created with the syngo.CT.<br>Clinical Extensions software package can<br>be used to assist trained technicians or<br>physicians in diagnosis. | | Table 2: Indications for Use / Intended Use Comparison As with the primary predicate device, the subject device is a bundle software package consisting of previously cleared software applications (unmodified and modified) that provide advanced visualization and measurement tools. Software version SOMARIS/8 VB40 supports additional post-processing application features for MR datasets, dual energy images, and endoscopic visualization tools. At a high-level, the subject and predicate devices are based on the following same or similar technological characteristics as listed in Table 3 below: {6}------------------------------------------------ | | | Table 3: Technological Characteristic Comparison | | |--|--|---------------------------------------------------|--| |--|--|---------------------------------------------------|--| | Feature | Subject Device | Predicate Device<br>and Supported Functionality | Comparison Result | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | | yngo.CT Extended Functionality | | | | Software<br>Version | SOMARIS/8 VB40 | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br>SOMARIS/8 VB30 | Modified to<br>support additional<br>functionality | | | 1. Interactive Spectral Imaging | | | | Interactive<br>Spectral<br>Imaging | The Interactive Spectral Imaging<br>functionality allows the user to display<br>different representations of Dual<br>Energy data with an interactive image<br>text. | Secondary Predicate Device<br>K150757, clearance date 08/11/2015<br><br>The user can change the visualization<br>of Dual Energy data generated from<br>Low and High data to different Dual<br>Energy types. | This feature is<br>new in the subject<br>device, but the<br>fundamental<br>technology has<br>been cleared with<br>the secondary<br>predicate device. | | | 2. Vascular/Vessel Extension | | | | Vascular/<br>Vessel<br>Extension | The Vascular Tool provides tools and<br>layouts for vascular assessment.<br>Additionally, the subject device<br>Vascular Tool provides a 2D Filter<br>Type Support and Multiphase Support<br>in Vessel Layout. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>The Vascular Tool provides tools and<br>layouts for vascular assessment and<br>CT data. | This modification<br>is a usability<br>improvement. | | | 3. Oncology Extension | | | | Oncology<br>Extension | The oncology Tool offers tools for<br>localization and evaluation of nodules.<br>Additionally, the subject device now<br>provides MR Support for Diameter<br>WHO. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>The oncology extension offers tools<br>for localization and evaluation of<br>nodules. | Modified to<br>support MR data<br>for Diameter<br>WHO. | | | 4. Osteo Extension | | | | Osteo<br>Extension | The Osteo extension is used for the<br>evaluation of Bone Mineral Density<br>(BMD) values (mg CA-HA/ml) of the<br>lumbar spine based on Osteo CT scans. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>The Osteo extension is used for the<br>evaluation of Bone Mineral Density<br>(BMD) values (mg CA-HA/ml) of the<br>lumbar spine based on Osteo CT<br>scans. | Same – There are<br>no modifications. | | | 5. Neuro DSA Extension | | | | Neuro DSA<br>Extension | Bone removal tool from a CT<br>angiography dataset. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>Bone removal tool from a CT<br>angiography dataset. | Same – There are<br>no modifications. | | | 6. Dual Energy ROI | | | | Dual<br>Energy ROI | Evaluation of low/high kV images from<br>dual energy data. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>Evaluation of low/high kV images<br>from dual energy data. | Same – There are<br>no modifications. | | 7. Endoscopic View | | | | | Endoscopic<br>View Tool | Fly through tubular structures which<br>are either filled by low-intensity (e.g.<br>air-filled) or high-intensity (e.g. blood-<br>filled) material. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br><br>Fly through tubular structures which<br>are either filled by low-intensity (e.g.<br>air-filled) or high-intensity (e.g.<br>blood-filled) material. | Same – There are<br>no modifications. | {7}------------------------------------------------ | Feature | Subject Device<br>syngo.CT Extended Functionality | Predicate Device<br>and Supported Functionality | Comparison<br>Result | |--------------------------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | 8. ROI HU Threshold | | | | | ROI HU<br>Threshold | Evaluation of HU value distributions<br>within a user defined region of interest. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br>Evaluation of HU value distributions<br>within a user defined region of<br>interest | Same – There are<br>no modifications. | | General, Extension-independent Functionality | | | | | Pre-<br>generated<br>results | Support of pre-generated results and the<br>ability to edit pre-generated results | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br>Support of pre-generated results and<br>the ability to edit pre-generated<br>results | Same – There are<br>no modifications. | | | | | | | Multiphase<br>support for<br>merged 4D<br>series | Grouping of multiphase series<br>generated by respiratory gated,<br>perfusion and cardiac datasets. | Primary Predicate Device:<br>K173625, clearance date 03/08/2018<br>Grouping of multiphase series<br>generated by respiratory gated and<br>perfusion datasets. | Usability<br>improvement: The<br>grouping logic has<br>been extended to<br>include cardiac<br>gated datasets. | Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, syngo.CT Extended Functionality 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 ## Software Verification and Validation Testing 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 included as part of this submission. ## Non-Clinical / Clinical Testing Summary syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards: | Recognition<br>Number | Product<br>Area | Title of Standard | Publication<br>Date | 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 | | 13-32 | Software | Medical Device Software –Software Life<br>Cycle Processes; 62304:2006 (1st Edition) | 08/20/2012 | AAMI, ANSI,<br>IEC | | 5-40 | Software/<br>Informatics | Medical devices – Application of risk<br>management to medical devices; 14971<br>Second Edition 2007-03-01 | 08/20/2012 | ISO | | 5-114 | General I<br>(QS/RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>IEC 62366-1:2015 | 12/23/2016 | IEC | Performance tests were conducted to test the Interactive Spectral Imaging (ISI) functionality of the syngo.CT Extended Functionality post-processing application. A phantom-based validation "Detailed Description and Bench {8}------------------------------------------------ Tests for the Plugin "Interactive Spectral Imaging"" has been conducted to show that the feature ISI operates as intended. Non-clinical tests and a phantom-based bench test have been conducted to establish the proficiency of the 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. ### General Safety and Effectiveness Concerns The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. # VIII. Conclusions syngo.CT Extended Functionality has the same indication for use as the primary predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate devices. 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.