syngo.CT Extended Functionality

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 9, 2017 Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., Mail Code 65-1A MALVERN PA 19355 Re: K163341 Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 17, 2016 Received: November 29, 2016 Dear Ms. Mangum: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D'Hara For Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K163341 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. 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) | |-------------------------------------------------| |-------------------------------------------------| 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. 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The background is white, which makes the text stand out. ## 510(K) Summary FOR SYNGO.CT EXTENDED FUNCTIONALITY Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: January 24, 2017 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. #### l. 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 Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448 - 6477 Fax: (610) 640 - 4481 Email: kimberly.mangum@siemens.com #### II. Device Name and Classification 510(k) Number: K163341 Product Name: syngo.CT Extended Functionality Propriety Trade Name: syngo.CT Extended Functionality Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90JAK {4}------------------------------------------------ # SIEMENS ## III. Predicate Device #### Predicate Device: Trade Name: syngo.CT Vascular Analysis 510(k) Number: K112020 08/18/2011 Clearance Date: Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: JAK #### Predicate Device: | Trade Name: | syngo.CT Lung CAD | |-----------------------|-----------------------------------------------------------| | 510(k) Number: | K143196 | | Clearance Date: | 05/12/2015 | | Classification Name: | Lung Computed Tomography System, Computer-Aided Detection | | Classification Panel: | Radiology | | CFR Section: | 21 CFR § 892.2050 | | Device Class: | Class II | | Product Code: | OEB | #### Predicate Device: - Osteo CT Option for SOMATOM CT Systems Trade Name: 510(k) Number: K971054 Clearance Date: 06/13/1997 Classification Name: System, X-Ray, Tomography, Computed Classification Panel: Radiology CFR Section: 21 CFR § 892.1750 Device Class: Class II Product Code: JAK Subsequent Product Code: KGI ### Predicate Device: | Trade Name: | syngo Neuro DSA CT | |-----------------------|-------------------------------------| | 510(k) Number: | K053024 | | Clearance Date: | 11/04/2005 | | Classification Name: | System, X-Ray, Tomography, Computed | | Classification Panel: | Radiology | | CFR Section: | 21 CFR § 892.1750 | | Device Class: | Class II | | Product Code: | JAK | ### IV. Device Description syngo.CT Extended Functionality is a software bundle consisting of previously cleared unmodified and modified post-processing applications that offer tools to support special clinical evaluations. 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. Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Extended Functionality software {5}------------------------------------------------ # SIEMENS package is designed to operate on the most recent version syngo-compatible postprocessing platform, which currently supports the following four tools: - 1. Preparation of Vascular Case for Reading Physician - 2. Preparation of Oncology Case for Reading Physician - 3. Preparation of Osteo Case for Reading Physician - 4. Preparation of Neuro DSA Bone Subtraction for Reading Physician The supported functionality can be used on any CT data if basic requirements are met (e.g. spiral or sequence scan, reconstruction kernel). The supported functionality will check to ensure the basic requirements are met and will not allow its execution or will provide a warning or info message to the user if appropriate. This check also allows combination of functionality of different clinical fields, (e.q. a vascular case can be prepared also on Neuro DSA bone subtracted data or on the same case as Lung CAD computation, etc.). Afterwards, any tool can be accessed as long as the data and viewing type allows it. For example, an evaluation of a ROI defined by a contour and two HU thresholds can be used to measure a certain area. No specific sequential workflow is required. The original clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners will not be modified in any form. The results of the syngo.CT Extended Functionality can be stored as additional DICOM images if needed as kev images or range or images. The subject device syngo.CT Extended Functionality is designed to operate on a syngo compatible host system (e. g. syngo.via VB20 software platform or higher). ### 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. 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 This subject device is a bundle software package consisting of previously cleared unmodified and modified software applications that provide advanced visualization and measurement tools. At a high-level, the subject and predicate device are based on the following same/similar technological characteristics: | Subject Supported<br>Functionality | Predicate Device and Supported<br>Functionality | Comparison Results | |------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Tools and layouts for vascular<br>assessment | predicate device:<br>K112020 - syngo.CT Vascular Analysis<br>Tools and layouts for vascular<br>assessment | Supports the same<br>unmodified functionality<br>from the predicate device. | | Display of the findings of the<br>Lung CAD algorithm | predicate device:<br>K143416 - syngo.CT Lung CAD | Supports the same<br>unmodified functionality | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image. | Subject Supported<br>Functionality | Predicate Device and Supported<br>Functionality | Comparison Results | |---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------| | | Display of the findings of the Lung CAD<br>algorithm | from the predicate device. | | Provides a set of routine tools<br>for the assessment of bone<br>mineral content | predicate device:<br>K971054 - Osteo CT Option for<br>SOMATOM CT Systems<br>Provides a set of routine tools for the<br>assessment of bone mineral content | Modified to evaluate<br>images from volume scans<br>and semi-automatically<br>calculate the position and<br>orientation of mid-vertebral<br>slices (MVS). | | Provides a set of tools for<br>assessment of the cerebral<br>vasculature by removing<br>interfering bone structures | predicate device:<br>K971054<br>Provides a set of tools for assessment of<br>the cerebral vasculature by removing<br>interfering bone structures | Supports the same<br>unmodified functionality<br>from the predicate device. | #### VII. Performance Data The following performance data were provided in support of the substantial equivalence determination. This submission contains performance data 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. The modifications described in this Premarket Notification were supported with verification/validation testing. Verification testing for the Osteo feature was conducted to demonstrate successful software integration and performance in accordance to Siemens internal procedure which includes risk identification and mitigation in accordance with ISO 14971. All verification and validation testing has been completed and meets Siemens acceptance criteria. Additionally, all risks for the complete subject device have been identified and mitigated in accordingly. #### Risk Analvsis 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. #### Software Verification and Validation Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. #### Non-Clinical Testing Summary Performance tests were conducted to test the functionality of the synqo.CT Extended Functionality. 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. #### 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. {7}------------------------------------------------ # SIEMENS syngo.CT Extended Functionality 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<br>Edition) | 08/20/2012 | AAMI, ANSI, 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 | | 5-95 | General I<br>(QS/RM) | Medical devices - Part 1: Application of<br>usability engineering to medical devices<br>IEC 62366-1:2015 | 06/27/2016 | IEC | | 19-4 | General II<br>(ES/EMC) | AAMI / ANSI ES60601-1:2005/(R)2012<br>and A1:2012, Medical electrical<br>equipment - part 1: general<br>requirements for basic safety and<br>essential performance (IEC 60601-<br>1:2005, mod) | 07/09/2014 | AAMI, ANSI | ## VIII. Conclusions This subject device combines four advanced visualization and measurement tools into one software bundle package. The fundamental software technology which is provided within the scope of the advanced tools is already cleared and remains unchanged in comparison to the predicate devices. The Indications for Use for the subject device has been adapted to provide a more specific description of the syngo.CT Extended Functionality realized as software package including a software bundle that consists of previously cleared post-processing software applications. The conducted modifications described in this Premarket Notification were supported with verification and validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The predicate devices were cleared based on non-clinical supportive information. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the predicate device. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Extended Functionality testing supports a finding of substantial equivalence.