syngo Application Software

{0}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three profiles facing to the right, representing the human element of the department's mission. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 9, 2017 Siemens Medical Solutions, USA, Inc. Patricia Jones Sr. Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A Malvern, Pennsylvania 19355 Re: K170747 Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 11, 2017 Received: May 12, 2017 Dear Mrs. Jones: 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 {1}------------------------------------------------ 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. 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/ResourcesforYou/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, For Michael D. O'Hara Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170747 Device Name syngo Application Software ### Indications for Use (Describe) The syngo Application Software is a medical software for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, postprocessing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems Angiography system family. It provides image guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options, which are intended to assist the physician in diagnosis, treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | |----------------------------------------------|---------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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There is a black line underneath the word. # 510(k) Summary: "syngo Application Software" (VD20) Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Date Prepared: May 11, 2017 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. ### General Information: 1. Importer / Distributor: Siemens Medical Systems USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869 Manufacturing Site: Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 ### 2. Contact Person: Ms. Patricia D Jones Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 Fax: (610) 640-4481 Email: patricia.d.jones@siemens-healthineers.com ### 3. Device Name and Classification: Trade Name: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code: syngo Application Software Picture Archiving and Communications system Radiology 21 CFR §892. 2050 Class II LLZ {4}------------------------------------------------ | Trade Name: | syngo Application Software | |-----------------------|-------------------------------------------------------------------------------| | 510(k) Clearance | K163285 | | Clearance Date | 02/14/2017 | | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892. 2050 | | Device Class: | Class II | | Product Code: | LLZ | | Recall Information: | This predicate device has not been the subject of any design related recalls. | ### 5. Device Description: The "syngo Application Software" (VD20) is medical diagnostic software for real-time viewing, diagnostic review, post-processing, image manipulation, optimization, communication, reporting and storage of medical images and data on exchange media. It provides image-guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image quided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. It can be deployed with a variety of syngo or Windows based software options, which are intended to assist the physician in the evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens "syngo Application Software" (VD20) is designed to work with digital radiographic, fluoroscopic, interventional and angiographic systems. The software platform with common software architecture, syngo application packages and basic services is the same as used with the "syngo Application Software" (VD20) cleared in K163285 with the exception of the added new software feature "syngo TrueFusion" Siemens Medical Solutions USA. Inc. hereby submits this Traditional 510(k) to request clearance for the addition of a new software feature to the syngo Application Software. # Proposed Device Modifications: - 1. Introduction of "syngo TrueFusion" software application for fusion of ultrasound information with 2D fluoroscopic images - 2. Proposed new product claims associated with device The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. The combination of "syngo Application Software" {5}------------------------------------------------ # SIEMENS (VD20) and the Siemens released PC hardware will be marketed also as "syngo X Workplace". The "syngo Application Software" (VD20) is within the same classification regulation and the intended use and the general Indications for Use Statement for Siemens'Picture Archiving and Communications System remains the same. Proposed new product claims associated with "syngo TrueFusion" | Claim # | Feature /Component | Labeling Claim | |---------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | syngo TrueFusion | syngo TrueFusion – Add TEE guidance to live fluoroscopy with ease | | 2. | syngo TrueFusion | Navigate with improved anatomical orientation | | 3. | syngo TrueFusion | Integrated efficiency in TEE guidance | | 4. | syngo TrueFusion | Reduce complexity in challenging procedures | | 5. | syngo TrueFusion | Navigate with confidence through integrated TEE guidance | | 6. | syngo TrueFusion | Achieve automated co-registration with eSie Sync<br>Automated probe detection in 2 single fluoro images and automated co-registration updates<br>eSie Sync integrates co-registration efficiently in your workflow | | 7. | syngo TrueFusion | eSie Sync integrates co-registration efficiently in your workflow | | 8. | syngo TrueFusion | Probe detection enhanced by machine learning | | 9. | syngo TrueFusion | Hardware markers and probe model enable robust algorithm | | 10. | syngo TrueFusion | True integration of ACUSON SC2000 PRIME | | 11. | syngo TrueFusion | True integration and possibility to synchronize views enhances communication | | 12. | syngo TrueFusion | Share perspectives efficiently with view synchronization* | | 13. | syngo TrueFusion | Set landmarks swiftly with eSie Valves modeling | | 14. | syngo TrueFusion | Identify key anatomical landmarks with one-click eSie Valves modeling | | 15. | syngo TrueFusion | Assess valves and fuse model with live fluoroscopy at any time during the procedure | | 16. | syngo TrueFusion | Valve model reduced to the relevant structures on the fusion image for a clear view of your devices | | 17. | syngo TrueFusion | Annulus landmark overlay on live fluoroscopy can help find the perpendicular view. | | 18. | syngo TrueFusion | Target-oriented guidance through TEE structural information fusion | | 19. | syngo TrueFusion | More intuitive orientation through overlay of TEE cone on live fluoro* | | 20. | syngo TrueFusion | Claim Removed | | 21. | syngo TrueFusion | Claim Removed | | 22. | syngo TrueFusion | Direct real-time guidance from the ultrasound system | | 23. | syngo TrueFusion | syngo TrueFusion can shorten the learning curve in challenging procedures as it enables more intuitive anatomical orientation* | | Claim # | Feature /Component | Labeling Claim | | 24. | syngo TrueFusion | Synchronization of TEE and angio image orientation allows to derive implantation angles from TEE. | | 25. | syngo TrueFusion | Assessment of valve morphology with eSie ValvesTM modeling and fusion of relevant structures supports accurate device placement | | 26. | syngo TrueFusion | Dedicated probe design enables rapid and reliable registration updates** | | 27. | syngo TrueFusion | Reliable image fusion with dedicated probe design and eSie sync | | 28. | syngo TrueFusion | Target-oriented device navigation via True Volume TEE landmarks | | 29. | syngo TrueFusion | Direct export of fusion landmarks from the compatible ultrasound system. | | 30. | syngo TrueFusion | Overlay of TEE cone on live fluoro for greater intuition in orientation* | | 31. | syngo TrueFusion | Fast and reliable documentation with integrated patient co-registration from angiography and ultrasound systems | | 32. | syngo TrueFusion | C-arm angulation planning without fluoroscopy | | 33. | syngo TrueFusion | A confident clear view combined on one screen | | 34. | syngo TrueFusion | Facilitated communication through first-hand guidance from the modality expert | | 35. | syngo TrueFusion | Synchronized views can speed up orientation and communication* | | 36. | syngo TrueFusion | Synchronized views facilitating orientation / for a faster grasp of orientation* | | 37. | syngo TrueFusion | Claim Removed | {6}------------------------------------------------ Inis is the result of individual user experience - results may vari **The quality of registration depends on the orientation of the probe, the angular difference between the two projections, the C-arm position, and the zoom stage. ### 6. Indications for Use: The syngo Application Software is a medical software for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures. The syngo Application Software can be deployed on independent hardware such as a stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the syngo Application Software can be deployed on systems of the Siemens Angiography system family. It provides image-guided solutions in the operating room, for image guided surgery, by image fusion and by navigation systems, image guided solutions in interventional cardiology and {7}------------------------------------------------ # EMENS electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology. The syngo Application Software can also be combined with fluoroscopy systems or radiographic systems. The syngo Application Software can be configured with a variety of syngo or Windows-based software options. which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available post-processing techniques and OEM options. Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment. - 7. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device: The subject device has the same intended use as the predicate device. Besides the proposed device modifications, the subject device has the same functionality and technology. Therefore the subject device is considered substantially equivalent to the commercially available Siemens' "syngo Application Software" (VD20). All software components of the subject device are the same as the ones from the predicate device except for the new software feature "syngo TrueFusion". The table below provides a comparison of the Subject Device modification to the Predicate Device. | Property | Subject Device<br>syngo Application<br>Software | Predicate Device<br>syngo Application<br>Software (K163285) | Comparison Results | |----------------------------------------|------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | SW VD20 New<br>Software<br>Application | Newly added<br>software feature:<br>syngo TrueFusion | "syngo TrueFusion" not<br>available. | The new syngo<br>TrueFusion software<br>feature does not raise<br>any new issues of<br>safety of<br>effectiveness.<br>Validation and testing<br>was conducted | The subject device modification does not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens' "syngo Application Software" (VD20), K163285. ### 8. Nonclinical Performance Testing: Non-clinical tests were conducted for the "syngo Application Software") during product development. {8}------------------------------------------------ # SIEMENS Siemens claims conformance to the following performance standards: Siemens claims conformance to the following performance standards: - ISO 14971:2012 ● - IEC 60601-1-6:2010 ● - IEC 62304:2006 AC:2008 ● - IEC 62366-1:2015 ● - IEC 80001-1:2010 ● The modifications described in this Premarket Notification were supported with verification and validation testing. # Verification and Validation: Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the "syngo Application Software" (VD20) during product development. The Risk analysis was completed and risk control implemented to mitiqate 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. The Human Factor Usability Validation showed no safety-relevant functions that need to be validated with a summative usability validation according to the IEC and FDA Guidelines. The "syngo Application Software" (VD20) has been found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. No further risk mitigations are necessary. Siemens conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital. Provided in the Software Section, is the required cybersecurity information. # Summary of the performance testing data: Performance tests were conducted to test the functionality of the "syngo Application Software" (VD20). These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and {9}------------------------------------------------ # SIEMENS clinical assessments were found acceptable and did not raise any new issues of safety or effectiveness. Performance to syngo TrueFusion is provided below. All software validation data 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. # Performance Verification/Validation & Test Report Summaries | Table 1: Validation Report Summary | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Subject Device Modification:<br>Added software feature “syngo TrueFusion” | | 2. | Objective or Purpose of Test:<br>Validate syngo TrueFusion results | | 3. | Explanation of sample size and Statistical Methods:<br>28 phantom test data sets | | 4. | Summary of Test Methodology:<br>Multiple Measurements were performed from different directions of the C-arm by a board certified cardiologist. | | 5. | Explanation of Study Endpoints:<br>All results are clinically accepted by a board certified radiologist. | | 6. | Explanation of Study Acceptance Criteria:<br>Mean deviation shall not exceed 3mm with a standard deviation not exceeding 2mm. | | 7. | Test Report Results:<br>Multiple Measurements were performed from different directions of the C-arm. The measurements show these mean and standard deviations from three different C-Arm positions (A, B, C): Experiment 1 position A mean 2,92mm with a standard deviation of 1,29mm, position B mean 2,59mm with a standard deviation of 1,50mm, position C mean 2,31mm with a standard deviation of 1,62mm, experiment 2 position A mean 2,76mm with a standard deviation of 1,31mm, position B mean 2,57mm with a standard deviation of 1,69mm, position C mean 2,13mm with a standard deviation of 1,48mm. The statistical significance – 80% successful experiments – is 0,0 for experiment 1 position A, 0,002 for B, 0,002 for C and 0,002 for experiment 2 position A, 0,015 for B and 0,002 for C. All results were clinically accepted by a board certified cardiologist. | | 8. | Supportive article reference(s) with explanation as for how it supports the modification:<br>This is not applicable | | 9. | Conclusion Statement:<br>The comparison of technological characteristic, non-clinical performance data, clinical images, Human Factor Usability data and software validation data 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 | {10}------------------------------------------------ ## 9. General Safety and Effectiveness Concerns: SIEMENS Instructions for use are included in the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore the operators are health care professionals familiar with and responsible for the evaluating and post-processing of medical images. ### 10. Conclusion as to Substantial Equivalence: The predicate device "syngo Application Software" (VD20), K163285, was cleared based on non-clinical supportive information and clinical images and data. Similar non-clinical test results demonstrate that the subject device "syngo Application Software" (VD20) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance data, clinical images, and software validation data 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.