syngo Application Software

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Siemens Medical Solutions, USA Inc. % Ms. Patricia Jones Sr. Technical Specialist, Regulatory Submissions 40 Liberty Boulevard. 65-1A MALVERN PA 19355 March 16, 2018 ### Re: K173611 Trade/Device Name: syngo Application Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 23, 2018 Received: February 26, 2018 Dear Ms. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------ 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'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}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K173611 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 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 turnor treatment. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------------| | 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: syngo Application Software (VD20B) Siemens Medical Solutions USA, Inc. Company: 40 Liberty Boulevard, 65-1A Malvern, PA 19355 March 9, 2018 Date Prepared: 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. - 1. General Information: 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 Senior Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Phone: (610) 448-6474 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. Legally Marketed Predicate Device Trade Name: syngo Application Software 510(k) Clearance K170747 {4}------------------------------------------------ Clearance Date Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information: 06/09/2017 Picture Archiving and Communications System Radiology 21 CFR §892. 2050 Class II LLZ This predicate device has not been the subject of any design related recalls. #### 5. Device Description: The "syngo Application Software" 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-quided solutions in the operating room, for imageguided 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. 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" (VD20B) 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" (VD20B) K170747 with exception of the added software options "Instant Fusion" and "Common Patient Registration". The new optional software features are only possible in an angiography (ARTIS Family) and CT (SOMATOM CT Sliding Gantry) systems configuration known as "nexaris Angio-CT". "Instant Fusion" and "Common Patient Registration" is the subject of this submission. These features seamlessly integrate Angio and CT together and facilitate combined use. The "Instant Fusion" is an overlay of CT datasets to the Angiography image. The overlay is a position based registration of the CT gantry. The "Common Patient Registration" is the patient data transfer from "syngo Application Software" to the CT system using a communication interface. Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance for new optional software features to the syngo Application Software. ## Proposed Device Modifications: - New optional software feature: "Instant Fusion" 1. - New optional software feature: "Common Patient Registration" 2. The "syngo Application Software" may be installed either on Siemens released PC hardware, on Siemens X-ray systems or on Siemens angiography systems. {5}------------------------------------------------ The combination of syngo Application Software: (VD20B) and the Siemens released PC hardware will be marketed also as "syngo X Workplace". The syngo Application Software: (VD20B) is within the same classification requlation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System remain the same. #### 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 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). {6}------------------------------------------------ All software components of the subject device are the same as the ones from the predicate device except for the new optional software applications "Instant Fusion" and "Common Patient Registration". The table below provides a comparison of the Subject Device modifications to the Predicate Device. | Modification | Subject Device<br>syngo Application<br>Software VD20B | Predicate Device<br>syngo Application<br>Software VD20A<br>(K170747) | Comparison<br>Results | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Instant Fusion | Image fusion is based on<br>position based registration.<br>Header information with<br>position data of the images<br>allows instantly<br>registration. | Image fusion is based<br>on image registration.<br>Two 2D acquisitions are<br>required to enable the<br>registration. | Subject device<br>position based<br>registration instead of<br>image-based<br>registration. | | Patient<br>Registration | Patient data transfer from<br>Angiography system to<br>syngo Application<br>Software and to CT<br>system | Patient data transfer<br>from Angiography<br>system to syngo<br>Application Software | Patient Registration<br>extended to CT<br>system | The subject device modifications do not alter the fundamental scientific technology from the 510(k) cleared predicate device Siemens syngo Application Software (VD20), K170749. #### 8. Nonclinical Performance Testing: Non-clinical tests were conducted for the syngo Application Software (VD20B) during product development. | Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization | |-----------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------|------------------------------------------| | 5-40 | General | Medical devices -<br>Application of risk<br>management to<br>medical devices | 14971 | 2012 | ISO | | 5-89 | General | Medical electrical<br>equipment Part 1-6:<br>General<br>requirements for<br>basic safety and<br>essential<br>performance -<br>Collateral standard:<br>Usability | 60601-1-6 | 2010 | IEC | | 13-32 | Radiology | Medical Device<br>Software - | 62304 | 2006 | AAMI ANSI IEC | Siemens claims conformance to the following performance standards: {7}------------------------------------------------ | Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and<br>Date | Publication<br>Date | Standards<br>Development<br>Organization | |-----------------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------------------|------------------------------------------| | | | Software life-cycle<br>process | AC | 2008 | | | 5-95 | General | Medical devices -<br>Part 1 Application<br>of usability<br>engineering to<br>medical devices | 62366-1 | 2015 | IEC | | 13-38 | Software/<br>Informatics | Application of risk<br>management for IT<br>- networks<br>incorporating<br>medical devices -<br>Part 1: Roles,<br>responsibilities, and<br>activities | 80001-1 | 2010 | IEC | The modifications described in this Premarket Notification were supported by 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, and "Off-The-Shelf Software Use in Medical Devices" 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 (VD20B) during product development. 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 for 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 (VD20B) 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 {8}------------------------------------------------ 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" (VD20B). These tests have been performed to assess the functionality of the subject device. Results of all conducted testing were found acceptable and did not raise any new issues of safety or effectiveness. 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: The optional software feature "Instant Fusion" performance functionality has been tested and validated. Measurements were performed with CT images to the interface simulator. The tests showed that CT images can be directly overlaid without additional 2D/3D registration. The syngo Application Software feature "Instant Fusion" has not been tested to demonstrate a specific registration accuracy of the fusion/overlay feature, and does not compensate for patient motion. "Instant Fusion" product Claim: "Zero radiation and Less Radiation". Disclaimer: This claim is applicable to the overlay (Instant Fusion) feature only. The optional software feature "Patient Registration" has been tested and validated. Measurements were performed with different patient images to the interface simulator. The tests showed that the Patient data is automatically transferred after Patient registration on the Angiography system. Performance tests were conducted to test the functionality of the syngo Application Software (VD20B). These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical assessment were found acceptable and do not raise any new issues of safety or effectiveness. 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. 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. Siemens claims conformance to the following table of FDA Guidance Documents for this 510(k) submission. {9}------------------------------------------------ | | FDA Guidance Document and Effective Date | |----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Guidance for Industry and FDA Staff – User Fees and Refunds for Premarket<br>Notification Submissions 510(k)<br>Document issued on October 2, 2017 | | 2. | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy<br>for 510(k)s<br>Document issued on January 30, 2018 | | 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s -<br>Guidance for Industry and FDA Staff<br>Document issued on August 12, 2005 | | 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:<br>Evaluating Substantial Equivalence in Premarket Notifications (510(k)<br>Document Issued on July 28, 2014 | | 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of Premarket<br>Notifications for Medical Image Management Devices Document issued on July 27,<br>2000 | | 6 | Guidance for Industry and FDA Staff: Guidance for the Content of Premarket<br>Submission for Software in Medical Devices<br>Document issued on May 11, 2005 | | 7 | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use in<br>Medical Devices<br>Document issued on September 9, 1999 | | 8 | Guidance for Industry and FDA Staff: Applying Human Factors and Usability<br>Engineering to Medical Devices.<br>Document issued February 3, 2016 | | 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging Device<br>Premarket Notifications.<br>Document issued on November 28, 2017 | | 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions for<br>Management of Cybersecurity in Medical devices.<br>Document issued on October 2, 2014 | #### 9. General Safety and Effectiveness Concerns: 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) was cleared based on non-clinical supportive information and clinical images and data. Similar nonclinical test results demonstrate that the Subject Device syngo Application Software (VD20B) acceptance criteria are adequate for the intended use of the device. The comparison of technological characteristic, non-clinical performance {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the word "SIEMENS" in all capital letters. The text is displayed in a bold, sans-serif font. The color of the text is a light blue or teal. 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.