syngo Application Software VD11

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three intertwined figures facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 4, 2016 Siemens Medical Solutions USA, Inc. % Ms. Patricia Jones Technical Specialist, Regulatory Submissions 40 Liberty Boulevard 65-1A MALVERN PA 19355 Re: K153346 Trade/Device Name: syngo Application Software VD11 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 5, 2016 Received: February 8, 2016 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 (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. 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}------------------------------------------------ | DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration<br><br><b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. | |-----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number (if known) | K153346 | | Device Name | syngo Application Software VD11 | | Indications for Use (Describe) | 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 VD11 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. | | Type of Use (Select one or both, as applicable) | <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | 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](mailto: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." FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. # Section 7 510(k) Summary The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word. ## 510(k) Summary: syngo Application Software VD11 Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Date Prepared: March 2, 2016 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. lmporter / 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 Reqistration Number: 3004977335 #### 2. Contact Person: Ms. Patricia D Jones Technical Specialist, Requlatory 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.com #### 3. Device Name and Classification: | Trade Name: | syngo Application Software VD11 | |----------------------------|---------------------------------------------| | Classification Name: | Picture Archiving and Communications system | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892. 2050 | | Device Class: | Class II | | Product Code: | LLZ | {5}------------------------------------------------ #### 4. Legally Marketed Predicate Device Trade Name: syngo X Workplace 510(k) Clearance K143319 February 24, 2015 Clearance Date Classification Name: Picture Archiving and Communications System Classification Panel: Radiology 21 CFR §892. 2050 CFR Section: 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 VD11 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 evaluation of digital radiographic examinations, including diagnosis and/or treatment planning. Siemens syngo Application Software VD11 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 X Workplace (K143319). Siemens Medical Solutions USA, Inc. hereby submits this Traditional 510(k) to request clearance for the Subject Device (syngo Application Software version VD11). The Subject Device is a modified version of the previously cleared syngo X Workplace software version VD10 cleared under Premarket Notification K143319 on February 24, 2015. The following modifications are made to the cleared syngo X Workplace software version VD10 which created the Subject Device: - 1. Updated Indications for Use Statement (Modification Affects: Labeling) - 2. VD10 Software renamed to VD11 (VD10 software features of the predicate device remain the same). The "syngo Application Software" VD11 consists of features cleared as SW Version VD10 in K143319. VD11 is provided as software only on a CD/DVD. (Modification Affects: Labeling). {6}------------------------------------------------ - 3. Provided update 510(k) information (see table below). The following minor modifications were made to the predicate device and are considered update 510(k) information for this submission. | Update Predicate Device Modifications Information | | |---------------------------------------------------|------------------------------------------| | 1. | syngo X Workplace - new PC Hardware M720 | | 2. | syngo.Interventional - VA30 | | 3. | syngo.Interventional - VB10 | The syngo Application Software VD11 may be installed either on Siemens released PC hardware or on Siemens X-ray systems also known as Siemens Angiography Systems. The combination of "syngo Application Software" and the Siemens released PC Hardware will be marketed as components of the "syngo X Workplace". The syngo Application Software VD11 is within the same classification requlation and the intended use and the general Indications for Use Statement for Siemens' Picture Archiving and Communications System. #### 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 quided solutions in the operating room, for image quided surgery, by Image Fusion and by navigation systems, image quided 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 VD11 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. {7}------------------------------------------------ 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 is comparable to general Indications for Use for medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. The subject device has the same intended use, functionality, technology and is considered substantially equivalent to the commercially available Siemens' syngo X workplace. The Indications for Use Statement is slightly altered from the predicate, but the intended use of the device remains the same. All Software components of the subject device are the same as the one from the predicate device. The Subject Device modifications do not alter its fundamental scientific technology from the 510(k) cleared predicate device Siemens' syngo X Workplace. See table below: | Technological<br>Characteristic | Subject Device:<br>"syngo Application Software"<br>SW VD11 on CD/DVD Only | Predicate Device:<br>syngo X Workplace<br>SW VD10 K143319 | Comparison<br>Results | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Unchanged<br>SW<br>Applications | syngo Dyna3D | syngo Dyna3D | Same | | | syngo DynaCT | syngo DynaCT | Same | | | syngo DynaCT Cardiac | syngo DynaCT Cardiac | Same | | | syngo DynaPBV Neuro | syngo DynaPBV Neuro | Same | | | syngo DynaPBV Body | syngo DynaPBV Body | Same | | | syngo DynaCT Large Volume | syngo DynaCT Large Volume | Same | | | syngo DynaCT 360 | syngo DynaCT 360 | Same | | | syngo Dyna3D HighSpeed | syngo Dyna3D HighSpeed | Same | | | syngo DynaCT Micro | syngo DynaCT Micro | Same | | | syngo Needle Guidance | syngo Needle Guidance | Same | | | syngo Electrophysiology<br>Guidance | syngo Electrophysiology<br>Guidance | Same | | | syngo Aortic Valve Guidance | syngo Aortic Valve Guidance | Same | | | syngo 3D Stenosis measurement | syngo 3D Stenosis<br>measurement | Same | | | syngo Neuro Aneurysm Analysis | syngo Neuro Aneurysm<br>Analysis | Same | | | syngo Neuro Virtual Stent | syngo Neuro Virtual Stent | | | | syngo 3D/3D Fusion | syngo 3D/3D Fusion | Same | | | syngo Toolbox | syngo Toolbox | Same | | | syngo 3D Roadmap | syngo 3D Roadmap | Same | | | syngo Dual Volume | syngo Dual Volume | Same | | | | | | | | syngo Angio (DSA) | syngo Angio (DSA) | Same | | | syngo Composing (AX/MR) | syngo Composing (AX/MR) | Same | | | -syngo AngioLeg Composing | -syngo AngioLeg Composing | | | | -syngo Spine Composing | -syngo Spine Composing | | | | -syngo OrthoLeg Composing | -syngo OrthoLeg Composing | | | | -syngo Ortho Measurement | -syngo Ortho Measurement | | | | -syngo Ortho Report | -syngo Ortho Report | | | | syngo iFlow | syngo iFlow | Same | | | syngo QVA (Quantitative<br>Vascular Analysis) | syngo QVA (Quantitative<br>Vascular Analysis) | Same | | | syngo QCA (Quantitative<br>Coronary Analysis) | syngo QCA (Quantitative<br>Coronary Analysis) | Same | | | syngo LVA and syngo LVA<br>Biplane (Left Ventricular<br>Analysis) | syngo LVA and syngo LVA<br>Biplane (Left Ventricular<br>Analysis) | Same | | | syngo IZ3D (3D-Quant) | syngo IZ3D (3D-Quant) | Same | | | syngo 4D viewer:<br>-Quick Zoom<br>-syngo Dyna4D<br>-3D Wizard<br>-syngo 2/D/3D Fusion<br>-syngo DynaCT SMART<br>-Dedicated Graphical User<br>Interface | syngo 4D viewer:<br>-Quick Zoom<br>-syngo Dyna4D<br>-3D Wizard<br>-syngo 2/D/3D Fusion<br>-syngo DynaCT SMART<br>-Dedicated Graphical User<br>Interface | Same | | syngo<br>Standard<br>Services | Patient Browser<br>Viewer (CT, MR, X-ray, NM,<br>PET, US), DICOM SR Viewer,<br>2D image display<br>Filming and Hardcopy<br>Archiving and Networking<br>-DICOM Storage<br>-DICOM Storage Commitment<br>-DICOM Query & Retrieve<br>-DICOM Media Storage<br>-DICOM Print<br>-Archiving (CD-R, DVD, film)<br>-Compression (JPEG, lossy<br>and lossless - 8 or 12 bit)<br>-Communication (TCP/IP<br>standard communication<br>protocol) | Patient Browser<br>Viewer (CT, MR, X-ray, NM,<br>PET, US), DICOM SR Viewer,<br>2D image display<br>Filming and Hardcopy<br>Archiving and Networking<br>-DICOM Storage<br>-DICOM Storage<br>Commitment<br>-DICOM Query & Retrieve<br>-DICOM Media Storage<br>-DICOM Print<br>-Archiving (CD-R, DVD, film)<br>-Compression (JPEG, lossy<br>and lossless - 8 or 12 bit)<br>-Communication (TCP/IP<br>standard communication<br>protocol) | Same | | syngo<br>Extended<br>Services | Security Package<br>3D Basic:<br>Multiplanar Reconstruction<br>(MPR)<br>Surface Shaded Display (SSD)<br>Maximum/Minimum Intensity<br>Projection (MIP)<br>3D Volume Rendering Technique<br>(VRT)<br>Editor package<br>Fly Through<br>Image Fusion: CT, MR, NM, PET | Security Package<br>3D Basic:<br>Multiplanar Reconstruction<br>(MPR)<br>Surface Shaded Display (SSD)<br>Maximum/Minimum Intensity<br>Projection (MIP)<br>3D Volume Rendering<br>Technique (VRT)<br>Editor package<br>Fly Through<br>Image Fusion: CT, MR, NM, PET | Same | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Siemens logo in blue, followed by the text "Traditional 510(k) Submission: syngo Application Software VD11". The Siemens logo is underlined, and the text is in black. The image is a document header or title, likely from a submission to a regulatory agency. {9}------------------------------------------------ | OEM software | Microsoft™ Office 2010™<br>Internet Explorer™<br>TrendMicro Antivirus Program<br>Version 10.6 at a minimum<br>CamTasia Studio Version 1.1.1<br>(or higher) | Microsoft™ Office 2010™<br>Internet Explorer™<br>TrendMicro Antivirus Program<br>Version 5.02 at a minimum<br>CamTasia Studio Version<br>n 1.1.1 (or higher) | Same | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | Integrated<br>Quantification | Quant including QCA 3D<br>K063344 | Quant including QCA 3D<br>K063344 | Same | | Operating<br>System | Windows 7 | Windows 7 | Same | | Image<br>Archiving | CD-R, DVD, Blue ray, film | CD-R, DVD, Blue ray, film | Same | #### 8. Nonclinical Performance Testing: Non-clinical tests were conducted for the syngo Application Software VD11 during product development. The modifications described in this Premarket Notification were supported with verification and validation testing. Siemens claims conformance to the following performance standards: 14971; 60601-1-6; 62304; 62366; and NEMA PS3. ## 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. Nonclinical tests were conducted on the syngo Application Software VD11 during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device including was found acceptable to support the claims of substantial equivalence. 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: Performance tests were conducted to test the functionality of the syngo Application Software VD11. These tests have been performed to assess the functionality of the subject device. Results of all conducted testing and clinical {10}------------------------------------------------ images were found acceptable and do not raise any new issues of safety or effectiveness. #### 9. General Safety and Effectiveness Concerns: Instructions for use are included within 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 was cleared based on non-clinical supportive information and clinical images. Similar non-clinical test results demonstrate that syngo Application Software VD11 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.