SYNGO DYNAMICS

{0}------------------------------------------------ K123922 # SIEMENS Healthcare JAN 1 6 2013 # 510(k) Summary ## svngo® Dvnamics (Version VA10A) 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. - General Information l. Date of Summary Preparation: December 5, 2012 #### Establishment: - Address: . Siemens Medical Solutions USA. Inc. 400 W. Morgan Road Ann Arbor, MI 48108 - Registration Number: ● 1836549 Contact Person: ● Yuri Ikeda Quality Engineer, Quality & Regulatory Phone: (734) 205-2442 Fax: (734) 205-2683 Email: yuri.ikeda@siemens.com #### Device Name and Classification: - Trade Name: syngo® Dynamics Version VA10A - Picture Archiving and Communications System Classification Name: . - Classification Panel: Radiology - 21 CFR §892.2050 CFR Number: ● - Class II Device Class: . - . Product Code: Safety and Effectiveness Information Supporting the Substantial ll. Equivalence Determination LLZ #### Intended Use: . syngo® Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting. As a Cardiology PACS and information system, syngo® Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other Siemens Medical Solutions USA, Inc. 400 West Morgan Road Ann Arbor, MI 48108 USA Tel .: +1-734-205-2400 www.usa.siemens.com/healthcare {1}------------------------------------------------ #### departments. syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S. #### Device Description: This premarket notification addresses the Siemens syngo® Dynamics Version VA10A Picture Archiving and Communication System. The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on. The hardware itself is not considered a medical device and not in the scope of this 510(k) submission. syngo® Dynamics is a system that includes a DICOM Server which receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, magnetic resonance and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows. syngo® Dynamics Version VA10A provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine), vascular ultrasound, including specific echo and cath lab oriented features for documentation support in the cardiology department. #### Data Management: syngo® Dynamics allows all authorized personnel fast and continuous access to data such as cardiovascular images and information. Its functionality ranges from availability of images with regard to data security, open interfaces, storage media and central system administration, to provide a flexible storage hierarchy. #### Technological Characteristics: syngo® Dynamics is a "software only" system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. Hardware must meet the defined requirements. Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians. The backend communication and storage solution is based on Windows 2008 operating system. The client machines are based on Windows XP, and Windows 7. Any hardware platform, which meets the specified recommended hardware and software requirements and with successful installation verification and {2}------------------------------------------------ validation activities can be supported. syngo® Dynamics supports DICOM formatted images and objects. syngo® Dynamics Version VA10A will be used to display, process, read, report, communicate, distribute and store digital medical images, much like its predicate, syngo® Dynamics Version 9.0 (K102150). The difference between the syngo® Dynamics Version VA10A and the predicate device syngo® Dynamics Version 9.0 are to give the subject device greater capabilities than the predicate device. syngo® Dynamics Version VA10A has similar technological characteristics as the predicate device and is similar to the functionalities of the predicate device. The table below summarizes the similarities and the differences between the two devices. | Functionality | syngo® Dynamics<br>Version VA10A | syngo® Dynamics<br>Version 9.0 | |-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Siemens Medical Solutions<br>USA, Inc. | Siemens Medical Solutions<br>USA, Inc. | | Intended Use | syngo® Dynamics is an image<br>and information system<br>intended for acceptance,<br>transfer, display, storage,<br>archive and manipulation of<br>digital medical images,<br>including review, analysis,<br>quantification and reporting.<br>As a Cardiology PACS and<br>information system, syngo®<br>Dynamics supports the | syngo® Dynamics is a Picture<br>Archiving and Communication<br>System (PACS) intended for<br>acceptance, transfer, display,<br>storage, archive and<br>manipulation of digital medical<br>images, including quantification<br>and report generation.<br>syngo® Dynamics is not<br>intended to be used for reading<br>of mammography images. | | | physician in interpretation and<br>evaluation of examinations<br>within healthcare institutions, in<br>particular, in Cardiology,<br>Obstetrics and Gynecology or<br>other departments. | | | | syngo Dynamics® is not<br>intended to be used for<br>displaying of digital<br>mammography images for<br>diagnosis in the U.S. | | | Functionality | syngo® Dynamics<br>Version VA10A | syngo® Dynamics<br>Version 9.0 | | Operating<br>Systems | Server<br>Windows 2008 R2 Server<br>Standard Edition R2 SP1 or<br>SP2 (64-bit)<br><br>Workplace<br>Microsoft Windows XP SP2 or<br>higher<br>32-bit or 64-bit, orMicrosoft Windows 7 or<br>Windows 7 SP1 or higher32-bit or 64-bitUltimate, Professional,<br>Enterprise, Ultimate N,<br>Professional N, or<br>Enterprise N<br>Portal Website Host<br>Windows Server 2008 R1 32-<br>bit or greater | Server<br>Windows Server 2008 R2 SP1<br>Standard Edition (64-bit)<br><br>Workplace<br>Windows 2000, 2003, XP,<br>Vista, 7 (32 or 64-bit)<br><br>Portal Website Host<br>Windows Server 2008 R1 32-<br>bit or greater | | Image Source | DICOM Ultrasound, XA, CT,<br>MR, DX, DR and Nuclear<br>Medicine, including PET. | DICOM Ultrasound, XA, CT,<br>MR, DX, DR and Nuclear<br>Medicine, including PET. | | Image Display | Ultrasound, XA, CT, MR, DX,<br>DR, PET and Nuclear Medicine<br>through Corridor4DM | Ultrasound, XA, CT, MR, DX,<br>DR, PET and Nuclear Medicine<br>through MI Mobile or<br>Corridor4DM | | Data Export<br>Image<br>Communication | DICOM, bmp, avi<br>Within the network, the<br>following communication<br>protocols are used:<br>TCP/IP: for communication<br>and transportDICOM and HL7 at<br>application levelHTTP for communication<br>and transport of thumbnails | DICOM, bmp, avi<br>Within the network, the<br>following communication<br>protocols are used:<br>TCP/IP: for communication<br>and transportDICOM and HL7 at<br>application levelHTTP for communication<br>and transport of thumbnails | | Image Data<br>Compression | Lossless compression with<br>compression factor 2 to 3 and<br>lossy compression with higher<br>compression rate. | Lossless compression with<br>compression factor 2 to 3 and<br>lossy compression with higher<br>compression rate. | | Imaging<br>Algorithms | Window/Leveling, Edge<br>Enhancement, and Digital<br>Subtraction | Window/Leveling, Edge<br>Enhancement, and Digital<br>Subtraction | | Quantitative<br>Algorithms | Pixel Size Evaluation | Pixel Size Evaluation | | Network Access | Yes | Yes | | Analysis | Yes | Yes | | Reporting | Yes | Yes | | Multimodality<br>storage and<br>review | Yes | Yes | | Functionality | syngo® Dynamics<br>Version VA10A | syngo® Dynamics<br>Version 9.0 | | Web Server for<br>images and clips | Yes | Yes | | Report upload to<br>Information<br>Systems | Yes, through broker or<br>interface engine | Yes, through broker or<br>interface engine | | DICOM Structured<br>Reporting | Yes | Yes | | Export/Import<br>Data Sets via<br>removable media<br>or network means | Yes | Yes | | Vascular<br>Quantification | Yes, measurements and<br>calculations | Yes, measurements and<br>calculations | | Data Mining | Yes | Yes | | Discrete Data<br>Export | Yes | Yes | | Cardiac<br>Measurements | Yes | Yes | | Interactive<br>graphical<br>documentation for<br>reporting | Yes, through Soarian<br>Cardiology, version 2.0 utilizing<br>patient/user context sharing | Yes, through Soarian<br>Cardiology, version 2.0 utilizing<br>patient/user context sharing | | Hemodynamic<br>data import (third<br>party vendor) | Yes | Yes | | Web Reporting | Yes | Yes | | Hardware | Software-only option for server<br><br>Workstation: software only<br>(HW is not part of the medical<br>device, but needs to meet<br>recommended requirements as<br>specified by syngo Dynamics) | Software-only option for server<br><br>Workstation: software only<br>(HW is not part of the medical<br>device, but needs to meet<br>recommended requirements as<br>specified by syngo Dynamics) | | Collaborative<br>Reporting | Yes | No | | Mobile Device<br>Support | Yes - Non-diagnostic, and<br>read-only. Support Apple<br>iPhone and iPad | No | {3}------------------------------------------------ : ・ . {4}------------------------------------------------ : # Summary of Non-Clinical Tests: Integration and System Testing were performed for verification and validation of The device. Siemens Medical Solutions USA, Inc. complies with voluntary standards DICOM Version 3.x (2011), IEC/ISO 10918-1:1994 + TC 1:2005 Standards DrOOm Version 6.X (2017) 1207 Version 2.3.1, IEC 62366:2007, and SMPTE. # 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 this device. {5}------------------------------------------------ Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify potential hazards. These potential hazards are controlled via software development, labeling, and verification and validation testing. The device has no patient contacting materials and is used only by trained professionals. The output of the device is evaluated by trained professionals allowing sufficient review for identification and intervention in the event of a malfunction. Siemens believes that syngo® Dynamics Version VA10A is as safe and effective as its predicate device as it does not, raise new types of safety and effectiveness concerns, or introduce new technology. #### Substantial Equivalence The syngo® Dynamics Version VA10A, addressed in this premarket modification is substantially equivalent to the following commercially available device: | Manufacturer | Predicate Device Name | FDA Clearance<br>Number | |----------------------------------------|----------------------------|-------------------------| | Siemens Medical Solutions<br>USA, Inc. | syngo Dynamics Version 9.0 | K102150 | The potential hazards of modifications to the device have been evaluated and controlled as part of the product development process, including risk analysis and design considerations. Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device. In summary, Siemens is of the opinion that syngo® Dynamics Version VA10A does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate device. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 #### January 16. 2013 Siemens Medical Solutions USA, Inc. % Mr. Yuri Ikeda Ouality Engineer, Ouality & Regulatory TUV SUD America, Inc. 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K123922 Trade/Device Name: syngo Dynamics (Version VA10A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 17, 2012 Received: December 20, 2012 Dear Mr. Ikeda: 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. Iisting 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 {7}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Sincerely yours, ## Sean M.ABoyd -S for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K123922 Device Name: syngo® Dynamics (Version VA10A) Indications for Use: syngo® Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting. As a Cardiology PACS and information system, syngo® Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments. syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) # Sean M. Boyd -S (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K123922 510(k) Page 1 of