SYNGO DYNAMICS VERSION 7.0

{0}------------------------------------------------ ### 510(k) Summary APR 2 5 2008 syngo® Dynamics (version 7.0) Date of Summary Preparation: March 28, 2008 # This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. #### General Information 1. # Specification Developer and Manufacturer Name and Address Siemens Medical Solutions USA, Inc. 400 West Morgan Road Ann Arbor, MI 48108 # Establishment Registration Number 1836549 #### 2. Contact Person Sieglinde Nina West Sr. Manager, Regulatory Affairs and Quality | Telephone: | (734) 205-2423 | |----------------|----------------------------| | Fax: | (734) 998-0123 | | email Address: | sieglinde.west@siemens.com | #### Device Name and Classification 3. | Trade Name: | syngo® Dynamics<br>Version 7.0 | |-----------------------|---------------------------------------------| | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Number: | 21 CFR §892.2050 | | Device Class: | Class II | | Product Code: | LLZ | {1}------------------------------------------------ # 4. Device Description This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 7.0. syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, MRI and xray angiography machines. The system has workplaces that can be irsend to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo® Dynamics new release focuses on advanced support for cardiology users. Reporting will be enhanced with the option of interactive coronary artery diagrams or the revised cardiac wall motion scoring model. Also, syngo Dynamics 7.0 will add support for CR and DR image types. Version 7.0 contains extended features for existing reporting functionality including hemodynamic data import from selected third party devices, easier serviceability and a flexible operating system support. syngo® Dynamics is a software device that is shipped as a turn key server system with pre-installed server software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers. The workstation with full viewing and report generation functionality is offered "software only" i.e. it will be delivered on CD or DVD media and installed bnothe end user or by a Siemens service engineer on the user's own computer hardward your #### 5. Intended Use syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngat Dynamics is not intended to be used for reading of mammography images, #### 6. Substantial Equivalence The syngo® Dynamics version, addressed in this premarket modification, is substantially equivalent to the following commercially available devices: | Predicate Device Name and<br>Manufacturer | 510(k)<br>Number | Clearance<br>Date | Product<br>Code | |-----------------------------------------------------------|------------------|-------------------|-----------------| | syngo Dynamics 6.0<br>Siemens Medical Solutions USA, Inc. | K070322 | 02/27/2007 | LLZ | | syngo Dynamics 5.0<br>Siemens Medical Solutions USA, Inc. | K053133 | 12/05/2005 | LLZ | | Centricity<br>GE Healthcare Integrated IT Solutions | K063628 | 12/26/2006 | LLZ | {2}------------------------------------------------ ### Summary of Technological Characteristics of the Principal Device as 7. Compared with the Predicate Device The syngo® Dynamics server is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. The workstations with full viewing and report generation capability are delivered "software only" i.e. on CD-/DVD-media and installed by the end user on his own computer hardware. This software-only delivery mechanism does require that the customer's computer hardware meet defined requirements. syngo® Dynamics servers use the Microsoft Windows 2003 Server operating system. The workplaces operate on the Microsoft Windows XP or the Microsoft Vista operating system. The herewith described syngo® Dynamics supports DICOM-formatted images and structured report objects. syngo® Dynamics 7.0 release adds multi-vendor hemodynamic data import, provides the option to use for reporting purpose interactive diagrams and enhanced measurements and calculations. It improves clinical reporting for many departments with its "smart" generated report text and supports customer specific workflow with the reports in formats suitable for delivery to a HIS, RIS or CIS repository. #### General Safety and Effectiveness Concerns 8. The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development and verification and validation testing. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practices and standards. #### 9. Conclusion as to Substantial Equivalence In summary, Siemens is of the opinion that syngo® Dynamics 7.0 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices. S. Vila. Cust Sieqlinde Nina West Sr. Manager, Regulatory Affairs and Quality 3/28/08 Date {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## APR 2 5 2008 Siemens Medical Solutions c/o Mr. Stefan Preiss TUV SUD America Inc. 1775 Old Highway 8 NW, Suite 104 NEW BRIGTON MN 55112 Re: K081018 Trade/Device Name: syngo® Dynamics (version 7.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: March 28, 2008 Received: April 10, 2008 Dear Mr. Preiss: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {4}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter. | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html. Sincerely vours. Nancy Cbrogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ### Indications for Use 510(k) Number (if known): _ _ C 08 /0 (8 Device Name: syngo® Dynamics (version 7.0) Indications for Use: syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngo® Dynamics is not intended to be used for reading of mammography images. ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use *X* (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K081018 Special 510(k) Siemens Medical Solutions USA, Inc. syngo® Dynamics Confidential