SYNGO DYNAMICS, VERSION 6.0

{0}------------------------------------------------ K070322 ## 510(k) Summary ## syngo® Dynamics (version 6.0) Date of Summary Preparation: February 23rd, 2007 FEB 27 2007 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92. ### 1. General Information # Specification Developer and Manufacturer Name and Address Siemens Medical Solutions, Inc. 400 W. Morgan Road, Suite 100 Ann Arbor, MI 48108 # Establishment Registration Number 1836549 ### Contact Person 2. Sieglinde Nina West Sr. Manager, Regulatory Affairs and Quality | Telephone: | (734) 205-2423 | |----------------|----------------------------| | Fax: | (734) 998-0123 | | email Address: | sieglinde.west@siemens.com | #### 3. Device Name and Classification | Trade Name: | syngo® Dynamics<br>Version 6.0 | |-----------------------|---------------------------------------------| | Classification Name: | Picture Archiving and Communications System | | Classification Panel: | Radiology | | CFR Number: | 21 CFR §892.2050 | | Device Class: | Class II | | Product Code: | LLZ | {1}------------------------------------------------ ### ব Device Description This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 6.0. 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 and x-ray anglography machines. The system has workplaces that can be used to review, edit, and masinilate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to launch 3rd party software applications either as stand alone application or via Internet Explorer, syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngg® Dynamics is installed by Siemens service engineers. Version 6.0 contains extended features for cardiac cath viewing and reporting as well as for cardiac echo reporting. Further on syngo® Dynamics 6.0 includes enhanced integration of the Siemens Sequoia Ultrasound Product and the Siemens Axiom Sensis product for reporting in the cath lab environment. syngo® Dynamics, version 6.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware. ## 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. synggo Dynamics is not intended to be used for reading of mammography images, ## 6. Substantial Equivalence The syngo® Dynamics, 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<br>Siemens Medical Solutions, Inc | K053133 | 12/05/2005 | LLZ | | Xcelera<br>Philips Medical Systems North America<br>Company | K061995 | 09/06/2006 | LLZ | {2}------------------------------------------------ ### Summary of Technological Characteristics of the Principal Device as 7. Compared with the Predicate Device syngo® Dynamics is a software device that is shipped as a turnkey system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers. It is also available as a "software only" workplace with full viewing and report generation. This softwareonly 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 are based on the Microsoft Windows XP operating system. The herewith described syngo® Dynamics supports DICOM-formatted images and structured report objects. syngo® Dynamics 6.0 release adds pediatric hemodynamics, electro-physiology, and enhanced adult cath reporting. It improves clinical reporting for many departments and supports customer specific workflow. ### 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 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices. S. Moore Carr Sieglinde Nina West Sr. Manager, Regulatory Affairs and Quality 2/23/07 Date {3}------------------------------------------------ # Third Party Review Quality Assessment ### Section 1 - Submission Information | 510(k) No.: | K070322 | |------------------------------------|-----------------------------| | Third Party Organization: | TÜV Product service | | Third Party's Primary Reviewer(s): | Olaf Teichert | | ODE/OIVD Division: | DRARD | | Branch/Team: | Radiological Devices Branch | Section 2 - 510(k) Decision | Third party recommendation: | SE ", NSE ____ Other (specify): ____ | |-----------------------------|--------------------------------------| |-----------------------------|--------------------------------------| ### SE _ V___ NSE _____ Other (specify): _. ______________________________________________________________________________________________________________________________________ ODE/OIVD final decision: ### Section 3 - Assessment of Third Party Review | Review Element | Rating (check one) | | | |------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------------------|-------------------| | | Adequate | Minor<br>Issue(s) | Major<br>Issue(s) | | a. Determination of device eligibility for third party review | √ | | | | b. Extent of pre-submission consultation with ODE/OIVD division | | | | | c. Organization and format of review documentation | √ | | | | d. Determination of 510(k) administrative completeness (screening<br>review) | √ | | | | e. Summary of device characteristics, intended use, and performance<br>(including accessories, if applicable) and reason for 510(k) submission | √ | | | | f. Comparison to legally marketed devices—identification and analysis of<br>key similarities and differences | √ | | | | g. Rationale for conclusions and recommendation | √ | | | | h. Use of guidance documents and standards | √ | | | | i. Resolution of 510(k) deficiencies and FDA requests for additional<br>information | | | | | j. Scope of reviewer expertise and use of consulting reviewers | | | | | k. Other (specify): | | | | Comments (explanation of ratings/issues): ____________________________________________________________________________________________________________________________________ ### Section 4 - ODE/OIVD Assessor Information Assessed by: Sunder Rajan - Date: 21-Feb-2007 Tel. No .: 240 276 3968 Routing: Division--Clip completed assessment (this page only) to inside front cover of 510(k). DMC -- Forward this page only to Eric Rechen, POS/ODE, Rm. 120J, Corp. Blvd. (HFZ-402). {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Siemens Medical Solutions, Inc. % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891 FEB 2 7 2007 Re: K070322 Trade/Device Name: syngo® Dynamics (version 6.0) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 31, 2007 Received: February 2, 2007 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 commence prior to May 28, 1976, the enactment date of the Medical Device Ameradments, 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 (Premarket Approval), 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. Image /page/4/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006". The logo features the letters "FDA" prominently in the center, with the word "Centennial" underneath. The years "1906-2006" are displayed above the letters "FDA". The logo has a dotted border. *Protecting and Promoting Public Health* {5}------------------------------------------------ Page 2 - 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 funding 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.l1tml. Sincerely yours, Nancy Cbrogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ Indications for Use 510(k) Number (if known): _ K070322 # Device Name: syngo® Dynamics (version 6.0) Indications for Use: syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulition 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<br>(Part 21 CFR 801 Subpart D) | <u>X</u> | AND/OR | Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |-------------------------------------------------|----------|--------|------------------------------------------------| |-------------------------------------------------|----------|--------|------------------------------------------------| (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K070322 | |---------------|---------| |---------------|---------| Special 510(k)Special 510(K) Siemens Medical Solutions USA, Inc. syngo® Dynamics Confidential