SYNGO IMAGING CCF VA10A

{0}------------------------------------------------ K073418 # FEB 2 9 2008 ## 510(k) Summary 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. ### I. GENERAL INFORMATION Establishment: | Address: | Siemens AG, Medical Solutions<br>Henkestrasse 127<br>D-91052 Erlangen<br>Germany | |---------------------------------|----------------------------------------------------------------------------------------------------------------| | Registration Number: | 3002808157 | | Contact Person: | Sabine Schroedel<br>Regulatory Affairs Manager<br>Telephone: +49 (9131) 84-8285<br>Telefax: +49 (9131) 84-2792 | | Device Name and Classification: | | | • Trade Name: | syngo® Imaging<br>CCF_VA10A | | • Classification Name: | Picture Archiving and Communications System | | • Classification Panel: | Radiology | | • CFR Section: | 21 CFR §892.2050 | | • Device Class: | Class II | | • Product Code: | LLZ | ### II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION #### . Device Description and Intended Use: This premarket notification addresses the Siemens syngo-based Picture Archiving and Communication System syngo® Imaging CCF VA10A. syngo Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis. {1}------------------------------------------------ It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space. All lossy compressed images are displayed with warning triangles to indicate that the images are not suitable for diagnosis. In DICOM transfers, the respective compression related DICOM attributes are filled. In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows. The system is a "hardware independent" solution to be distributed combined with common IT hardware which must comply to predefined minimum hardware requirements. syngo® Imaging CCF VA10A supports the following additional features: - NAS based central enterprise storage of 10x compression 배 - . Data replication between sites in a multisite environment - 트 Automatic data reconciliation (in synch with information systems) - 프 Client redirectin - for high availability and to enable cross reading - Enterprise patient context (multi MRN support) - 의 Comprehensive server performance monitoring Basically these functionalities do not alter the fundamental scientific technology of syngo® Imaging CCF VA10A. ### syngo® Imaging Data Management ... ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy. The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports. For PACS server the syngo® Imaging CCF VA10A Data Management can be used as a DICOM-Archive (LTS Long-term Storage) in accordance with the DICOM Conformance Statement. ### Integration: The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the syngo® Imaging CCF VA10A PACS a consistent workflow - from patient registration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks. {2}------------------------------------------------ #### Technological Characteristics: . syngo® Imaging (CCF VA10A) is a "software plus hardware"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of common IT hardware and preinstalled software. syngo® Imaging CCF_VA10A will be installed by Siemens service engineers. Defined Hardware requirements are to be met. The backend communication and storage solution (DM) is based on LINUX and Windows 2003 operating system. The workplaces are based on Windows XP. Any hardware platform, which is Windows / Windows XP certified, will be supported. The herewith described syngo® Imaging (CCF VA10A) supports DICOM formatted images and objects. #### t General Safety and Effectiveness Concerns: The device labelling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device. Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards. #### t . Substantial Equivalence: The syngo® Imaging CCF VA10A, addressed in this premarket notification, is substantially equivalent to the following commercially available devices: | Siemens | syngo Imaging | K071114 | |---------|-------------------------------------------|---------| | Siemens | SIENET MagicWeb (Web Server), MagicLink I | K973131 | The syngo® Imaging CCF VA10A described in this 510(k) has the same intended use and similar technical characteristics as the devices listed above in regard to the specific functionalities. In summary, Siemens is of the opinion that syngo® Imaging CCF VA10A does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 FEB 2 9 2008 Siemens AG, Medical Solutions % Mr. Stefan Preiss TUV SUD America, Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891 Re: K073418 Trade/Device Name: syngo® Imaging CCF VA10A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2008 Received: February 14, 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 (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/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars at the bottom of the logo. Protecting and Promoting Public Health. {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" (21 CFR 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 C. Brogdon 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): Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: syngo Imaging CCF is a Picture Archiving and Communication System intended for enterprise wide storage, archiving and distribution of digital radiology images and reports to clinical personnel for viewing of current and prior studies. It is not intended for primary diagnosis. It offers the possibility to store the images in uncompressed/lossless compressed and lossy compressed format depending on modality specific configuration to optimize usage of storage space. All lossy compressed images are displayed with warning triangles to indicate that the images are not suitable for diagnosis. In DICOM transfers, the respective compression related DICOM attributes are filled. In a comprehensive imaging suite, syngo Imaging integrates hospital information systems (HIS) to enable customer specific workflows. × Prescription Use (Part 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) (Please do not write below this line - continue on another page if needed) ーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー Concurrence of the CDRH, Office of Device Evaluation (ODE) 510(k) for syngo® Imaging CCF VA10A October 22nd, 20 Page A 2 l (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K073418