VISAGE PACS/CS, RELEASE VERSION 5.0

{0}------------------------------------------------ K072205 Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 August 22, 2007 United States of America # E. 510(k) Summary AUG 2 9 2007 # E.1 Company Identification Company Contact: Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 United States of America Registration No : 3000131217 9040273 Owner/Operator No.: # E.2 Official Correspondent | Name/Contact: | David Quimby | |---------------|---------------------------| | | 199 Riverneck Road | | | Chelmsford, MA 01824-2820 | | | United States of America | | | Tel.: 978-967-1699 | | | Fax: 978-256-0588 | # E.3 Date of Submission August 22, 2007 # E.4 Device Name | Trade name: | VISAGE PACS/CS | |-------------------------|----------------------------------------------------------------------------------------------------------------------------| | Release Version: | 5.0 | | Common name: | VISAGE PACS/CS | | Classification Name: | Picture Archiving and Communications System | | Reference: | per 21 CFR 892.2050 | | Class: | II | | Review Panel: | Radiology | | Product Classification: | 90 LLZ, Picture Archiving and Communications System | | Previous 510(k) No.: | K062490 | | Guidance document: | Guidance for the submission of premarket notifications for<br>medical image management systems (issued on July 27<br>2000) | # E.5 Substantial Equivalence The Visage PACS/CS 5.0 Software is substantially equivalent, in the opinion of Mercury Computer Systems Inc., to: Trade name: AquariusNet Server/Thin client K012086 510(k) No.: {1}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 August 22, 2007 United States of America Picture Archiving and Communications System Classification Name: per 21 CFR 892.2050 Reference: Class: II Review Panel: Radiology 90 LLZ, Picture Archiving and Communications System Product Classification: TeraRecon, Inc. Manufacturer: 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 USA # E.6 Device Description Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components: - Visage PACS Storage 1 - -Visage PACS Web - Visage CS - ### Visage PACS Storage A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. The modalities that are supported by Visage PACS Storage are listed in the DICOM Conformance Statement. Visage PACS Storage offers an archiving option for long-term storage of image data. Only the data consistency on archive media is guaranteed, the system provider has to take own appropriate means (e.g. redundancy) for safety against data loss caused by media destruction. Without the archiving option, the Visage PACS system features no components for long-term data archiving. Additional archiving on film or in digital form is therefore necessary. ### Visage PACS Web Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients. The image data transfer is done in DICOM format via the Intranet or the Internet, for example to stations located in a doctor's office, throughout hospitals or a physician's home. Strong data encryption is provided (SSL) to ensure a secure data transfer. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page. ### Visage CS Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. It remains on the 3D Application Server at any time, ensuring safe and consistent access to large 3D data throughout the hospital enterprise. Instead of image data, a stream of compressed screen content information is transmitted during interaction. {2}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 #### August 22, 2007 United States of America If Visage CS is used in un-secure networks (e.g. WAN) third party VPN (Virtual Private Network) solutions have to be used to secure the data transfer between the Visage Server and the client machines. ### E.6.1 Description of Modification This is to describe the significant changes associated with the implementation of the cardiac analysis option. With the new version of the software the user can import cardiac CT time series in order to utilize them for the LV analysis (analysis of the left ventricle). The LV analysis tool card helps with the analysis of the left ventricle in cardiac CT time series, which show the heart in various phases of one heart beat. This toolcard quides the user through an LV analysis step by step. After the user has completed the last step the LV Results tool card is displayed as a floating window. The user can review his/her results now and export them to a report. The LV tools support the physician in finding the left ventricle in the image data. The LV tool card supports the user to find and display the long and short axes of the left ventricle and to segment the left ventricle. It supports the user to calculate the total volume of the left ventricle over one heart cycle, the stroke volume and the ejection fraction of the various LV regions and the accumulated wall motion. ### E.7 Intended Use Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components: Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data. Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients. Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-ofthe-art scanning modalities. Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography. # E.8 Substantial Equivalence Comparison Chart Annotation: {3}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Cheimsford, MA 01824-2820 # Our Visage product line consists of 2D Web based PACS software and a separate 3D Visage Server and Thin Clients to give the end user a complete 2D/3D PACS experience. Substantial Equivalence comparison chart regarding the modification: | | SE-DEVICE | | PREDICATE DEVICES | |------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------|-----------------------------------| | Product | Visage PACS/CS 5.0 | Visage PACS/CS 4.1 | AquariusNet<br>Server/Thin client | | Company Name | Mercury Computer<br>Systems, Inc. | Mercury Computer<br>Systems, Inc. | TeraRecon, Inc. | | 510 (k) number | TBD | K062490 | K012086 | | New Features in<br>Version 5.0 | | | | | Cardiac Analysis<br>Option | | | | | Volume measure-<br>ments | Yes | No | Yes | | Semi-automatic<br>coronary artery<br>segmentation | Yes | No | Yes | | Coronary artery<br>navigation and<br>measurement | Yes | No | Yes | | Functional analysis<br>of the left ventricle<br>(wall motion, ejec-<br>tion fraction) | Yes | No | Yes | | Additional Fea-<br>tures | | | | | Vessel segmenta-<br>tion tool with in-<br>creased specificity<br>and improved per-<br>formance | Yes | No | Yes | | Fusion and side-by-<br>side registration as<br>separate concepts | Yes | No | Yes | | Pixel probing sup-<br>port in fusion mode | Yes | No | Yes | | Change of algo-<br>rithm for curved<br>slices | Yes | No | Yes | | Automatic genera-<br>tion of thick slices | Yes | No | Yes | | Improved bone<br>removal for CT<br>runoff studies | Yes | No | Yes | Mercury Computer Systems, Inc. {4}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 #### August 22, 2007 United States of America | Product | SE-DEVICE | PREDICATE DEVICES | | |------------------------------------------------------------------------------|--------------------|--------------------|-----------------------------------| | | Visage PACS/CS 5.0 | Visage PACS/CS 4.1 | AquariusNet<br>Server/Thin client | | Changed curved<br>planar reformat<br>(CPR) viewer | Yes | No | Yes | | Changed lumen<br>view | Yes | No | Yes | | 4D cardiac CT data<br>support | Yes | No | Yes | | Coronary artery<br>navigation and<br>measurement | Yes | No | Yes | | Automatic<br>short/long axis view | Yes | No | Yes | | Semi-automatic<br>segmentation of left<br>ventricle and coro-<br>nary artery | Yes | No | Yes | | Functional analysis<br>of left ventricle | Yes | No | Yes | | Volume measure-<br>ment | Yes | No | Yes | | Remaining feature as from K062490 see complete table in U.1 | | | | # E.9 Safety and Effectiveness ### E.9.1 General Safety and Effectiveness Concerns VISAGE PACS/CS is a medical device that is to be used by trained health care professionals who are responsible for the correct and accurate use of medical images e.g. as a means for providing diagnosis. The device labeling contains instructions for use and the intended use/indications for use. Warnings, faults etc are explained in the user's manual. Data that are compressed are properly identified in the image information as being compressed as specified by the DICOM standard. This compression identification remains with the image for the entire life of the image. The correctness of the compression 30 party software is validated by the testing routine for 30 party components during the system/integration test. # E.9.2 Validation and Effectiveness The VISAGE PACS/CS 5.0 risk analysis has been performed to identify all potential safety or health hazards during system operation. The hazards are controlled by a risk management plan, including hazard analysis, verification and validation tests (according to our software development process) and evaluations by hospitals. {5}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 ### August 22, 2007 United States of America According to our risk analysis and risk management there are no software components within the VISAGE PACS/CS 5.0 Software, whose failure or latent design flaw would be expected to result in death or injury to a patient. Requirement tracing covering specification, design, implementation and verification/validation ensures the fulfillment of all phase requirements, EHR and DMR ensures direct access to all documents. Integration test plan defines full testing at integration and system testing level. According to this test plan integration and system testing including full testing of hazard mitigation has been performed. Decision Reviews at the conclusion of each software development phase ensure the fulfillment of the phase results and the validity of the Intended Use and the risk analysis. Testing is an integral part of our Software Design Process. ### E.9.3 Substantial Equivalence Any differences between the VISAGE PACS/CS 5.0 Software and the substantially equivalent device have no significant influence on safety and effectiveness. ### E.9.4 Technological characteristics VISAGE PACS/CS is a stand-alone software package used on general purpose hardware, as long as the minimum hardware requirements specified in the manuals are met. It is based upon standard Microsoft™ technology. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information delivered by VISAGE PACS/CS. ### E.9.5 Conclusion We believe that the 510(k) premarket notification contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device. VISAGE PACS/CS has been and will be manufactured in accordance with the mandatory and voluntary standards listed in this submission. This submission contains the result of the hazard analysis and all potential hazards have been classified as minor. Mercury Computer Systems, Inc. {6}------------------------------------------------ Image /page/6/Picture/11 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads 'Department of Health & Human Services USA' in a circular arrangement. The central graphic consists of three curved lines that appear to represent stylized human figures or flowing water, creating a sense of movement and connection. # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Mercury Computer Systems, Inc. c/o Martin Gabler Prosystem AG BEIM STROHHAUSE 27 HAMBURG, GERMANY 20097 AUG 2 9 2007 Re: K072205 VISAGE PACS/CS 5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 6, 2007 Received: August 8, 2007 Dear Mr. Gabler: 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/6/Picture/10 description: The image shows a logo with the text "FDA Centennial" and the years "1906-2006" in a circular design. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a smaller font. Three stars are arranged beneath the word "Centennial". {7}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Nat FDA has made a determination that your device complies with other requirements of the Act that I Drines made a and regulations administered by other Federal agencies. You must or any I 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 forul in and quants bysteins (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) I his letter notification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated 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 if you dosn't spother 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 (21 CF I T at 00 : 77). " roof 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/cdrl/industry/support/index.litml. Sincerely vours. Nancy C Hodgon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Mercury Computer Systems, Inc. 199 Riverneck Road Chelmsford, MA 01824-2820 August 22, 2007 United States of America # D. Statement of Indications for Use 510(k) Number (if known): _ Device Name: VISAGE PACS/CS 5.0 Indications for Use: Visage PACS is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components: Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data. Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients. Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces. Only DICOM for presentation images can be used on an FDA approved monitor for mammography for primary image diagnosis. Only uncompressed or non-lossy compressed images must be used for primary image diagnosis in mammography. | Prescription Use (Part 21 CFR 801 Subpart D) | X | |----------------------------------------------|---| |----------------------------------------------|---| AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | | |---------------------------------------------|--| |---------------------------------------------|--| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) JWhang | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Reproductive, Abdominal and | | | Radiological Devices | | | 510(k) Number | K072265 | Page 1 of 1 Mercury Computer Systems, Inc. D-1