VISION (WITH OFF-LINE REVIEW)

{0}------------------------------------------------ 510(k) Summary K052391 The following information is provided following the format of 21CFR 807.92 for Vision™ with Off-Line Review feature. NOV 2 3 2005 - 1. Submitter: Varian Medical Systems 3100 Hansen Way M/S E110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: August 29, 2005 ### 2. Name of Device: Trade/Proprietary name: Vision™ (with Off-Line Review) Common or Usual Name: Image Database Classification Name: Radiological Image processing system 21CFR §892.5840 Class II Product Code: 90 LLZ - 3. Predicate Device: Vision™, K042956 #### 4. Description of the Device: The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, and to perform quality assurance of the treatments, i.e., to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, treatment plan definition, manipulation and scheduling. The Vision device (K042956) has been modified to introduce a module called Offline Review. Off-line Review allows the authorized user to review treatment images and provide capabilities to do quantitative image matching in order to define patient setup corrections for subsequent treatments, such as, Port Image Review: 2D/3D kV image matching, match Field Edges Plot, match Structures, Related Images; Manual / Automatic anatomy match; Statistics/Trends visualization of match results; export of patient setup correction data and entry for patient setup corrections for subsequent patient positioning and comments to images. {1}------------------------------------------------ The Vision device is based on the client-server architecture, and thus all Vision clients/workstations load data from and store data to the common database. The database server provides data storage for other software products developed by Varian Medical Systems, Inc. (e.g., Eclipse, Acuity, PortalVision, and VARiSVision). #### 5. Intended Use Statement: The Vision product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, and plan verification and treatment. Vision also stores the treatment histories including dose delivered to defined sites, and provides tools to verify performed treatments. - 6. Summary of Technological Characteristics: The Substantial Equivalence Comparison chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Tab 8 of the submission. {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038 Re.: K052391 NOV 2 3 2005 Trade/Device Name: Vision™ (with Off-Line Review) Regulation Number: 21 CFR 892.5050 21 CFR 892.5840 Regulation Name: Medical charged-particle radiation therapy system; Radiation therapy simulation system Regulatory Class: II Product Code: IYE; KPQ Dated: August 29, 2005 Received: August 31, 2005 Dear Ms. Tran: 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 (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 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); 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. Image /page/2/Picture/11 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, stacked on top of each other. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I his icler with anow you'ts oogin mannelling of substantial equivalence of your device to a legally premarked predication: "The I Dr. missification 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 desire specific acriee tor your de 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 Also, production other general information on your responsibilities under the Act from the 007.777. I va may ooum barees, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. hogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known): Device Name: Vision™ with Off-Line Review Indications For Use: Vision is designed to assist the radiation therapy staff to prepare and approve treatment plans, vision is dosigned to abservate of the treatments, i.e. to follow-up the delivered treatments and dose to the defined sites. The preparation tasks include image acquisition, viewing and manipulation, and treatment plan definition, manipulation and scheduling. Prescription Use (Part 21 CFR 801 Subpart D) 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) Daniel h. Dyson livision Sig 510(k) Number (Optional Format 3-10-98) -