4D INTEGRATED TREATMENT CONSOLE

{0}------------------------------------------------ # VARÍAN Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com JAN 27 2014 medical systems ### 4DITC 510(k) Summary as required by 21 CFR 807.92 | Submitter's Name: | Varian Medical Systems<br>3100 Hansen Way, M/S C-255<br>Palo Alto, CA 94304 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Phone: 650.424.5731<br>Fax: 650.842.5040 | | Contact Name: | Peter J. Coronado<br>Director, Regulatory Affairs<br>submissions.support@varian.com | | Date Prepared: | October 28, 2013 | | Trade Name: | 4D Integrated Treatment Console | | Common Name: | 4DITC | | Classification Name: | Medical charged-particle radiation therapy system<br>21 CFR 892.5050<br>Class II, Product Code MUJ | | Predicate Device: | Varian Medical Systems, Inc., 4D Integrated Treatment<br>Console (k091132) | | Device Description: | The 4D Integrated Treatment Console (4DITC) allows the<br>user to retrieve treatment plans and images from the<br>Oncology Information System (IS) and send the plan and<br>images to the Treatment Console System (TCS). The<br>planned treatment parameters from the OIS are verified<br>against the TCS delivery parameters for accuracy. All<br>treatment parameters on the TCS must match the treatment<br>parameters on the 4DITC before treatment can be delivered.<br>After the treatment has been completed for the session, the<br>user closes the session and treatment history is sent to the<br>OIS to be recorded. The recorded treatment history can then<br>be displayed and reviewed in the OIS. | The 4D Integrated Treatment Console has been modified to support additional treatment tasks and import/export interfaces. The following chart shows the new features as well as two features that have been removed in version 13. 1 . . {1}------------------------------------------------ Varian Medical Systems, Inc. 3100 Hausen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 ww.varian.com medical systems VARŽAN Technological Characteristics: Changes to the predicate devices are listed in the below table: | Features | Predicate Device<br>4DITC (v8.8)<br>K091132 | Modified Device<br>4DITC (v 13) | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General description | The 4D Integrated Treatment<br>Console (4DITC) is designed to<br>allow treatment plans and images<br>to be retrieved from the Oncology<br>Information System (OIS) and<br>sent to the Treatment Console<br>System (TCS), planned treatment<br>plan parameters to be verified<br>against the TCS delivery<br>parameters for accuracy and<br>treatment history to be recorded<br>in the OIS for use and display. | The 4D Integrated Treatment<br>Console (4DITC) is designed to<br>allow treatment plans and<br>images to be retrieved from the<br>Oncology Information System<br>(OIS) and sent to the Treatment<br>Console System (TCS), planned<br>treatment plan parameters to be<br>verified against the TCS delivery.<br>parameters for accuracy and<br>treatment history to be recorded<br>in the OIS for use and display. | | Indications for Use/Intended Use | The 4D Integrated Treatment<br>Console is designed to assist the<br>operator of a radiation therapy<br>device in providing accurate<br>treatment setups for each patient<br>by monitoring setup parameters<br>and preventing the radiation<br>therapy device from commencing<br>irradiation when any parameter is<br>out of conformance with the<br>treatment plan | The 4D Integrated Treatment<br>Console provides assistance for<br>accurate treatment delivery by<br>monitoring linear accelerator<br>parameters and preventing the<br>radiation therapy device from<br>commencing irradiation when<br>any parameter is out of<br>conformance with the treatment<br>plan | | General Usage | | | | Imaging Only Sessions | No | Yes | | Ad hoc kV imaging supported | No | Yes | | Support the saving of<br>Acquisition Module images in<br>QA Mode | No | Yes | | Conical Collimator support | Yes | Yes, Barcode Conical Collimator<br>Verification (BCCV) and<br>Integrated Conical collimator<br>Verification & Interlock system<br>(ICVI) | | Bolus | Yes, Barcode verification | Yes, Barcode verification and<br>Manual verification | | Gantry angle acquired for<br>treatment fields with adhoc CBCT<br>fields | Yes | No | | Support for Unplanned<br>Treatments | No. | Yes | | Support for Flattening Filter Free<br>treatments | No | Yes | | Delta couch shift | No | Yes | | Features | Predicate Device<br>4DITC (v8.8)<br>K091132 | Modified Device<br>4DITC (v 13) | | Enter in treatment notes and<br>SSD's per plan/field | No | Yes | | Support for multiple isocenters<br>with grouping in a single plan | No | Yes | | Major plan edits | Yes | No | | High Intensity Mode (HIM) Also<br>known as FFF (Flattening Filter<br>Free) | No | Yes | | UNIQUE Support | No | Yes | | Varian Volumetric Modulated Arc<br>Therapy (VVMAT vs. RapidArc<br>support) | No | Yes | | National Language Support<br>(NLS) | No | Yes | | Unicode Support | No | Yes | | Stereotactic (SRS) - Dose Limit<br>support for High Dose Technique | No | Yes | | Integrated Conical Collimator<br>Verification | No | Yes, Integrated Conical<br>Collimator Verification and<br>Interlock System (ICVI) | {2}------------------------------------------------ Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com ### Note the reasons for the removal of features: - 1. Major Plan Edits: We are no longer supporting major plan edits which were User Riahts controlled outside of Unplanned Treatment Mode. This change will assure that edits to major plan parameters occur only in the Treatment Planning/Oncology Information Planning software or in the 4D Unplanned Treatment Mode. - 2. Gantry angle acquired for treatment fields with adhoc CBCT fields: The intention of the feature was to allow the user to acquire the gantry angle on the adhoc CBCT field. The consequence was that the user could also acquire the new gantry angle for the treatment fields which is considered a major plan edit. Removing the capability to acquire the gantry angle for the treatment fields continues to allow the user to acquire the CBCT gantry angle, while honoring the Plan Edit Preferences in 4DITC Administration. ### Verification and Validation Testing Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements. Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel. {3}------------------------------------------------ K133331 page 4 of 4 ## VARŽAN medical systems ### 3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com Varian Medical Systems, Inc. ### Verification &Validation Summary Report Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human figure or a bird-like shape. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002 January 27, 2014 Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304 Re: K133331 Trade/Device Name: 4d Integrated Treatment Console Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: October 28, 2013 · Received: October 29, 2013 Dear Mr. Coronado: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. {5}------------------------------------------------ Page 2 - Mr. Peter J. Coronado . . . .. .. .. . If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Richard D. O'Hara Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ### Indications for Use 510(k) Number (if known): K133331 Device Name: 4D Integrated Treatment Console (4DITC) Indications For Use: The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Michael D. O'Hara (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Page 1 of _ 1 __ K133331 510(k)