Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" in blue text next to and below it. June 28, 2018 Varian Medical Systems, Inc. Peter J. Coronado Director, Regulatory Affairs 3100 Hansen Wav Palo Alto, California 94304 Re: K181404 Trade/Device Name: Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: May 25, 2018 Received: May 29, 2018 Dear Peter 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K181404 Device Name Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (MLC) Indications for Use (Describe) The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, turnors and conditions anywhere in the body when radiation treatment is indicated. The Varian Multileaf Collimator is intended to assist the clinician in the delivery of external beam radiation to defined target volumes during radiosurgery and radiotherapy while sparing surrounding normal tissue and critical organs from excess radiation. X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "varian" in a simple, sans-serif font. The letters are all lowercase and evenly spaced. The word is in black and the background is white. #### Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304 650.493.4000 800.544.4636 varian.com Image /page/3/Picture/5 description: The image contains three blue circles in a horizontal row. The circles are evenly spaced and appear to be the same size. The background is white, which makes the blue circles stand out. The image is simple and minimalist, with a focus on the geometric shapes and color. # Premarket Notification 510(K) Summary The following information is provided according to 21 CFR 807.92. | Submitter: | Varian Medical Systems, Inc.<br>3100 Hansen Way Palo Alto, CA 94304<br>Contact Name: Peter J. Coronado<br>Phone: 650.424.6320<br>Fax: 650.646.9200<br>E-mail: submissions.support@varian.com<br>Date Prepared: May 25, 2018 | | |---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade/Proprietary Names: | Varian High Energy Linear Accelerator<br>• Novalis Tx, Trilogy, Trilogy Tx<br>• Clinac iX, Clinac Cx<br>• Clinac 2100C, 2100 C/D, 2300 C/D<br>• Clinac 21 EX, 23 EX Clinac DHX, DMX<br><br>UNIQUE<br>• UNIQUE Power Edition<br>• UNIQUE Performance Edition<br><br>Varian Multileaf Collimator (MLC)<br>• Millennium 52-leaf Multileaf Collimator<br>• Millennium 80-leaf Multileaf Collimator<br>• Millennium 120-leaf Multileaf Collimator<br>• High-Definition 120 Multileaf Collimator (HD120 MLC) | | | | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator (MLC) | | | | Classification Name:<br>Medical Charged Particle Radiation Therapy System, 21 CFR §892.5050<br>Common/Usual Name:<br>Medical Linear Accelerator<br>Regulatory Class:<br>Class II<br>Product Code:<br>IYE | Predicate Devices:<br>Varian High Energy Linear Accelerator<br>(Version 9.1, K162476)<br><br>UNIQUE<br>(Version 9.1, K132705)<br><br>Varian Multileaf Collimator<br>(Version 8.0, K133240) | | Device | Varian High Energy Linear Accelerator | | | Description: | The High Energy Linear Accelerator is a radiotherapy treatment unit. The equipment consists of<br>a gantry, couch, stand and control console. The device is permanently installed. The<br>radiotherapy treatment beam is generated by a linear accelerator assembly consisting of an<br>electron gun, waveguide and collimator. | | | | All other features and technological characteristics of the Varian High Energy Linear<br>Accelerator models remain as cleared by K162476. | | | | UNIQUE | | | | The UNIQUE is a radiotherapy treatment unit. The equipment consists of a gantry, couch, stand<br>and control console. The device is permanently installed. The radiotherapy treatment beam is<br>generated by a linear accelerator assembly consisting of an electron gun, waveguide and<br>collimator.<br>All other features and technological characteristics of the UNIQUE models remain as cleared by<br>K132705. | | | | Varian Multileaf Collimator (MLC) | | | | The Varian Multileaf Collimator (MLC) is an accessory X-ray collimator designed to be mounted<br>on a Varian radiotherapy linear accelerator. The MLC head is mounted on a Varian Linear<br>Accelerator, where it shapes the radiation beam before it is delivered to the patient. The MLC<br>head is permanently bolted onto the casting that holds the X-Jaws and Y-Jaws of the Varian<br>Linear Accelerator gantry. | | | | All other features and technological characteristics of the Varian Multileaf Collimator (MLC)<br>models remain as cleared by K133240. | | | Intended/<br>Indications<br>For Use<br>Statement: | The indications for use and the intended use are identical in the subject devices as for the predicate. | | | | Varian High Energy Linear Accelerator | | | | Intended Use | Indications for Use | | | The Varian High Energy Linear Accelerator is<br>intended to provide stereotactic radiosurgery and<br>precision radiotherapy for lesions, tumors and<br>conditions anywhere in the body when radiation<br>treatment is indicated | The Varian High Energy Linear Accelerator is<br>indicated for stereotactic radiosurgery and<br>precision radiotherapy for lesions, tumors and<br>conditions anywhere in the body when radiation<br>treatment is indicated. | | | UNIQUE | | | | Intended Use | Indications for Use | | | The UNIQUE is intended to provide stereotactic<br>radiosurgery and precision radiotherapy for<br>lesions, tumors and conditions anywhere in the<br>body when radiation treatment is indicated. | The UNIQUE is indicated for stereotactic<br>radiosurgery and precision radiotherapy for<br>lesions, tumors and conditions anywhere in the<br>body when radiation treatment is indicated. | | | Varian Multileaf Collimator (MLC) | | | | Intended Use | Indications for Use | | | The Varian Multileaf Collimator is intended to<br>assist the clinician in the delivery of external<br>beam radiation to defined target volumes during<br>radiosurgery and radiotherapy while sparing<br>surrounding normal tissue and critical organs<br>from excess radiation. | The Varian Multileaf Collimator is intended to<br>assist the clinician in the delivery of external<br>beam radiation to defined target volumes during<br>radiosurgery and radiotherapy while sparing<br>surrounding normal tissue and critical organs<br>from excess radiation. | {4}------------------------------------------------ {5}------------------------------------------------ This bundled Special 510(k) submission provides detail on one significant change and its impact on three Varian devices so they could be addressed during one review: Varian High Energy Linear Accelerator. UNIQUE, and Multileaf Collimator (MLC). The indications for use and the intended use are identical in the subject devices as for the predicate. Note: The Varian High Energy Linear Accelerator and UNIQUE devices are referred to as Clinac Console and Varian Multileaf Collimator (MLC) is referred to as MLC Controller. ### Significant Difference The significant difference compared to the predicate devices is: - Architecture Change: The Clinac Console and MLC Controller has a new integrated hardware ● platform known as CCMC and the software is ported to support CCMC using VxWorks operating system The High Energy Linear Accelerator and UNIQUE Clinac Console software, C-Series version 9.5, Multileaf Collimator (MLC) software, MLC version 8.5 is ported to support the new hardware platform CCMC. The complete list of new risks and modified risks to High Energy Linear Accelerator, UNIQUE, and Varian Multileaf Collimator (MLC) are documented in "Summary of testing for Significant Change" in Section 18 of this submission. | | Device Trade Names or Proprietary<br>names | Predicate | This 510(k)<br>Submission | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------| | Varian High<br>Energy<br>Linear<br>Accelerator | Novalis Tx, Trilogy, Trilogy Tx,<br>Clinac iX, Clinac CX<br>Clinac 2100C, Clinac 2100 C/D,<br>Clinac 2300 C/D<br>Clinac 21 EX, Clinac 23 EX<br>Clinac DHX, Clinac DMX | K162476<br>(Clinac console software<br>referred to as C-Series v9.1) | Clinac Console<br>software referred<br>to as<br>C-Series v9.5 | | UNIQUE | UNIQUE Power Edition<br>UNIQUE Performance Edition | K132705<br>(Clinac console software<br>referred to as C-Series v9.1) | Clinac Console<br>software referred<br>to as<br>C-Series v9.5 | | Varian<br>Multileaf<br>Collimator<br>(MLC) | Millennium 52-leaf Multileaf Collimator<br>Millennium 80-leaf Multileaf Collimator<br>Millennium 120-leaf Multileaf Collimator<br>High-Definition 120 Multileaf Collimator<br>(HD120 MLC) | K133240<br>(MLC controller software<br>referred to as MLC v8.0) | MLC controller<br>software referred<br>to as MLC v8.5 | ### Performance Data Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for all three devices was considered as a "major" level of concern. The modified devices High Energy Linear Accelerator. UNIQUE, and Varian Multileaf Collimator (MLC) are substantially equivalent to the predicate devices K162476, K132705, and K133240 respectively. Compared with the predicate device, the basic operation and technological characteristics are the same. {6}------------------------------------------------ Operational differences are described in the Instructions for Use and accompanying user documentation. The indications for use and the intended use for each device are identical. The subject devices conform in whole or in part with standards provided in Section 09 of this submission. For those recognized standards in which there are clauses that are not applicable, Summary Reports with justifications have been included in the submission. ### Summary of Non-Clinical Tests No animal studies or clinical tests have been included in this pre-market submission. Verification testing was performed to demonstrate that the performance and functionality of the new C-Series operating system and MLC controller existing features met the design input requirements for CCMC. Regression testing was performed to verify the integrity of any changes. Validation testing was performed on production equivalent devices, under clinically representative conditions by qualified personnel. ### Conclusion The non-clinical data for CCMC supports the safety of the devices and the software verification and validation demonstrate that the subject devices should perform as intended in the specified use conditions. Varian therefore considers the High Energy Linear Accelerator, UNIQUE, and Varian Multileaf Collimator (MLC) to be safe and effective and to perform at least as well as the predicate devices.