Eclipse Treatment Planning System (18.1)

{0}------------------------------------------------ December 11, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that. Varian Medical Systems Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 64304 Re: K242378 Trade/Device Name: Eclipse Treatment Planning System (18.1) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: August 9, 2024 Received: August 9, 2024 Dear Lynn Allman: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See {2}------------------------------------------------ the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Locon Weidner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K242378 Device Name Eclipse Treatment Planning System (18.1) Indications for Use (Describe) The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal radiation (brachytherapy) treatments. Type of Use (Select one or both, as applicable) > 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." {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the Varian logo, which is a black, bold, sans-serif font. Below the logo, in a smaller font, it says "A Siemens Healthineers Company". At the top of the image, it says "1 of 4", indicating that this is the first image in a series of four. # Premarket Notification - 510(k) Summary Traditional 510(k) Submission for Eclipse Treatment Planning System v18.1 ## Legally Marketed Equivalent Device (Predicate) | Product: | Eclipse Treatment Planning System v18.0 | |----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number: | K230557 | | Intended Use: | The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy<br>treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan<br>external beam irradiation with photon, electron and proton beams, as well as for internal<br>radiation (brachytherapy) treatments. | There is no change in intended use between the predicate and subject device. - l. Submitter's Name Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304 Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: August 9, 2024 #### ll. Device Information Proprietary Name: Eclipse Treatment Planning System v18.1 Classification Name: Medical charged-particle radiation therapy system Regulation Number: §892.5050 Product Code: MUJ #### III. Predicate Device Eclipse Treatment Planning System v18.0 (K230557) #### IV. Device Description Eclipse provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. It is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments. Eclipse is used for planning external beam radiation therapy treatments employing photon energies between 1 and 50 MV, electron energies between 1 and 50 MeV, for proton energies between 50 and 300 MeV, and for planning internal radiation (brachytherapy) treatments with any clinically approved {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the Varian Medical Systems logo, which is a black, bold, sans-serif font. Below the logo, in a smaller font, it says "A Siemens Healthineers Company". At the top of the image, it says "2 of 4". radioisotope. The treatment planning system utilizes a patient model or virtual patient derive from medical imaging techniques to simulate, calculate and optimize the radiation dose distribution inside the body during a treatment procedure in order to ensure effective treatment of the tumor but to minimize damage to surrounding tissue. #### V. Comparison of Technological Characteristics with the Predicate Device The modified device, referred to as the "subject device" throughout this summary, is release version v18.1 (version 18.1) of the Eclipse Treatment Planning System with additional software changes incorporated since the release version of the predicate device, version 18.0 (K230557). At a high level, both the predicate device and the subject device are based on the same characteristics: - Both the subject device and the predicate provide software tools for planning the treatment of ● malignant or benign diseases with radiation. - They are computer-based software devices used by trained medical professionals to design and simulate radiation therapy treatments. - They are both capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments. RapidScan and RapidArc Dynamic are new features and are described below: - RapidScan: RapidScan is an integrated proton therapy solution between Eclipse Treatment Planning System and ProBeam Proton Delivery System. It offers control over more parameters during treatment planning and provides enhanced feedback on plan quality and field-wise delivery times. - RapidArc Dynamic: RapidArc Dynamic is an improved optimization algorithm that enables the benefits of a dynamic collimator, directional control of IMRT and efficiency of VMAT in a single solution. RapidArc Dynamic allows static gantry angle modulation to be incorporated with VMAT using a single optimization algorithm, increasing the quality of the plan while minimally impacting planning and treatment delivery time compared to VMAT only treatments. The changes being addressed in this 510(k): - Significant changes - o RapidArc Dynamic - o RapidScan - o Support of Multiple Institutions - O Enhanced calibration curve support - o Enabling volume of interest for Proton AcurosPT - O AcurosPT SFO dose optimization - Plan Checker o - Non-significant changes - Enabling Proton ESAPI intermediate dose O - O Updates to RT Peer Review - Core algorithm updates O {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the Varian Medical Systems logo, which is a black, bold, sans-serif font. Below the logo, in a smaller font, it says "A Siemens Healthineers Company". Above the logo, it says "3 of 4". #### VI. Summary of Performance Testing (Non-Clinical Testing) The following performance data was provided in support of the substantial equivalence determination. ## Software Verification and Validation Testing: 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 this device was considered as a "major" level of concern. Cybersecurity and Interoperability requirements were assessed per FDA guidance's "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023)", "Postmarket Management of Cybersecurity in Medical Devices (Jan 2016)", "Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices (Jan 2016)". Testing of new features in Eclipse TPS 18.1 followed a multi-level test approach, through unit, integration, and system (end-to-end) level testing. Testing to support that new features in Eclipse TPS 18.1 are comparable to the predicate device was performed through measurement comparison tests using Gamma evaluation criteria, plan comparisons using clinical objectives and workflow testing. Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this pre-market submission. ### Use of Consensus Standards: The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy. | ISO 14971:2019 | Medical devices - Application of risk management to medical devices | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and<br>information to be supplied - Part 1: General requirements | | ISO 20417:2021 | Information supplied by the manufacturer of medical devices | | IEC 62304:2006 + A1:2016 | Medical Device Software - Software Lifecycle processes | | IEC 62366-1:2015+A1:2020 | Application of Usability Engineering to Medical Devices | | IEC 82304-1:2016 | Health software Part 1: General requirements for product safety | | AAMI RT2:2017 | Radiation Therapy Readiness Check | | IEC 61217:2011 | Radiotherapy Equipment, Coordinates, Movements and Scales | | IEC 62083:2009 | Medical electrical equipment – Requirements for the safety of radiotherapy<br>treatment planning systems | | UL ANSI 2900-1:2017 | Standard for Software Cybersecurity for Network-Connectable Products, Part 1:<br>General Requirements | | UL ANSI 2900-2-1:2017 | Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular<br>Requirements for Network Connectable Components of Healthcare and Wellness<br>Systems | {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the Varian logo, which is a black, bold, sans-serif font. Below the logo, in a smaller font, it says "A Siemens Healthineers Company". At the top right corner of the image, it says "4 of 4". | IEC 81001-5-1:2021 | Health Software and Health IT Systems Safety, Effectiveness and Security - Part 5-1 | |--------------------|-------------------------------------------------------------------------------------| | | Security - Activities In The Product Life Cycle | #### VII. Determination of Substantial Equivalence to the Predicate A subset of software features and characteristics of the subject device are different from the predicate device. However, Varian considers these differences to be enhancements of the predicate. The principle of operation of the subject device is the same as that of the existing predicate device. Verification and validation demonstrate that the subject device is as safe and effective as the predicate. Varian therefore believes that the subject device is substantially equivalent to the predicate device.