Varian Medical Systems · Class II · Cleared Dec 11, 2024
| K-number | K242378 |
| Device name | Eclipse Treatment Planning System (18.1) |
| Applicant | Varian Medical Systems |
| Product code | MUJ |
| Device class | Class II |
| Decision date | Dec 11, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 892.5050 |
The Eclipse Treatment Planning System (v18.1) is a software tool used by medical professionals to plan radiation therapy treatments for patients with malignant or benign diseases. It designs and simulates external beam radiation therapy using photon, electron, and proton beams, as well as internal radiation (brachytherapy) treatments.
The v18.1 subject device adds new features compared to the predicate v18.0: RapidScan (integrated proton therapy solution with enhanced planning control), RapidArc Dynamic (improved optimization algorithm combining static gantry angle modulation with VMAT), support for multiple institutions, enhanced calibration curve support, enabling volume of interest for Proton AcurosPT, AcurosPT SFO dose optimization, and Plan Checker. Non-significant changes include enabling Proton ESAPI intermediate dose, RT Peer Review updates, and core algorithm updates.
ISO 14971:2019 (risk management), ISO 15223-1:2021 and ISO 20417:2021 (labeling), IEC 62304:2006+A1:2016 (software lifecycle), IEC 62366-1:2015+A1:2020 (usability engineering), IEC 62083:2009 (radiotherapy treatment planning system safety), IEC 61217:2011 (radiotherapy equipment coordinates), AAMI RT2:2017 (radiation therapy readiness), and UL ANSI 2900-1:2017 and 2900-2-1:2017 (cybersecurity standards).
Although v18.1 includes new software features and enhancements, the principle of operation remains identical to the predicate device v18.0. Both systems perform the same fundamental function of planning radiation treatments using the same modalities (photon, electron, proton, brachytherapy). Software verification and validation testing through unit, integration, and system-level testing demonstrated that new features are comparable to the predicate via measurement comparison tests (Gamma evaluation), plan comparisons using clinical objectives, and workflow testing. These tests confirmed conformance to applicable requirements and specifications, establishing that the subject device is as safe and effective as the predicate.
View the full FDA submission: accessdata.fda.gov