TheraSphere 360™ Y-90 Management Platform

The TheraSphere 360 Y-90 Management Platform is a browser-based software platform that supports radioembolization treatment with TheraSphere Microspheres. It includes treatment planning and activity calculation tools to determine the required radioactive dose based on desired dose, lung shunt fraction, residual waste, and liver mass; vial selection and ordering functionality; and optional post-treatment analysis for retrospective dose evaluation.

The V2.0 version introduces Any Day Dosing, which imports actual vial calibration dates instead of using a preset Sunday noon calibration date, allowing users to select vials based on Days Post Calibration rather than Week 1/Week 2. User interface enhancements provide more information during vial selection, enhanced filtering and sorting capabilities, and improved visualizations. The underlying principles of operation and MIRD dosimetry schema remain unchanged from V1.1.2.

The device is subject to the Quality Management System Regulation (21 CFR Part 820), which incorporates ISO 13485 requirements for design controls (clause 7.3), nonconforming product (clause 8.3), and corrective and preventative action (clause 8.5). Verification and validation testing, including unit and integration testing, cybersecurity evaluation, design validation, and usability evaluation, were performed.

Substantial equivalence is established because: (1) the indications for use are identical and unchanged, and (2) the technology and principles of operation of TheraSphere 360 V2.0 are the same as the predicate device (K252547), with Any Day Dosing and UI changes representing modifications that do not alter the core technological principles or introduce new or different safety and effectiveness issues.