TrueFit Bolus

TrueFit Bolus is a 3D-printed, patient-matched radiation therapy accessory placed on the patient's skin to attenuate and/or compensate external beam (photon or electron) radiation during prescribed radiation therapy for cancer or other non-malignant tissue conditions. The device is designed by radiation therapy professionals using patient imaging data, must be verified and approved prior to use, and can be reused throughout the treatment course. It is prescription-only and restricted to sale by or on the order of a physician.

The design change adds methacrylate resin as a new material for SLA (stereolithography) 3D printing technology, in addition to the existing MJF printing with polyamide or polyurethane. The rigid clear resin increases usability during device fitting on patient anatomy due to material transparency, while maintaining the same fundamental design and function as the predicate device.

The document references ISO 13485 (Design controls, Nonconforming product, Corrective and preventative action) and mentions compliance with the Quality Management System Regulation (QMSR). Specific test methods included spatial fidelity (≥95% of points within ±3 mm of STL design), physical density (0.90–1.30 g/cc), and radiological density/uniformity (Hounsfield units between –100 and 500).

The TrueFit Bolus remains substantially equivalent to predicate K243057 because the addition of methacrylate resin material does not change the device's fundamental intended use, mechanism of action, clinical application, or conditions of use. Testing demonstrates acceptable spatial fidelity, tissue-equivalent physical properties, and appropriate radiological properties for radiation therapy. The updated indications for use clarification does not introduce new disease conditions, patient populations, or risks; it merely reflects current clinical practice without altering safety and effectiveness.