Ricoh 3D for Healthcare Bolus

The Ricoh 3D for Healthcare Bolus is a patient-specific device placed on a patient's skin during radiation therapy to help control radiation dose delivery. Designed by radiation therapy professionals using DICOM patient imaging data, it modifies the shape of the radiation therapy beam to match the physician's prescribed treatment plan. It is intended for patients of all ages receiving radiotherapy and was evaluated using 6 MV photons, 6 MeV electrons, and 9 MeV electrons.

The subject device uses additive manufacturing (3D printing) via stereolithography (SLA) technology with BIOMED Elastic 50A material (Shore 50A durometer), whereas the predicate uses multijet printing (MJP) technology with VisiJet M2E-BK70 material (Shore 70A durometer). Both devices accept DICOM input and are designed by radiation therapy professionals. The subject device adds evaluation at 6 MeV electrons compared to the predicate.

Biocompatibility testing per ISO 10993 for the product's indication and contact duration. Quality Management System Regulation requirements include ISO 13485 clauses for design controls, nonconforming product handling, corrective action, and preventive action.

The subject device is substantially equivalent because it has nearly identical indications for use to the predicate (differing only in the addition of 6 MeV electron evaluation), uses the same manufacturing method (additive manufacturing/3D printing), accepts identical device inputs (DICOM), and performance data demonstrate equivalent fit, geometric dimensions, dose distribution, biocompatibility, cleaning effectiveness, and packaging integrity. Minor differences in material properties do not affect substantial equivalence given comparable performance outcomes.