AquaCast Mask

The AquaCast Mask is a low-temperature thermoplastic device used to position and immobilize patients' heads during external beam radiation therapy for cancer treatment. It is made of polycaprolactone material that softens when heated to 150–158°F, is molded to the patient's anatomy, and is mounted to a support frame. The device is single-patient reusable and non-sterile.

The AquaCast Mask uses perforated polycaprolactone sheets (2.4 mm and 3.2 mm thick) that soften via heat for molding and are fastened to patient support hardware. Key properties include softening temperature of 150–160°F (vs. predicate 160–170°F), rigidity of 1.080 lbs/in², shrinkage of 0.9–1.5%, and X-ray attenuation less than 2%. Biocompatibility is limited-contact duration (<24 hours) for skin contact.

ASTM D790 Procedure A for rigidity testing; ISO 10993-1, -5, -10, and -23 for biocompatibility (cytotoxicity, irritation, sensitization). Testing also included radiation attenuation measurement on a Varian Clinic iX linear accelerator and cleaning/disinfection validation.

The AquaCast Mask is substantially equivalent to the Embrace Thermoplastic predicate (K120335) because both devices share the same intended use (patient positioning and immobilization for radiation therapy), identical design principles (moldable thermoplastic sheets pre-mounted to support frames), and equivalent technological/material composition (polycaprolactone). The minor difference in softening temperature (150–160°F vs. 160–170°F) does not introduce new risks, and all performance characteristics including rigidity, shrinkage, biocompatibility, and radiation attenuation are equivalent or equivalent-performing to the predicate.