DSPS-Prominent® baseplate, MR (113820); DSPS-Prominent® baseplate (113120); DSPS-Prominent® Cradle-I (113140); DSPS-Prominent® Cradle-II (113150); DSPS-Prominent® Cradle-III (113160); DSPS-Prominent® Cradle-IV (113170); DSPS-Prominent® Cradle-VI (113180); DSPS-Prominent® Cradle-VII (113260); Mask DSPS®-PROSCVRL set/5 (113760); Mask DSPS®-PROSC set/5 (113770); Mask DSPS®-PROSCVR set/5 (113780); Mask DSPS®-PROSCL set/5 (113790); Mask DSPS®-PROSHVRL set/5 (113890); Mask DSPS®-PROSH set

The DSPS-Prominent system is a collection of patient positioning and immobilization devices used in radiotherapy, including baseplates, cradles, thermoplastic masks, and accessories. These devices support accurate head, neck, and shoulder positioning during radiation treatment and image acquisition, with some components MR-safe for use in magnetic resonance imaging environments.

The subject devices maintain the same design principles, shape, and functionality as predicates but incorporate material substitutions: carbon fiber replaces glass fiber in baseplates and cradles. Cradles are shorter and attach to baseplates rather than directly to treatment tables. New 'head only' mask variants are shorter and do not extend to the shoulder region. Thermoplastic masks use identical materials and molding principles as predicates.

Not stated in this summary.

MacroMedics argues substantial equivalence based on identical intended use, design principles, and functional performance despite material and form factor changes. The key reasoning: carbon fiber provides equivalent structural and radiological properties (same attenuation and water equivalence) as glass fiber; cradle attachment methods do not alter positioning capability; 'head only' masks use identical thermoplastic materials and achieve the same submillimeter positional accuracy as full-length masks. Clinical and non-clinical testing confirmed new devices perform as safely and effectively as predicates.