Guided DAS Surgical Kit

The Guided DAS Surgical Kit is a reusable sterilization tray designed to organize, protect, and enclose dental surgical instruments during steam sterilization. It consists of a rigid polyphenylsulfone base, lid, and removable inner tray with silicone holders, and requires wrapping in an FDA-cleared sterilization wrap before being subjected to moist heat (steam) sterilization at 132°C for 4 minutes with 30 minutes drying time.

The subject device and predicate (K201878, ST-Z5) both feature rigid polymer bases with removable inner trays, polyphenylsulfone construction, perforated components for sterilant penetration, and identical sterilization methods (pre-vacuum steam at 132°C for 4 minutes with 30 minutes drying). Both are reusable trays requiring FDA-cleared wrap. The subject device has one configuration and 50 use cycles versus the predicate's two configurations and 101 cycles; their overall dimensions and vent-to-volume ratios are similar, with any differences mitigated by sterilization validation testing.

ANSI/AAMI/ISO 17665-1 and 17665-2 (sterilization validation including penetration and dry time); ANSI/AAMI/ISO 10993-5 and 10993-12 (biocompatibility/cytotoxicity); FDA Guidance on Reprocessing Medical Devices (manual cleaning and life-cycle validation).

The subject device is substantially equivalent because it shares the same intended use (enclosing and protecting instruments for steam sterilization), same product code (KCT), same sterilization method and cycle parameters, and comparable design and materials as the legally marketed predicate. Although the subject device has fewer configurations and reuse cycles, sterilization validation testing demonstrated equivalent performance, and the similar vent-to-volume ratios and overall dimensions ensure comparable sterilant penetration and drying characteristics.