Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit)

The Autoclavable Cassette is a reusable polyphenylsulfone plastic container with three components (lid, base, tray) used to organize, store, and transport surgical and prosthetic instruments during sterilization in healthcare facilities. The cassette is not intended to maintain sterility by itself; it must be used with an FDA-cleared sterilization wrap and is validated for steam sterilization at 132°C for 4 minutes with 30 minutes drying time.

The subject device uses the same polyphenylsulfone material, silicone grommets, perforated design, and moist heat sterilization method as the predicate. Key differences include three size variants (641g, 476g, and 192g maximum loads), varying vent-to-volume ratios, an additional stainless steel hinge pin in the medium-size cassette, and 30 minutes drying time versus the predicate's 20 minutes.

ISO 10993-1:2018 and ISO 10993-5 (biocompatibility/cytotoxicity), ANSI/AAMI ST98:2022 (manual cleaning validation), ANSI/AAMI/ISO 17665-1:2006/(R)2013 (sterilization validation), ASTM D4169-23e1 (packaging performance), and FDA guidance on reprocessing medical devices.

The subject device shares the same intended use, design principle, sterilization method (pre-vacuum steam at 132°C for 4 minutes), and regulatory classification as the predicate Straumann BLX Surgical Cassette. Although the subject device is larger (validated to 641g vs 300g) and requires longer drying time, these dimensional and parameter differences do not raise new safety or effectiveness concerns because the worst-case cassettes passed identical performance testing protocols including sterilization validation (SAL ≤10⁻⁶), 100-cycle reprocessing simulation, biocompatibility, and cleaning validation, demonstrating equivalent performance characteristics.