ONE TRAY® Sealed Sterilization Container System

The ONE TRAY® Sealed Sterilization Container is a reusable rigid container system designed to enclose reusable medical devices for steam sterilization in healthcare settings. It maintains sterility of enclosed devices during storage, transport, and until use, compatible with prevac steam sterilization at 270°F for 4 minutes with a 15-minute dry time.

The subject device features a perforated aluminum base and lid with anodized aluminum construction, silicone gaskets, and single-use polypropylene SMS filters. Key differences from the predicate (Aesculap AICON): the subject has a perforated bottom versus the predicate's solid bottom with enhanced drying system, a 15-minute dry time versus 20 minutes, and lacks additional sterilization modalities (ethylene oxide, Steris VPRO, Sterrad) that the predicate supports.

ANSI/AAMI ST77:2013, ANSI/AAMI TIR12:2010 and 2020, ISO 17665-1, AAMI ST98:2022, ISO 10993-5:2009, and FDA Guidance on Reprocessing Medical Devices in Health Care Settings.

The subject device and predicate share identical steam sterilization cycle parameters (270°F, 4-minute exposure), the same 365-day event-related storage period, similar size ranges, and identical materials (anodized aluminum, silicone, polypropylene filters). Although the subject has a perforated bottom design (vs. predicate's solid bottom) and shorter dry time (15 vs. 20 minutes), comprehensive nonclinical testing—including sterilization efficacy, dry time validation, microbial aerosol challenge, biocompatibility, and 365-day shelf-life studies—all passed and demonstrated that these design differences have no adverse impact on safety or effectiveness.