NUVENTUS NV.C™ Surgical Cassette and Tray

The NUVENTUS NV.C™ Surgical Cassette and Tray is a reusable rigid container made of polyphenylsulfone with a removable inner tray and silicone holders, designed to enclose and organize surgical instruments for sterilization by healthcare providers. It must be wrapped in an FDA-cleared sterilization wrap and sterilized using moist heat (steam) at 132°C for 4 minutes with 30 minutes drying time, and is intended for non-porous loads only.

The subject device is a single-configuration rigid polymer tray with polyphenylsulfone construction and silicone holders, measuring 138L × 98W × 62H mm with a vent-to-volume ratio of 0.0172 cm²/cm³. It is reusable for 225 sterilization cycles, slightly smaller than the predicate device (which has two configurations and larger dimensions), but shares identical design principles, materials, sterilization method, and requirement for FDA-cleared wraps.

ISO 17664 and AAMI ST98 (cleaning validation), ISO 17665 and AAMI TIR 12 (sterilization validation), ISO 13402:1995 (use-life testing), ISO 10993-5 and ISO 10993-12 (biocompatibility/cytotoxicity), and FDA guidance on reprocessing medical devices in health care settings.

The subject device is substantially equivalent because it shares the same intended use, product code (KCT), and regulatory classification as the predicate ST-Z5 tray, employs identical materials and design architecture (rigid polymer base/lid with removable inner tray), uses the same sterilization method with comparable cycle parameters, and all nonclinical testing (cleaning, sterilization, biocompatibility, and use-life) met acceptance criteria. Minor dimensional and configuration differences are supported by validated cleaning and sterilization testing demonstrating the device achieves the required sterility assurance level of 10⁻⁶.