STERRAD 100NX Sterilization System with ALLClear Technology (10104)

The STERRAD 100NX Sterilizer with ALLClear Technology is a hydrogen peroxide gas plasma sterilization system designed to sterilize both metal and nonmetal medical devices at low temperatures. It uses a multiphase process combining hydrogen peroxide vapor and plasma exposure to achieve sterilization without leaving toxic residue, suitable for heat- and moisture-sensitive instruments.

The subject device uses identical technology, sterilization cycles, and validation methods as the predicate device. The key difference is an expanded indication for the EXPRESS Cycle to support validation loads of up to 25 lbs per shelf and 50 lbs per cycle, compared to the predicate's single tray (10.7 lbs) validation. All other technological parameters—chamber volume (152L), hydrogen peroxide concentration (59-94%), pressure, temperature, and process controls—remain identical.

Not stated in this summary. The document references ISO 13485 (Design Controls and Corrective/Preventive Action) and ISO 13484 (Nonconforming Product) as regulatory requirements, but does not cite specific consensus standards for sterilization validation testing.

The subject device is substantially equivalent to predicate K250802 because both utilize the same hydrogen peroxide gas plasma sterilization technology, share identical hardware and sterilization cycles, and employ the same validation methodology. The expanded EXPRESS Cycle load capacity was validated through comprehensive non-clinical testing (sterilization verification, surface sterilization, growth inhibition, in-use and simulated-use testing, and usability) demonstrating no new safety or effectiveness concerns, and all critical process parameters conform to EXPRESS Cycle specifications.