STERRAD® 100NX Sterilizer 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. This submission expands the DUO Cycle indications to include one dual-channel flexible endoscope with two polyethylene and Teflon lumens (1 mm or larger diameter, 885 mm or shorter length, weighing 3.4 kg).

The device uses identical technology, sterilization cycles, chamber volume (152L), hydrogen peroxide concentration (59-94%), critical process parameters (pressure, temperature, H2O2 dose, exposure time), and a plasma-based secondary step for residual H2O2 removal as the predicate device. No modifications were made to existing sterilization cycles or physical features.

Not stated in this summary. The document references performance testing including sterilization verification (SAL of 10^-6), surface sterilization, mated surface sterilization, growth inhibition, biocompatibility, simulated use testing, and device functionality/material compatibility testing, but does not cite specific ISO, IEC, or ASTM standards.

The subject device uses the same hydrogen peroxide gas plasma technology and sterilization methodology as the predicate (K234082), with identical chamber design, critical process parameters, and sterilization cycles. The only change is an expansion of DUO Cycle claims to include a specific dual-channel endoscope configuration; all performance testing (sterilization verification, biocompatibility, simulated use) demonstrated equivalent safety and effectiveness, and no new questions regarding safety or effectiveness were raised by the expanded claim.