SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

The SYSTEM 1E Processor (Model P6700) and SYSTEM 1 endo Processor (Model P6900) are automated liquid chemical sterilization systems that use peracetic acid (S40 Sterilant Concentrate) to sterilize cleaned, reusable heat-sensitive medical devices in 6 minutes at 45.5–60°C. The P6700 processes critical and semi-critical devices and rinses with extensively treated water (pre-filtered, UV-irradiated, dual 0.1-micron filtered). The P6900 processes semi-critical devices only and rinses with 0.2-micron filtered water. Both are intended for healthcare facility use.

The P6700 features an updated electronic controller with touchscreen interface, barcode scanner, USB drive for electronic cycle data download, and optional web-based data management system, while maintaining identical sterilization cycles, process parameters, and diagnostic functions to its predicate (P6500). The P6900 is identical to its predicate except for the same user interface enhancements (touchscreen, barcode scanner, USB, web-based system). Both use standardized, operator-unalterable cycles with identical critical parameters: 6-minute exposure, 46–55°C typical temperature, ≥1820 mg/L peracetic acid concentration, and automated water filter integrity testing.

Software validation per ANSI/AAMI/IEC 62304:2006/A1:2016; electrical safety per UL 61010-1 (3rd Edition) and IEC 60601-1-2:2015 +A1:2021; biocompatibility per ISO 10993-1:2018; cybersecurity assessment (CVSS scoring); sporicidal activity per AOAC Official Method 966.04; fungicidal activity per AOAC 955.17; bactericidal activity per AOAC 955.14, 955.15, 964.02; viricidal testing per EPA DIS/TSS-7 (Nov. 1981); tuberculocidal activity per Ascenzi Quantitative Suspension Test; device material compatibility through accelerated use testing (300 cycles for flexible endoscopes, 150 for rigid devices).

Both proposed devices are substantially equivalent because they maintain identical indications for use, sterilization cycle parameters, process monitoring, and S40 Sterilant Concentrate formulation as their respective predicates. The modifications are limited to user interface enhancements (touchscreen, barcode scanner, electronic data management, optional printer) that do not alter the sterilization mechanism, efficacy, or safety. All new testing (software validation, electrical safety, cybersecurity, biocompatibility) confirms the devices perform as well or better than their predicates. The P6700 and P6900 are therefore substantially equivalent under 21 CFR 880.6885 to their legally marketed predicates (K232914).