System 83 Revolve Endoscope Washer/Disinfector

The System 83 Revolve® Endoscope Washer/Disinfector is an automated, computer-controlled system that washes and high-level disinfects one or two flexible submersible endoscopes used in gastrointestinal and pulmonary procedures. It uses detergent and FDA-cleared disinfectant in a processing chamber, followed by rinsing with filtered water and an alcohol/air flush to achieve high-level disinfection.

The subject device is nearly identical to the predicate System 83 Plus in operating principles, process parameters, monitoring systems, and cycle specifications. Minor differences include a Virtual Keyboard instead of a physical keyboard, a Barcode Scanner for data entry, an LED Process Status Indicator, an electromechanical touch pad for hands-free lid operation (versus foot pedal), relocated circuit breaker, and an internal-mount LED for channel monitoring (versus external mount). All critical parameters—HLD contact time (12 minutes minimum), temperature (20°C minimum), water and HLD volumes, channel flow/pressure monitoring, and ultrasonic function (12 transducers at 40 kHz)—remain identical.

Electrical Safety: UL 61010-1:2012, CSA C22.2#61010-1, IEC 61010-2-040:2021, and CSA C22.2#61010-2-040:2021. EMC Testing: IEC 60601-1-2 ed 4.1 (2020-09). Software Validation: BS EN 62304 (2006+A1:2015). Cybersecurity: AAMI TIR57 (2016[R]2019). Predicate device testing included ISO 10993-5:2009 for toxicological evaluation.

The subject device maintains identical intended use, indications, operating principles, and all critical process parameters as the predicate. The technological differences (barcode scanner, virtual keyboard, touch pad control, LED status indicator) are minor design enhancements that do not alter the fundamental disinfection mechanism or safety profile. New testing demonstrates the device passes electrical safety, EMC, software validation, and cybersecurity standards. The predicate's extensive performance testing—including high-level disinfection validation (≥6 log reduction), in-use testing, toxicological evaluation, and water filtration validation—all passed acceptance criteria, and these same validated disinfection parameters are maintained in the subject device.