CORIS System

The CORIS System is an automated electromechanical device that cleans the channels of compatible reusable flexible endoscopes using the CORIS QUANTUM Cleaning Agent delivered as a slurry. The system performs physical cleaning through friction as cleaning agent particles pass through endoscope lumens, ports, and cylinders, followed by rinsing and air purging. It is intended for over-the-counter use by trained healthcare personnel in healthcare facilities.

Both the subject and predicate devices are software-controlled automated endoscope channel cleaners using the same CORIS QUANTUM Cleaning Agent and operating principle of physical friction-based cleaning. The subject device has an expanded shelf life for the cleaning agent (7 months vs. 6 months) and extended open-bottle shelf life (5 days vs. 1 day), different accessory configurations, but identical operating principles, software controls, self-disinfection cycles, RFID traceability, color touch screen interface, and communication ports.

ISO 13485, IEC 62366-1, ISO 10993-1, ISO 14971, IEC 60601-1-2, IEC 61010-1, IEC 61010-2-040, IEC 62304, ISO 27001, ANSI/AAMI SW96:2023, ANSI/AAMI ST98:2022, ASTM D4169-22, ASTM F1980-21, ASTM D543-21, ISO 17664-2:2021, AOAC 965.12, and AAMI TIR12:2020.

The subject CORIS System is substantially equivalent to the predicate device (DEN240018) because both share identical intended use, operating principles, and fundamental technological characteristics as automated endoscope channel cleaners using physical friction-based cleaning. Minor differences in accessory configurations and cleaning agent shelf life have been validated through equivalent verification and validation testing demonstrating they do not raise new safety or effectiveness questions.