Hydro Irrigation System

The Hydro Irrigation System is a device consisting of an irrigation console, disposable cassette, tubing, and foot switch used to clean the distal lens of rigid endoscopes during endoscopic neurosurgical procedures via an endonasal approach. It maintains clear visualization without removing the scope from the surgical site and provides two irrigation modes: Clean (brief stream) and Flush (continuous stream).

The subject device features a microprocessor-controlled peristaltic pump with adjustable flow intervals, a display screen with two rotary knobs for user control, optional RISE compatibility for integration with Stryker devices via ethernet, and 4-channel RFID wireless technology. Compared to the predicate Karl Storz Clearvision II, the subject device offers a front-facing integrated irrigation tube set and enhanced user interface capabilities, but shares the same fundamental principle of operation, safety standards (IEC 60601 series), and core system components.

Testing was conducted per FDA-recognized voluntary consensus standards including ISO 11607 (packaging/shelf-life), ISO 10993 (biocompatibility), ASTM F series standards (materials, cleaning, sterilization), AAMI ST98 and ST72 (sterilization validation), ISO 17664 (reprocessing), IEC 62304 (software), IEC 60601 series (electrical safety and EMC), and FCC 47 CFR Part 15 (radio frequency devices). No animal or clinical testing was required.

The Hydro Irrigation System is substantially equivalent to the predicate Karl Storz Clearvision II because it shares the same classification, intended use, principles of operation, and safety standards. Both are Class II neurological endoscopes for lens cleaning during endoscopic procedures. Performance testing and risk analysis demonstrate the subject device is as safe and effective as the predicate and does not raise new or different questions of safety or effectiveness.