RZ Resectoscope System

The RZ Resectoscope System is an endoscopic surgical instrument consisting of a working element, shaft, and electrode, intended for use by qualified surgeons to cut, ablate, vaporize, and coagulate tissue during urological and gynecological electrosurgical procedures. Non-sterile components are reusable and must be sterilized before each use; sterile electrodes are single-use only.

The device shares identical technological characteristics with the predicate device: stainless steel and PTFE materials, 2.0–4.0 mm diameter working elements, monopolar and bipolar electrosurgical modes, identical electrode shapes (loops, knives, balls, rollers), tungsten and stainless steel electrodes with PTFE insulation, and 11–28.5 Fr sheaths with round drilled flushing holes. All component specifications (materials, sterilization, diameters) match the predicate.

ISO 11607-1:2019 and ISO 11607-2:2019 for packaging validation; ISO 17665-1:2006 and FDA guidance for steam sterilization validation of reusable devices; ISO 11135:2014 for ethylene oxide sterilization validation of sterile electrodes; ASTM F1980 for accelerated aging of sterile packages.

The subject device is substantially equivalent because it has identical materials, design, dimensions, and functional specifications as the legally marketed predicate device (HSW Resection Instruments, K173070), covering the same indications for use in endoscopic urological and gynecological procedures. Non-clinical bench testing (visual inspection, leakage, flow, functionality, and mechanical force tests) confirmed performance parity. Biocompatibility can be leveraged from the predicate since materials are formulated and processed identically. The minor difference in sheath diameter nomenclature (11–28.5 Fr without inner/outer distinction versus predicate's categorical labeling) does not raise different safety or effectiveness questions.