Medical Shaver System (Morcellator) (YSB-IIIA)

The Medical Shaver System (Morcellator) YSB-IIIA is a reusable morcellation device designed for use under endoscopic visualization to cut and remove dissected benign prostatic hyperplasia (BPH) tissue during endoscopic urology procedures. It consists of a control unit, handpiece, footswitch, blades, waste bottle, collection bottle, and suction tube.

The device uses a cutting mechanism created by relative movement of an internal and external tube. Key differences from the predicate include: AC power supply (vs. battery-powered predicate), integrated suction pump (predicate requires external system), morcellation velocity of 10-20 grams/minute (predicate ~17 grams/minute), rotational speed of 300-1600 R/min (predicate 500-1475 RPM), and non-sterile reusable construction (predicate supplied sterile). Blade dimensions, suction flow rates, and regulatory compliance standards are comparable.

Device tested to IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2, IEC 62304, ISO 10993-1/5/10/11/23 (biocompatibility), ISO 14971 (risk management), ISO 8600-1 (endoscopes), ISO 17664-1 and ISO 17665:2024 (sterilization and reprocessing), and ASTM D4169-22 (shipping containers). Compliance confirmed for safety, electromagnetic compatibility, usability, and software lifecycle processes.

The YSB-IIIA is substantially equivalent to the predicate Cyber Blade (K192499) because both devices share identical intended use (morcellation of BPH tissue under endoscopy), the same operating principle (cutting via tube movement), and comparable performance characteristics including blade dimensions, rotational speeds, and suction flow rates. Minor differences in power supply, reusability, and morcellation rates are within acceptable ranges and do not raise new safety or effectiveness questions; the manufacturer demonstrated through bench testing that performance parameters are equivalent or superior to the predicate.