Strauss Surgical cystoscope, hysteroscope and accessories Instruments

The Strauss Surgical cystoscope, hysteroscope, and accessories are rigid or flexible endoscopic instruments designed for minimally invasive diagnostic and therapeutic procedures in the urinary bladder and uterus. They consist of an optical system, illumination source, and working channels that allow introduction of instruments for biopsies, stone removal, stent placement, and other surgical procedures through natural orifices.

The subject and predicate devices are identical in technological characteristics. Working length ranges from 269–302 mm, outer diameter 2.7–4.0 mm, distal tip outer diameter 2.7–4.0 mm, with Xenon or LED light sources and deflection capability of 0°–70°. The only difference is the sponsor name.

ISO 10993-1 (biocompatibility), ISO 1993-5 (cytotoxicity), ISO 14971 (risk analysis), 510(k) guidance for hysteroscopes and gynecology laparoscopes, IEC 60601-2-18 Section 201.11.1.2.2, ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 8600-5, and ISO 8600-6.

The subject device is substantially equivalent to the predicate (K171336) because they are identical in design, intended use, indications, and technological characteristics. Non-clinical testing demonstrates the subject device is as safe, effective, and performs the same as the predicate device. Both devices are intended for endoscopic diagnostic and therapeutic procedures in urological and gynecological surgery via minimally invasive approach using natural orifices.