Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo

The Strauss Surgical Cystoscopes & Hysteroscopes are rigid endoscopes used to illuminate and visualize the male urethra, prostate, and bladder (cystoscopes) or the cervical canal and uterine cavity (hysteroscopes) for diagnostic and surgical procedures. Each device consists of a fiber optic cable with a light guide connector and an objective lens at the distal end to transmit images to an eyepiece.

The subject and predicate devices have identical technological characteristics. Both use external light sources transmitted through fiber optic systems to illuminate the target area. The cystoscopes/hysteroscopes have similar outer surfaces made from metal alloys (Phynox cobalt-nickel-chromium stainless steel or 304 stainless steel) with fiber optics for light transmission and rigid lenses for image transmission. Both devices have the same sheath diameter and insertion tube length (2.9mm; 4mm/ 302mm) and require identical reprocessing methods including manual/automated cleaning, high-level disinfection, and steam sterilization.

Not stated in this summary.

The subject device has identical technological characteristics to the predicate device (Schoelly Cystoscopes/Hysteroscopes). Because both devices use the same optical principles, materials, manufacturing processes, and reprocessing methods with no differences in safety or performance, performance testing was deemed unnecessary. The indications for use are equivalent, differing only in wording for consistency but raising no different questions of safety or effectiveness.