KARL STORZ HOPKINS Telescopes for Urology

The KARL STORZ HOPKINS Telescopes for Urology are rigid cystoscope systems that provide visualization and operative access during diagnostic and therapeutic urological procedures in adults and pediatrics. They consist of telescopes, sheaths, obturators, accessories, and instruments that combine into a complete cystoscope system for procedures in the lower urinary tract including the prostate, bladder, and urethra.

The subject device is a rigid, rod-lens endoscope with outer diameters of 1.9–4 mm (compact telescopes: 6.6 & 7.9 mm), working lengths of 11.7–30.3 cm, direction of view 0–120°, and field of view 37.1–100°. It uses an external light source and stainless steel as the primary patient-contacting material. Sterilization methods include steam, STERRAD, and V-PRO modalities. The predicate device has similar specifications but lacks compact telescopes and supports different sterilization methods (steam and EtO only).

Biocompatibility per ISO 10993 series (parts 1, 2, 5, 10, 11, 12, 18, 23); reprocessing validation per ISO 11138-1, 14937, 17664-1/2, 17665-1, 11737-1/2/3, 22441, and AAMI/ANSI standards (TIR12, ST8, ST77, ST79, ST98); bench performance per ISO 8600-1/3/5, IEC 62471, and IEC 60601-2-18.

The subject device employs the same rigid, rod-lens design and external light source as the predicate, with comparable optical parameters and outer diameters. The addition of compact telescopes and STERRAD/V-PRO sterilization methods are minor modifications that do not alter the fundamental function or safety profile. Non-clinical performance testing demonstrates the subject device meets the same biocompatibility and reprocessing standards as the predicate, establishing that the design changes do not raise new questions of safety or effectiveness.