Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)

The Flexible Cystoscope is a sterile, single-use endoscope designed to visualize and provide operative access to the lower urinary tract (bladder and urethra) for diagnostic and therapeutic procedures in adults. It works with a video processor (cleared via K243497) to display endoscopic images and is intended for use in hospital and medical office environments.

The device consists of a handle with deflection lever and working channel, a flexible insertion section with CMOS image sensor and LED illumination at the distal tip, and an endoscope connector. It comes in two sizes (CY50H-20 and CY55H-24) with differences in outer diameter and working channel diameter. US and EU versions differ only in deflection direction. The subject device is compatible with the additional video processor cleared via K243497, whereas the predicate was not.

Electrical safety and electromagnetic compatibility per ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD 2:2021]; ANSI AAMI IEC 60601-1-2:2014 [including AMD 1:2021]; IEC 60601-2-18 Edition 3.0 2009-08; and IEC/TS 60601-4-2 Edition 1.0 2024-03. Optical performance evaluated per image quality parameters including field of view, MTF/DOF, color performance, SNR/Dynamic Range, distortion, and image intensity uniformity.

The subject device has identical indications for use as the predicate (flexible cystoscope for lower urinary tract visualization and access). Both devices employ the same technological approach: LED illumination, CMOS image sensor, maneuverable distal tip, and flexible insertion cord for endoscopic imaging. The only technological difference is compatibility with an additional video processor (K243497), which does not affect device safety or effectiveness. Non-clinical testing demonstrates the subject device meets the same electrical safety, EMC, and optical performance standards as the predicate, establishing substantial equivalence.