Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)

This device consists of a single-use flexible cystoscope and a digital video monitor for endoscopic visualization and treatment of the adult bladder. The cystoscope comes in eight different models with varying instrument channel sizes (2.0–2.4 mm) and outer diameters. The digital video monitor displays real-time imaging from compatible endoscopes for diagnosis, treatment, and video recording in professional healthcare facilities.

Both the proposed device and predicate (Ambu AScope 4 Cysto) use CMOS digital video technology with LED illumination, are single-use and sterile, support irrigation, and feature similar biocompatibility profiles. The proposed device has a slightly smaller field of view (110° vs. 120°), a larger bending angle (210° down vs. ≥120°), longer working length (400 mm vs. 390 mm), and offers eight specifications compared to the predicate's two specifications. Outer diameters range from 5.25–5.65 mm versus the predicate's 6.0 mm.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1 and IEC 60601-2-18 (electrical safety), IEC 60601-1-2 and IEC 60601-4-2 (electromagnetic compatibility), ISO 11135 (EO sterilization validation), ISO 8600-1 and ISO 8600-4 (mechanical performance), IEC 62471:2006 (photobiological safety), ASTM F1980-21 (accelerated aging), and ASTM D4169-22 (simulated transportation).

The proposed device matches the predicate in intended use (flexible cystoscopy for adult bladder examination using compatible display units), operation principle, design approach, and core technologies (CMOS, LED, single-use, sterile). Minor differences in field of view, bending angle, working length, and outer diameter do not compromise intended use, as they represent design refinements rather than fundamental changes. All non-clinical testing (biocompatibility, electrical safety, sterilization, mechanical and optical performance) demonstrates equivalent safety and effectiveness to the predicate.