Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope [Reverse Deflection] (URS3005E); Medical Video Endoscope [Standard Deflection] (URS3006); Medical Video Endoscope [Reverse Deflection] (URS3006E); Medical Video Endoscope [Standard Deflection] (URS3016); Medical Video Endoscope [Reverse Deflection] (URS3016E); Image processor (DIS8000)

A medical video endoscope system designed for minimally invasive urological procedures within the urinary tract and kidney interior. The system comprises sterile flexible endoscopes (in standard and reverse deflection models) with on-tip camera and LED lighting, paired with a reusable image processor (DIS8000) that provides power and displays video output for use with therapeutic accessories like biopsy forceps.

The subject device offers three endoscope sizes (URS3005, URS3006, URS3016) with outer diameters of 3.0mm, 2.5mm, and 2.2mm respectively, compared to the predicate's 3.2mm. Deflection capability is up/down 275° versus the predicate's 270°. Both use CMOS sensors, LED illumination, 120° field of view, and EO sterilization. The minimum instrument channel width is 1.2mm (predicate: 1.0mm). The image processor is DIS8000 (predicate used UTV100).

ISO 8600-1, ISO 8600-3, ISO 8600-4 (optical performance); ISO 10993-5, 10993-10, 10993-11 (biocompatibility); ISO 11135:2014 (sterilization validation); ISO 10993-7:2008 (EO residual testing); ASTM F1980-21 (accelerated aging); ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886/F1886M-16, ASTM F88/F88M-23, ASTM F1929-23 (package validation); IEC 60601-1, IEC 60601-2-18 (electrical safety), IEC 60601-1-2 (EMC).

The subject device and predicate share identical intended use (urological endoscopy with therapeutic accessories), anatomical site, patient population, setting, and regulatory classification. Both employ the same technology platform (flexible CMOS endoscopes with LED illumination, EO sterilization, 10⁻⁶ SAL). Physical differences (outer diameter ranges of 3.0/2.5/2.2mm vs. 3.2mm, deflection of 275° vs. 270°, channel width 1.2mm vs. 1.0mm) are minor variations within normal manufacturing tolerances. Comprehensive bench testing—optical performance, color reproduction, mechanical durability, and software validation—demonstrates functional and performance equivalence. The use of different image processors (DIS8000 vs. UTV100) represents a system-level improvement rather than a fundamental design change.