Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm (M006

The Navigator HD Ureteral Access Sheath Set is a single-use medical device consisting of a semi-rigid outer sheath and semi-rigid inner dilator with interlocking hub. It is indicated for use in endoscopic procedures to facilitate passage of endoscopes and urological instruments into the urinary tract and to enable injection of fluids. The device is advanced over a guidewire to provide access during urology procedures.

The proposed device has identical intended use, reusability (single-use), sterility, sterilization method (ethylene oxide), packaging (Tyvek/Poly pouch), and mechanical specifications (sizes 11/13 F, 12/14 F, 13/15 F; lengths 28, 36, and 46 cm) as the predicate. The only technological difference is the hydrophilic coating formulation, which changed from Lubricent UV460 to Lubricent UV540, representing a similar but improved lubricant system.

Not stated in this summary. No specific ISO, IEC, or ASTM standards are cited in the provided document.

The proposed device is substantially equivalent because it maintains identical intended use, single-use design, sterilization approach, and all mechanical specifications as the predicate device K140323. Although the hydrophilic coating formulation changed, this is a material improvement supported by Design Verification and Summative Usability testing demonstrating safe and effective use, plus verification that shelf-life was unaffected. Biocompatibility contact classification remains identical with no new biocompatibility risks. The change represents a refinement rather than a fundamental redesign, preserving equivalence in safety and effectiveness.