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The LithoVue Elite Digital Flexible Ureteroscope System is intended to by used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The LithoVue Elite Digital Flexible Ureteroscope System is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart Connect Console and the Single-Use Digital Flexible Ureteroscope. The LithoVue Elite Digital Flexible Ureteroscope System is designed to allow the physician to access, visualize and perform procedures in the urinary tract. The proposed devices within the scope of this Special 510(k) premarket notification are the StoneSmart Connect Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring). Changes to the StoneSmart Connect Console (cleared under K221515 on 02-FEB-2023) include software changes to introduce a new user control feature (referred to as "Aiming Beam Mode") that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system and implement software bug fixes and enhancements. The proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope is the same as the predicate LithoVue Elite Sinqle-Use Digital Flexible Ureteroscope with pressure monitoring (K221515) with respect to its design, performance, intended use, operating principle, and fundamental technology, except that it does not possess the pressure monitoring capability.