LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)

The LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring is a digital endoscope system designed to visualize the urinary tract (urethra, bladder, ureter, calyces, and renal papillae) via transurethral or percutaneous access. It can be used with endoscopic accessories to perform diagnostic and therapeutic procedures. The device includes a pressure sensor at the distal tip that transmits real-time intraluminal pressure readings to an external console for display.

The proposed device maintains identical technological characteristics to its predicate: single-use flexible ureteroscope, sterile, ethylene oxide sterilized, CMOS imager at distal tip, LED illumination, 68 cm shaft working length, 9.5F shaft outer diameter, 3.6F working channel, 270° deflection in both directions, 120° field of view, and identical pressure measurement accuracy specifications (±10 mmHg at 0-100 mmHg for first 60 minutes, ±5 mmHg + 5% for 100-300 mmHg range).

ISO 10993-1 for biocompatibility evaluation with testing for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. FDA guidance on biological evaluation of medical devices was also cited.

The proposed device differs from the predicate only in having an updated pressure sensor assembly and minor modifications to the distal tip and PCBA for compatibility, but the new sensor is functionally equivalent to the predicate's sensor. Since all mechanical, optical, and pressure measurement specifications remain identical, and biocompatibility testing confirms the body contact classification and contact duration are unchanged, the design modifications do not alter the device's suitability for its intended use. Performance testing on mechanical, pressure measurement, and durability parameters all met predicate specifications.