SPY Cystoscope/Hysteroscope

The SPY Cystoscope/Hysteroscope is an optical instrument designed to visualize a patient's anatomy during minimally invasive endoscopic procedures in urology and gynecology. It transmits light through the visible spectrum to illuminate the surgical site and relays images to a camera system for processing and display.

The device has a smaller outer diameter and increased field-of-view compared to the predicate device. These design differences do not raise new safety or effectiveness questions, as confirmed by bench testing demonstrating equivalent optical performance.

Non-clinical testing was conducted in accordance with applicable requirements and standards, including performance bench testing for optical characteristics, mechanical attributes (Optimal Object Distance/Depth of Field, Fiber Transmission, Optical Transmission, Distortion, Modulated Transfer Function Center and Fringes, Vignetting, FOV, AFOV, Image Runout, Chromatic Aberration, Contrast Testing), and Hardware Compatibility for Stryker and Karl Storz series models.

The subject device has identical intended use and indications for use as the predicate, and employs fundamental technology equivalent to the predicate. Non-clinical testing demonstrates that differences in outer diameter and field-of-view do not compromise safety or effectiveness, with optical performance bench testing confirming equivalence and risk management showing acceptable residual risk.