SP Endoscope, 0° (430600)

The SP Endoscope, 0° is a component of the da Vinci SP Firefly Imaging System that provides real-time stereoscopic imaging for minimally invasive robotic-assisted surgery. It transmits visible light and near-infrared fluorescence to enable surgeons to visualize the surgical site, assess vessels, blood flow, and tissue perfusion during surgery.

The subject device is designed to support increased clinical usage with 50 lives and 60 reprocessing cycles, compared to the predicate's 33 lives and 40 cycles. Both devices use the same sterilization method (steam), cleaning approach (manual with thermal disinfection), materials, optical performance, and mechanical design; the differences are in durability specifications to accommodate extended use.

ISO 10993-1:2018 (biocompatibility), IEC 60601-1-2 Edition 4.1 (electromagnetic compatibility), AAMI ST98:2022 and AAMI TIR 12:2020 and AAMI TIR 30 (cleaning validation), ISO 17664-1:2022 (reprocessing information), ASTM D4169-22 (shipping/transit testing), and FDA guidance on reprocessing validation and biological evaluation.

The subject device is substantially equivalent because it maintains identical indications for use, intended use, intended patient population, and operational principles as the predicate device. The design modifications—increased lives and reprocessing cycles—represent engineering improvements to durability rather than changes in fundamental technology or safety profile. Comprehensive testing (reliability, cleaning validation, biocompatibility, EMC) demonstrates the device safely withstands the increased use conditions without introducing new safety or effectiveness concerns.