da Vinci SP Firefly Imaging System

The da Vinci SP Firefly Imaging System provides real-time endoscopic visible and near-infrared fluorescence imaging for minimally invasive surgery. It uses near-infrared light in conjunction with Indocyanine Green (ICG) imaging agent to visualize vessels, blood flow, and tissue perfusion. The system consists of a near-infrared laser light source in the Endoscope Controller connected to an endoscope with imaging sensors at the tip.

The subject device adds a new intraoperative fluorescence imaging mode called 'Sensitive Firefly' compared to the predicate. In this mode, the endoscope emits only near-infrared light (without blue light background illumination), allowing image sensors to detect ICG with greater sensitivity in situations where ICG concentrations are relatively low. This addresses anatomical variations in ICG perfusion strength while maintaining the same core fluorescence imaging technology as the predicate.

Not stated in this summary.

Both devices underwent identical verification and validation testing protocols: software verification testing, bench verification testing of the fluorescence-capable endoscope, and clinical validation testing with animal models. Testing confirmed the subject device exhibited no issues of safety or effectiveness analogous to predicate results. The indications for use are identical between predicate and subject devices. The Sensitive Firefly mode represents a software enhancement to an existing imaging capability rather than a fundamentally different technological approach, maintaining the same mechanism of fluorescence detection.