da Vinci SP Surgical System (SP1098)

The da Vinci SP Surgical System is a robotic-assisted surgical platform consisting of a Surgeon Console, Vision Cart, and Patient Cart that enables minimally invasive surgery. The system controls EndoWrist instruments through a single surgical port for urologic, colorectal, general thoracoscopic, and transoral otolaryngology procedures (benign tumors and T1-T2 malignancies). This 510(k) submission adds transanal local excision (TALE) as a new representative procedure in the labeling.

The da Vinci SP Surgical System remains technologically unchanged from its predicate device (K242318) in design, performance, and capabilities. No modifications were made to hardware, software, or mechanical systems. The submission is purely a labeling change to include TALE as an approved procedure, with the system continuing to provide robotic instrument control, 3D visualization, and single-port access through compatible access platforms.

Not stated in this summary.

Substantial equivalence is established through three mechanisms: (1) the device is unmodified from the predicate device K242318, with identical intended use and technological characteristics; (2) bench performance testing in cadaver models confirmed the system can safely perform TALE procedures with secure port installation and appropriate instrument motion; and (3) systematic literature review of published clinical outcomes comparing da Vinci SP TALE (4 publications, LOE 4) to hand-held device alternatives (TEM/TAMIS/TEO; 42 publications, LOE 1-3) demonstrated similar safety and efficacy profiles across operative time, complications, margins, and oncological outcomes, showing TALE does not raise different safety or effectiveness questions.