da Vinci SP Surgical System (SP1098)

The da Vinci SP Surgical System (Model SP1098) is a computer-controlled surgical robot that assists physicians in performing minimally invasive surgery through a single port. It is indicated for urologic, colorectal, general thoracoscopic, and select transoral otolaryngology procedures (benign tumors and T1-T2 malignancies) in adults, and consists of a surgeon console, patient-side cart, vision-side cart, endoscope, instruments, and accessories.

The subject device is technologically similar to its predicate with limited differences: updated system software for modifications to Adjust Mode when using an SP SureForm 45 Stapler, and a new insertion jump detection algorithm for the SP SureForm 45 Stapler.

Not stated in this summary.

The subject device has identical indications for use as the predicate device and employs substantially similar technology. Software verification and validation were conducted at unit, integration, and system levels to confirm continued compliance with design requirements. Human factors evaluation and usability validation demonstrated the device remains safe and effective for its intended use by trained physicians in the operating room. The software modifications are limited in scope to stapler functionality and do not fundamentally alter the device's performance characteristics or safety profile.