da Vinci SP Surgical System (SP1098)

The da Vinci SP Surgical System is a minimally invasive robotic surgical platform consisting of a surgeon console, vision cart, and patient cart that enables complex surgical procedures through single-port access. It is controlled by a surgeon using hand controls and foot pedals to manipulate instruments and an endoscope, with application to urologic, colorectal, thoracoscopic, transoral otolaryngology, and nipple-sparing mastectomy procedures in adults.

The device has identical technological characteristics to the predicate device (K243714); no hardware or design modifications were made. The only change is a labeling update to add nipple-sparing mastectomy (NSM) as a new indicated procedure in the instructions for use.

Not stated in this summary. The document references previous validation for cleaning, sterilization, packaging, shelf life, biocompatibility, software, cybersecurity, electrosurgical performance, electromagnetic compatibility, electrical safety, mechanical performance, and reliability, but does not cite specific standards.

The da Vinci SP SP1098 is substantially equivalent because it is technologically unchanged from the predicate device and the labeling addition of NSM procedures does not alter safety or performance requirements. Bench testing with cadaver models and a prospective randomized clinical trial (26 subjects, 46 breasts vs. 27 controls, 48 breasts) demonstrated comparable safety and effectiveness to open NSM, with no conversions to open surgery and no device-related serious adverse events in the robotic arm, supporting the new indication.