Da Vinci Surgical System (IS5000)

The da Vinci Surgical System, Model IS5000 is a software-controlled, electro-mechanical robotic surgical platform that assists surgeons in performing minimally invasive procedures. It enables precise control of endoscopic instruments for grasping, cutting, dissection, ligation, electrocautery, and suturing across urologic, general laparoscopic, gynecologic laparoscopic, and thoracoscopic surgical procedures in adult patients.

The subject device is technologically similar to its predicate device (K232610). The primary modification is a software enhancement adding a new 'force gauge' graphical user interface element that visually displays forces applied during tasks with da Vinci Force Feedback instruments. The overall principles of operation and technological architecture remain unchanged.

Not stated in this summary.

The device demonstrates substantial equivalence because it maintains identical intended use and indications for use as the predicate device, with only a software modification to add a force gauge display feature. Software verification and validation testing was conducted at unit, subsystem integration, and system levels confirming continued compliance with design specifications. Human factors validation was performed on impacted critical tasks using comparative task analysis and use-related risk analysis, and all testing passed. The underlying robotic platform, principles of operation, and safety/effectiveness profile remain unchanged from the predicate.