da Vinci Surgical System, IS5000

The da Vinci Surgical System, Model IS5000 is a software-controlled, electromechanical robotic surgical system that assists surgeons in performing minimally invasive surgery. It consists of a surgeon console, patient-side robotic cart, and vision system cart, and is used to control endoscopic instruments for procedures including urologic, general laparoscopic, gynecologic, and thoracoscopic surgeries in adult patients.

The subject device is technologically similar to the predicate device with identical regulation number, classification, product code, and hardware. The key technological differences are limited to software updates enabling three new features: Focused Mode (a menu interface for accessing other features), 3D Model Viewer (displays and manipulates 3D and 2D images on the console), and Video Review (records surgical video, creates bookmarks, and allows intraoperative review).

Not stated in this summary.

Substantial equivalence is established because the subject device maintains identical intended use, indications for use, regulatory classification, product code, and hardware as the predicate device. The software additions (Focused Mode, 3D Model Viewer, Video Review) do not alter the fundamental function of instrument control or change the surgical procedures for which the device is indicated. Comprehensive software verification/validation, human factors validation testing, and cybersecurity testing all met predetermined acceptance criteria, and the new features do not raise new questions about safety or effectiveness.