da Vinci Surgical System (IS5000)

The da Vinci Surgical System, Model IS5000, is a software-controlled electro-mechanical robotic surgical system that assists surgeons in performing minimally invasive procedures. It consists of a surgeon console, patient-side cart, and vision cart, and is used to control endoscopic instruments for tissue manipulation including grasping, cutting, dissection, suturing, and ablation probe placement across urologic, general laparoscopic, gynecologic, and thoracoscopic procedures in adult patients.

The subject device is technologically similar to the predicate with unchanged principles of operation. The key difference is updated system software enabling a new 'Networked Central Configuration Management' feature that allows Intuitive technical support to remotely push configuration data and system settings to network-connected systems for user updates.

Not stated in this summary.

The device maintains the same intended use, indications for use, and principles of operation as the predicate device (K232610). Software verification and validation were conducted at unit, integration, and system levels per FDA guidance on device software. Cybersecurity verification and validation confirmed adequate risk control measures per FDA cybersecurity guidance. The modification is limited to configuration management software functionality, which does not alter the core surgical assistance capability or safety profile compared to the predicate device.