da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)

The da Vinci Xi and X Surgical Systems are minimally invasive robotic surgical platforms consisting of a surgeon console, patient-side cart, and vision-side cart. They assist surgeons in controlling endoscopic instruments for urologic, general laparoscopic, gynecologic laparoscopic, thoracoscopic, and cardiac procedures in adult and pediatric patients.

The subject devices are technologically similar to their predicates, with the primary difference being updated software that enables a new 'Networked Central Configuration Management' feature, allowing Intuitive technical support to remotely push configuration data and site preference settings to networked systems. Device labeling was also modified.

Not stated in this summary.

The intended use and indications for use remain unchanged from the predicate devices. Software verification and validation were conducted at unit, integration, and system levels to confirm continued compliance with design requirements. Cybersecurity verification and validation confirmed adequate risk control measures per FDA guidance. Because the modification is limited to configuration management software and labeling with no changes to device hardware or core functionality, and performance testing confirms the devices continue to meet requirements, they are substantially equivalent to their predicates.