da Vinci Surgical System (IS5000)

The da Vinci Surgical System, Model IS5000, is a software-controlled robotic surgical platform consisting of a surgeon console, patient-side cart, and vision-side cart. It assists surgeons in accurately controlling endoscopic instruments for minimally invasive surgery across urologic, general laparoscopic, gynecologic laparoscopic, and thoracoscopic procedures in adult patients. The system is used by trained physicians in operating rooms and is intended for adult use only.

The subject device is technologically similar to its predicate with unchanged operational principles. The key difference is updated system software that extends existing instrument control to support Harmonic ACE™ Curved Shears compatibility, which was previously cleared for use with the IS4000 model. Device labeling for instruments and accessories was also modified. The Harmonic ACE instrument itself remains unchanged.

Software testing per FDA Guidance Content of Premarket Submissions for Device Software Functions (June 14, 2023); Electrical Safety and EMC compliance with IEC 60601-1-2; Cybersecurity testing per FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (June 27, 2025); Human Factors assessment per FDA Draft Guidance Content of Human Factors Information in Medical Device Marketing Submissions (December 9, 2022).

Substantial equivalence is established because: (1) the intended use and indications for use are identical to the predicate IS5000 (K232610); (2) technological differences are limited to software updates enabling compatibility with an existing cleared instrument (Harmonic ACE, previously cleared for IS4000); (3) software verification and validation confirm design requirements remain met; (4) electrical safety and EMC testing demonstrate no new concerns; (5) human factors analysis found no new critical tasks or usability issues impacting risk; and (6) the modified device performs the same function with the same safety profile as the predicate.