da Vinci Surgical System (IS5000)

The da Vinci Surgical System (IS5000) is a software-controlled, electromechanical robotic platform that assists surgeons in performing minimally invasive surgery. It consists of a surgeon console, patient-side cart, and vision system tower, and is used with an endoscope and specialized instruments to enable precise tissue manipulation including grasping, cutting, suturing, and ablation across urologic, general laparoscopic, gynecologic, and thoracoscopic procedures. The system is indicated for adult use by trained physicians in operating room settings.

The IS5000 is technologically equivalent to its predicate (IS5000, K232610) with no changes to operational principles. The modifications consist exclusively of software updates and labeling revisions to enable compatibility with two existing 510(k)-cleared cardiac instruments (Atrial Retractor Short Right and Cardiac Probe Grasper) and expanded indications for thoracoscopically-assisted cardiac procedures using non-force feedback instruments, with nine new representative uses defined (mitral valve repair, IMA mobilization, patent foramen ovale closure, atrial septal defect repair, left atrial appendage closure, atrial myxoma excision, mitral valve replacement, tricuspid valve repair, and epicardial pacing lead placement).

Not stated in this summary.

The subject device is substantially equivalent because it shares the same intended use, operational design, and technological characteristics as the predicate device, with only minor software and labeling modifications. Software verification and validation were conducted at unit, integration, and system levels per FDA guidance on device software. Cadaver and animal equivalence studies comparing the IS5000 to the reference IS4000 system demonstrated comparable surgical performance and safety during cardiac procedures. Systematic literature reviews and real-world Premier Healthcare Database analysis of over 7,000 robotic and non-robotic procedures showed clinical outcomes for robotic-assisted mitral valve repair and coronary artery bypass grafting were substantially equivalent to non-robotic approaches, establishing that the expanded cardiac indications do not raise new safety or effectiveness concerns.