Authors: Samir Narula, MD & Luca Milone, MD
The da Vinci X/Xi (IS4200/IS4000) and da Vinci S/Si (IS2000/IS3000) EndoWrist Instruments, produced by Intuitive Inc, have a unique articulating design at their distal tips that mimics the human wrist. While seated at the console of the surgical system, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks: grasping, suturing, cutting, cauterizing, or tissue manipulation.
The Intuitive Surgical Endoscopic Instrument Control System, da Vinci X/Xi (IS4200/IS4000) and da Vinci S/Si (IS2000/IS3000) are intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments, including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery, accessories for endoscopic manipulation of tissue and delivery and placement of microwave and cryogenic ablation probes and accessories. These instruments are used during urologic, general laparoscopic, gynecologic laparoscopic, general thoracoscopic and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the specific procedures set forth in the Professional Instructions for Use.
The da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments (5mm & 8mm) are also indicated for transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures.
On February 10th 2021 the FDA determined that da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments and da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments by Intuitive Surgical, Inc. are substantially equivalent to legally marketed predicate devices and therefore can be marketed.
Performance test data demonstrates that the subject device is substantially equivalent to the predicate device. The testing conducted consisted of cleaning validation, thermal disinfection validation, reliability/life testing and human factors testing.
Reprocessing Instructions have been updated to include an optional automated cleaning and disinfection process using an automated washer/disinfector.