Search Results
Found 1 results
510(k) Data Aggregation
(133 days)
The EndoWrist ProGrasp Forceps instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System and the Intuitive Surgical IS3000 da Vinci Si Surgical System for grasping and manipulation of tissue.
The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, 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 pediatic use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The subject device is a remanufactured 420093 ProGrasp Forceps with a grasping end effector to be used with the Intuitive Surgical da Vinci Endoscopic Instrument Control System (IS 2000 / IS 3000) for grasping and manipulating tissue during and endoscopic procedure. The mechanism of action and principles of operation for the subject device are identical to the predicate device, as there has been no modification to the mechanical design, materials, or dimensions. There are no changes to the claims, intended use, dinical applications. patient population, or method of operation.
This document is an FDA 510(k) clearance letter for a remanufactured medical device. It does not describe acceptance criteria or a study proving that an AI device meets acceptance criteria. The document explicitly states that the device is a remanufactured mechanical component (EndoWrist ProGrasp Forceps) and its substantial equivalence to a predicate device is based on "no modification to the mechanical design, materials, or dimensions." There is no mention of AI, algorithms, or any form of software performance evaluation in this document.
Therefore, I cannot provide the requested information from the provided text.
Ask a specific question about this device
Page 1 of 1