Device Name: da Vinci 5
Author(s): Jamie Benson, MD, and Matthew D. Burstein, MD, PhD, FACS, DABOM
Intuitive Surgical, Inc received FDA approval for da Vinci Surgical System Model IS5000, along with da Vinci Insufflator and Tube Set with Smoke Evacuation, more commonly known as together as “da Vinci 5” or “da Vinci Gen 5”on March 14, 2024.
The da Vinci 5 has the same core features as Xi and some instrument backwards compatibility as well, with improvements in console ergonomics, introduction of force feedback instruments, integrated controls duplicated on the tower, console, and robot, as well as a heated scope, revised high flow ports, and an integrated tower with the E200 generator and new insufflation with smoke evacuation. Additionally, the new system is 10,000 times more powerful in processing speed, permitting novel vision and AI features, initially aimed at video review and coaching software, utilizing video and instrument usage data from prior procedures.
Research has included simulated use in animal and cadaveric models and human factors testing observing simulated surgical tasks and high-risk scenarios. Testing was completed for urologic, thoracic, and colorectal procedures using either canine or porcine models comparing Xi to Gen 5 systems. And finally, human testing was completed with a prospective, multi-center, single-arm confirmatory clinical investigation with 53 subjects across four specialties.
The FDA determined that this device is substantially equivalent to Intuitive Surgical da Vinci Surgical System, Model IS4000 (K131861, with subsequent clearances for additional features, instruments, accessories – K141077, K151794, K152892, K161271, K191529; and representative uses – K152578, K153276, K161178, K170713, K171632, K171699, K172086, K172643, K173585, K173842, K182140, K183086, K202834, K211784, K223080, K231224), World of Medicine Pneumoclear Insufflation System (K201361), and Endoscope Sterilization Tray (K183139). Additionally, the following are reference devices: K171120 Senhance Surgical Robotic System (force feedback instruments) and K190303 AirSeal iFS System.
This device is intended for us in the abdominal and thoracic cavities in adults. It is intended for use in bariatric patients, during urologic, general laparoscopic, gynecologic and general thoracoscopic surgical procedures.
There was an increase in unplanned hospital readmission due to vaginal bleeding for the da Vinci 5 device compared to the predicate device in the prospective trial during the 30 day observation period. In light of this, the use of the force feedback needle drivers is contraindicated in hysterectomy and myomectomy. The use of predicate non-force feedback needle drivers is recommended for suturing in these procedures.
Review of Some Critical Features:
The new da Vinci 5 includes the tower, console, and patient cart. 
Force feedback is selectively turned on by the user on the console, and to a variable degree. It is experienced as the controls pushing back against the user, potentially reducing tissue injury. 
The new console is of higher resolution and color compared to the prior generation. 
The new console is more open, with more ergonomic seated position and greater mobility of the upper viewport. 
The new patient cart allows for easier docking and improved control over surgeon settings, which are also assessable via the console. 
The new patient cart allows for easier docking and improved control over surgeon settings, which are also assessable via the console. 
The new large bore insufflator works with an updated port, with a hexagonal inner shape and an improved cross section at the tip to increase air exchange, The smoke evacuation intelligently activates with energy device usage according to user preferences. 
The new large bore insufflator works with an updated port, with a hexagonal inner shape and an improved cross section at the tip to increase air exchange, The smoke evacuation intelligently activates with energy device usage according to user preferences. 
The new large bore insufflator works with an updated port, with a hexagonal inner shape and an improved cross section at the tip to increase air exchange, The smoke evacuation intelligently activates with energy device usage according to user preferences. 
The new large bore insufflator works with an updated port, with a hexagonal inner shape and an improved cross section at the tip to increase air exchange, The smoke evacuation intelligently activates with energy device usage according to user preferences. 
My Intuitive App and Case Insights from instrument tracking and AI vision processing allow for improved coaching of experienced surgeons as well as trainees.