Author: Thom E. Lobe, MD
Intuitive Surgical, Inc., received FDA approval for its Da Vinci SP Surgical System, EndoWrist SP Instruments, and accessories on 03/14/2019.
The Da Vinci SP Surgical System represents the company’s 4th generation robot. The da Vinci SP (single port) system includes three, multi-jointed, wristed instruments and the first da Vinci fully wristed 3D HD camera. The instruments and the camera all emerge through a single cannula and are properly triangulated around the target anatomy to avoid external instrument collisions that can occur in narrow surgical workspaces. The system enables flexible port placement and excellent internal and external range of motion (e.g., 360-degrees of anatomical access) through the single SP arm. Surgeons control the fully articulating instruments and the camera on the da Vinci SP system, which uses a similar surgeon console as the da Vinci X and Xi systems.
The newly approved multiple-use 6mm instrumentation is comprised of an endowrist joint and a flexible elbow which represents an advance over the existing technology used in the da Vinci X and Xi systems. This system has been tested thoroughly in the laboratory and now in the clinical setting.
The FDA has not determined that this device was substantially equivalent to predicate devices.
The Da Vinci SP Surgical System, EndoWrist SP Instruments, and accessories are currently approved for Urological uses including surgery of the prostate and kidney. Approval for additional uses including gastrointestinal and ENT are currently pending.
The Da Vinci SP Surgical System, EndoWrist SP Instruments, and accessories should not be used in patients in whom laparoscopic or robotic surgery is contraindicated. The surgical system should not be operated by individuals who have not been trained in its use.