da Vinci Surgical System (IS5000)

The da Vinci Surgical System (IS5000) is a robotic surgical platform that assists surgeons in controlling endoscopic instruments for minimally invasive procedures. It enables manipulation of various surgical tools including scissors, forceps, needle drivers, and electrocautery devices across urologic, general laparoscopic, gynecologic, and thoracoscopic procedures in adult patients. The system is intended for use by trained physicians in operating room environments.

The da Vinci Force Feedback Instruments are 8mm multi-use endoscopic instruments with articulating wrists that provide surgeons natural dexterity and range of motion. They feature the ability to render forces measured at the instrument tip back to hand controls at the console. The subject devices are technologically similar to predicates with unchanged principles of operation; modifications focus on increasing the number of surgical uses (6 vs. 3-4) and reprocessing cycles (9 vs. 5-6).

ANSI/AAMI ST98:2022 (cleaning validation), AAMI TIR12:2020 (reusable device design and labeling), ASTM F3208-20 (test soil selection for cleaning validation), IEC 60601-2-2:2017 (high frequency surgical equipment safety), and FDA guidance on reprocessing validation and electrosurgical device submissions.

The subject instruments are substantially equivalent because they maintain identical intended use, indications for use, and technological principles as the predicates while performing the same surgical functions. Performance testing demonstrates that increased use and reprocessing cycles do not compromise safety or effectiveness: cleaning validation confirmed the manual process remains efficacious, life verification showed mechanical and sensor performance is maintained through the extended cycles, dielectric strength and jaw force testing confirmed electrical safety and functional integrity after simulated design life exposure, and reprocessing instructions were appropriately modified to support the extended use profile.