da Vinci Force Feedback Instruments

The da Vinci Force Feedback Instruments are 8 mm multi-use endoscopic surgical instruments designed for use with the da Vinci Surgical System Model IS5000. They feature an articulating wrist providing natural dexterity and the ability to render forces measured at the instrument tip back to the surgeon's hand controls, enabling tasks such as suturing, grasping, and tissue manipulation across urologic, general laparoscopic, gynecologic, and thoracoscopic procedures in adults.

The subject instruments have the same intended use and fundamental scientific technology as their predicate devices with unchanged principles of operation. Key changes include modifications to product design and cleaning methods driven by updates to cleaning architecture, an increase in maximum surgical uses and reprocessing cycles, incorporation of compatible sterilization containers, and labeling and software updates that do not substantively alter safety or performance.

Cleaning validation per ANSI/AAMI ST98:2022 and ASTM F3208-20; sterilization per ANSI/AAMI/ISO 17665-1:2006 and ISO 17664-1:2021; packaging per ASTM D4169-23; biocompatibility per ISO 10993-1:2018; electrical safety per ANSI/AAMI ES 60601-1:2005 and IEC 60601-1-2 Edition 4.1; software per ANSI/AAMI/IEC 62304; and cybersecurity per FDA 2025 guidance.

The subject instruments are substantially equivalent to the predicate da Vinci Force Feedback Instruments (K243641) because they maintain identical intended use, indications for use, and fundamental technology while incorporating design refinements and increased durability that do not change core safety or performance characteristics. Comprehensive performance testing validated that all modifications—cleaning methods, reprocessing cycles, sterilization, and software—meet applicable standards and support equivalent functionality.