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The Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System - Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, 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, 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 pediatric use. 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 Robotic Surgical Instruments, Permanent Cautery Hook (470183) and Permanent Cautery Spatula (470184), are reusable, non-sterile instruments intended for use with the da Vinci X/Xi Surgical System – Intuitive Surgical, Inc. The Permanent Cautery Spatula and Permanent Cautery Hook are intended to be used with the da Vinci Xi System or the da Vinci X System for precise dissection and division of tissue with monopolar cautery.

Each instrument consists of four primary components: the housing, shaft, wrist, and tip. The shaft and wrist enable multiple axes of articulation, while the tip is designed for direct interaction with tissue. When operated in conjunction with the appropriate robotic system, these instruments provide enhanced dexterity and a greater range of motion than the human hand, facilitating precise tissue manipulation and dissection in minimally invasive procedures.

The remanufactured devices are intended for up to ten (10) additional clinical use cycles beyond the OEM-cleared use life, as supported by validated reprocessing and performance testing. The design, materials, and intended use are identical to the Predicate Device (K131861) in form, fit, and function. The mechanism of action is unchanged and remains based on the same fundamental mechanical architecture and dimensions.

There are no changes to:

• The indications for use
• Clinical applications
• Patient population
• Performance specifications
• Method of operation

In accordance with the Design Control process, a comprehensive risk analysis was conducted to evaluate the impact of remanufacturing. The remanufacturing process includes validated inspection, repair, testing, and cleaning procedures to ensure safety and effectiveness. Design verification and validation activities confirmed that the Subject Devices meet all applicable design input requirements. The following evaluations were performed, or rationales were provided where testing was not required, consistent with applicable standards and FDA guidance:

• Biocompatibility (per ISO 10993)
• Functional performance testing (mechanical and electrical)
• Cleaning validation (including protein, hemoglobin, and TOC residue analysis)
• Electrical safety testing (per IEC 60601-1 and relevant clauses)

Test results support that the remanufactured instruments are as safe and effective as the Predicate Devices and meet all required specifications for intended use.

Additionally, FDA-cleared Reference Device (K203632) is cited to support the validated cleaning and reprocessing methods associated with the proposed ten (10) reuse cycles.

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