Vessel Sealer Curved (480522)

The Vessel Sealer Curved is a sterile, single-use 8 mm bipolar electrosurgical instrument designed for use with the da Vinci Surgical System. It grasps, dissects, coagulates, and mechanically cuts blood vessels up to 7 mm in diameter, lymphatic vessels, and tissue bundles; it is explicitly not indicated for tubal sterilization or coagulation.

The device has the same fundamental bipolar electrosurgical technology as its predicate (Vessel Sealer Extend). Key differences include addition of specific vessels to the indications, changes in end-effector jaw design and materials, and modifications to the electrical cable at the distal end. These differences do not substantively alter the safety and performance profile relative to the predicate's function.

Design verification per IEC 60601-1 and IEC 60601-1-2; shelf-life testing per ASTM F1980; transit testing per ASTM D4169-16; biocompatibility per ISO 10993-1:2018 and FDA guidance on ISO 10993 Part 1 (September 2020). Design validation included burst pressure testing, thermal spread on vessels, and chronic animal study.

The subject device shares identical intended use and underlying bipolar electrosurgical technology with the predicate. Although design and materials changed at the end effector and electrical cable, these modifications address the same clinical need without altering fundamental safety or performance. Comprehensive testing—mechanical bench verification, reliability, compatibility, biocompatibility, and animal validation—demonstrated that design outputs meet design inputs, confirming the device performs equivalently to the predicate for its intended applications.