POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)

The POWERSEAL Open Extended Jaw Sealer and Divider is a bipolar electrosurgical instrument used in open surgical procedures to seal and divide vessels, tissue bundles, and lymphatics up to 7 mm in diameter. It operates by applying radiofrequency energy to create a seal, then uses an internal blade to cut along the seal line. The device is sterile, single-use, and designed for general surgery and related specialties including urologic, colorectal, vascular, thoracic, and gynecologic procedures.

The subject device has a 21 cm shaft compared to the predicate's 18 cm, due to repositioned shaft rotation control, though both lengths are clinically equivalent. Both devices are bipolar electrosurgical instruments with identical intended use, primary mode of action, delivery method (sterile single-use), and regulatory classification. The subject device demonstrates comparable performance in vessel sealing metrics including seal time, burst pressure, thermal margin, heat profile, and tissue sticking.

Testing followed IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62366-1, ISO 14971, ISO 11135, ISO 11607-1, ASTM F1980-16, ISO 10993 series (biocompatibility), and FDA guidance documents on bipolar electrosurgical vessel sealers for general surgery issued August 15, 2016 and March 9, 2020.

The subject device is substantially equivalent to the predicate LigaSure Impact because both share the same intended use, indications, technology, regulatory classification, and performance characteristics. Bench testing and animal studies (acute and chronic) demonstrated that the subject device performs as safely and effectively as the predicate for vessel sealing, with comparable burst pressure, thermal characteristics, and tissue effects. Any differences, such as shaft length, have been validated and do not raise questions of safety or efficacy.