ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M)

The ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) is a sterile, single-use bipolar electrosurgical instrument used with the ArtiSeal Generator during minimally invasive or open surgical procedures to seal and divide vessels and tissue bundles up to 7 mm in diameter. The device applies radiofrequency energy to generate heat for ligation, and features an articulating jaw that can bend up to ±90° and rotate 360°.

The subject device (AS01M) is dimensionally similar to the predicate (AS01L) with identical materials, operating principle, and energy type (bipolar radiofrequency), differing only in shaft length (345 mm versus 415 mm). Both devices use the same ArtiSeal Generator and employ identical patient-contacting materials evaluated per ISO 10993-1 biocompatibility standards.

ISO 10993-1 (biocompatibility), ISO 11135 (ethylene oxide sterilization), ISO 11607-1 and ISO 11607-2 (packaging validation), IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 (electrical safety and electromagnetic compatibility).

The subject device demonstrates substantial equivalence through identical intended use, operating principle, energy type, electrode configuration, and materials as the predicate device. Comprehensive nonclinical testing—including bench testing, ex vivo burst pressure testing (mean >240 mmHg), acute thermal spread (<2 mm), and 21-day chronic survival studies—confirmed equivalent mechanical performance, sealing effectiveness, and tissue safety, with all results meeting predefined acceptance criteria.