Endomina EZFuse system

The Endomina EZFuse system is an endoscopic device for placing sutures and approximating soft tissue in the gastrointestinal tract. It consists of a triangulation platform that attaches to a flexible endoscope and a suture delivery instrument with anchors connected by braided polyester suture, enabling interrupted stitches to be created during endoscopic procedures.

The EZFuse suture has a backbevel needle design with three grinding facettes (versus lancet design in predicate), shorter overall device length (1295mm vs 1375mm), and modified anchor dimensions (one anchor is 10mm × 1.2mm OD vs two anchors of 1.1mm OD in predicate). Both are single-use, terminally sterilized to SAL 10⁻⁶, with 2-year shelf-life, and use non-absorbable braided polyester suture with PEEK anchors.

EN ISO 11135:2014/A1:2019 (sterilization validation), ASTM F1929-23 and ASTM F1886-16 (packaging integrity), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and implantation), and USP <151> (material-mediated pyrogenicity).

Substantial equivalence is established because the device shares the same intended use (endoscopic suture placement and tissue approximation in the GI tract), comparable technological characteristics (single-use, sterile, same materials and sterilization method), and demonstrated performance across all bench tests including needle function, anchor strength, and device performance. No new safety or efficacy issues were identified compared to the predicate K211309 endomina system.