SimpleStitch Suturing System

The SimpleStitch Suturing System is a sterile, single-use endoscopic device that enables placement of sutures and approximation of soft tissue within the gastrointestinal tract. It consists of a suture device, suture cartridge, and suture cinch, designed for compatibility with single-channel endoscopes (gastroscopes and colonoscopes) with a minimum 2.8mm working channel. The device is intended for closure and healing of ESD/EMR sites and closing of fistula, perforation, or leaks.

The SimpleStitch uses a circular needle with circular driving arm motion (versus the predicate's straight/curved motion), but both enable full-thickness suture placement. The SimpleStitch offers USP 2-0 and 0 sutures in non-absorbable braided polyester (versus the predicate's polypropylene or polydioxanone monofilament). Both devices have 185cm sutures, identical cinch unlock force (2.4 lb), identical MRI compatibility (1.5/3T conditional), and identical sterilization (EO to SAL 10-6) and shelf life (3 years). The SimpleStitch device lengths are 120-175cm compared to the predicate's 117-130cm.

ISO 19993 (biocompatibility), ISO 11135 (ethylene oxide sterilization validation), and FDA Guidance Document on ISO 10993-1 (biological evaluation of medical devices). MRI safety testing was also performed.

Both devices share identical intended use, patient populations, and principle of operation: endoscopic tissue approximation using sutured approximation with knotless fixation. Though needle configuration and suture material differ, both support full-thickness suturing. Bench testing and a controlled animal study demonstrated equivalent performance in closure and healing of mucosal defects over one month. The specific clinical indications cited in SimpleStitch (ESD/EMR sites, fistula, perforation, leaks) fall within accepted parameters for general endoscopic tissue approximation, as evidenced by medical publications. The devices are biocompatible, sterilized identically, and have identical safety specifications, raising no additional safety or effectiveness questions beyond the predicate.