Suture-TOOL System

The Suture-TOOL System is a single-use sterile suturing device consisting of a handheld applicator with a pre-mounted polydioxanone (absorbable) suture and double-pointed needle. It is intended for abdominal wall closure after laparotomy in patients 18 years and older.

The device uses identical absorbable polydioxanone surgical sutures to the predicate (Filbloc), manufactured by the same supplier with identical materials, specifications, formulation, processing, sterilization, and geometry. It is available in USP size 2-0 with tensile strength retention of 71.7% at 4 weeks and 16.5% at 8 weeks, absorbing over 180-210 days. The needle is double-pointed AISI 316L stainless steel, sterilized with ethylene oxide gas.

USP 41-NF36:2018 standards including <861> suture diameter, <871> needle attachment, and <881> tensile strength testing. ISO 10993-1:2018 for biocompatibility evaluation. FDA Guidance for Industry on applying human factors and usability engineering to medical devices (2016).

The Suture-TOOL System is substantially equivalent to the Filbloc predicate because both devices use identical absorbable polydioxanone sutures with the same manufacturer, materials, and performance characteristics (tensile strength and absorption profile). While the subject device includes a reusable applicator (making it a complete system) compared to the predicate suture alone, it is compared to the SafePath Suturing System reference device, which is also a complete suturing system with identical regulation and product code. The subject device meets all USP performance standards and raises no new safety or effectiveness questions.