Suture-TOOL System

The Suture-TOOL System is a single-use, sterile surgical suture applicator with a polydioxanone (PDO) resorbable suture pre-mounted to a needle. It is intended for abdominal wall closure after laparotomy in patients 18 years old and older. The suture is dyed with D&C Violet No. 2 and is sterilized using ethylene oxide gas.

The subject device adds USP size 0 suture in addition to the predicate's USP 2-0 size, with identical material (poly(p-dioxanone)), design, needle type (double-pointed AISI 316 L), and performance characteristics. Both devices have approximately 71.7% tensile strength residual at 4 weeks and 16.5% at 8 weeks, with absorption occurring over 180-210 days post-implantation.

USP 41-NF36:2018 standards were applied: <881> Tensile Strength (6-415), <861> Sutures - Diameter (6-416), and <871> Sutures - Needle Attachment (6-417). All USP criteria were met or exceeded.

The subject and predicate devices are technologically identical except the subject expands the product line to include USP size 0. Since size 0 has the same material composition, design, manufacturing process, intended use, and performance specifications as the predicate (USP 2-0), and all sutures meet the same USP performance standards, the addition of this size does not raise new safety or effectiveness questions. The devices share identical regulatory classification, sterilization method, and mechanical properties.