V-soft Line™ Barbed Surgical Suture (Various)

The V-Soft Line™ Barbed Surgical Suture is a sterile, absorbable synthetic suture made of polydioxanone (PDO) with a violet dye, supplied with a needle attachment. It features bi-directional barbs along the suture monofilament that allow tissue approximation without tying surgical knots, and is indicated for soft tissue approximation on the skin for dermatological applications only, not for internal body cavities or tissue lifting/support.

The subject device is made of the same PDO material as the predicate (Miracu™) and uses identical stainless steel 304L needles. Both feature two-way barb formation on monofilament sutures sterilized with ethylene oxide. Minor differences exist in suture sizes (subject: 3-0, 2-0, 2 versus predicate: 4-0, 3-0, 2-0, 0), barb angles, barb spacing, barb length, and interval between barbed sections, but these are stated to have no impact on form, fit, function, or safety.

USP 43-NF 38 Section <861> (Sutures—Diameter), Section <871> (Sutures—Needle Attachment), and Section <881> (Sutures—Tensile Strength); ISO 10993-1 (biocompatibility); USP 37 NF:2014 (absorbable surgical suture standards); suture retention barb holding strength testing.