(162 days)
Exofin® High Viscosty Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Exofin® High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In vitro studies have shown that Exofin®High Viscosity Tissue Adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
This document is a 510(k) premarket notification for the Exofin® High Viscosity Tissue Adhesive. It does not describe acceptance criteria or a study proving that an AI-powered device meets acceptance criteria. Instead, it describes performance testing for a medical device (a tissue adhesive) against established ASTM standards and biocompatibility in accordance with ISO 10993-1.
Therefore, I cannot provide the requested information regarding acceptance criteria and an AI study.
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.