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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.

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derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile. liquid topical skin adhesive containing a monomeric (2-octy) 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 also containing 2 Indothene HD Grade HD50MA180 applicator tips. The dauber applicator is comprised of a selfpuncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. derma+flex® QS™ High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity derma+flex® QS™ 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.

This document is a 510(k) summary for a medical device (derma+flex QS High Viscosity Tissue Adhesive). It confirms substantial equivalence to a predicate device and details the indications for use. However, it does not contain the specific information required to answer the questions about acceptance criteria, study details, and ground truth establishment.

A 510(k) summary typically compares a new device to an existing legally marketed predicate device to demonstrate "substantial equivalence." While it might mention performance equivalence, it rarely includes the detailed study reports, acceptance criteria, and ground truth methodologies that would be found in a full submission or a scientific publication.

Therefore, I cannot provide the requested information from the given text. The document states:
"derma+flex® QS™ High Viscosity Tissue Adhesive was evaluated in tests to establish a performance and safety profile in accordance with the Class II Specials Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin."
This indicates that studies were performed, but the details of those studies (acceptance criteria, sample sizes, ground truth, etc.) are not present in this summary.

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