Atrauman® Ag

Atrauman® Ag is a non-adherent, silver-impregnated antimicrobial wound dressing that maintains a moist wound environment. It consists of a meshed hydrophobic polyamide textile coated with metallic silver (2.1 mg/sq inch) combined with a hydrophilic triglyceride matrix. It is indicated for moderately exuding wounds including pressure wounds, venous leg ulcers, diabetic ulcers, partial thickness burns, skin graft donor sites, surgical wounds, and abrasions.

Both Atrauman® Ag and the predicate (UrgoTul Ag) share a non-adherent contact layer of hydrophobic polyamide mesh and incorporate silver for antibacterial properties within a hydrophilic impregnated matrix to maintain moist wound environment and absorb exudate. The key difference is that Atrauman Ag fibers are coated with elemental silver, whereas UrgoTul Ag uses silver sulfate in the matrix applied to the polyamide mesh with other ingredients.

ISO 10993-1 (biocompatibility), ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (irritation/intracutaneous reactivity), ISO 10993-11:2017 (pyrogenicity and systemic toxicity), ISO 10993-6:2016 (implantation), EN ISO 11137 series (radiation sterilization), EN ISO 11737 series (microbiological methods), ASTM D4169 (transport testing), and ANSI/AAMI ST72:2019 (bacterial endotoxins).

Both devices have identical product codes (FRO, unclassified) and nearly identical indications for moderately exuding wounds. Functionally, they are equivalent: non-adherent contact layer, silver-based antibacterial mechanism, hydrophilic matrix for moisture management, and 7-day antimicrobial effectiveness. The differences in silver form (elemental vs. sulfate) and indications (UrgoTul supports graft sites; Atrauman does not yet) do not raise new safety or effectiveness questions. Performance testing demonstrates Atrauman meets applicable biocompatibility and sterilization standards equivalent to predicate performance.