(211 days)
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor abrasions, minor lacerations, and minor burns.
The devices are available in three configurations, which are Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing and Antimicrobial non-woven sponge dressing. All of them consist of (1) a dressing (base material) and (2) anti-microbial agent. For each configuration, it is available in several models, which are different in size and quantity of anti-microbial agent.
Based on in vitro testing, the product can achieve board spectrum antimicrobial effect within the dressing for Gram+ and Gram- Bacteria and Fungi. It has been shown to have 4 log bacterial reduction in vitro against the following test organisms: Staphylococcus aureus (ATCC 6538), Escherlchia coli (ATCC 25922), Candida albicans (ATCC 10231), Pseudomona aeruginosa (ATCC 9027) and Bacillus subtilis (ATCC 6633), Streptococcus pyogenes (ATCC 19615), Serratia marcescens (ATCC 31026), Aspergillus niger (ATCC 16404). The effective inhibition of bacteria is 7 days.
This document is a 510(k) summary for antimicrobial sponge dressings and does not involve AI/ML technology. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for AI/ML device performance, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document focuses on demonstrating substantial equivalence of the proposed antimicrobial dressings to previously cleared predicate devices, primarily by showing similar intended use, technological characteristics (materials, antimicrobial agents, sterilization), and a reliance on non-clinical testing (biocompatibility, antimicrobial effectiveness, absorbency). It explicitly states that "No clinical study is included in this submission." Consequently, there are no acceptance criteria or study details regarding human or AI performance to report.
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