(263 days)
Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns.
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.
The provided text describes the 510(k) summary for an "Antibacterial Bandage" (K201324) and compares it to a predicate device (K113583). It outlines non-clinical tests performed to demonstrate substantial equivalence, but it does not include a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or details on ground truth for AI model training/testing, as it is not an AI/ML device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Acceptance Criteria | Reported Device Performance |
|---|---|
| Peel Adhesion (per ASTM D3330/D3330M) | Peel strength > 1.0 N/cm |
| Antimicrobial Efficacy (per AATCC-100) | Meets the requirement of 4 log reduction (effective against Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans, and Aspergillus Niger for up to 24 hours). |
| Sterile Barrier Packaging (Seal strength per ASTM F88/F88-15) | Device package can maintain its integrity. |
| EO ECH Residue (per ISO 10993-7:2008) | Did not exceed the limit. |
| Bacteria Endotoxin Limit (per USP 42-NF 37 ) | Did not exceed 20 EU/device. |
| Shelf Life Evaluation | Maintain its performance during the claimed shelf life (verified by Peel Adhesion, Package Tests on aging samples). |
| Biocompatibility (for breached/compromised surfaces, 1.0 N/cm as per ASTM D3330/D3330M. |
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm.
N/A