Search Results

KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.

The provided text is a 510(k) summary for a medical device (Kendall Kerlix MD Antimicrobial Gauze Dressing) and the FDA's clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices based on nonclinical testing. However, it does not contain any information regarding clinical studies, acceptance criteria for device performance, or human-in-the-loop performance evaluation.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance through substantial equivalence, which primarily relies on comparison to existing legally marketed devices, rather than a clinical performance study with specific acceptance criteria.

To elaborate on why the requested information cannot be found in the provided text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, wound healing rates) or acceptance criteria are mentioned. The document states "Biocompatibility testing... has demonstrated that it meets the requirements of quidelines presented in the 10993 ISO Standard, Part 1," but these are safety/biocompatibility guidelines, not performance criteria for a diagnostic or therapeutic effect.
• Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts related to clinical performance studies, which are not detailed in this 510(k) submission. The document relies on "nonclinical testing" (biocompatibility) and comparison to predicate devices' intended use and composition.

Ask a specific question about this device