(187 days)
Over the counter use as a primary or secondary dressing for light to moderate draining wounds.
The Kendall Kerlix AMD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with polyhexamethylene biguanide hydrochloride, and is available in both sponge and roll form.
The provided text describes a 510(k) premarket notification for a medical device called the "Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC)". This notification focuses on substantial equivalency to a previously cleared device, rather than providing a detailed study proving performance against pre-defined acceptance criteria in the way one might expect for a novel AI/software medical device.
Therefore, many of the requested sections regarding a study proving acceptance criteria cannot be directly extracted from the provided text. The submission relies on the established performance and safety of the predicate device.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The submission does not define specific quantitative "acceptance criteria" in the traditional sense of a performance study for a novel device. Instead, the core "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use Equivalence: | The Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) is identical in intended use to the predicate device, with the primary purpose of this 510(k) being to allow OTC retail marketing. The specific OTC indications for use are: "Over the counter use as a primary or secondary dressing for light to moderate draining wounds." |
| Function Equivalence: | The device is equivalent to the referenced predicate device in that it is intended to be used as a wound covering, it contains an ingredient that enhances the bacterial barrier function of the dressing, and it has a broad spectrum of antimicrobial activity. |
| Composition Equivalence: | The Kendall Kerlix AMD Antimicrobial Gauze Dressing is a sterile, single-use, wound dressing consisting of gauze treated with polyhexamethylene biguanide hydrochloride, and is available in both sponge and roll form. This composition is the same as the predicate. |
| Biocompatibility & Safety: | Biocompatibility testing of the predicate Kendall Kerlix AMD Antimicrobial Gauze Dressing has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. The dressing subject to this submission is identical to the predicate device with the exception of OTC labeling. |
| Performance (Antimicrobial activity): | The predicate device (and thus the new device due to identical composition) has a broad spectrum of antimicrobial activity and enhances the bacterial barrier function of the dressing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to a predicate device. There is no new clinical performance study for this specific device described in the provided text. The biocompatibility testing mentioned refers to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This information is not provided because there was no new clinical performance study with a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm/AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device through its prior clearance and the testing it underwent (e.g., biocompatibility consistent with ISO 10993-1).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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