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510(k) Data Aggregation
(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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(62 days)
Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.
This document is a 510(k) summary for the Kendall Excilon® A.M.D. Antimicrobial Sponges. It focuses on demonstrating substantial equivalence to previously marketed devices and does not contain information about specific acceptance criteria, device performance, or human subject studies as typically described for software or AI-based devices.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Reported Device Performance: This submission is for a physical wound dressing, not a software or AI device. The document states that "Biocompatibility testing of the proposed device 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." This is the extent of performance "criteria" discussed, and it's for biocompatibility, not for a functional or diagnostic performance as would be expected for a device where a table of acceptance criteria and reported performance would be relevant.
- No Study Data for Software/AI Performance: The submission does not describe a study that proves device performance in the context of AI or software. There are no mentions of test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This is not applicable to a non-digital, physical medical device like an antimicrobial sponge.
- No AI or Software Component: The device described is an antimicrobial wound dressing. It does not incorporate any AI, machine learning, or software components that would require the types of studies and criteria outlined in your request.
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