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510(k) Data Aggregation
(71 days)
The KerraContact® Ag Perf Advanced Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.
Exciton Technologies Inc. has developed the exsalt® technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven spunlace polyester laminated with gray Delnet® HDPE mesh layers on both sides. Silver in the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing (KerraContact® Ag Perf) inhibits bacterial growth in the dressing for up to 7 days. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/ cm² (4.5% w/w). The KerraContact® Ag Perf has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.
KerraContact® Ag Perf meets pyrogen limit specifications.
This document (K182680) is a 510(k) summary for a wound dressing, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove device performance, especially those related to AI/ML and human-in-the-loop performance, adjudication methods, and training/test set details, are not applicable to this submission.
The 510(k) is demonstrating substantial equivalence of the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing to a predicate device (KerraContact® Ag Advanced Silver Wound Dressing, K113564).
Here's an analysis based on the provided text, reinterpreting "acceptance criteria" as performance characteristics and "study" as comparative evaluation to the predicate:
1. Table of Acceptance Criteria (Performance Characteristics) and the Reported Device Performance
The "acceptance criteria" here are generally that the performance characteristics of the new device are equivalent to the predicate, or that any differences do not raise new safety or effectiveness concerns.
| Performance Characteristic | Acceptance Criteria (Relative to Predicate K113564) | Reported Device Performance (KerraContact® Ag Perf) |
|---|---|---|
| Silver Content | Equivalent Total Silver, Release, and Qualitative Ag2+/3+ | Found equivalent to predicate. |
| Moisture Content | Equivalent | Found equivalent to predicate. |
| pH | Equivalent | Found equivalent to predicate. |
| Absorbency | Equivalent | Found equivalent to predicate. |
| Anti-bacterial Effectiveness | Equivalent effectiveness in vitro | Shown to be effective in vitro against specified bacteria, similar to predicate. |
| Pyrogen Limit | Meets specifications | Meets pyrogen limit specifications. |
| Sterilization Method | Identical (gamma irradiation) | Sterilized by gamma irradiation. |
| Materials | Identical skin-contacting materials | Identical skin-contacting materials. |
| Bacterial Barrier | May differ, but without new safety/effectiveness concerns | The predicate provides a bacterial barrier, whereas the subject device does not. This difference did not raise new safety or effectiveness concerns. |
| Biocompatibility | Non-toxic, non-irritant, non-sensitizing | Leveraged predicate data; no new concerns identified from perforations. |
2. Sample Size Used for the Test Set and the Data Provenance
This information is not provided in the text for the performance tests. The studies are described as "performance tests" and "comparative evaluation" between the subject and predicate devices. No specific sample sizes for these tests are mentioned.
The provenance of the data (e.g., country of origin, retrospective/prospective) for these in vitro or physical properties tests is also not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable as this is not an AI/ML device requiring expert ground truth for interpretation of medical images or data. Performance was measured through laboratory tests.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This question is not applicable as this is not an AI/ML device or a study involving human interpretation that would require an adjudication method.
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
This question is not applicable as this is not an AI/ML device. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI/ML device.
7. The Type of Ground Truth Used
For the performance characteristics, the "ground truth" was established by standard laboratory testing protocols and specifications for material properties, chemical composition, and antimicrobial activity, compared against the known performance of the predicate device. For biocompatibility, it relied on established biocompatibility testing standards and results from the predicate device.
8. The Sample Size for the Training Set
This question is not applicable to this type of device. There is no concept of a "training set" for physical and chemical performance testing of a wound dressing.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the reasons stated above.
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