(104 days)
The Acticoat® Moisture Control dressing, an addition to the Acticoat® Dressing line of products is intended as an absorbent dressing which provides an effective barrier to bacterial penetration. Acticoat® Moisture Control Dressing is indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites. Acticoat® Moisture control may be used over debrided and partial thickness wounds.
The absorbent, antimicrobial barrier dressing consists of three layers. An outer blue polyurethane film layer, a central polyurethane foam layer and a nanocrystalline silver coated polyurethane film wound contact layer. The layers are heat laminated together to form a single dressing. The dressing can be cut to size and maintains its antimicrobial activity for up to 7 days.
This 510(k) premarket notification for K050030, the Acticoat® Moisture Control Dressing, is for a wound dressing and as such, does not involve the typical software-driven device acceptance criteria and studies you might expect for an AI/ML product. The submission is focused on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device.
Therefore, the requested information about acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not applicable to this type of device submission.
Instead, the "acceptance criteria" for this submission are met by demonstrating the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Description of Acceptance | Reported "Device Performance" (as evidence of substantial equivalence) |
|---|---|---|
| Intended Use | Identical to predicate device. | The labeled indications of the Acticoat Moisture Control Dressing (light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, 1st and 2nd degree burns, and donor sites) are identical to those of the predicate device Acticoat Foam (K000051). |
| Design, Materials & Manufacturing Methods | Comparable to predicate device and do not raise new safety/effectiveness issues. | The absorbent, antimicrobial barrier dressing consists of three layers: an outer blue polyurethane film, a central polyurethane foam, and a nanocrystalline silver coated polyurethane film wound contact layer. These layers are heat laminated. The nanocrystalline silver layer is applied by physical vapor deposition, an identical manufacturing process approved for the predicate device Acticoat Foam (K000051) and other Acticoat brand dressings. The materials (polyurethane foam, polyurethane film, nanocrystalline silver) are comparable to the predicate and similar existing devices (Allevyn, Hydrasorb). |
| Biocompatibility | No additional safety risk over predicate device. | Biocompatibility has been demonstrated through appropriate in vivo and in vitro tests and previous tests on individual components, in accordance with ANSI/AAMI/ISO 10993. The product introduces no additional safety risk over the predicate device Acticoat Foam (K000051). |
| Directions for Use | Equivalent to predicate device. | The directions for use are equivalent to those of the predicate device Acticoat Foam (K000051). |
| Antimicrobial Activity | Maintains antimicrobial activity for specified duration. | The dressing maintains its antimicrobial activity for up to 7 days. (This is an inherent feature of the silver coating, proven in predicate devices, rather than a new performance claim requiring a specific study for this submission beyond equivalence). |
| Absorbency | Functions as an absorbent dressing. | The device is described as an "absorbent dressing." (This is a functional characteristic inherent in the polyurethane foam layer, comparable to the predicate). |
| Barrier to Bacterial Penetration | Provides effective barrier. | The device is intended to provide an "effective barrier to bacterial penetration." (This is attributed to the presence of nanocrystalline silver, validated in predicate Acticoat devices). |
Regarding the specific questions which are NOT applicable to this 510(k) submission for a wound dressing:
- Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a wound dressing substantial equivalence submission. Performance data for a direct animal or human study for this specific claim of equivalence is not detailed in the summary.
- 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. "Ground truth" in the context of AI/ML models is not relevant here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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/imaging device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- 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 legally marketed predicate device.
- The sample size for the training set: Not applicable. There is no AI/ML model for which a training set would be used.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) document demonstrates substantial equivalence by comparing the new device's intended use, technological characteristics (materials, design, manufacturing), and biocompatibility to a predicate device (Acticoat® Foam Dressing K000051) which has already been deemed safe and effective. The FDA's acceptance of this submission means they agreed that the Acticoat® Moisture Control Dressing is substantially equivalent to the predicate and does not raise new questions of safety or effectiveness.
N/A