(104 days)
The exsalt® SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic 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. The exsalt® SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.
Exciton Technologies Inc. has developed the exSALT® technology, a proprietary chemical process, which deposits oxidized silver species onto a substrate; a non-woven polyester with a gray Delnet® HDPE mesh layer thermally laminated to one side (wound contact layer). The pad is backed with a clear polyurethane film with acrylate adhesive to hold the dressing in the exsalt® SD7 Wound Dressing with Adhesive Backing inhibits bacterial growth in the dressing pad. The concentration of the silver and oxidized silver species on the dressing pad is 0.4 mg/cm² (1.8%w/w). The exsalt® SD7 Wound Dressing with Adhesive Backing has been shown to be effective in vitro against Staphylococcus aureus. Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.
The provided text describes a Special 510(k) submission for the exsalt® SD7 Wound Dressing with Adhesive Backing, which is an modification of an already cleared device, exsalt® SD7 Wound Dressing (K103067). This type of submission generally focuses on demonstrating that the changes do not raise new questions of safety or effectiveness, often by comparing the modified device's performance to the predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Silver Content | Same as predicate | Same as predicate |
| Moisture Content | Same as predicate | Same as predicate |
| pH | Same as predicate | Same as predicate |
| Absorbency | Same as predicate | Same as predicate |
| Anti-bacterial Effectiveness (against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii) | Effective for up to 7 days | Effective for up to 7 days |
| Silver Release | Same as predicate | Same as predicate |
| Biocompatibility | Non-toxic, non-irritant, no sensitization response (for dressing pad); safe for intended use (for adhesive film) | Non-toxic, non-irritant, no sensitization response (for dressing pad); safe for intended use (for adhesive film) |
| X-ray Diffraction | Same as predicate | Same as predicate |
Study Proving Device Meets Acceptance Criteria:
The submission explicitly states: "All performance characteristics of the exsalt® SD7 Wound Dressing with Adhesive Backing are the same as the predicate." This indicates that the primary study proving the device meets the acceptance criteria is a comparison to the predicate device (exsalt® SD7 Wound Dressing, K103067). The core argument is that, because the wound-contacting materials and the underlying technology are the same, and the modifications (addition of adhesive backing) do not impact the core performance aspects, the new device inherently meets the same performance standards as the predicate.
The document lists "The following performance tests were conducted on the exsalt® SD7 Wound Dressing". While it doesn't explicitly state new tests were conducted on the "exsalt® SD7 Wound Dressing with Adhesive Backing" for all these characteristics, the phrasing implies that these characteristics were evaluated for the predicate device, and the new device is deemed equivalent based on its identical core components. Biocompatibility testing was specifically performed on the adhesive backing component to ensure its safety.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for individual performance tests. The document refers to the predicate device's performance results as the basis for equivalence. For biocompatibility, the adhesive film was tested, but specific sample sizes are not given.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are internal performance tests conducted by Exciton Technologies Inc. or their commissioned labs.
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)
- Number of Experts: Not applicable or specified. Performance testing for medical devices like wound dressings typically involves standardized laboratory methods, not expert consensus on interpretations.
- Qualifications of Experts: Not specified. Standard laboratory personnel or qualified technicians would perform these types of tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication of results in the way image analysis or clinical trials might. The performance tests are objective laboratory measurements.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for wound dressings.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a wound dressing, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The "ground truth" for the performance characteristics are established scientific and engineering standards and methods for testing wound dressings, and the performance of the previously cleared predicate device. For example:
- Antibacterial Effectiveness: In vitro testing against specific bacterial strains.
- Biocompatibility: Standardized tests (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization.
- Material properties: Standardized tests for silver content, pH, absorbency, etc.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device doesn't involve a machine learning algorithm or AI that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
N/A