(195 days)
The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.
The Compeed® Psoriasis Dressing is a non-sterile, hydrocolloid dressing marketed in Europe for the management of chronic plaque-type Psoriasis.
The provided text describes a 510(k) submission for the Compeed® Psoriasis Dressing. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics. Therefore, aspects of your request, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not applicable to this document.
The document's focus is on comparing the new device to a legally marketed predicate device (Compeed® Athletic Dressing K883588) to establish substantial equivalence.
Here's a breakdown of what is available based on the provided text, and where your requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device.
- Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics that would typically come from a clinical trial. The comparison focuses on device composition, physical characteristics, and intended use as compared to the predicate.
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable. This document does not describe a clinical study with a test set of data.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts/Qualifications: Not applicable. Ground truth establishment for a clinical study is not described.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done or reported in this document.
6. Standalone Performance:
- Standalone Performance: No, standalone (algorithm only without human-in-the-loop performance) was not done or reported. This device is a dressing, not an algorithm.
7. Type of Ground Truth Used:
- Type of Ground Truth: Not applicable. Clinical ground truth (e.g., pathology, outcomes data) for a new clinical study is not described. The "ground truth" for this 510(k) is the existing characteristics and performance of the predicate device.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This document does not describe a machine learning model or a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable.
Summary derived from the document regarding substantial equivalence:
The Compeed® Psoriasis Dressing demonstrated substantial equivalence to the Compeed® Athletic Dressing (K883588). The comparison in Table 1 (provided in your input) highlights the similarities and differences.
Key points of equivalence and differences:
| Feature | Compeed® Psoriasis Dressing | Compeed® Athletic Dressing (Predicate K883588) | Equivalence Demonstrated |
|---|---|---|---|
| Composition | Carboxymethylcellulose, Petroleum hydrocarbon resin, copolymer, Dioctyl adipate, Polyurethane film, silicone paper | Carboxymethylcellulose, Petroleum hydrocarbon resin, copolymer, Dioctyl adipate, Polyurethane film, silicone paper | Yes |
| Function | Skinprotector | Skinprotector | Yes |
| Sterilization | Non-sterile | Non-sterile | Yes |
| Packaging | Hard plastic casing | Hard plastic casing | Yes |
| Intended Use | Non-sterile skin protector for use on chronic plaque-like psoriasis | Non-sterile, skin protector to prevent blisters and protect skin from friction that leads to calluses and corns | Yes (similar skin protection function, different target condition) |
| Shape | Triangular | Oval | No (different) |
| Sizes | One size | Small, medium, large | No (different) |
| Location of Device | Knees and elbows | Foot | No (different) |
The FDA's letter (K982493) confirms the "substantial equivalence" determination, allowing the device to be marketed, provided it adheres to general controls and specific labeling limitations (e.g., cannot be labeled for third-degree burns, accelerated wound healing, or as artificial skin). The changed indications (from blister/callus prevention to psoriasis management) and minor design changes (shape, size, target location) were deemed not to raise new questions of safety or effectiveness when compared to the predicate device.
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