(394 days)
Rx Indications for Use: DermaFINE Wound Dressing is indicated for topical use in the management of full and partial thickness wounds including dermal ulcers, leg ulcers, superficial wounds, first and second degree burns and donor sites to include: Radiation Dermatitis Various types of dermatoses Atopic dermatitis Allergic contact dermatitis Dry waxy skin by maintaining a moist wound and skin environment.
OTC Indications for Use: DermaFINE Wound Dressing Emulsion is indicated for the management of minor cuts, minor burns, and minor lacerations by maintaining a moist wound and skin environment.
DermaFINE Wound Dressing is a preserved emulsion intended to be used as a topically applied preparation to breached and intact skin and is provided in a patient ready, 28 gram (one (1) ounce), 45 gram and 90 gram collapsible tube.
The provided text describes a 510(k) premarket notification for the DermaFINE Wound Dressing, which is seeking substantial equivalence to predicate devices. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies for proof of efficacy. As such, the information you've requested regarding acceptance criteria and detailed study results typical of a de novo or PMA submission is largely not applicable in this context for proving clinical effectiveness of the device itself.
However, the document does provide information about non-clinical performance data which serves as the basis for demonstrating equivalence and safety.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are generally aligned with demonstrating that the new device shares the same technological characteristics and intended use as the predicate device, and that it performs safely. The provided document details the non-clinical tests performed to demonstrate this safety.
| Non-Clinical Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (DermaFINE Wound Dressing) |
|---|---|---|
| Agar Overlay (direct contact) Cytotoxicity | Non-cytotoxic (similar to predicate) | Grade 0 cytotoxic grade (Non-cytotoxic) |
| Primary Skin Irritation ISO Direct Contact | No erythema, no edema (similar to predicate) | No erythema, no edema |
| Kligman Maximization Test ISO Direct Contact | Non-sensitizing or low allergenic potential (similar to predicate) | Grade 1, weak allergenic potential |
| Antimicrobial Preservatives Effectiveness Test | Effective preservation (similar to predicate) | (Implied as acceptable; no specific result provided but mentioned as performed) |
| Dermal Irritant | No (similar to predicate) | No |
| Cytotoxic | No (similar to predicate) | No |
| Dermal Sensitizer | No (similar to predicate) | No |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the sample sizes used for the non-clinical tests (e.g., number of cells for cytotoxicity, number of animal subjects for irritation/sensitization).
- Data Provenance: The tests are described as being conducted "in accordance with Part 10-993 of the International Standard Organization (ISO)." This indicates in vitro and potentially in vivo (animal) testing common to medical device biocompatibility evaluations. The country of origin for the data is not specified beyond adherence to ISO standards. The data is implicitly prospective as it was conducted to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable for the non-clinical tests described. Biocompatibility tests like cytotoxicity, irritation, and sensitization follow standardized protocols where results are objectively measured and interpreted by trained laboratory personnel, rather than relying on expert consensus for "ground truth" as might be the case in an imaging or diagnostic study.
4. Adjudication method for the test set
This information is not applicable for the non-clinical tests described. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or studies involving human interpretation of data (e.g., radiology reads) to resolve discrepancies. The non-clinical tests rely on validated laboratory methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "DermaFINE Wound Dressing has not been studied in a clinical setting."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not applicable to a wound dressing device. Standalone performance refers to the performance of an artificial intelligence algorithm or diagnostic without human intervention. This device is a physical wound dressing emulsion.
7. The type of ground truth used
For the non-clinical performance data, the "ground truth" is established by adherence to standardized ISO test methodologies and their inherent measurement criteria. For instance, in cytotoxicity, the "ground truth" is the observed cellular response according to the defined grading scale. For skin irritation, it's the absence or presence of erythema/edema as per the standard.
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train machine learning models. The DermaFINE Wound Dressing is a physical product, not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
N/A