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510(k) Data Aggregation
(331 days)
Infection Elimination Solutions, LLC
Dermalage for over-the-counter use is intended for cleansing wounds for the removal of foreign material, such as debris and dirt, from dermal wounds.
Dermalage is a liquid solution intended for cleansing wounds. The solution is applied by spraying directly onto the affected area until wet and then allowed to air dry. When sprayed, Dermalage moves across the wound bed by mechanical action to aid in the removal of foreign objects such as dirt and debris from granulating wounds. The Dermalage solution is provided in a bottle with a manual spray pump configuration.
Dermalage is a combination product that contains water, sodium laureth sulfate, sodium lauryl sulfoacetate, disodium laureth sulfosuccinate, cocamidopropyl betaine, sorbitol, Imidazolidinyl Urea, and sodium hydroxide. Imidazolidinyl Urea acts solely as a preservative to inhibit growth of microorganisms within the product before opening and between uses.
Dermalage is limited to use by a single patient for up to 24 hours.
The provided FDA 510(k) Clearance Letter for Dermalage (K243166) does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria related to AI or algorithm effectiveness. The document focuses on demonstrating substantial equivalence to a predicate device (K103713 Elta Wound Cleanser) for its intended use as a wound cleanser through various safety and performance tests.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance in the context of cleaning wounds (e.g., a specific percentage of debris removal). Instead, it lists various safety and effectiveness tests:
| Acceptance Criteria / Test Type | Reported Device Performance (Summary) |
|---|---|
| Cytotoxicity (ISO 10993-5) | Carried out to demonstrate substantial equivalence to the predicate device. (Implies met acceptance criteria for non-cytotoxicity as per ISO 10993-5, though specific results are not detailed). |
| Maximization (ISO 10993-10) | Carried out to demonstrate substantial equivalence to the predicate device. (Implies met acceptance criteria for non-sensitization as per ISO 10993-10, though specific results are not detailed). |
| Intracutaneous Reactivity (ISO 10993-10) | Carried out to demonstrate substantial equivalence to the predicate device. (Implies met acceptance criteria for non-irritation as per ISO 10993-10, though specific results are not detailed). |
| Acute Toxicity (ISO 10993-11) | Carried out to demonstrate substantial equivalence to the predicate device. (Implies met acceptance criteria for non-acute toxicity as per ISO 10993-11, though specific results are not detailed). |
| Pyrogenicity (ISO 10993-11, USP) | Carried out to demonstrate substantial equivalence to the predicate device. (Implies met acceptance criteria for non-pyrogenicity as per ISO 10993-11 / USP, though specific results are not detailed). |
| Toxicological Risk Assessment | Carried out to demonstrate substantial equivalence to the predicate device. (Implies a favorable risk assessment, though specific findings are not detailed). |
| Shelf-Life Testing | "met all relevant acceptance criteria." (Specific duration and criteria not detailed). |
| Antimicrobial Effectiveness Testing (USP ) | "met all relevant acceptance criteria." (Specific microbial reduction or inhibition criteria not detailed). |
| Biocompatibility | "Same, both met satisfactory biocompatibility requirements for wound washes. Limited information is publicly available on the predicate device. Additional biocompatibility testing has been conducted on the subject device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on specific sample sizes for the performance tests (e.g., number of test subjects or samples for biocompatibility, shelf-life, or antimicrobial effectiveness). The data provenance (country of origin, retrospective/prospective) is also not specified.
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)
This information is not provided in the document. The tests described (biocompatibility, shelf-life, antimicrobial effectiveness, etc.) are standard laboratory and ISO-based assessments, not typically requiring "experts to establish ground truth" in the same way an AI diagnostic device for image analysis would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments, which are not detailed in this document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. This type of study is relevant for AI-powered diagnostic or assistive devices where human-AI interaction is evaluated. Dermalage is a physical wound cleanser, not an AI or algorithmic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not mentioned as Dermalage is a liquid wound cleanser, not an algorithmic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the performance and safety tests listed (biocompatibility, shelf-life, antimicrobial effectiveness), the "ground truth" would be established by the validated and standardized protocols of the respective ISO standards (10993 series) and USP monographs (e.g., USP , USP ). These standards define the methods and criteria for determining cytotoxicity, irritation, sensitization, acute toxicity, pyrogenicity, and antimicrobial effectiveness.
8. The sample size for the training set
This information is not applicable as Dermalage is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
Summary:
The provided FDA 510(k) clearance letter pertains to a physical medical device (a wound cleanser), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the questions related to AI device evaluation (sample sizes for test/training sets, expert ground truth, MRMC studies, standalone algorithm performance) are not addressed or applicable in this context. The document focuses on demonstrating the substantial equivalence of Dermalage to a predicate wound cleanser through standard biocompatibility, chemical, and stability testing, confirming its safety and effectiveness for its intended use.
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