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510(k) Data Aggregation
(184 days)
TROPAZONE LOTION
Tropazone Lotion is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. It helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Tropazone Lotion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a polyacrylic acid polymer as the thickening agent. The oil composition of Tropazone lotion is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.
This device, Tropazone Lotion, is a hydrogel wound dressing. The provided text outlines its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a dedicated study.
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a Class I unclassified device (hydrogel wound dressing), the "acceptance criteria" are primarily established by demonstrating equivalency to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics to these predicates.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Tropazone Lotion) | Comments |
|---|---|---|
| Intended Use equivalent to predicates | Used to manage and relieve burning and itching with various dermatoses (radiation, atopic, allergic contact dermatitis); maintains moist wound/skin environment for healing. | Intended use explicitly stated as "identical to that of MimyX and Zenieva." |
| Technological Characteristics (e.g., composition, application frequency, product description, physical properties) similar to predicates | Ingredients: Purified water, liquid paraffin (mineral oil), petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, lecithin, polysorbate 60, DEA-Cetyl Phosphate, dimethicone, carbomer, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine, fragrance. | |
| # applications per day: 3 times per day or as needed. | ||
| Product Description: Water-based emulsion. | ||
| Physical Properties: Non-sterile white to off-white lotion. | Compared against MimyX, Zenieva, and Biafine. While ingredients differ, the overall product descriptions and physical properties are presented as similar (e.g., water-based emulsion, non-sterile white/off-white). The 3x/day application is common. | |
| Biocompatibility/Safety (Non-Primary Irritant, Non-Primary Sensitizer) | Considered a non-primary irritant and a non-primary sensitizer to skin under occlusion testing. | This directly addresses safety for skin contact. |
| Cytotoxicity (low/acceptable biological reactivity) | L929 Agar overlay cytotoxicity study showed mild/moderate reaction. | This indicates a generally acceptable level of cellular interaction. |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not describe a test set or clinical study in the traditional sense for evaluating the novel performance of Tropazone Lotion. Instead, it relies on:
- Human Safety Test: "Tropazone when tested under occlusion may be considered a non-primary irritant and a non-primary sensitizer to skin." The sample size for this test is not specified. The data provenance is also not specified, but given it's for a US regulatory submission, it's presumably from a study conducted to relevant safety standards. It does not specify if it was retrospective or prospective.
- In-vitro Test: "In a L929 Agar overlay cytotoxicity study using Tropazone, the cells exhibited a mild/moderate reaction." The sample size for this in-vitro test is not specified. Data provenance is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no specific "ground truth" derived from expert consensus for a test set in the context of device performance evaluation. The safety and biocompatibility assessments would typically rely on established dermatological and toxicological endpoints, interpreted by qualified personnel, but the number and qualifications of such experts are not specified in this summary.
4. Adjudication Method for the Test Set
Not applicable. No clinical or performance test set requiring adjudication is described.
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
Not applicable. This device is a topical lotion, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was done
Not applicable. This device is a topical lotion, not an algorithm.
7. The Type of Ground Truth Used
For the safety data:
- The biocompatibility/irritation/sensitization ground truth would be based on established dermatological endpoints in human or animal models (e.g., skin reactions scored according to a toxicity scale).
- The cytotoxicity ground truth would be based on cellular viability and morphology in an in-vitro assay, compared to controls.
For the substantial equivalence claim:
- The "ground truth" is the established performance and safety profile of the predicate devices (K041342, K073246, and K964240), based on their prior clearances.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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