(91 days)
Tropazone CR is for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, 1st and 200 degree burns, including sunburns, and radiation dermatitis.
Tropazone CR is a non-sterile, semi-viscous emulsion intended for topical application. It is presented as a prescription medication, requiring a physician's diagnosis of disease state prior to use. This product is formulated as an oil-in-water emulsion containing moisturizing ingredients to keep the area moist. The oil composition of Tropazone CR is composed of mineral oil, lecithin, fatty acids and a silicon-based organic polymer.
This document describes the premarket notification (510(k)) for Tropazone CR, a hydrogel wound dressing. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in this document are based on demonstrating substantial equivalence to predicate devices, focusing on technological characteristics and safety. The performance is assessed through specific tests to show the device is non-irritating and non-sensitizing, and that it meets cytotoxicity standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance for Tropazone CR |
|---|---|---|
| Biocompatibility (Skin) | Non-primary irritant and non-primary sensitizer (as assessed by human patch testing). | Met: Repeat Insult Patch Testing with 50 human subjects showed Tropazone CR to be a non-primary irritant and non-primary sensitizer to the skin. |
| Biocompatibility (Cytotoxicity) | Meeting the requirements of the L929 Agar Overlay Cytotoxicity Test as described in ISO 10993-5 and USP 23, Biological Reactive Tests In-Vitro (87). | Met: In a L929 Agar Overlay Cytotoxicity study using Tropazone CR, the cells exhibited a mild to moderate reaction, meeting the specified requirements. |
| Technological Equivalence | Similar ingredients, application frequency, claims, product description, and physical properties to predicate devices. | Met: Table 1 provides a detailed technological comparison showing similarities across these categories with the predicate devices (Biafine, Tropazone Lotion, MimyX cream, and Zenieva). |
2. Sample Size Used for the Test Set and Data Provenance
- Human Subjects (Biocompatibility - Irritation/Sensitization):
- Sample Size: 50 human subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, ethnicity). It is a prospective study.
- L929 Agar Overlay Cytotoxicity Study:
- Sample Size: Not applicable in the same way as human subjects. This is an in vitro test using L929 cells.
- Data Provenance: In vitro laboratory study.
The document does not specify geographical origin but indicates these are studies conducted to support the 510(k) submission, implying they were performed for this purpose (prospective relative to the submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- For human patch testing: The document does not specify the number or qualifications of experts involved in establishing the "ground truth" (i.e., assessing the skin reactions). Typically, board-certified dermatologists or allergists would conduct and interpret such studies.
- For cytotoxicity testing: Similarly, the document does not specify experts. These are standardized laboratory tests, where "ground truth" is established by adherence to ISO and USP protocols and interpretation by qualified laboratory personnel.
4. Adjudication Method
Not applicable. These studies are clinical (human patch test) and lab-based (cytotoxicity) tests that follow established protocols, not typically requiring adjudication in the context of expert review of images or diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a hydrogel wound dressing, not an imaging or diagnostic device that would typically involve human readers interpreting data with and without AI assistance. The studies performed are focused on biocompatibility and physicochemical equivalence.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
No, a standalone (algorithm only) performance study was not conducted. This is a medical device (a wound dressing), not an algorithm or AI system.
7. Type of Ground Truth Used
- For human patch testing: The ground truth is generally considered to be the observed physiological reaction of the human skin (e.g., erythema, edema) as assessed by a trained professional following a standardized scoring system.
- For cytotoxicity testing: The ground truth is the in vitro cellular response to the device extract, measured against established criteria within the ISO 10993-5 and USP 23 standards.
8. Sample Size for the Training Set
Not applicable. This device is a wound dressing, not an algorithm that requires a training set. The studies performed are for safety and performance testing, not for training AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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