(247 days)
Zenieva 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. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
Zenieva 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 crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
This submission describes Zenieva, a hydrogel wound dressing, and its substantial equivalence to the predicate device, MimyXTM cream (K041342). The provided text focuses on the device's composition, intended use, and non-clinical performance data, as well as the FDA's clearance letter.
Device Acceptance Criteria and Performance
The acceptance criteria for Zenieva are based on demonstrating substantial equivalence to the predicate device, MimyXTM cream. The study presented is a non-clinical performance evaluation, which aims to show that Zenieva performs similarly to the predicate and meets safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Zenieva) |
|---|---|---|
| Formulation | Identical chemical ingredients as predicate (MimyX™) | Zenieva's ingredients are identical to MimyX™. (Ingredients provided in the table: Purified water, olive oil, glycerin, pentylene glycol, palm glycerides, vegetable oil, hydrogenated lecithin, squalane, betaine, palmitamide MEA, sarcosine, acetamide MEA, hydroxyethyl cellulose, sodium carbomer, carbomer, xanthan gum) |
| Intended Use | Identical intended use as predicate | Zenieva's intended use is identical to MimyX™: to manage and relieve burning and itching from various dermatoses (radiation, atopic, allergic contact dermatitis) and maintain a moist wound/skin environment for healing. (Claim identical to predicate) |
| Physical Properties | Identical physical properties as predicate | Zenieva's physical properties are identical to MimyX™: Non-sterile white to off-white thick cream; Water-based emulsion. |
| Application Instructions | Identical application frequency as predicate | 3 times per day or as needed, identical to MimyX™. |
| In Vitro Cytotoxicity | Non-toxic | Zenieva was shown to be non-toxic when tested as a "surface device" with limited contact (24 hours) on breached surfaces. |
| Skin Sensitization | Non-sensitizer | Zenieva was shown to be a non-sensitizer. |
| Primary Skin Irritation | Non-irritant | Zenieva was shown to be a non-irritant. |
| Acute Systemic Toxicity | Not applicable (topical use, not injection) | Test was performed but deemed not applicable, as the product is for topical application. |
| Microbial Limits | Acceptable bioburden levels throughout shelf-life (non-sterile) | Microbial limit testing was performed to ensure acceptable bioburden levels throughout the shelf-life, as the product is non-sterile. (No specific numerical results provided, but stated as a conducted and met measure). |
2. Sample Size for the Test Set and Data Provenance
The provided summary does not detail the sample sizes for the in vitro cytotoxicity, skin sensitization, and primary skin irritation tests. It states that Zenieva was tested as a "surface device" with "limited contact duration (24 hours) on breached surfaces." The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin, but it is implied to be from testing conducted by Gorbec Pharmaceutical Services Inc. to support this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
This submission does not involve clinical studies with human assessors establishing ground truth for performance metrics in a typical sense (e.g., image interpretation). Instead, the "ground truth" for the non-clinical tests (cytotoxicity, sensitization, irritation) would be established by the results of standardized laboratory assays, interpreted by qualified laboratory personnel and toxicologists. The specific number and qualifications of experts for interpreting these non-clinical tests are not detailed in the provided document.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical tests (cytotoxicity, sensitization, irritation) are typically objective laboratory assays with predefined endpoints, rather than requiring expert consensus or adjudication on subjective interpretations for a "test set" in the context of diagnostic or treatment efficacy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission for a hydrogel wound dressing, not an AI-assisted diagnostic or treatment device that would typically involve a MRMC study. Therefore, no effect size for human readers with and without AI assistance is reported.
6. Standalone Performance Study
Yes, in a sense. The non-clinical performance tests (cytotoxicity, skin sensitization, primary skin irritation) assess the intrinsic biological safety of the device (Zenieva) in isolation, without human-in-the-loop performance influencing the assay results. The device's "performance" in this context is its safety profile.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on standardized laboratory assay results and regulatory definitions for toxicity, sensitization, and irritation. For example, a "non-toxic" finding is based on the cellular response in a cytotoxicity assay meeting predefined criteria, rather than expert consensus on a clinical outcome or pathology.
8. Sample Size for the Training Set
Not applicable. This device is a medical product (hydrogel wound dressing) and not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.