(24 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 cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
The provided document, K083721 for Zenieva Hydrogel Wound Dressing, does not contain the kind of detailed study information typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers.
This submission is for a hydrogel wound dressing, a Class I non-exempt device. The context indicates it's a modification to an already cleared device, and the primary assessment is for substantial equivalence to a predicate device. The information provided heavily emphasizes the physical and chemical properties remaining unchanged.
Therefore, most of the requested information regarding acceptance criteria derived from a study, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as would apply to a diagnostic or AI-powered device, is not applicable or available in this document.
Here is a breakdown based on the information provided, highlighting where the requested details are absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Substantial Equivalence | No change in chemical composition | "The modification to Zenieva does not change the chemical composition" | Directly stated. |
| No change in intended indications for use | "This intended use is identical to the intended use previously cleared for Zenieva." | Directly stated. | |
| No change in physical properties | "The modification to Zenieva does not change... physical properties" | Directly stated. | |
| No change in claims | "The modification to Zenieva does not change... claims" | Directly stated. | |
| Safety & Efficacy | Product remains safe | "Tests and performance data are satisfactory and indicate the product remains safe." | General statement. No specific metrics or thresholds provided. |
| Product remains effective | "Tests and performance data are satisfactory and indicate the product remains... effective." | General statement. No specific metrics or thresholds provided. | |
| Performance Data | Satisfactory change related to modification | "The modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product." | General statement. "Satisfactory" is the acceptance, but no detailed performance metrics are given. |
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. This document describes a modification to a hydrogel wound dressing, not a diagnostic device involving a test set of data. The "performance testing" mentioned is likely related to the physical or chemical properties of the dressing itself (e.g., pH, viscosity, stability), not clinical data from patients in the manner of an AI/ML or diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. Ground truth as understood for diagnostic or AI/ML devices is not relevant for this type of product and submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. Adjudication methods are specific to studies involving expert review of cases, which is not described here.
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:
- No. This is a hydrogel wound dressing, not an AI/ML device. An MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hydrogel wound dressing, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for this submission revolves around the chemical composition and physical properties of the dressing aligning with its predicate and previously cleared version, and confirming no compromise to safety or efficacy. This is assessed via "Performance testing for Zenieva" which implies laboratory tests, not clinical "ground truth" for diagnosis.
8. The sample size for the training set:
- Not Applicable/Not Provided. This device does not involve a training set as it's not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. As above, no training set or relevant ground truth for such a set.
Summary of the Study (as described in the document):
The "study" described in the 510(k) summary is rather a verification process for a modification to an existing Class I device (Zenieva Hydrogel Wound Dressing, previously cleared under K082865).
- Objective: To demonstrate that the modified Zenieva product remains substantially equivalent to its predicate device despite a change (the nature of which is not explicitly detailed but implied to be minor as it doesn't affect core properties).
- Methodology: "Performance testing for Zenieva was conducted and assessed." This testing was then "compared to the approved device." The specific tests are not enumerated, but given the product type, they would likely involve:
- Stability testing (shelf life, environmental resilience)
- Chemical characterization (to confirm unchanged composition)
- pH, viscosity, spreadability (physical properties relevant to hydrogels)
- Biocompatibility (if any new materials were introduced, though the document states "modification to Zenieva does not change the chemical composition").
- Conclusion: The tests indicated that "the modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product." The product's "ingredients and performance characteristics have remained unchanged."
In essence, this is a regulatory submission for a minor change to a non-AI medical device, focusing on bench testing and comparison to established parameters rather than a clinical study with patient data and expert review.
§ 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.