(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 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.
The provided document is a 510(k) summary for a hydrogel wound dressing called "Zenieva." It details a submission for a modification to an already cleared device (K073246).
The key takeaway from the document regarding acceptance criteria and studies is that no new performance data or studies were conducted or required for this particular submission. The modification was solely a labeling change to add a contraindication. Therefore, the device is considered to meet acceptance criteria because its core composition, intended use, and technological characteristics remain unchanged from the previously cleared device.
Here's how the information requested applies to this specific submission:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance No new acceptance criteria were established or evaluated. The submission is for a labeling change to an already cleared device. The product's ingredients and performance characteristics are stated to have remained unchanged from the previously cleared predicate device (K073246). Not Applicable (N/A). No new performance data was generated or required as the device itself was not modified. -
Sample Size Used for the Test Set and Data Provenance:
- N/A. No new test set or performance study was conducted. The submission is for a labeling change to an already cleared device.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- N/A. No new ground truth establishment was required as no new performance study was conducted.
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Adjudication Method for the Test Set:
- N/A. No new test set or adjudication was required.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done. The device is a hydrogel wound dressing, not an AI-assisted diagnostic tool.
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Standalone (i.e. algorithm only without human-in-the loop performance) Study:
- No. This is a medical device (hydrogel wound dressing), not an algorithm.
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Type of Ground Truth Used:
- N/A. No new ground truth was established for this specific submission as there were no new performance studies. The substantial equivalence for the original device would have been based on appropriate clinical or non-clinical data for a hydrogel wound dressing.
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Sample Size for the Training Set:
- N/A. This is a medical device, not a machine learning algorithm requiring a training set.
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How the Ground Truth for the Training Set Was Established:
- N/A. Not applicable, as there is no training set for this type of medical device.
Summary Explanation:
The 510(k) submission K082865 for "Zenieva" is a resubmission or modification of a previously cleared device (K073246). The core of this submission is a labeling change to add a contraindication for one of the ingredients. The document explicitly states:
- "The proposed modification to Zenieva does not change the chemical composition, intended indications for use, physical properties, or claims."
- "Research has shown that a labeling change - adding a contraindication for one of the ingredients - is necessary. This is adding safety to the product."
- "The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are not applicable: research has shown that adding a contraindication statement for an ingredient is necessary. The product itself is not being modified; we are putting the appropriate measures in place to increase the product's safety."
Therefore, the device meets its acceptance criteria by demonstrating that the modification itself (labeling change) does not alter the fundamental safety and effectiveness of the device as previously established by the original clearance. No new studies were required or conducted for this specific 510(k) submission K082865 because the device's performance characteristics remain identical to the predicate device.
§ 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.