(65 days)
The OTC Manuka Honey Wound Dressing is indicated for minor cuts, minor abrasions, minor scalds and minor burns.
OTC Elasto-Gel Manuka dressings are supplied as a gel (amorphous) a thickened viscosity honey or a gel sheet. OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product . The dressings will be supplied in many sizes, for example: 2x3, 4x4, 6x8, and possibly other additions sizes and shapes.
The amorphous gel is a mixture of a super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. The crosslinked polyacrylamide polymer is insoluble in the wound fluid but has a relatively high capacity for absorption of the wound fluid, while releasing the glycerine, honey, and water into the wound fluid to establish a chemical equilibrium. The OTC Elasto-Gel Manuka Honey Amorphous gel dressing, is formulated to produce a high viscosity fluid mixture suitable for surface wounds cuts, scrapes and abrasions. The gel sheet is a moderately adhesive soft gel sheet that will protect the wound from shear, friction and pressure, suitable as a protective padding and cushioning device as well as functioning as a dressing. The OTC Elasto-Gel with Manuka Honey are limited to a slight change in indications and over the counter use.
The products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished . The provide a moist healing environment and will aid in the healing process.
This document is a 510(k) summary for the ELASTO-GEL OTC MANUKA HONEY WOUND DRESSING. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:
Analysis of Acceptance Criteria and Study Information:
The provided document is a 510(k) submission summary to the FDA. For medical devices, particularly those seeking substantial equivalence, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally demonstrated through a rigorous comparison to legally marketed predicate devices, along with performance testing to show that differences do not raise new questions of safety or effectiveness.
In this case, the acceptance criteria are not explicitly stated in a quantitative manner as one might find for a software algorithm, but are implicitly met by demonstrating substantial equivalence to existing predicate devices for the intended use. This is common for wound dressings, where the focus is on material properties, biocompatibility, and intended use as compared to similar, already approved products.
The "study" proving the device meets these criteria is primarily the comparison to predicate devices presented in the table and the stated information that the "OTC Elasto-Gel Manuka Honey sheet dressing is the same composition and identical to the Parent Product."
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a substantial equivalence claim for a wound dressing, the "acceptance criteria" are not numerical performance metrics like sensitivity/specificity. Instead, the acceptance criteria are linked to the properties and intended use of the legally marketed predicate devices. The "reported device performance" is the description of the new device that aligns with these criteria.
| Acceptance Criteria (based on Predicate Devices) | Reported Device Performance (OTC Elasto-Gel Manuka Honey Wound Dressing) |
|---|---|
| Intended Use: Similar indications for use (Wound management) | Intended Use: Minor Cuts & Abrasions, Scrapes, Surface Wounds, Minor Scalds and Burns. (This is a slight change in indications from the parent product, focusing on OTC use and specific minor wound types, but consistent with the general category of wound management of predicates.) |
| Materials: Composition suitable for wound care, often including polyacrylamide, glycerine, water, and Manuka honey. | Materials: Polyacrylamide+glycerine+Water + Manuka Honey or PolyAcrylate + Water + Manuka honey +glycerine (For gel sheet: same composition as Parent Product). Amorphous gel is a mixture of super absorbent crosslinked sodium polyacrylic acid, glycerine, honey and water. |
| Properties: e.g., Absorbent, Soft Sheet, Biocompatible, Sterile, Does not dry out or stick to wound, Provides moist healing environment. | Properties: Absorbent Soft Sheet: Yes. Bio-Compatibility: Yes. Sterile: Yes. Products will not dry out or become stuck to the wound. In most cases soon after application to the wound the pain level will be diminished. They provide a moist healing environment and will aid in the healing process. (The comparison table also explicitly states "No" for "Dissolves or 'melts' in wound fluid," distinguishing it from some predicates but implying this difference does not raise new questions of safety/effectiveness). |
| Similar Mechanism of Action: E.g., providing a moist healing environment, managing exudate. | Mechanism: Absorbs wound fluid while releasing glycerine, honey, and water to establish chemical equilibrium, providing a moist healing environment, protecting from shear, friction, and pressure. |
| Safety: No new safety concerns raised by the device. | (Implicitly demonstrated through substantial equivalence to legally marketed devices and material compatibility). |
| Effectiveness: Similar effectiveness to predicate devices for the stated intended use. | (Implicitly demonstrated through substantial equivalence and the claim that it will "aid in the healing process"). |
2. Sample size used for the test set and the data provenance:
- None provided. The document is a 510(k) summary for a wound dressing, which typically relies on material characterization and comparison to predicate devices rather than clinical "test sets" in the manner of diagnostic algorithms. Data provenance is not applicable here as it's not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "test set" in the context of expert-adjudicated ground truth for a wound dressing 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 document describes a wound dressing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This describes a physical medical device (wound dressing), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the purpose of this 510(k), the "ground truth" is the established safety and effectiveness of the predicate devices as determined by their prior FDA clearance. The new device demonstrates "ground truth" by showing substantial equivalence to these products in terms of materials, indications, and performance characteristics.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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