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510(k) Data Aggregation
(152 days)
The Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds.
For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Nonadhesive) with Leptospermum Honey may be used for:
- minor abrasions
- minor cuts
- minor scalds
- minor burns
Under the supervision of a healthcare professional, The Derma Sciences Medihoney Hydrogel Sheet Dressings provide a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. The Medihoney Hydrogel Sheet Dressings are intended for the management of the following:
- diabetic foot ulcers
- leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)
- pressure ulcers / sores (partial and full thickness)
- 1st and 2nd degree partial thickness burns
- donor sites, and traumatic and surgical wounds
Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are sterile, single-use wound care dressings for use in moist wound management. The dressings are comprised of 63% Leptospermum Honey and hydrogel both with and without an adhesive border. The Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are offered in the following sizes: 2 ¼" x 2 ¾", 4 1/3" x 4 1/3", 6" x 9", 4 1/3" x 4 1/3" (adhesive border), 6" x 6" (adhesive border).
This is not a medical device that uses AI/ML, therefore the requested information regarding acceptance criteria, study details, and AI/ML specific questions (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training data details) are not applicable.
Here's a summary of the provided information about the Derma Sciences Medihoney Hydrogel Sheet Dressings:
1. Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a wound dressing, the "acceptance criteria" are typically related to demonstrating substantial equivalence to a legally marketed predicate device, rather than specific performance metrics (like sensitivity/specificity for diagnostic AI devices). The reported performance is based on non-clinical testing.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Technological Characteristics: Similar to predicate devices (honey-based dressings suitable for various wounds). | The proposed device is substantially equivalent to predicate devices as it is also a honey-based dressing for wound management. The change in formulation (63% Leptospermum Honey with hydrogel vs. 80% Manuka Honey and 20% sodium alginate powder or ~30% honey in other predicates) is considered a slight change that provides a wider variety of honey dressings and does not represent a significant change in technological characteristics. |
| Intended Use/Indications for Use: Identical to predicate devices (moist environment conducive to wound healing). | The intended use and indications for use are identical to the predicate devices, covering a range of wounds including minor abrasions, cuts, scalds, burns (OTC), and diabetic foot ulcers, leg ulcers, pressure ulcers, 1st & 2nd degree partial thickness burns, donor sites, traumatic, and surgical wounds (under healthcare professional supervision). |
| Biocompatibility: Safe for intended use after formulation change. | Biocompatibility testing (cytotoxicity, systemic toxicity, sensitization, acute irritation in rabbit testing) demonstrated safety for intended use. |
| No New Issues of Safety and Effectiveness: The proposed device should not raise new safety or effectiveness concerns. | The device raises no new issues of safety and effectiveness, and non-clinical testing met all test specifications. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No clinical testing on human subjects was conducted for this 510(k) submission. The "test set" in this context refers to the non-clinical biocompatibility tests.
- Data Provenance: Not applicable for clinical data. For biocompatibility, it refers to laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Biocompatibility testing follows established laboratory protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a diagnostic device requiring expert adjudication of test results.
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 is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For biocompatibility: Laboratory standards and test endpoints (e.g., cell viability for cytotoxicity, physical observation for irritation).
- For substantial equivalence: Comparison to the known characteristics and performance of legally marketed predicate wound dressings.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML powered device, so there's no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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