(14 days)
For over the counter use, MEDIHONEY™ APIMED, PRIMARY and 100% HONEY Dressings with Active Manuka Honey may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a healthcare professional, The Derma Sciences Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for nonexuding to moderately exuding wounds. All of the Medihoney Wound 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.
The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel) with Active Manuka Honey are designed to provide a moist environment conducive to wound healing and are indicated abrasions, minor burns, minor cuts and minor lacerations.
The Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences OTC Medihoney APIMED Primary Dressings with Active Manuka Honey are offered in several sizes including the following: 2x2, 4x4, % x 12, The OTC Medihoney Primary Dressings with Active Manuka Honey are offered in 1.5" x 2", 2" x 2", 4" x 5", and 2"x3" sizes and are offered both with and without an adhesive backing. The OTC Medihoney 100% Honey Gel Dressings are offered in .5, 1, and 1.5 oz. sizes.
The proposed OTC Medihoney Dressings with Active Manuka Honey are identical in fundamental technology and very similar in indications to the parent API-MED Active Manuka Honey Dressings described in K053095, the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey The dispensed from a tube pending 510(k) premarket notification (K080315). modifications made to the API-MED, Medihoney Primary and Medihoney 100% Gel Active Manuka Honey Dressings to produce the Derma Sciences OTC Medihoney Dressings with Active Manuka Honey are limited to a slight change in indications and over the counter use. The formulation and function are identical to that described in the original 510(k)'s.
This 510(k) summary (K081584) describes a wound dressing and focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with specific acceptance criteria that are typical for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/ML device is not applicable or not present in this document.
Here's an analysis based on the provided text, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or detailed performance metrics in the way an AI/ML device submission would. The basis for clearance is substantial equivalence to predicate devices.
| Acceptance Criterion (Not explicitly stated for performance, but implied for safety) | Reported Device Performance (Implied from substantial equivalence and testing) |
|---|---|
| Biocompatibility: Absence of cytotoxicity, sensitization, irritation, implantation. | "Biocompatibility testing performed to support the dressings demonstrates that the Medihoney Primary Dressings with Active Manuka Honey are safe for their intended use. Cytotoxicity, sensitization, irritation and implantation testing was performed successfully using the Derma Sciences Wound Dressings." |
| Functionality (Implied: Provides moist wound environment for healing) | "The Derma Sciences OTC Medihoney Dressings... are designed to provide a moist environment conducive to wound healing..." (Inferred to be achieved because formulation and function are identical to cleared predicates). |
| Intended Use (Same as predicates) | The device can be used for the specified indications (minor abrasions, cuts, burns, various ulcers) as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a wound dressing, not an AI/ML device evaluating a test set of data. The "test set" in this context would refer to the materials and subjects used in biocompatibility testing. The document states biocompatibility testing was performed, but does not provide details on sample size or data provenance for these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic or predictive task.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of an AI/ML diagnostic or predictive device requiring adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This device is a wound dressing, not an AI/ML system that assists human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an algorithm or AI system.
7. The Type of Ground Truth Used
For biocompatibility testing, the "ground truth" would be the observed biological response to the materials (e.g., absence of toxic reactions, irritation, etc.), determined through standardized laboratory tests. The document doesn't detail the specific endpoints or how "truth" (e.g., "safe") was established beyond stating the tests were "performed successfully."
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this device.
Summary regarding this specific submission:
This 510(k) submission for Derma Sciences OTC Medihoney Dressings demonstrates substantial equivalence to previously cleared predicate devices (K053095, K072956, K080315). The primary "study" proving the device meets acceptance criteria (for safety and efficacy) is:
- Demonstration of identical fundamental technology, formulation, and function to the predicate devices. The modifications are explicitly stated to be "limited to a slight change in indications and over the counter use."
- Biocompatibility testing: "Cytotoxicity, sensitization, irritation and implantation testing was performed successfully." This indicates that the materials used are safe for their intended use.
The acceptance criterion for clearance via the 510(k) pathway in this case is primarily "substantial equivalence" to a legally marketed predicate device, rather than meeting specific performance metrics derived from a de novo clinical study with pre-defined statistical endpoints.
N/A