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K Number
K150985
Device Name
Medihoney Wound Gel
Manufacturer
DERMA SCIENCES, INC.
Date Cleared
2015-11-19

(219 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K101793,K131176
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Derma Sciences Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing.

For over the counter use, Medihoney Wound Gel may be used for:

  • minor abrasions
  • lacerations
  • minor cuts
  • minor scalds and burns.

Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing and are indicated for non-draining to moderately exuding wounds. The Medihoney Wound Gel is 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.
Device Description

The primary component of the Medihoney Wound Gel is Active Leptospermum Honey. The purpose of this 510(k) is to obtain clearance for a slightly modified version of the Derma Sciences Medihoney Wound Gel Dressings subject of K101793. The original Medihoney Gel Dressings contain Active Manuka Honey, Myristate, and Plantacare. The proposed Medihoney Gel Dressings contains a slightly different formulation than the original Medihoney Gel Dressings in that Sodium Benzoate has been added as a preservative to the formulation. Due to the limitations in hermetically sealing the Wound Gel jar lids, this product will be Gamma Irradiated at 25-45kGy dosage, which will help reduce the product bioburden. However this product will not be claimed sterile. Gamma Irradiation will aid in reducing the product bioburden and the preservative Sodium Benzoate will act as a preservative within the gel.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called Medihoney Wound Gel. It explicitly states that the device is "Unclassified" and establishes substantial equivalence to legally marketed predicate devices rather than proving a device meets specific performance criteria through a study.

Therefore, the information requested in the prompt regarding acceptance criteria and performance studies, such as:

  1. A table of acceptance criteria and the reported device performance: Not applicable. This document is about demonstrating substantial equivalence, not meeting performance criteria through a quantitative study.
  2. Sample sizes used for the test set and data provenance: No test sets are described for performance evaluation.
  3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. No ground truth establishment for a test set is described.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted device, nor is it a comparative effectiveness study.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable. This device is not an AI/ML model that requires training data.
  9. How the ground truth for the training set was established: Not applicable.

Instead, the document focuses on:

  • Device Description: The Medihoney Wound Gel contains Active Leptospermum Honey, with a slightly modified formulation (addition of Sodium Benzoate as a preservative) and gamma irradiation (though not sterile).
  • Intended Use: Maintains a moist wound environment for minor abrasions, lacerations, minor cuts, minor scalds and burns (over-the-counter), and under professional supervision, for diabetic foot ulcers, leg ulcers, pressure ulcers/sores, 1st and 2nd degree partial thickness burns, donor sites, traumatic and surgical wounds.
  • Substantial Equivalence: The primary argument is that the device is substantially equivalent to existing Medihoney Gel Dressings With Active Manuka (K101793) and BioTD S.A. Ross Ru Skin Discontinuities (K131176). The key argument for equivalence is that the modification (addition of sodium benzoate as a preservative and non-sterile status) does not affect the safety or effectiveness of the device, as sodium benzoate is a GRAS substance and the function of the gel remains the same (providing a moist wound environment).
  • Performance Testing (Safety, not Efficacy):
    • The Medihoney Wound Gel has been subjected to cytotoxicity, sensitization, irritation, and implantation testing. These are general biocompatibility tests, not clinical efficacy studies.
    • The document also notes that the original Medihoney Wound Gel devices have been on the market since 2011 with no unanticipated adverse events, implying a history of safe use supports the current device.

In summary, this document is a 510(k) submission that demonstrates substantial equivalence of a modified medical device to existing predicate devices, primarily through justification of material changes and historical safety data, rather than through a a clinical study with specific acceptance criteria as you might see for a novel AI/ML device.

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