The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.

For over the counter use, Medihoney Gel 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 Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate exuding wounds. The Medihoney Gel 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.

Device Description

Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are sterile, wound care dressings for use in moist wound management. The Derma Sciences Medihoney Gel Dressing with Active Manuka Honey is offered in 10, 20, and 25 oz tubes sizes. The dressings are comprised of honey an emulsifier and a surfactant.

The proposed Medihoney Gel Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing.

The proposed Medihoney Gel Wound Dressings with Active Manuka Honey are comprised of 80% Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810 compared to the parent Medihoney Primary Dressings which are comprised of 100% honey, 80% Active Manuka Honey and 20% sodium alginate powder or 95% w/w Active Manuka Honey and 5% w/w Calcium Alginate. The addition of the Myristyl Myristate and Plantacare 810 increases the viscosity of the gel which helps to improve adherence to the wound bed.

AI/ML Overview

This document is a 510(k) Summary for a medical device called "Derma Sciences Medihoney Gel Dressings with Active Manuka Honey." It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing new performance criteria through a standalone clinical study with acceptance criteria and reported performance metrics in the way a novel diagnostic or AI device might.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable in this context. The document describes a formulation change and demonstrates biocompatibility and substantial equivalence to existing devices.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of data is not provided in the document as it is a 510(k) submission for a device with a formulation change, relying on substantial equivalence to predicate devices, not on proving new clinical efficacy metrics against specific acceptance criteria.

The document states:

"Biocompatibility testing performed to support the formulation change for the modified dressings demonstrates that the Medihoney Gel Dressings with Active Manuka Honey are safe for their intended use."
"The biocompatibility testing included cytotoxicity, implantation, sensitization, and irritation testing (repeat patch insult testing)."

There are no quantitative acceptance criteria or reported values for these tests mentioned in the provided text. The output is a qualitative statement of safety for its intended use.

2. Sample size used for the test set and the data provenance

Not Applicable in the context of clinical performance demonstrating efficacy against acceptance criteria. The performance testing mentioned is biocompatibility. Details on the sample size and provenance for the biocompatibility tests are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This document does not describe a study involving expert-established ground truth for a test set. The determination is based on the safety and substantial equivalence of the material.

4. Adjudication method for the test set

Not Applicable. No test set requiring adjudication in the context of clinical performance is described.

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 device, and no MRMC study is described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a medical dressing, not an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used

For biocompatibility testing, the "ground truth" would typically be established by standardized laboratory methods and benchmarks for toxicology (cytotoxicity, irritation, sensitization) and material compatibility (implantation). These are widely accepted scientific standards, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not Applicable. This document does not describe a machine learning algorithm or a training set.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set for a machine learning model is involved.

Summary of Device and Evidence Presented:

The document describes the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey.

Acceptance Criteria/Performance: The primary "acceptance criteria" for a 510(k) submission of this nature are demonstrating substantial equivalence to existing predicate devices and showing that biocompatibility testing (cytotoxicity, implantation, sensitization, and irritation) supports the safety of the modified formulation for its intended use. The document states that the biocompatibility testing demonstrates that the Medihoney Gel Dressings... are safe for their intended use. There are no quantitative performance metrics against specific acceptance criteria reported in this summary.
Study: The "study" mentioned is biocompatibility testing. This testing was performed to support a slight formulation change in the product (addition of Myristyl Myristate and Plantacare 810 to increase viscosity and adherence to the wound bed).
Purpose: The goal was to prove that the new formulation maintains safety and efficacy comparable to the predicate devices, thereby establishing substantial equivalence for the same intended uses.

Summary

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Page 1 of 3

FEB 2 2 2011

510(k) Summary for Derma Sciences Medihoney Gel Dressings with Active Manuka Honey

SPONSOR

Kam Garcha Derma Sciences, Inc. 104 Shorting Road Toronto, Ontario MIS 3S4 Canada 416-299-4003 Telephone:

Date Prepared: June 23, 2010

2. DEVICE NAME

Derma Sciences Medihoney Gel Dressing with Active Proprietary Name: Manuka Honey Wound Dressing Common/Usual Name: Classification Name: Dressing

3. PREDICATE DEVICES

· Derma Sciences OTC Medihoney Dressings with Active Manuka Honey (K081584)
· Derma Sciences Medihoney Dressing with Active Manuka Honey (K080315)
· Medihoney Primary Wound Dressings with Active Manuka Honey (K072956)
· API-MED Active Manuka Honey Wound Dressings (K053095)

4. DEVICE DESCRIPTION

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5. INTENDED USE

The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.

For over the counter use, Medihoney™ Gel Dressings with Active Manuka Honey may be used for:

minor abrasions
lacerations
minor cuts
minor scalds and burns

· 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.

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The technological characteristics of the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey and the parent Medihoney Wound Dressings with Active Manuka Honey are substantially equivalent in that they are all honey based dressings suitable for use on pressure sores, leg ulcers, post-operative wounds, superficial wounds and abrasions. In addition, both the proposed and predicate devices are intended for both OTC and prescription use.

The modifications made to the Medihoney Wound Dressings with Active Manuka Honey Dressings to produce the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are limited to a slight change in formulation. The proposed Medihoney Gel Wound Dressings with Active Manuka Honey are comprised of 80%

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K101793

Active Manuka Honey, 15% Myristyl Myristate and 5% Plantacare 810 compared to the parent Medihoney Primary Dressings which are comprised of 100% honey, 80% Active Manuka Honey and 20% sodium alginate powder or 95% w/w Active Manuka Honey and 5% w/w Calcium Alginate. The addition of the Myristyl Myristate and Plantacare 810 increases the viscosity of the gel which helps to improve adherence to the wound bed. This slight change in formulation provides the user with a wider variety of honey dressings and does not represent a significant change in technological

The intended use of the Derma Sciences Medihoney Gel Dressings with Active Manuka Honey and the predicate devices are identical in that they are all intended to provide a moist environment conducive to wound healing. The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are identical to the parent Medihoney Dressing in indications in that they are both indicated for management of light to moderately exuding wounds including partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

7. PERFORMANCE TESTING

Biocompatibility testing performed to support the formulation change for the modified dressings demonstrates that the Medihoney Gel Dressings with Active Manuka Honey are safe for their intended use. The biocompatibility testing included cytotoxicity, implantation, sensitization, and irritation testing (repeat patch insult testing).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Derma Sciences, Inc. % Medical Device Consultants, Inc. Mr. Ronald S. Warren 49 Plain Street North Attleboro, Massachusetts 02760

FEB 2 2 251

Re: K101793

Trade/Device Name: Derma Sciences Medihoney Gel Dressings with Active Manuka Honey Regulatory Class: Unclassified Product Code: FRO Dated: January 17, 2011 Received: January 19, 2011

Dear Mr. Warren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 - Mr. Ronald S. Warren

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101793
page 1 of 1

Indications for Use

510(k) Number (if known):

Device Name: Derma Sciences Medihoney Gel Dressings with Active Manuka Honey

K 101793

Indications for Use:

The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.

For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for:

minor abrasions -
lacerations -
minor cuts
minor scalds and burns

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. .

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use × (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Da-l. Kume bu MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101793

Regulation Number and Section

N/A