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

Device Description

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).

AI/ML Overview

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.

Summary

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K 110546
Page 1074

JUL 2 7 2011

for Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey

510(k) Summary

1. SPONSOR

Sharmini Atheray Derma Sciences, Inc. 104 Shorting Road Toronto, Ontario M1S 3S4 Canada Telephone: 416-299-4003 Ext. 245

2. CONSULTANT/CONTACT

Medical Device Consultants, Inc. 11440 West Bernardo Drive, Suite 300 San Diego, CA 92127 Telephone: 858-753-1961 Facsimile: 858-753-1962

Primary Contact: Ron Warren Date Prepared: February 24, 2011

3. DEVICE NAME

Derma Sciences Medihoney Hydrogel Sheet Dressings Proprietary Name: (Adhesive and Non-adhesive) with Leptospermum Honey Common/Usual Name: Wound Dressing Classification Name: Dressing

4. PREDICATE DEVICES

· Medihoney Primary Wound Dressings with Active Manuka Honey (K072956)
· L-Mesitran® Dressing Family (K053613)

5. DEVICE DESCRIPTION

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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).

6. INDICATION FOR USE/INTENDED USE

The Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey provide 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 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 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

7. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICES

The technological characteristics of the Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey, the parent Medihoney Primary Wound Dressings with Manuka Honey, and the L-Mesitran® Dressing Family 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 the L-Mesitran® Dressing Family predicate devices are intended for both OTC and prescription use.

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The modifications made to the Medihoney Wound Dressings with Manuka Honey Dressings to produce the Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are limited to a slight change in formulation. The proposed Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are hydrogel dressings containing 63% Manuka Honey compared to the parent Medihoney Primary Dressings which are comprised of 80% Manuka Honey and 20% sodium alginate powder and the L-Mesitran® Dressings which are hydrogel dressings containing ~30% honey. This slight change in formulation provides the user with a wider variety of honey dressings and does not represent a significant change in technological characteristics.

The intended use of the Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum 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 Hydrogel Sheet Dressings with Leptospermum Honey are identical to the parent Medihoney Dressings and the L-Mesitran® Dressings in indications in that they are all indicated for management of wounds including partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).

8. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Biocompatibility testing performed to support the formulation change for the modified dressings demonstrates that the Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are safe for their intended use. The biocompatibility testing included cytotoxicity, systemic toxicity, sensitization, and irritation testing (acute irritation in rabbit testing).

9. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No clinical testing was conducted or required in support of this premarket clearance notification.

10. SUMMARY OF OTHER INFORMATION

This submission included comparison of intended use statements, proposed product labeling and summary information and labeling on predicate devices.

11. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the information provided in this 510(k), Derma Sciences believes that the proposed Medihoney Hydrogel Sheet Dressings with Leptospermum Honey is

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K110546
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substantially equivalent to the previously cleared parent Medihoney Primary Wound Dressings with Manuka Honey, and the L-Mesitran® Dressing Family. The proposed device raises no new issues of safety and effectiveness. The non-clinical testing performed demonstrates that the proposed device met all test specifications and is suitable for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wavy lines representing the body.

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 11440 W. Bernardo Court, Suite 300 San Diego, California 92127

JUL 2 7 2011

Re: K110546

Trade/Device Name: Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey Regulatory Class: Unclassified Product Code: FRO Dated: June 9, 2011 Received: June 10, 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. Iisting 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" (21CFR 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/ReportalProblem/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 vours.

Sincerely yours,

Mark A. Milkein

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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Indications for Use

510(k) Number (if known): K110546

Device Name: Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey

Indications for Use:

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

. 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)

David Kruse for MXA
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10546

Regulation Number and Section

N/A