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.

Device Description

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.

AI/ML Overview

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.

Summary

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K081584
page 1 of 3

510(k) Summary

JUN 1 9 2008

for

Derma Sciences OTC APIMED, Medihoney Primary and Medihoney 100% Honey Dressings with Active Manuka Honey

1. SPONSOR
  Derma Sciences 214 Carnegie Center Suite 100 Princeton, NJ 08540

Barry Wolfenson Contact Person: Derma Sciences 214 Carnegie Center, Suite 100 Princeton, NJ 08540 Telephone: 609.514.4744 x1103

June 9, 2008 Date Prepared:

2. DEVICE NAME

Proprietary Name:

Common/Usual Name: Classification Name:

OTC Derma Sciences APIMED, Medihoney Primary, and Medihoney 100% Honey Dressings with Active Manuka Honey Wound Dressing Dressing

3. PREDICATE DEVICES

API-MED Active Manuka Honey Wound Dressing that was cleared for marketing ♥ in the U.S. (K053095). (now called Medihoney)
Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a . hydrocolloid sheet (K072956)
Medihoney Active Manuka (Leptospermum) 100% Honey dispensed from a tube . 510(k) premarket notification (K080315)
OTC Dermaphylyx Calcium Alginate Wound Dressings (K991608) .
OTC CuraPharm Phytacare Sodium Alginate Wound Dressing (K053538) .
OTC NOCC Wound Gel Dressing cleared under K080010 .

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OTC and Rx Aquacel Ag Wound dressing cleared under K013814. ●

4. DEVICE DESCRIPTION

5. INTENDED USE

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 -

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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. ●

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The technological characteristics of the proposed Derma Sciences OTC Medihoney Dressings with Active Manuka Honey and the parent API-MED, Medihoney Primary and Medihoney 100% Active Manuka Honey Wound Dressings are substantially equivalent in that they are the same dressings with the identical technology and formulation. No changes have been made to the physical device or specifications for the proposed OTC Medihoney Wound Dressings.

The modifications made to the API-MED, Medihoney Primary and Medihoney !00% 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 proposed OTC Medihoney Wound Dresings are formulated from the exact same composition as the predicate devices described in the predicate API-MED Active Manuka Honey Wound Dressing. (K053095) (now called Medihoney), the Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) and the Medihoney Active Manuka (Leptospermum) 100% Honey Dressing.

7. PERFORMANCE TESTING

Biocompatibility testing performed to support the dressings demonstrates that the Medihoney Primary Dressings with Active Manuka Honey are safe for their intended Cytotoxicity, sensitization, irritation and implantation testing was performed use. successfully using the Derma Sciences Wound Dressings.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2008

Derma Sciences, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane 49 Plain Street North Attleboro, Massachusetts 02760

Re: K081584

Trade Name: Derma Sciences OTC Medihoney Dressings with Active Manuka Honey Regulatory Class: Unclassified Product Code: FRO Dated: June 5, 2008 Received: June 6, 2008

Dear Ms. McNamara-Cullinane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 – Ms. Mary McNamara-Cullinanc

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known):

K081584

Derma Sciences OTC Medihoney Dressings with Active Device Name: Manuka Honev

Indications for Use:

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 *

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	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use	X
(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)

Neil RP. Ogl for mrm
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K091584

Derma Sciences 510(k) June 4, 2008 OTC Medihoney Dressings with Active Manuka Honey

Regulation Number and Section

N/A