The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds such as:

. 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 Primary Dressings with Active Manuka Honey are sterile, single-use wound care dressings for use in moist wound management. The Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are offered in several sizes including 2" x 2", ¾ x 12", 4" x 4" and 4" x 5". The dressings are comprised of honey and sodium alginate.
The proposed Medihoney Primary 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, and allows intact removal.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a wound dressing, not a medical device that would typically have performance criteria like sensitivity, specificity, or reader studies. The "acceptance criteria" and "study" described in this document relate to demonstrating substantial equivalence to a predicate device, focusing on biocompatibility and formulation changes.

Here's an interpretation based on the provided text, addressing the points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met (Device demonstrated safety for intended use)
Cytotoxicity	Performed successfully
Sensitization	Performed successfully
Irritation	Performed successfully

2. Sample Size Used for the Test Set and Data Provenance

This section is Not Applicable in the context of the provided document. The "tests" mentioned are biocompatibility tests on the device material itself, not a clinical study involving a "test set" of patients or data, nor does it refer to an AI/algorithm-driven device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This section is Not Applicable. There is no mention of human experts establishing ground truth for a test set in the context of this device's evaluation.

4. Adjudication Method for the Test Set

This section is Not Applicable. There is no "test set" for expert adjudication mentioned.

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

This section is Not Applicable. This document does not describe an AI-driven device or an MRMC study.

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

This section is Not Applicable. This document does not describe an AI/algorithm-driven device.

7. The type of ground truth used

This section is Not Applicable in the traditional sense of a clinical or imaging study. The "ground truth" for the performance claims relates to established scientific and regulatory standards for biocompatibility testing to ensure the safety of the device's components.

8. The Sample Size for the Training Set

This section is Not Applicable. There is no "training set" as this is not an AI/algorithm device.

9. How the Ground Truth for the Training Set was Established

This section is Not Applicable. There is no "training set" or establishment of ground truth for such a set.

Summary of the Study Demonstrated for Substantial Equivalence:

The primary "study" described to demonstrate the device meets acceptance criteria (specifically, being substantially equivalent to a predicate device) is Biocompatibility Testing.

Acceptance Criteria: The device must be safe for its intended use, as demonstrated by meeting standard biocompatibility requirements.
Study Performed: Cytotoxicity, sensitization, and irritation testing was conducted on the Derma Sciences Medihoney Primary Dressings.
Results: The testing was "performed successfully," indicating that the device met the biocompatibility standards and was deemed safe for its intended use.
Purpose: This testing supported the formulation change from the predicate device, confirming that the new composition does not adversely affect safety.

The basis for calling this a "study" is the regulatory requirement to demonstrate that any changes (in this case, formulation) from a predicate do not raise new questions of safety or effectiveness. The successful completion of these standard biological tests served as the evidence for this device.

Summary

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K072956 page 1/3

510(k) Summary for Derma Sciences Medihoney Primary Dressings with Active Manuka Honev

1. SPONSOR

Derma Sciences 214 Carnegie Center Suite 100 Princeton, NJ 08540

NOV 0 7 2007

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

Date Prepared: October 18, 2007

2. DEVICE NAME

Proprietary Name:	Derma Sciences Medihoney Primary Dressings withActive Manuka Honey
Common/Usual Name:	Wound Dressing
Classification Name:	Dressing

3. PREDICATE DEVICES

API-MED Active Manuka Honey Wound Dressings (K053095)

4. DEVICE DESCRIPTION

The proposed Medihoney Primary Dressing with Active Manuka Honey contains Active Manuka Honey. As wound exudate is absorbed, the alginate forms a gel,

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K072956 page 2/3

which assists in maintaining a moist environment that aids supports the autolytic debridement for optimal wound healing, and allows intact removal.

5. INTENDED USE

The Derma Sciences Honey Primary Wound Dressing provides a moist environment conducive to wound healing and is indicated for light to moderately wounds such as:

. 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 Derma Sciences Honey Primary Wound Dressing into the market is essentially identical to the parent API-MED Active Manuka Honey Wound Dressings subject of K0453095. The differences between the Derma Sciences Medihoney Primary Dressings with Active Manuka Honey and the predicate device are limited to a slight formulation change, the addition of an optional adhesive backing and a slight indication change.

The technological characteristics of the Derma Sciences Medihoney Primary Dressings with Active Manuka Honey and the parent API-MED Active Manuka Honey Wound Dressings are substantially equivalent in that they are all dressings suitable for use on pressure sores, leg ulcers, post-operative wounds, superficial wounds and abrasions.

The modifications made to the API-MED Active Manuka Honey Dressings to produce the Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are limited to a slight change in formulation. The proposed Honey Primary Wound Dresings are comprised of 80% w/w of Active Manuka Honey and 20% hydrocolloidal gelling agents and the parent API-MED Active Manuka Honey Dressings are comprised of 95% Active Manuka Honey and 5% calcium alginate. This slight change in formulation simply provides the user with a wider variety of honey dressings and does not represent a significant change in technological characteristics of the Medihoney Primary Dressings with Active Manuka Honey. The only differences between the Derma Sciences Medihoney Primary Dressings with

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K0729 56 page 3/3

Active Manuka Honey and the predicate devices include slightly different dressing composition which are minor and do not affect the safety and effectiveness of the device.

7. PERFORMANCE TESTING

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

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 7 2007

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

Re: K072956

Trade/Device Name: Derma Sciences Medihoney Primary Dressing with Active Manuka Honey Regulatory Class: Unclassified Product Code: FRO Dated: October 18, 2007 Received: October 19 2007

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 - Mary McNamara-Cullinane

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Sonall 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 vo

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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

K072956 510(k) Number (if known):

Device Name: Derma Sciences Medihoney Primary Dressing with Active Manuka Honey

Indications for Use:

The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for light to moderately exuding wounds such as:

. 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 (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)

Nol
(Division Sign-Off)

(Division Sign Of General Restorative, Division
and Neurological Devices

510(k) Number K072951

Regulation Number and Section

N/A