HONEY ALGINATE DRESSING by DERMA SCIENCES CANADA, INC.

Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily 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 API-MED™ Active Manuka Honey Absorbent Dressing

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The letter primarily:

Confirms the FDA's review of the 510(k) submission (K053095).
States that the device is substantially equivalent to legally marketed predicate devices.
Grants permission to market the device, subject to general controls provisions.
Outlines general regulatory responsibilities.
Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the given input. The document is solely a regulatory approval letter, not a technical report or study summary.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three horizontal lines that curve and converge, resembling a stylized human form or a symbol representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Derma Sciences Canada, Inc. % Sharmini Atheray, M.Sc. Corporate Director QA/RA 104 Shorting Road Toronto, Ontario MIS 3S4 Canada

JUL 1 2 2007

Re: K053095

Trade/Device Name: Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 29, 2007 Received: March 30, 2007

Dear Ms. Atheray:

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. 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

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Page 2 - Sharmini Atheray, M.Sc.

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 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. 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): K053095

Derma Sciences API-MEDTM Active Manuka Honey Absorbent Device Name: Dressing

Indications for Use:

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)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number	1053090
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Regulation Number and Section

N/A