MANUKAPLI WOUND DRESSING

K092689 · Manuka Medical Limited · FRO · May 20, 2010 · SU

Device Facts

• Record ID: K092689
• Device Name: MANUKAPLI WOUND DRESSING
• Applicant: Manuka Medical Limited
• Product Code: FRO · SU
• Decision Date: May 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for: > Minor Abrasions > Lacerations > Minor Cuts > Minor Scalds and Burns Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for: > Leg Ulcers > Pressure Ulcers > 1st and 2nd Degree Burns (superficial and Partial Thickness) > Diabetic Foot Ulcers > Surgical Wounds > Traumatic Wounds

Device Story

Manukapli Wound Dressing is a sterile, single-use wound dressing designed to maintain a moist wound healing environment. The device consists of medical-grade Manukapli (honey) sealed in polyethylene tubes with a non-replaceable twist-and-shear-off end cap. It is applied topically to wounds by medical staff or patients (OTC). The dressing provides a physical barrier and moist environment to facilitate healing. It is intended for various wound types, including ulcers, burns, and surgical/traumatic wounds. The device is sterilized via gamma irradiation.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, specifically biocompatibility testing performed in accordance with ISO 10993-1 and FDA General Program Memorandum #G95-1.

Technological Characteristics

Medical-grade Manukapli (honey) contained in polyethylene tubes. Sterilized via gamma irradiation. Single-use design with non-replaceable twist-and-shear-off end cap. Biocompatibility testing conducted per ISO 10993-1.

Indications for Use

Indicated for moist wound management. OTC use: minor abrasions, lacerations, cuts, scalds, and burns. Professional use: leg ulcers, pressure ulcers, 1st/2nd degree burns, diabetic foot ulcers, surgical wounds, and traumatic wounds.

Predicate Devices

• Derma Sciences Medihoney 100% Honey Dressings with Active Manuka Honey (K081584)

Submission Summary (Full Text)

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092689
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MAY 2 0 2010

### 510(k) SUMMARY

#### Submitted by:

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#### Contact Person:

Date Prepared:

Trade Name:

Common Name:

Classification Name:

Device Class:

Procode: CFR Reference:

Predicate Device:

Predicate 510(k) #:

Device Description:

Thomas Buckley Manuka Medical, Ltd. Unit 18, Mansfield I-centre Oakham Business Park Hamilton Way Mansfield Nottinhamshire NG18 5BR United Kingdom Phone: [phone] Fax: E:Mail: [e-mail]

James Smith, Ph.D., RAC DeFerris. Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 Phone: [phone] Fax: E-mail: [e-mail]

August 27, 2009

Manukapli Wound Dressing

Dressing, Wound

Dressing, Wound, Drug

Unclassified

# FRO

N/A

Derma Sciences Medihoney 100% Honey Dressings with Active Manuka Honey

#### K081584

Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic

MANUKA MEDICAL, LTD.

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Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied Nottinghamshire NG18 5BR. I Inited Kingdom

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### MANUKAMED

wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.

#### Intended Use:

Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:

- > Minor Abrasions
- > Lacerations
- > Minor Cuts
- > Minor Scalds and Burns

Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:

- > Leg Ulcers
- > Pressure Ulcers
- 1st and 2nd Degree Burns (superficial and Partial Thickness)
- A Diabetic Foot Ulcers
- > Surgical Wounds
- > Traumatic Wounds

#### Technology Comparison:

The Manukapli Wound Dressings are substantially equivalent to the predicate devices. The devices are similar in function, composition, and intended use.

#### Nonclinical Testing:

Standard biocompatibility tests were performed on the Manukapli Wound Dressings. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.

Conclusion of Comparison: The Manukapli Wound Dressings is substantially equivalent to the currently-marketed predicate devices.

> Manuka Medical, LTD. Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied ttinghamohira NG18 SRD IInitad Kinadam

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

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

MAY 2 0 2010

Manuka Medial Limited % DeFerris, Inc. James Smith, PhD, RAC 29442 Pointe Royale Laguna Niguel, California 92677

Re: K092689

Trade/Device Name: Manukapli Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2010 Received: May 6, 2010

Dear Dr. Smith:

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 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.

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### Page 2 - James Smith, PhD, RAC

lf 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/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

cerely yours,

k N. Mellekerson

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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Image /page/4/Picture/0 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a swirl inside, resembling a flower or a honey swirl. Below the logo, the word "MANUKAMED" is written in a bold, sans-serif font.

## INDICATIONS FOR USE

K092689 510(k) Number (if known): __

Device Name: Manukapli Wound Dressings

Indications for Use:

Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli Wound Dressings may be used Over-The-Counter for:

- > Minor Abrasions
- > Lacerations
- > Minor Cuts
- > Minor Scalds and Burns

Under the supervision of a healthcare professional, Manukapli Wound Dressings may be used for:

- > Leg Ulcers
- Pressure Ulcers
- > 1st and 2nd Degree Burns (superficial and Partial Thickness)
- > Diabetic Foot Ulcers
- > Surgical Wounds
- > Traumatic 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)

Dainl Krome for MKM
(Division Sign Off)

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

510(k) Number K092689

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Manuka Medical, Ltd. Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied Nottinghamshire NG18 5BR. United Kingdom