MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER

K102659 · Manuka Medical Limited · FRO · Dec 8, 2010 · SU

Device Facts

• Record ID: K102659
• Device Name: MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
• Applicant: Manuka Medical Limited
• Product Code: FRO · SU
• Decision Date: Dec 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd 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, MANUKAhd 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

MANUKAhd wound dressings are sterile, single-use, absorbent dressings for moist wound management. The device consists of a super absorbent polymer (SAP) fiber matrix impregnated with 100% active Leptospermum medical-grade Manuka honey and coated with carboxymethyl cellulose (CMC). The CMC coating facilitates dressing removal by combining with wound exudate. Available in versions with adhesive borders or as a spiral-cut rope for packing wound beds. Used by healthcare professionals or patients (OTC) to manage various wound types. The dressing provides a moist environment to support healing. Clinical benefit is derived from the honey-impregnated matrix which assists in wound care management.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted in accordance with ISO 10993-1, including cytotoxicity, intracutaneous reactivity, systemic toxicity, and sensitization studies. The device met all acceptance criteria.

Technological Characteristics

Materials: Super absorbent polymer (SAP) fiber, medical-grade Leptospermum Manuka honey, carboxymethyl cellulose (CMC) coating. Form factor: Absorbent pad, optional adhesive border, or spiral-cut rope. Sterilization: Individually sterilized packaging. Connectivity: None.

Indications for Use

Indicated for moist wound management in patients with minor abrasions, lacerations, cuts, scalds, and burns (OTC use) or leg ulcers, pressure ulcers, 1st/2nd degree burns, diabetic foot ulcers, surgical wounds, and traumatic wounds (professional use).

Predicate Devices

• Derma Sciences MediHoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K081584)
• Manuka Medical, Ltd. Manukapli Wound Dressing (K092689)

Submission Summary (Full Text)

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K102659
Page 1 of 3

DEC - 8 2010

# 510(k) SUMMARY

## Submitted by:

Sponsor's Name: Address:

Manuka Medical, Ltd. Mansfield I-centre Oakham Business Park Hamilton Way Mansfield Nottinhamshire, NG18 5BR United Kingdom Tom Buckley, Chief Operating Officer 949-753-0001 949-753-7412 [e-mail]

#### Contact Person:

Contact:

Fax:

E-mail:

Telephone:

Company Address

Contact: Telephone Fax: E-mail:

#### Date Prepared:

Trade Name:

Common Name:

Classification Name:

Device Class:

Procode:

Predicate Device 1:

Predicate 510(k) #:

Predicate Device 2:

Predicate 510(k) #:

Device Description:

DeFerris, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 James Smith, Ph.D. 949-340-7261 949-340-7141 jrsmith(@deferris.com

September 10, 2010

MANUKAhd wound dressings

Adhesive Wound Dressing

Dressing, Wound, Drug

Unclassified

FRO

Derma Sciences MediHoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet.

K081584

Manuka Medical, Ltd. Manukapli Wound Dressing

K092689

MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical

MANUKA MEDICAL, LTD.

Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfield Nottinghamshire NG18 5BR, United Kingdom

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Image /page/1/Picture/0 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a spiral design inside. Below the logo, the word "MANUKAMED" is printed in all capital letters.

K 102659
Page 2 of 3

Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honeyimpregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.

### Intended Use:

MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. Under the supervision of a healthcare professional, MANUKAhd wound dressings may be used for:

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

The MANUKAhd wound dressings are substantially Technology Comparison: equivalent to the predicate devices. The devices are similar in function, composition, and intended use. All devices utilize Manuka honey incorporated into an absorbent matrix (SAP fiber for MANUKAhd products, and hydrocolloid gel for MediHoney products. MANUKAhd dressings have a hydrocolloid surface coating that combines with exudate to assist in dressing removal. Product configurations are also similar, including optional adhesive backings and a variety of sizes to accommodate a variety of wounds types. All products are provided as single-use devices in individuallysterilized packaging.

Standard biocompatibility tests were performed on the Nonclinical Testing: MANUKAhd wound dressings; including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. The tests executed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological

#### MANUKA MEDICAL, LTD.

Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfield Nottinghamshire NG18 5BR, United Kingdom

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Image /page/2/Picture/1 description: The image shows the logo for ManukaMed. The logo consists of a stylized flower-like symbol above the word "MANUKAMED" in all capital letters. The flower symbol is a geometric design with a central spiral or swirl.

Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). The MANUKAhd wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.

Conclusion of Comparison: The MANUKAhd wound dressings are substantially equivalent to the currently-marketed predicate devices.

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

Manuka Medical, Ltd. % DeFerris, Inc. James Smith, Ph.D. 29442 Pointe Royale Laguna Niguel, California 92677

DEC - 8 2010

Re: K102659

Trade/Device Name: MANUKAhd Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: November 07, 2010 Received: November 12, 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

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Page 2 - James Smith, Ph.D.

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/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,

Mark N. Miller

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

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## INDICATIONS FOR USE

510(k) Number (if known): K102659

DEC - 8 2010

MANUKAhd wound dressings Device Name:

Indications for Use:

MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd 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, MANUKAhd 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

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danil Krone for MKM

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

510(k) Number K102659