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 Description

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 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.

AI/ML Overview

The provided text describes a medical device, Manukapli Wound Dressings, and the nonclinical testing performed to demonstrate its biocompatibility. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic accuracy, which is typically what "acceptance criteria" and "device performance" implies for AI/ML devices.

The information primarily focuses on:

Device Description: What the Manukapli Wound Dressing is.
Intended Use: The types of wounds it's designed to treat (e.g., minor abrasions, leg ulcers, burns).
Technology Comparison: Stating substantial equivalence to predicate devices based on function, composition, and intended use.
Nonclinical Testing (Biocompatibility): Tests performed to ensure the material is safe for contact with the human body.

There is no mention of an AI/ML component, diagnostic capabilities, or any performance metrics like sensitivity, specificity, AUC, or reader studies. Therefore, I cannot construct the requested table or answer the specific questions related to AI/ML device performance and ground truth establishment.

Here's a breakdown of what can be extracted and why other parts cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: The document states, "The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested." However, the specific numerical or qualitative criteria for these biocompatibility tests (e.g., "no cytotoxicity observed," "irritation score < 1.0") are not detailed.
Reported Device Performance: The reported performance is simply that the device "met the acceptance criteria" for biocompatibility. No detailed performance metrics (like those used for diagnostic AI devices) are provided.

2. Sample size used for the test set and the data provenance

Not Applicable. This device is a wound dressing, not a diagnostic AI/ML device. The "test set" in this context refers to samples used for biocompatibility testing (e.g., cells, animal tissues for irritation tests), not a dataset of patient cases. The document does not specify the sample sizes for these biocompatibility tests, only that they were performed according to ISO 10993-1.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This question is relevant for diagnostic AI/ML devices where ground truth often relies on expert consensus. The "ground truth" for biocompatibility testing is determined by standardized protocols and laboratory measurements, not human expert interpretation of images or patient data.

4. Adjudication method for the test set

Not Applicable. Adjudication methods like "2+1" are used in human reader studies for diagnostic accuracy. This is not relevant for biocompatibility testing.

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

Not Applicable. No MRMC study was mentioned as this is not an AI/ML diagnostic device.

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

Not Applicable. No algorithm is described.

7. The type of ground truth used

The "ground truth" for the nonclinical biocompatibility tests would be the established scientific standards and measurements for evaluating material compatibility with biological systems (e.g., cell viability assays, irritation indices from animal models).

8. The sample size for the training set

Not Applicable. There is no mention of a "training set" for an AI/ML algorithm.

9. How the ground truth for the training set was established

Not Applicable. There is no mention of a "training set" for an AI/ML algorithm.

In summary, the provided document describes a medical device (wound dressing) and its nonclinical biocompatibility testing for regulatory clearance. It does not provide information relevant to the performance evaluation of an AI/ML diagnostic device.

Summary

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092689
page 1 of 2

MAY 2 0 2010

510(k) SUMMARY

Submitted by:

್ನು

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: 949-752-0001 949-753-7412 Fax: E:Mail: tbuckley@linksmed.com

James Smith, Ph.D., RAC DeFerris. Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 Phone: 949-340-7261 949-340-7141 Fax: E-mail: jrsmith@deferris.com

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

MANUKA MEDICAL, LTD.

Page 5 of 21

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

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page 2 of 2

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

Page 6 of 21

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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 (800) 638-2041 or (301) 796-7100 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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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

Page 4 of 21

Page 1 of

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

Regulation Number and Section

N/A