MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKAtex 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, MANUKAtex 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

MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. The primary device is Leptospermum scoparium honey from New Zealand impregnated into acetate gauze. MANUKAtex is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium medical grade Manuka honey that is harvested and processed under controlled conditions.

AI/ML Overview

The provided text is a 510(k) summary for the MANUKAtex wound dressing. It focuses on demonstrating substantial equivalence to predicate devices and detailing non-clinical testing for biocompatibility.

Here's an analysis of the document in relation to your request about acceptance criteria and study details, highlighting what information is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met acceptance criteria for all tests conducted (cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies). Considered biocompatible under the conditions tested.
Sterilization Validation	All acceptance criteria were met.
Shelf-Life	All acceptance criteria were met (under accelerated and real-time conditions).
Packaging Validation	All acceptance criteria were met.

Missing Information: The document states that "all acceptance criteria were met for all tests conducted," but does not explicitly list the specific quantitative or qualitative acceptance criteria for each test (e.g., specific limits for cytotoxicity, or pass/fail conditions for wound healing studies).

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

Missing Information: The document states that "Standard biocompatibility tests were performed…wound healing studies" but does not specify the sample size for any of these tests. It also does not mention data provenance (e.g., country of origin of data, retrospective or prospective).

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

Missing Information: This information is not applicable as the studies described are non-clinical (biocompatibility, sterilization, shelf-life, packaging validation) and do not involve human expert assessment for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: This information is not applicable as the studies described are non-clinical.

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

Missing Information: This information is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool, and the studies described are non-clinical.

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

Missing Information: This information is not applicable. The device is a wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests (biocompatibility, sterilization, shelf-life, packaging validation), the "ground truth" would be established by international standards and validated test methods (e.g., ISO Standard 10993-1 for biological evaluation of medical devices). The document explicitly states, "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 Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA)."

8. The sample size for the training set

Missing Information: This is not applicable as the device is a medical dressing and not an AI/machine learning model that would require a training set.

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

Missing Information: This is not applicable as the device is a medical dressing and not an AI/machine learning model.

In summary:

The provided document details non-clinical performance criteria and states that the device met these criteria through tests conducted according to international standards (ISO 10993-1). However, it lacks specific quantitative details about the acceptance criteria themselves, sample sizes for the tests, and is not relevant to questions pertaining to AI/ML device evaluations or human expert-led studies.

Summary

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K110042
page 1 of 3

Image /page/0/Picture/1 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with curved lines inside, resembling a flower or honeycomb. Below the symbol, the word "MANUKAMED" is written in a bold, sans-serif font.

MAR 2 4 2011

510(k) SUMMARY

Submitted by: Sponsor's Name:

Address:

Contact: Telephone: Fax: E-mail:

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 tbuckley@linksmed.com

Contact Person:

Company Address

Contact: Telephone Fax: E-mail:

Date Prepared:

Common Name:

Trade Name:

MANUKAtex wound dressing

Wound Dress

Classification Name:

Device Class:

Procode:

Predicate Device 1:

Predicate 510(k) #:

Predicate Device 2:

Predicate 510(k) #:

Device Description:

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

December 24, 2010

DeFerris, Inc.

MANUKAtex wound dressings

Wound Dressing

Dressing, Wound, Drug

Unclassified

FRO

Manuka Medical, Ltd. MANUKAhd Border Wound Dressing

K102659

Manuka Medical, Ltd. MANUKApli Wound Dressing

K092689

Device Description:

MANUKA MEDICAL, LTD.

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

న-1

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K 110042
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Image /page/1/Picture/1 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a swirl inside, above the word "MANUKAMED" in all caps. The logo is black and white.

is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium medical grade Manuka honey that is harvested and processed under controlled conditions.

MANUKAtex wound dressings are sterile, single-use wound Intended Use: care dressings for use in moist wound management. MANUKAtex 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, MANUKAtex 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 The MANUKAtex wound dressings are substantially Technology Comparison: equivalent to the predicate devices. The devices are similar in function, composition, and intended use. Leptospermun scoparium honey is the primary ingredient for all three devices. MANUKApli honey wound dressing is provided in a tube; whereas the MANUKAhd Border dressings incorporate the honey into an adsorbent matrix and provided with and without an adhesive backing. Like the MANUKAhd Border wound dressings, MANUKAtex wound dressings have a hydrocolloid surface coating that combines with exudate to assist in dressing removal. All products are provided as single-use devices in individuallysterilized packaging. Standard biocompatibility tests were performed on the Nonclinical Testing:

MANUKAtex 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

MANUKA MEDICAL, LTD.

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

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K110042
page 3 of 3

Image /page/2/Picture/1 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a spiral design inside. Below the shape, the word "MANUKAMED" is written in all capital letters.

Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). The MANUKAtex wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested. Additional testing included sterilization validation, shelf-life under accelerated and real-time condition, and packaging validation. All acceptance criteria were met for all tests conducted.

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

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

ર-૩

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

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

Re: K110042

Trade/Device Name: MANUKAtex wound dressings Regulatory Class: Unclassified Product Code: FRO Dated: December 24, 2011 Received: January 6, 2011

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

MAR 2 4 201

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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/CDRHQffices/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.

A. B. 12h

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

K110042 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MANUKAtex wound dressings Device Name:

Indications for Use:

MANUKAtex wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKAtex 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, MANUKAtex 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane Ru MXM

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

510(k) Number K110042

Regulation Number and Section

N/A