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

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

AI/ML Overview

This submission describes the "MANUKA IG wound dressings" and its substantial equivalence to the predicate device "MANUKAtex Wound Dressing". The acceptance criteria and the study performed are focused on demonstrating the safety and performance of the new device relative to its predicate, rather than an AI-powered diagnostic device. Therefore, some of the requested information regarding AI-specific criteria (like AI vs. human reader improvement, standalone algorithm performance, number of experts for ground truth, sample size for training set, etc.) are not applicable to this document.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	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) for cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing.	"The MANUKA IG wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested."
Sterilization	Not explicitly stated, but implied to meet performance requirements for sterility.	"All acceptance criteria were met for all tests conducted," including sterilization validation. "MANUKA IG... meet performance requirements for sterility."
Shelf-Life	Not explicitly stated, but implied to meet performance requirements for shelf-life under accelerated and real-time conditions.	"All acceptance criteria were met for all tests conducted," including shelf-life under accelerated and real-time conditions. "MANUKA IG... meet performance requirements for... shelf-life."
Packaging Validity	Not explicitly stated, but implied to meet performance requirements for packaging.	"All acceptance criteria were met for all tests conducted," including packaging validation. "MANUKA IG... meet performance requirements for... packaging."

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

The document does not specify a "test set" in the context of evaluating an AI or diagnostic algorithm on patient data. The nonclinical testing performed (biocompatibility, sterilization, shelf-life, packaging) would involve samples of the device and biological models for biocompatibility, but the specific sample sizes for these lab tests are not detailed in this summary. There is no information about data provenance (e.g., country of origin, retrospective/prospective) as this is not a clinical study involving patient data in the typical sense for a diagnostic device.

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

Not applicable. This is not a study requiring expert-established ground truth for a diagnostic test.

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

Not applicable. This is not a study requiring an adjudication method for a diagnostic test.

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. This device is a wound dressing, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is a wound dressing, not an algorithm.

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

For the biocompatibility studies, the "ground truth" would be established by the biological responses observed in the tests (e.g., cell viability for cytotoxicity, skin reaction for intracutaneous reactivity, etc.). For sterilization, shelf-life, and packaging, the ground truth would be based on validated scientific methods and measurements to confirm sterility, stability over time, and package integrity, respectively. These are standard laboratory measures, not clinical outcomes or expert consensus.

8. The sample size for the training set

Not applicable. This device is a wound dressing, not an AI algorithm requiring a training set.

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

Not applicable. This device is a wound dressing, not an AI algorithm.

Summary

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K120976
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Links Medical Products Inc.

510(k) SUMMARY

Submitted by:

Owner's Name: Address:

Contact: Telephone: Fax: E-mail:
Links Medical Products, Inc. 9247 Research Drive Irvine, CA 92618 Tom Buckley, Chief Executive Officer 949-753-0001 949-753-7412 tbuckley@linksmed.com

Contact Person:

Company Address

Contact: Telephone Fax: E-mail:

Date Prepared: Trade Name: Common Name: Classification Name: Device Class: Product Code: Predicate Device: Predicate 510(k) #: Device Description:

NanoSmart, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 James Smith, Ph.D. 949-340-7261 949-340-7141 jrsmith00@cox.net

March 25, 2012 MANUKA IG wound dressings Wound Dressing Dressing, Wound, Drug Unclassified FRO MANUKAtex Wound Dressing (Manuka Medical, Ltd.) K110042

MAY 2 3 2012

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K 12 0976
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Links Medical Products Inc.

Intended Use:

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

Minor Abrasions A
A Lacerations
Minor Cuts
a Minor Scalds and Burns

Under the supervision of a healthcare professional, MANUKA IG wound dressings may be used for:

Leg Ulcers
Pressure Ulcers
A 1st and 2nd Degree Burns (Superficial and Partial Thickness)

dressing are substantially equivalent to the predicate device.

intended use. Leptospermun scoparium honey is the primary ingredient for MANUKA IG and the predicate device. Both wound dressings incorporate the honey into an absorbent, acetate gauze dressing and have a hydrocolloid surface

The technical characteristics of MANUKA IG wound

The devices are similar in function, composition, and

Diabetic Foot Ulcers
Surgical Wounds
Traumatic Wounds

Technology Comparison:

Nonclinical Testing:

coating that combines with exudate to assist in dressing removal. Both MANUKA IG and the predicate device are provided as single-use device in individually-sterilized packaging.

Standard biocompatibility tests were performed on the MANUKA IG wound dressings; including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. 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). The MANUKA IG wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.

LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618

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K 120976
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Links Medical Products Inc.

Additional testing included sterilization validation, shelf-life under accelerated and real-time conditions, and packaging validation. All acceptance criteria were met for all tests conducted.

Conclusion of Comparison: MANUKA IG and the predicate device were both demonstrated to be biocompatible and meet performance requirements for sterility, shelf-life, and packaging. Based upon technological characteristics and nonclinical performance data, MANUKA IG wound dressings are substantially equivalent and as safe and effective as the currently-marketed predicate device.

LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Links Medical Products, Inc % Nano Smart Incorporated James Smith, Ph.D. Consultant 29442 Pointe Royale Laguna Niguel, California 92677

Re: K120976

Trade/Device Name: MANUKA IG wound dressings Regulation Class: Unclassified Product Code: FRO Dated: March 27 , 2012 Received: April 02, 2012

Dear Dr. James 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

MAY 2 3 2012

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Page 2 - Dr. James Smith

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/ReportalProblem/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.

Mark A. Milken

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

510(k) Number (if known): K120976

Device Name:

MANUKA IG wound dressings ...

Indications for Use:

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

Minor Abrasions
Lacerations A
Minor Cuts
A Minor Scalds and Burns

Under the supervision of a healthcare professional, MANUKA IG wound dressings may be used for:

Leg Ulcers
A Pressure Ulcers
188 and 2nd Degree Burns (Superficial and Partial Thickness)
A Diabetic Foot Ulcers
Surgical Wounds A
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 Kurefor MKM

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

510(k) Number K120976

Regulation Number and Section

N/A