Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
MANUKA FILL wound dressing may be used Over-The-Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.

Device Description

MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized using gamma irradiation.

AI/ML Overview

The provided document outlines the acceptance criteria and the study conducted for the MANUKA FILL wound dressing, focusing primarily on nonclinical testing for substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Biocompatibility	In accordance with ISO 10993-1 and FDA Biocompatibility Matrix for cytotoxicity, skin irritation, and skin sensitization.	MANUKA FILL wound dressing met the requirements for cytotoxicity, skin irritation, and skin sensitization.
Wound Healing Study	Test articles should not impair healing and be as safe and effective as predicate devices.	The test articles did not impair healing and were determined to be as safe and effective as the predicate devices (K121227 and K072068) in a full-thickness dermal wound study in swine.
Sterilization Validation	Device meets applicable sterilization standards.	MANUKA FILL wound dressing met the acceptance criteria for sterilization validation.
Shelf-Life	Device maintains performance under accelerated and real-time conditions.	MANUKA FILL wound dressing met the acceptance criteria for shelf-life under accelerated and real-time conditions.
Packaging Validation	Device packaging integrity and protection maintained.	MANUKA FILL wound dressing met the acceptance criteria for packaging validation.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly mentions a "wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine." However, it does not specify the sample size used for this study.

The data provenance for the nonclinical testing appears to be prospective, as it describes tests conducted specifically for the submission of the MANUKA FILL wound dressing. The document states, "All tests were performed by North American Science Associates (NAMSA)," suggesting the data was generated in a controlled, scientific testing environment. The country of origin for the data is not explicitly stated, but NAMSA has facilities in the U.S. and Europe. The honey itself is stated to be from New Zealand.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the nonclinical studies, particularly the biocompatibility and wound healing studies, the "ground truth" refers to the scientific assessment of the device's performance against established standards. The document does not specify the number of experts or their specific qualifications involved in establishing the ground truth or evaluating the results of these nonclinical tests. It only states that "All tests were performed by North American Science Associates (NAMSA)," which is a contract research organization specializing in medical device testing.

4. Adjudication Method for the Test Set

The document does not mention any human adjudication method (like 2+1 or 3+1). The studies described are nonclinical, focusing on laboratory and animal model testing, which typically involves quantitative measurements and adherence to scientific protocols rather than expert consensus on subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or imaging devices where human readers interpret data, and the document describes a wound dressing, which is a therapeutic device. There is no mention of comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance study was not done. The MANUKA FILL wound dressing is a physical medical device, not a software algorithm, and therefore this type of study is not applicable.

7. The Type of Ground Truth Used

For the nonclinical tests:

Biocompatibility: Ground truth was based on established ISO 10993-1 standards and the FDA Biocompatibility Matrix, which define acceptable levels for cytotoxicity, skin irritation, and skin sensitization.
Wound Healing Study: Ground truth was based on observed healing outcomes in swine models, comparing the device's performance to predicate devices and assessing whether healing was impaired. This is a form of outcomes data in an animal model.
Sterilization, Shelf-Life, Packaging Validation: Ground truth was based on established industry and regulatory standards for these performance requirements.

8. The Sample Size for the Training Set

The document describes nonclinical studies for substantial equivalence. It does not mention a "training set" because this term is relevant to machine learning or AI algorithm development, which is not applicable to this physical wound dressing device.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device and study, this information is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Links Medical Products Inc. The logo is in black and white and features the letters "LMP" in a stylized font. The letters are connected and have a three-dimensional appearance. Below the letters, the words "Links Medical Products Inc." are written in a smaller, sans-serif font.

MAR 1 4 2014 K131796

510(k) SUMMARY

Submitted by:
Owner's Name:	Links Medical Products, Inc.
Address:	9247 Research DriveIrvine, CA 92618
Contact:	Tom Buckley, Chief Executive Officer
Telephone:	949-753-0001
Fax:	949-753-7412
E-mail:	tbuckley@linksmed.com
Contact Person:
Name	James Smith, Ph.D.
Address	29442 Pointe RoyaleLaguna Niguel, CA 92677
Telephone	949-340-7261
Fax:	949-340-7141
E-mail:	jrsmith00@cox.net
Date Prepared:	March 10, 2014
Trade Name:	MANUKA FILL
Common Name:	Wound Dressing
Classification Name:	Dressing, Wound, Drug
Device Class:	Unclassified
Product Code:	FRO
Predicate Devices:	MANUKA FILL Wound Dressing (Links Medical Products, Inc.), BioAquaCare (BioArtificial Gel Technologies)
Predicate 510(k) #:	K121227 (MANUKA FILL), K072068 (BioAquaCare)
Device Description:	MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized using gamma irradiation.

LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive

Irvine, CA 92618

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Image /page/1/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo is a stylized, blocky design with the letters "LMP" stacked on top of each other. The letters are outlined in white, and the background is black. Below the logo, the words "Links Medical Products Inc." are printed in a smaller font.

Intended Use: Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. The technical characteristics of MANUKA FILL are Technology Comparison: substantially equivalent to the predicate devices. The wound dressings maintain a moist wound environment that promotes autolytic debridement conducive to wound healing. MANUKA FILL and its predicate (K121227) accomplish this by using 100% Leptospermun socparium honey as the primary ingredient, whereas BioAquaCare utilizes a hydrogel (95% water) to achieve the same goal. MANUKA FILL and its predicates are provided as single-use devices in individually sterilized packaging. Despite minor differences in materials, the devices are similar in function and intended use. Nonclinical Testing: Standard biocompatibility tests were performed on the MANUKA FILL wound dressing in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine. The test articles did not impair healing and were determined to be as safe and effective as the predicate devices. All tests were performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and realtime conditions, and packaging validation. The MANUKA FILL wound dressing met the acceptance criteria for all tests conducted.

LINKS MEDICAL PRODUCTS, INC.

9247 Research Drive Irvine, CA 92618

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Image /page/2/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized, interconnected design. The letters are bold and outlined, with a three-dimensional effect. Below the logo, the text "Links Medical Products Inc." is printed in a simple, sans-serif font.

Conclusion of Comparison: MANUKA FILL and its predicate devices were demonstrated to be biocompatible and met performance requirements for sterility, shelf life, and packaging. Based upon the technological characteristics and nonclinical performance data, MANUKA FILL wound dressings have been determined to be substantially equivalent and as safe and effective as its predicate devices (Manuka Fill and BioAquaCare).

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

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Image /page/3/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo is a stylized version of the letters "LMP" stacked on top of each other. The words "Links Medical Products Inc." are printed in a smaller font below the logo. The logo is black and white.

MAR 1 4 2014

510(k) SUMMARY

Submitted by:
Owner's Name:	Links Medical Products, Inc.
Address:	9247 Research DriveIrvine, CA 92618
Contact:	Tom Buckley, Chief Executive Officer
Telephone:	949-753-0001
Fax:	949-753-7412
E-mail:	tbuckley@linksmed.com
Contact Person:
Name	James Smith, Ph.D.
Address	29442 Pointe RoyaleLaguna Niguel, CA 92677
Telephone	949-340-7261
Fax:	949-340-7141
E-mail:	jrsmith00@cox.net
Date Prepared:	March 10, 2014
Trade Name:	MANUKA FILL
Common Name:	Wound Dressing
Classification Name:	Dressing, Wound, Drug
Device Class:	Unclassified
Product Code:	FRO
Predicate Devices:	MANUKA FILL Wound Dressing (Links Medical Products,Inc.), BioAquaCare (BioArtificial Gel Technologies)
Predicate 510(k) #:	K121227 (MANUKA FILL), K072068 (BioAquaCare)
Device Description:	MANUKA FILL wound dressing is a sterile, single-use,wound care dressing that helps maintain a moist woundenvironment conducive to wound healing. The primarydevice consists of 100% Leptospermum scoparium honeyfrom New Zealand sealed into low-density polyethylene(LDPE) tubes and sterilized using gamma irradiation.

Links Medical Products, Inc.

9247 Research Drive
Irvine, CA 92618

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Image /page/4/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized font, with the letters overlapping each other. The words "Links Medical Products Inc." are printed below the logo in a smaller font. The logo is black and white.

MANUKA FILL wound dressing may be used Over-The-Intended Use: Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. The technical characteristics of MANUKA FILL are Technology Comparison: substantially equivalent to the predicate devices. The wound dressings maintain a moist wound environment that promotes autolytic debridement conducive to wound healing. MANUKA FILL and its predicate (K121227) accomplish this by using 100% Leptospermun socparium honey as the primary ingredient, whereas BioAquaCare utilizes a hydrogel (95% water) to achieve the same goal. MANUKA FILL and its predicates are provided as single-use devices in individually sterilized packaging. Despite minor differences in materials, the devices are similar in function and intended use. Standard biocompatibility tests were performed on the Nonclinical Testing: MANUKA FILL wound dressing in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine. The test articles did not impair healing and were determined to be as safe and effective as the predicate devices. All tests were performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and realtime conditions, and packaging validation. The MANUKA FILL wound dressing met the acceptance criteria for all tests conducted.

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

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Image /page/5/Picture/0 description: The image shows the logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized, interconnected design. The letters are outlined in white against a black background, giving them a bold and modern appearance. Below the logo, the full name of the company, "Links Medical Products Inc.," is printed in a simple, sans-serif font.

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

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 14, 2014

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

Re: K131796

Trade/Device Name: MANUKA FILL Regulatory Class: Unclassified Product Code: FRO Dated: February 14, 2014 Received: February 18, 2014

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, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

MANUKA FILL wound dressing may be used Over-The-Counter for the management of:

Minor Abrasions
Minor Lacerations
Minor Cuts
Minor Scalds and Minor Burns

MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.

Prescription Use (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)

Jiyoung Dang -S

{9}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of:

Leg Ulcers
Pressure Ulcers
1st and 2nd Degree Burns
Diabetic Foot Ulcers
Surgical Wounds
Trauma Wounds

MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyoung Dang -S

Regulation Number and Section

N/A