← Product Code FRO · K110042 # MANUKATEX (K110042) _Manuka Medical Limited · FRO · Mar 24, 2011 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K110042 ## Device Facts - **Applicant:** Manuka Medical Limited - **Product Code:** FRO - **Decision Date:** Mar 24, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended 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 ## Device Story MANUKAtex is a sterile, single-use wound dressing for moist wound management. It consists of medical-grade Leptospermum scoparium (Manuka) honey impregnated into acetate gauze, coated with carboxymethyl cellulose (CMC). The device is applied topically to the wound site. The CMC coating interacts with wound exudate to facilitate dressing removal. Used in clinical settings by healthcare professionals or via self-use for minor injuries. The honey provides a moist environment conducive to healing. Benefits include effective wound management and ease of removal due to the hydrocolloid-like surface properties. ## Clinical Evidence Bench testing only. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, intracutaneous reactivity, systemic toxicity, and sensitization. Additional testing included sterilization validation, shelf-life (accelerated and real-time), and packaging validation. All acceptance criteria met. ## Technological Characteristics Materials: Leptospermum scoparium honey, acetate gauze, carboxymethyl cellulose (CMC). Form factor: Impregnated gauze dressing. Sterilization: Individually sterilized packaging. Biocompatibility: Tested per ISO 10993-1. ## Predicate Devices - MANUKAhd Border Wound Dressing ([K102659](/device/K102659.md)) - MANUKApli Wound Dressing ([K092689](/device/K092689.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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:** 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 MANUKA MEDICAL, LTD. Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfield Nottinghamshire NG18 5BR, United Kingdom న-1 {1}------------------------------------------------ K 110042 page 2 of 2 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ page 1 of 1 # 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 --- **Source:** [https://fda.innolitics.com/device/K110042](https://fda.innolitics.com/device/K110042) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com