(413 days)
Wound Dressing with Manuka Honey is indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds and surgical wounds. For single-use only.
Wound Dressing with Manuka Honey is indicated for minor abrasions, minor scalds, and minor burns. For single-use only.
Not Found
I am sorry, but after carefully reviewing the provided document, I cannot find the specific information you requested regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a "Wound Dressing with Manuka Honey" and focuses on the device's substantial equivalence and indications for use.
It does not include details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for a training set was established.
This type of information would typically be found in the premarket notification submission itself (the 510(k) summary or detailed reports), which is not part of the provided FDA letter.
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Image /page/0/Picture/1 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Manuka Heath New Zealand LTD % Dr. David Bechtel Intertek Cantox 1011 United States Highway 22, Suite 200 Bridgewater, New Jersey 08807
Re: K133729
Trade/Device Name: Wound Dressing with Manuka Honey Regulatory Class: Unclassified Product Code: FRO Dated: December 19, 2014 Received: Decmeber 22, 2014
Dear Dr. Bechtel:
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for Manuka Health New Zealand. The logo features a stylized tree with a human figure at the top, all in a light color, set against a dark blue background. Below the tree, the words "manuka health" are written in a sans-serif font, with "manuka" in a larger size than "health". Underneath "manuka health", the words "NEW ZEALAND" are written in a smaller, green font.
Indications for Use
510(k) Number (if known): K133729
Device Name: Wound Dressing with Manuka Honey
Indications for Use:
Prescription (Rx)
Wound Dressing with Manuka Honey is indicated for use in management of wounds. Full and partial thickness wounds, pressure ulcers (stages I-IV), venous stasis ulcers, diabetic ulcers, abrasions, surface wounds, traumatic wounds (healing by secondary intention), donor site wounds and surgical wounds. For single-use only.
Over-the-Counter (OTC)
Wound Dressing with Manuka Honey is indicated for minor abrasions, minor scalds, and minor burns. For single-use only.
Prescription Use × Over-The-Counter Use AND (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N/A