(84 days)
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd 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, MANUKAhd 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
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical grade Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honey-impregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.
The provided document describes the ManukaMed MANUKAhd wound dressings, a medical device. The information details nonclinical testing performed to establish biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cytotoxicity | Met acceptance criteria |
| Intracutaneous Reactivity | Met acceptance criteria |
| Systemic Toxicity | Met acceptance criteria |
| Sensitization | Met acceptance criteria |
| Wound Healing Studies | Met acceptance criteria |
| Overall Conclusion | Considered biocompatible under the conditions tested. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Standard biocompatibility tests were performed," including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. However, the exact sample size used for each of these tests is not specified in the provided text.
Regarding data provenance:
- Country of origin of the data: Not explicitly stated for each test, but the testing organization, North American Science Associates, Inc. (NAMSA), is implied to be conducting tests in accordance with US FDA guidelines and ISO standards. NAMSA is a global company, but the submission is to the US FDA, suggesting the results would be presented in a US format.
- Retrospective or prospective: Biocompatibility tests are typically prospective studies designed specifically to evaluate the device's interaction with biological systems.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. Biocompatibility testing often relies on standardized protocols and laboratory analysis performed by trained technicians and overseen by scientific experts (e.g., toxicologists, pathologists), but these details are not present in this summary.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Biocompatibility test results are generally interpreted based on predefined criteria within the test protocol and ISO standards, rather than requiring an adjudication process in the way clinical studies or image interpretations might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes nonclinical biocompatibility testing, not clinical studies involving human readers or comparative effectiveness 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. This device is a wound dressing, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the biocompatibility tests, the "ground truth" would be established by:
- Standardized biological responses/observations: For cytotoxicity, it would be cell viability; for sensitization, it would be skin irritation scores; for systemic toxicity, it would be physiological parameters and organ histopathology; for wound healing, it would be observations of tissue repair and inflammation.
- Adherence to ISO standards: The 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)." These standards define the methods and criteria for evaluating biological responses.
8. The Sample Size for the Training Set
Not applicable. This device is a physical wound dressing, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is irrelevant.
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Image /page/0/Picture/0 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a swirl design inside. Below the hexagon is the word "MANUKAMED" in all capital letters.
K102659
Page 1 of 3
DEC - 8 2010
510(k) SUMMARY
Submitted by:
Sponsor's Name: Address:
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:
Contact:
Fax:
E-mail:
Telephone:
Company Address
Contact: Telephone Fax: E-mail:
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Device Class:
Procode:
Predicate Device 1:
Predicate 510(k) #:
Predicate Device 2:
Predicate 510(k) #:
Device Description:
DeFerris, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 James Smith, Ph.D. 949-340-7261 949-340-7141 jrsmith(@deferris.com
September 10, 2010
MANUKAhd wound dressings
Adhesive Wound Dressing
Dressing, Wound, Drug
Unclassified
FRO
Derma Sciences MediHoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet.
Manuka Medical, Ltd. Manukapli Wound Dressing
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings for use in moist wound management. The primary device is a super absorbent polymer (SAP) fibre material impregnated with medical
MANUKA MEDICAL, LTD.
Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfield Nottinghamshire NG18 5BR, United Kingdom
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Image /page/1/Picture/0 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a spiral design inside. Below the logo, the word "MANUKAMED" is printed in all capital letters.
K 102659
Page 2 of 3
Manuka honey and coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum medical grade Manuka honey that is harvested and processed under controlled conditions. One version of the product (MANUKAhd Border) has the honeyimpregnated pad retained in a central position on an adhesive backing. Another version of the device (MANUKAhd Rope) is identical to the primary device, but spiral cut to provide the care provider flexibility in packing a wound bed.
Intended Use:
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. Under the supervision of a healthcare professional, MANUKAhd wound dressings may be used for:
-
Leg Ulcers
- Pressure Ulcers A
- 1st and 2nd Degree Burns (Superficial and Partial Thickness)
- A Diabetic Foot Ulcers
- A Surgical Wounds
-
Traumatic Wounds
The MANUKAhd wound dressings are substantially Technology Comparison: equivalent to the predicate devices. The devices are similar in function, composition, and intended use. All devices utilize Manuka honey incorporated into an absorbent matrix (SAP fiber for MANUKAhd products, and hydrocolloid gel for MediHoney products. MANUKAhd dressings have a hydrocolloid surface coating that combines with exudate to assist in dressing removal. Product configurations are also similar, including optional adhesive backings and a variety of sizes to accommodate a variety of wounds types. All products are provided as single-use devices in individuallysterilized packaging.
Standard biocompatibility tests were performed on the Nonclinical Testing: MANUKAhd 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 Memorandum #G95-1 Part-10993-1 of the International Standard Organization (ISO) Standard (Biological
MANUKA MEDICAL, LTD.
Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfield Nottinghamshire NG18 5BR, United Kingdom
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Image /page/2/Picture/1 description: The image shows the logo for ManukaMed. The logo consists of a stylized flower-like symbol above the word "MANUKAMED" in all capital letters. The flower symbol is a geometric design with a central spiral or swirl.
Evaluation of Medical Devices) by North American Science Associates, Inc. (NAMSA). The MANUKAhd wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.
Conclusion of Comparison: The MANUKAhd wound dressings are substantially equivalent to the currently-marketed predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Manuka Medical, Ltd. % DeFerris, Inc. James Smith, Ph.D. 29442 Pointe Royale Laguna Niguel, California 92677
DEC - 8 2010
Re: K102659
Trade/Device Name: MANUKAhd Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: November 07, 2010 Received: November 12, 2010
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
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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/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/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,
Mark N. Miller
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Indications for Use
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INDICATIONS FOR USE
510(k) Number (if known): K102659
DEC - 8 2010
MANUKAhd wound dressings Device Name:
Indications for Use:
MANUKAhd wound dressings are highly absorbent, sterile, single-use wound care dressings, with or without adhesive borders, for use in moist wound management. MANUKAhd 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, MANUKAhd wound dressings may be used for:
-
Leg Ulcers
-
Pressure Ulcers
- 1st and 2nd Degree Burns (superficial and Partial Thickness) >
- A 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)
Danil Krone for MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102659
N/A