(260 days)
Not Found
No
The description focuses on the material composition and physical design of a wound dressing, with no mention of AI or ML capabilities. The performance studies are standard biocompatibility tests, not related to algorithmic performance.
Yes
The device is a sterile wound care dressing used for conditions such as minor abrasions, lacerations, burns, and ulcers, which are all therapeutic indications.
No
The document describes "Manukapli Wound Dressings" which are wound care dressings used for direct wound treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "sterile wound dressing" constructed using "medical grade Manukapli" sealed into "polyethylene tubes." This describes a physical, hardware-based medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Manukapli Wound Dressing is a topical wound care product applied directly to the wound surface. It is designed to promote a moist healing environment.
- Lack of Diagnostic Testing: The description focuses on the physical application and properties of the dressing for wound management, not on analyzing biological samples for diagnostic purposes.
The device is clearly described as a wound dressing for therapeutic use, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli 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, Manukapli 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical staff / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standard biocompatibility tests were performed on the Manukapli Wound Dressings. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a black and white drawing of a symbol. The symbol is composed of a spiral shape on the right side, and three chevron-like shapes on the left side. The spiral is enclosed by a curved line, and the chevrons are stacked on top of each other.
092689
page 1 of 2
MAY 2 0 2010
510(k) SUMMARY
Submitted by:
್ನು
Contact Person:
Date Prepared:
Trade Name:
Common Name:
Classification Name:
Device Class:
Procode: CFR Reference:
Predicate Device:
Predicate 510(k) #:
Device Description:
Thomas Buckley Manuka Medical, Ltd. Unit 18, Mansfield I-centre Oakham Business Park Hamilton Way Mansfield Nottinhamshire NG18 5BR United Kingdom Phone: 949-752-0001 949-753-7412 Fax: E:Mail: tbuckley@linksmed.com
James Smith, Ph.D., RAC DeFerris. Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 Phone: 949-340-7261 949-340-7141 Fax: E-mail: jrsmith@deferris.com
August 27, 2009
Manukapli Wound Dressing
Dressing, Wound
Dressing, Wound, Drug
Unclassified
FRO
N/A
Derma Sciences Medihoney 100% Honey Dressings with Active Manuka Honey
K081584
Manukapli Wound Dressing consists of a sterile wound dressing designed to promote a moist wound healing environment. The device is constructed using medical grade Manukapli that is harvested and processed under controlled conditions. This Manukapli is sealed into polyethylene tubes before sterilization using gamma irradiation and is intended to be used by medical staff as part of a treatment program for patients with problematic
MANUKA MEDICAL, LTD.
Page 5 of 21
Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied Nottinghamshire NG18 5BR. I Inited Kingdom
1
Image /page/1/Picture/0 description: The image shows a black and white logo. The logo is a stylized hexagon shape with a swirling design inside. The swirl appears to be a stylized letter or symbol. To the bottom right of the logo is the trademark symbol.
page 2 of 2
MANUKAMED
wound care requirements. The device is provided sterile and is designed to be single used only. This is achieved by the tube design having a twist & shear off end cap that cannot be replaced.
Intended Use:
Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli 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, Manukapli 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
Technology Comparison:
The Manukapli Wound Dressings are substantially equivalent to the predicate devices. The devices are similar in function, composition, and intended use.
Nonclinical Testing:
Standard biocompatibility tests were performed on the Manukapli Wound Dressings. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The Manukapli Wound Dressings met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.
Conclusion of Comparison: The Manukapli Wound Dressings is substantially equivalent to the currently-marketed predicate devices.
Manuka Medical, LTD. Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied ttinghamohira NG18 SRD IInitad Kinadam
Page 6 of 21
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
MAY 2 0 2010
Manuka Medial Limited % DeFerris, Inc. James Smith, PhD, RAC 29442 Pointe Royale Laguna Niguel, California 92677
Re: K092689
Trade/Device Name: Manukapli Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: April 30, 2010 Received: May 6, 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 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.
3
Page 2 - James Smith, PhD, RAC
lf 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,
cerely yours,
k N. Mellekerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for ManukaMed. The logo consists of a stylized hexagon shape with a swirl inside, resembling a flower or a honey swirl. Below the logo, the word "MANUKAMED" is written in a bold, sans-serif font.
INDICATIONS FOR USE
K092689 510(k) Number (if known): __
Device Name: Manukapli Wound Dressings
Indications for Use:
Manukapli Wound Dressings are sterile, single-use wound care dressings for use in moist wound management. Manukapli 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, Manukapli 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-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dainl Krome for MKM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092689
Page 4 of 21
Page 1 of
Manuka Medical, Ltd. Unit 18, Mansfield I-centre, Oakham Business Park, Hamiliton Way, Mansfied Nottinghamshire NG18 5BR. United Kingdom