(84 days)
Not Found
No
The device description and performance studies focus on the material properties and biological effects of the wound dressing, with no mention of AI or ML technology.
Yes
The device is a wound dressing designed for moist wound management, which is a therapeutic intervention for various types of wounds, including lacerations, burns, and ulcers.
No
Diagnostic devices are used to identify a disease or condition. This device is a wound dressing, which is a therapeutic device used in the management and treatment of wounds. Its described use is for "moist wound management" and various types of wounds, indicating a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical wound dressing made of materials like super absorbent polymer fibre, Manuka honey, and carboxymethyl cellulose. It also mentions adhesive borders and a rope version, all indicating a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a wound dressing for moist wound management. This involves direct application to the body for therapeutic purposes.
- Device Description: The description details the physical components of a wound dressing (super absorbent polymer, Manuka honey, CMC, adhesive backing).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is applied to the body for wound care.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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 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.
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
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 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 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.
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 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
1
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
2
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.
3
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
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/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
5
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