Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of a honey-impregnated wound dressing. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is a wound dressing used for managing wounds, which falls under the definition of a therapeutic device as it treats or alleviates a condition.
No
The device is a wound dressing designed for moist wound management, which is a treatment rather than a diagnostic function.
No
The device description clearly states that the device is a physical wound dressing made of honey and gauze, not software.
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. It is applied externally to wounds.
- Device Description: The description details the physical components of the wound dressing (honey, gauze, CMC).
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. Its function is to manage the wound itself.
IVD devices are used to perform tests in vitro (outside the body) on biological samples to diagnose, monitor, or screen for diseases or conditions. This wound dressing does not perform such a function.
N/A
Intended Use / Indications for Use
MANUKA IG wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA IG 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, MANUKA IG 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
MANUKA IG 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. MANUKA IG is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium Manuka honey that is harvested and processed under controlled conditions.
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
Over-The-Counter
Under the supervision of a healthcare professional
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 MANUKA IG wound dressings; including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. 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 MANUKA IG 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 conditions, and packaging validation. All acceptance criteria were met for all tests conducted.
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
K120976
Pose 1 of 3
Image /page/0/Picture/1 description: The image shows a logo with the letters "tmp" in a stylized font. The letters are bold and blocky, with rounded corners. The logo is black and white, with a thick white outline around the letters. The letters are arranged horizontally, with the "t" on the left, the "m" in the middle, and the "p" on the right.
Links Medical Products Inc.
510(k) SUMMARY
Submitted by:
Owner's Name: Address:
- Contact: Telephone: Fax: E-mail:
Links Medical Products, Inc. 9247 Research Drive Irvine, CA 92618 Tom Buckley, Chief Executive Officer 949-753-0001 949-753-7412 tbuckley@linksmed.com
Contact Person:
Company Address
Contact: Telephone Fax: E-mail:
Date Prepared: Trade Name: Common Name: Classification Name: Device Class: Product Code: Predicate Device: Predicate 510(k) #: Device Description:
NanoSmart, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 James Smith, Ph.D. 949-340-7261 949-340-7141 jrsmith00@cox.net
March 25, 2012 MANUKA IG wound dressings Wound Dressing Dressing, Wound, Drug Unclassified FRO MANUKAtex Wound Dressing (Manuka Medical, Ltd.) K110042
MANUKA IG 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. MANUKA IG is coated with carboxymethyl cellulose (CMC). The device incorporates 100% active Leptospermum scoparium Manuka honey that is harvested and processed under controlled conditions.
MAY 2 3 2012
1
Image /page/1/Figure/0 description: The image shows a logo with the letters "lmp" in a stylized, bold font. The letters are interconnected and have a rounded, almost cartoonish appearance. The logo is black with a white outline, set against a white background. The overall design is simple and eye-catching.
K 12 0976
Page 2 of 3
Links Medical Products Inc.
Intended Use:
MANUKA IG wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKA IG Wound Dressings may be used Over-The-Counter for:
- Minor Abrasions A
- A Lacerations
-
Minor Cuts
- a Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKA IG wound dressings may be used for:
-
Leg Ulcers
-
Pressure Ulcers
- A 1st and 2nd Degree Burns (Superficial and Partial Thickness)
dressing are substantially equivalent to the predicate device.
intended use. Leptospermun scoparium honey is the primary ingredient for MANUKA IG and the predicate device. Both wound dressings incorporate the honey into an absorbent, acetate gauze dressing and have a hydrocolloid surface
The technical characteristics of MANUKA IG wound
The devices are similar in function, composition, and
-
Diabetic Foot Ulcers
-
Surgical Wounds
-
Traumatic Wounds
Technology Comparison:
Nonclinical Testing:
coating that combines with exudate to assist in dressing removal. Both MANUKA IG and the predicate device are provided as single-use device in individually-sterilized packaging.
Standard biocompatibility tests were performed on the MANUKA IG wound dressings; including cytotoxicity, intracutaneous reactivity, systemic toxicity, sensitization, and wound healing studies. 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 MANUKA IG wound dressing met the acceptance criteria for all tests conducted and is considered biocompatible under the conditions tested.
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618
5-2
2
Image /page/2/Figure/0 description: The image shows a logo with the letters "tmp" in a stylized font. The letters are bold and outlined, with a rounded, geometric design. The logo has a vintage or retro appearance, possibly due to the font style and the slightly distressed texture of the image. The letters are connected, forming a single, cohesive shape.
K 120976
page 3 of 3
Links Medical Products Inc.
Additional testing included sterilization validation, shelf-life under accelerated and real-time conditions, and packaging validation. All acceptance criteria were met for all tests conducted.
Conclusion of Comparison: MANUKA IG and the predicate device were both demonstrated to be biocompatible and meet performance requirements for sterility, shelf-life, and packaging. Based upon technological characteristics and nonclinical performance data, MANUKA IG wound dressings are substantially equivalent and as safe and effective as the currently-marketed predicate device.
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Links Medical Products, Inc % Nano Smart Incorporated James Smith, Ph.D. Consultant 29442 Pointe Royale Laguna Niguel, California 92677
Re: K120976
Trade/Device Name: MANUKA IG wound dressings Regulation Class: Unclassified Product Code: FRO Dated: March 27 , 2012 Received: April 02, 2012
Dear Dr. James 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
MAY 2 3 2012
4
Page 2 - Dr. James Smith
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/ReportalProblem/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 A. Milken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known): K120976
Device Name:
MANUKA IG wound dressings ...
Indications for Use:
MANUKA IG wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA IG wound dressings may be used Over-The-Counter for:
-
Minor Abrasions
- Lacerations A
- Minor Cuts
- A Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKA IG wound dressings may be used for:
-
Leg Ulcers
- A Pressure Ulcers
- 188 and 2nd Degree Burns (Superficial and Partial Thickness)
- A Diabetic Foot Ulcers
- Surgical Wounds A
- 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 Kurefor MKM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120976