(30 days)
Not Found
No
The device description and performance studies focus on the material properties and biocompatibility of the honey-based wound dressing, with no mention of AI or ML.
Yes
The device is used to treat specific conditions such as abrasions, lacerations, cuts, burns, ulcers, and wounds, which aligns with the definition of a therapeutic device.
No
The provided text explicitly states that MANUKA FILL wound dressings are "wound care dressings for use in moist wound management." Their intended use is to aid in the management and healing of wounds, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states that the device is a wound dressing made of honey sealed in polyethylene tubes, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- MANUKA FILL Function: The description clearly states that MANUKA FILL wound dressings are used for "moist wound management" and are applied directly to the wound. They are a topical treatment, not a device that examines specimens from the body.
- Intended Use: The intended uses listed are all related to treating and managing wounds on the body, not analyzing biological samples.
Therefore, MANUKA FILL wound dressings fall under the category of wound care devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
MANUKA FILL wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKA FILL Wound Dressings may be used Over-The-Counter for:
- Minor Abrasions
- Lacerations
- Minor Cuts
- Minor Scalds and Burns A
Under the supervision of a healthcare professional, MANUKA FILL wound dressings may be used for:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns (Superficial and Partial A Thickness)
- Diabetic Foot Ulcers
- Surgical Wounds
- Traumatic Wounds A
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
MANUKA FILL 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 that is harvested and processed under controlled conditions. This honey is sealed into low density polyethylene tubes (LDPE) before sterilization using gamma irradiation.
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 FILL wound dressings; including cytotoxicity, skin irritation, 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 FILL 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
K121227
page 1 of 3
MAY 2 3 2012
Image /page/0/Picture/2 description: The image shows a logo with the letters "lmp" in a stylized, interconnected design. The letters are bold and outlined, with rounded corners and a retro aesthetic. The background is black, and the letters are white, creating a high-contrast visual. The logo has a slightly distressed or aged appearance, adding to its vintage feel.
Links Medical Products Inc
510(k) SUMMARY
Submitted by:
ું મું
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 irsmith00@cox.net
April 17, 2012 MANUKA FILL wound dressings Wound Dressing Dressing, Wound, Drug Unclassified FRO Manukapli wound dressings (Manuka Medical, Ltd.) K092689 MANUKA FILL 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 that is harvested and processed under
controlled conditions. This honey is sealed into low density polyethylene tubes (LDPE) before sterilization using gamma irradiation.
1
Image /page/1/Figure/0 description: The image contains handwritten text. The top line reads 'K121227'. The second line reads 'posi 2 of 3'. The text appears to be written in black ink on a white background.
Image /page/1/Figure/1 description: The image shows a logo with the letters "LMP" in a stylized, blocky font. The letters are outlined in white and filled in with black. The logo has a retro or vintage feel due to the font style and the slightly distressed appearance of the image.
Links Medical Products Inc.
Intended Use:
MANUKA FILL wound dressings are sterile, single-use wound care dressings for use in moist wound management. MANUKA FILL Wound Dressings may be used Over-The-Counter for:
- s Minor Abrasions
-
Lacerations
-
Minor Cuts
- Minor Scalds and Burns A
Under the supervision of a healthcare professional, MANUKA FILL wound dressings may be used for:
-
Leg Ulcers
- Pressure Ulcers s
- 1st and 2nd Degree Burns (Superficial and Partial A Thickness)
- A Diabetic Foot Ulcers
- a Surgical Wounds
- Traumatic Wounds A
The technical characteristics of MANUKA FILL wound dressing are substantially equivalent to the predicate device. The devices are similar in function, composition, and intended use. Leptospermun scoparium honey is the primary ingredient for MANUKA FILL and the predicate device. Both MANUKA FILL and the predicate device are provided as a single-use device in individually-sterilized packaging.
Standard biocompatibility tests were performed on the MANUKA FILL wound dressings; including cytotoxicity, skin irritation, 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 FILL 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
Technology Comparison:
Nonclinical Testing:
ર-2
2
Image /page/2/Picture/0 description: The image shows a logo with the letters 'LMP' in a stylized, interconnected design. The letters are bold and outlined, with the 'L' and 'M' sharing a common base. The 'P' is a rounded shape connected to the 'M'. The logo has a retro or vintage feel due to its design and the image quality.
K 12 12 27
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 FILL 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 FILL 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
5-3
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Links Medical Products, Incorporated % Nano Smart Incorporated James Smith, Ph.D. Consultant 29442 Pointe Royale Laguna Niguel, California 92677
WAY 2 3 2012
Re: K121227 Trade/Device Name: MANUKA FILL wound dressings Regulatory Class: Unclassified Product Code: FRO Dated: April 16 , 2012 Received: April 23, 2012
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
4
Page 2 - Dr. Smith
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 (OS) 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. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: MANUKA FILL wound dressings
Indications for Use:
MANUKA FILL wound dressings are sterile, single-use, wound care dressings for use in moist wound management. MANUKA FILL wound dressings may be used Over-The-Counter for:
-
Minor Abrasions
- A Lacerations
- A Minor Cuts
-
Minor Scalds and Burns
Under the supervision of a healthcare professional, MANUKA FILL wound dressings may be used for:
-
Leg Ulcers
-
Pressure Ulcers
- A 1st and 2nd Degree Burns (Superficial and Partial Thickness)
-
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 Kroneberger MM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121227