(269 days)
Not Found
No
The device description and performance studies focus on the properties of the honey-based wound dressing and its biological effects, with no mention of AI or ML.
Yes.
The device is indicated for the management of various wounds, including ulcers and burns, and is explicitly described as a "wound care dressing that helps maintain a moist wound environment conducive to wound healing." These indications and functions categorize it as a therapeutic device.
No
Explanation: The device is a wound dressing used for management and healing of wounds, not for diagnosing conditions.
No
The device description explicitly states that the primary device consists of honey sealed into LDPE tubes, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that MANUKA FILL wound dressing is for the management of various types of wounds (ulcers, burns, surgical wounds, etc.) by providing a moist wound environment. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a wound care dressing consisting of honey. This is a topical application for wound healing, not a test performed on a sample taken from the body to diagnose a condition.
- No mention of diagnostic testing: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. MANUKA FILL wound dressing does not fit this description.
N/A
Intended Use / Indications for Use
Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
AND/OR
MANUKA FILL wound dressing may be used Over-The-Intended Use: Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized 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
Under the supervision of a healthcare professional (for certain indications); Over-The-Counter use (for minor indications)
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)
Nonclinical Testing: Standard biocompatibility tests were performed on the MANUKA FILL wound dressing in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine. The test articles did not impair healing and were determined to be as safe and effective as the predicate devices. All tests were performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and realtime conditions, and packaging validation. The MANUKA FILL wound dressing met the acceptance criteria 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.
K121227 (MANUKA FILL), K072068 (BioAquaCare)
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 Links Medical Products Inc. The logo is in black and white and features the letters "LMP" in a stylized font. The letters are connected and have a three-dimensional appearance. Below the letters, the words "Links Medical Products Inc." are written in a smaller, sans-serif font.
MAR 1 4 2014 K131796
510(k) SUMMARY
| Submitted by: | |
|---|---|
| Owner's Name: | Links Medical Products, Inc. |
| Address: | 9247 Research Drive |
| Irvine, CA 92618 | |
| Contact: | Tom Buckley, Chief Executive Officer |
| Telephone: | 949-753-0001 |
| Fax: | 949-753-7412 |
| E-mail: | tbuckley@linksmed.com |
| Contact Person: | |
| Name | James Smith, Ph.D. |
| Address | 29442 Pointe Royale |
| Laguna Niguel, CA 92677 | |
| Telephone | 949-340-7261 |
| Fax: | 949-340-7141 |
| E-mail: | jrsmith00@cox.net |
| Date Prepared: | March 10, 2014 |
| Trade Name: | MANUKA FILL |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Devices: | MANUKA FILL Wound Dressing (Links Medical Products, Inc.), BioAquaCare (BioArtificial Gel Technologies) |
| Predicate 510(k) #: | K121227 (MANUKA FILL), K072068 (BioAquaCare) |
| Device Description: | MANUKA FILL wound dressing is a sterile, single-use, wound care dressing that helps maintain a moist wound environment conducive to wound healing. The primary device consists of 100% Leptospermum scoparium honey from New Zealand sealed into low-density polyethylene (LDPE) tubes and sterilized using gamma irradiation. |
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive
Irvine, CA 92618
1
Image /page/1/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo is a stylized, blocky design with the letters "LMP" stacked on top of each other. The letters are outlined in white, and the background is black. Below the logo, the words "Links Medical Products Inc." are printed in a smaller font.
Intended Use: Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of: > Leg Ulcers A Pressure Ulcers > 1st and 2nd Degree Burns > Diabetic Foot Ulcers > Surgical Wounds > Trauma Wounds MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. The technical characteristics of MANUKA FILL are Technology Comparison: substantially equivalent to the predicate devices. The wound dressings maintain a moist wound environment that promotes autolytic debridement conducive to wound healing. MANUKA FILL and its predicate (K121227) accomplish this by using 100% Leptospermun socparium honey as the primary ingredient, whereas BioAquaCare utilizes a hydrogel (95% water) to achieve the same goal. MANUKA FILL and its predicates are provided as single-use devices in individually sterilized packaging. Despite minor differences in materials, the devices are similar in function and intended use. Nonclinical Testing: Standard biocompatibility tests were performed on the MANUKA FILL wound dressing in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine. The test articles did not impair healing and were determined to be as safe and effective as the predicate devices. All tests were performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and realtime conditions, and packaging validation. The MANUKA FILL wound dressing met the acceptance criteria for all tests conducted.
LINKS MEDICAL PRODUCTS, INC.
9247 Research Drive Irvine, CA 92618
2
Image /page/2/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized, interconnected design. The letters are bold and outlined, with a three-dimensional effect. Below the logo, the text "Links Medical Products Inc." is printed in a simple, sans-serif font.
Conclusion of Comparison: MANUKA FILL and its predicate devices were demonstrated to be biocompatible and met performance requirements for sterility, shelf life, and packaging. Based upon the technological characteristics and nonclinical performance data, MANUKA FILL wound dressings have been determined to be substantially equivalent and as safe and effective as its predicate devices (Manuka Fill and BioAquaCare).
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618
3
Image /page/3/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo is a stylized version of the letters "LMP" stacked on top of each other. The words "Links Medical Products Inc." are printed in a smaller font below the logo. The logo is black and white.
MAR 1 4 2014
510(k) SUMMARY
| Submitted by: | |
|---|---|
| Owner's Name: | Links Medical Products, Inc. |
| Address: | 9247 Research Drive |
| Irvine, CA 92618 | |
| Contact: | Tom Buckley, Chief Executive Officer |
| Telephone: | 949-753-0001 |
| Fax: | 949-753-7412 |
| E-mail: | tbuckley@linksmed.com |
| Contact Person: | |
| Name | James Smith, Ph.D. |
| Address | 29442 Pointe Royale |
| Laguna Niguel, CA 92677 | |
| Telephone | 949-340-7261 |
| Fax: | 949-340-7141 |
| E-mail: | jrsmith00@cox.net |
| Date Prepared: | March 10, 2014 |
| Trade Name: | MANUKA FILL |
| Common Name: | Wound Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Device Class: | Unclassified |
| Product Code: | FRO |
| Predicate Devices: | MANUKA FILL Wound Dressing (Links Medical Products, |
| Inc.), BioAquaCare (BioArtificial Gel Technologies) | |
| Predicate 510(k) #: | K121227 (MANUKA FILL), K072068 (BioAquaCare) |
| Device Description: | MANUKA FILL wound dressing is a sterile, single-use, |
| wound care dressing that helps maintain a moist wound | |
| environment conducive to wound healing. The primary | |
| device consists of 100% Leptospermum scoparium honey | |
| from New Zealand sealed into low-density polyethylene | |
| (LDPE) tubes and sterilized using gamma irradiation. |
Links Medical Products, Inc.
,
9247 Research Drive
Irvine, CA 92618
:
4
Image /page/4/Picture/0 description: The image shows a logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized font, with the letters overlapping each other. The words "Links Medical Products Inc." are printed below the logo in a smaller font. The logo is black and white.
MANUKA FILL wound dressing may be used Over-The-Intended Use: Counter for the management of: > Minor Abrasions > Minor Lacerations > Minor Cuts > Minor Scalds and Minor Burns MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue. The technical characteristics of MANUKA FILL are Technology Comparison: substantially equivalent to the predicate devices. The wound dressings maintain a moist wound environment that promotes autolytic debridement conducive to wound healing. MANUKA FILL and its predicate (K121227) accomplish this by using 100% Leptospermun socparium honey as the primary ingredient, whereas BioAquaCare utilizes a hydrogel (95% water) to achieve the same goal. MANUKA FILL and its predicates are provided as single-use devices in individually sterilized packaging. Despite minor differences in materials, the devices are similar in function and intended use. Standard biocompatibility tests were performed on the Nonclinical Testing: MANUKA FILL wound dressing in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FILL to full-thickness dermal wounds in swine. The test articles did not impair healing and were determined to be as safe and effective as the predicate devices. All tests were performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and realtime conditions, and packaging validation. The MANUKA FILL wound dressing met the acceptance criteria for all tests conducted.
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618
5
Image /page/5/Picture/0 description: The image shows the logo for Links Medical Products Inc. The logo consists of the letters "LMP" in a stylized, interconnected design. The letters are outlined in white against a black background, giving them a bold and modern appearance. Below the logo, the full name of the company, "Links Medical Products Inc.," is printed in a simple, sans-serif font.
Conclusion of Comparison: MANUKA FILL and its predicate devices were demonstrated to be biocompatible and met performance requirements for sterility, shelf life, and packaging. Based upon the technological characteristics and nonclinical performance data, MANUKA FILL wound dressings have been determined to be substantially equivalent and as safe and effective as its predicate devices (Manuka Fill and BioAquaCare).
LINKS MEDICAL PRODUCTS, INC. 9247 Research Drive Irvine, CA 92618
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2014
Links Medical Products Incorporated James Smith, Ph.D. Consultant 29442 Pointe Royale Laguna Niguel, California 92677
Re: K131796
Trade/Device Name: MANUKA FILL Regulatory Class: Unclassified Product Code: FRO Dated: February 14, 2014 Received: February 18, 2014
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.
7
Page 2 - James Smith, Ph.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
MANUKA FILL wound dressing may be used Over-The-Counter for the management of:
-
Minor Abrasions
-
Minor Lacerations
-
Minor Cuts
-
Minor Scalds and Minor Burns
MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
Prescription Use (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)
Jiyoung Dang -S
9
INDICATIONS FOR USE
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Under the supervision of a healthcare professional, MANUKA FILL wound dressing is indicated for the management of:
-
Leg Ulcers
-
Pressure Ulcers
-
1st and 2nd Degree Burns
-
Diabetic Foot Ulcers
-
Surgical Wounds
-
Trauma Wounds
MANUKA FILL wound dressing provides a moist wound environment. A moist wound environment allows autolytic debridement of necrotic tissue.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S