(130 days)
Not Found
No
The summary describes a wound dressing with honey and foam, and the performance studies focus on biocompatibility and wound healing, not AI/ML performance. There are no mentions of AI, ML, image processing, or data sets for training/testing.
Yes
The device is described as "wound care dressings" used for the "moist wound management of: Leg Ulcers, Pressure Ulcers, 1st and 2nd Degree Burns, Diabetic Foot Ulcers, Surgical Wounds, Trauma Wounds." This indicates its intended use for treating wounds, which is a therapeutic purpose.
No
The device is a wound dressing designed to help manage moist wounds and facilitate healing, not to diagnose medical conditions.
No
The device description clearly states it is a physical wound dressing made of foam-fiber material impregnated with honey, and includes physical components like a polyurethane border and adhesive. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of various types of wounds by maintaining a moist environment. This is a direct application to the body for therapeutic purposes.
- Device Description: The device is a wound dressing made of foam and honey, designed to be applied externally to a wound.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (on the body) for wound care.
N/A
Intended Use / Indications for Use
MANUKA FOAM HC wound dressings are sterile, single-use wound care dressings for use in moist wound management of:
- Leg Ulcers
- Pressure Ulcers
- 1st and 2nd Degree Burns
- Diabetic Foot Ulcers
- Surgical Wounds
- Trauma Wounds
A moist wound environment allows autolytic debridement of necrotic tissue.
Product codes
FRO
Device Description
MANUKA FOAM HC wound dressings are sterile, single use wound care dressings that help maintain a moist wound environment. The primary device consists of 100% Leptospermum scoparium honey from New Zealand impregnated into an absorbent foam-fiber hybrid material. One version of the product includes a polyurethane border with a silicone adhesive. Another version of the product includes a polyurethane border with an acrylic adhesive.
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
Standard biocompatibility tests were performed on the MANUKA FOAM HC wound dressings, in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, primary skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FOAM HC wound 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 real-time conditions, and packaging validation. The MANUKA FOAM HC wound dressings met the acceptance criteria for all tests conducted.
Key Metrics
Not Found
Predicate Device(s)
K120976 (MANUKA IG), K072068 (BioAquaCare)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Links Medical Products Inc. The logo features the letters "LMP" in a stylized, interconnected design. Below the logo, the full name of the company, "Links Medical Products Inc.," is printed in a smaller, sans-serif font.
ﺰ
MAY 02 2014
K133934
510(k) SUMMARY
Submitted by: Links Medical Products, Inc. Owner's Name: Address: 9247 Research Drive Irvine, CA 92618 Tom Buckley, Chief Executive Officer Contact: 949-753-0001 Telephone: 949-753-7412 Fax: tbuckley@linksmed.com E-mail: Contact Person: James Smith, Ph.D. Name Address 29442 Pointe Royale Laguna Niguel, CA 92677 949-340-7261 Telephone 949-340-7141 Fax: irsmith00@cox.net E-mail: April 1, 2014 Date Prepared: Trade Name: MANUKA FOAM HC Wound Dressing Common Name: Dressing, Wound, Drug Classification Name: Unclassified Device Class: FRO Product Code: Predicate Devices: MANUKA IG Wound Dressing (Links Medical Products, Inc.), BioAquaCare (BioArtificial Gel Technologies) K120976 (MANUKA IG), K072068 (BioAquaCare) Predicate 510(k) #: MANUKA FOAM HC wound dressings are sterile, single Device Description: use wound care dressings that help maintain a moist wound environment. The primary device consists of 100% Leptospermum scoparium honey from New Zealand impregnated into an absorbent foam-fiber hybrid material. One version of the product includes a polyurethane border 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 consists of the letters "LMP" in a stylized, interconnected design. The letters are bold and outlined, with a black fill. Below the logo, the text "Links Medical Products Inc." is printed in a simple, sans-serif font.
with a silicone adhesive. Another version of the product includes a polyurethane border with an acrylic adhesive.
MANUKA FOAM HC wound dressings are sterile, single-Intended Use: use wound care dressings for use in moist wound management of:
-
Leg Ulcers
-
Pressure Ulcers
-
1st and 2nd Degree Burns
-
Diabetic Foot Ulcers
-
Surgical Wounds
-
Trauma Wounds
A moist wound environment allows autolytic debridement of necrotic tissue.
The technical characteristics of MANUKA FOAM HC are Technology Comparison: substantially equivalent to the predicate devices: Manuka IG and BioAquaCare. MANUKA FOAM HC and its predicate devices maintain a moist wound environment that promotes autolytic debridement conducive to wound healing. Like MANUKA FOAM HC, Manuka IG maintains a moist wound environment by using 100% leptospermun scoparium honey as the primary ingredient, and uses an absorbent secondary dressing to manage excess wound exudate. BioAquaCare utilizes a hydrogel (95% water) to maintain a moist wound environment. MANUKA FOAM HC 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 FOAM HC wound dressings, in accordance with 1 ISO 10993-1 (Biological Evaluation of Medical Devices) and the FDA Biocompatibility Matrix, including cytotoxicity, primary skin irritation, and skin sensitization. In addition, a wound healing study was conducted to assess the impact of repeated application of MANUKA FOAM HC wound 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
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 features the letters "lmp" in a stylized, blocky font, with a thick outline around each letter. The text "Links Medical Products Inc." is written in a smaller, sans-serif font below the logo.
performed by North American Science Associates (NAMSA). Additional testing included sterilization validation, shelf-life under accelerated and real-time conditions, and packaging validation. The MANUKA FOAM HC wound dressings met the acceptance criteria for all tests conducted.
Conclusion of Comparison: MANUKA FOAM HC 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 FOAM HC wound dressings have been determined to be substantially equivalent and as safe and effective as its predicate devices (Manuka IG and BioAquaCare).
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
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
May 2, 2014
Links Medical Products Incorporated Mr. James Smith Consultant 29442 Pointe Royale Laguna Hills, California 92677
Re: K133934
Trade/Device Name: MANUKA FOAM HC Regulatory Class: Unclassified Product Code: FRO Dated: January 31, 2014 Received: February 6, 2014
Dear Mr. 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.
4
Page 2 - Mr. James Smith
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific ad 1100 tor your Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S 2014.05.02 1:8:09:36-04'00'
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
5
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
MANUKA FOAM HC wound dressings are sterile, single-use wound care dressings for use in moist wound management of:
-
Leg Ulcers
-
Pressure Ulcers
-
1st and 2nd Degree Burns
-
Diabetic Foot Ulcers
-
Surgical Wounds
-
Trauma Wounds
A moist wound environment allows autolytic debridement of necrotic tissue.
Prescription Use × (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)
Peter L. Hudson -S