(413 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the physical and chemical properties of a wound dressing with silver, with no mention of AI or ML.
Yes
The device is indicated for the management of various wounds and injuries, including ulcers and burns, and assists in inhibiting bacterial growth to promote healing, which are therapeutic actions.
No
The device is a wound dressing designed for managing partial to full thickness wounds and minor skin injuries, not for diagnosing medical conditions.
No
The device description clearly outlines a physical wound dressing made of polyurethane foam and silver compound, with different structural models. It is a tangible medical device, 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 managing various types of wounds. This involves direct application to the body surface for therapeutic purposes (exudate absorption, maintaining a moist environment, antibacterial effect).
- Device Description: The description details the physical structure and composition of a wound dressing, including foam, backing, and adhesive layers. It explains how it functions to absorb exudate and release silver ions for antibacterial effect within the dressing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue) to provide information about a person's health status, disease, or condition. IVDs are designed for diagnostic purposes, not for direct treatment or management of a physical wound.
- Performance Studies: The performance studies focus on the physical properties of the dressing (absorbency, barrier function, antibacterial effectiveness in vitro), biocompatibility, and wound healing in an animal model. These are typical evaluations for wound care products, not IVDs.
In summary, the LUOFUCON® Ag+ Foam Dressing is a therapeutic device intended for wound management, not a diagnostic device used to analyze biological samples.
N/A
Intended Use / Indications for Use
The marketing authorization for LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, superficial second-degree burns, donor sites, surgical wounds, lacerations and abrasions. LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® Aq+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is a sterile, single-use wound dressing. The device has a single or multi-layer structure and its foam layer is containing 0.40mg/cm² maximum content of ionic silver. According to the different composition of product structure, the device provides three models: Easy, Backing and Adhesive.
- (a) The first model, Easy, consist of a single exudate absorption layer (Polyurethane foam containing silver compound).
- (b) The second model, Backing, consist of a backing layer (Polyurethane film); an exudate absorption layer (Polyurethane foam containing silver compound).
- (c) The third model, Adhesive, consist of a self-adhesive layer (Adhesive tape); an exudate absorption layer (Polyurethane foam containing silver compound); a release liner covers on the adhesive tape.
Depending on its exudate absorption layer, the device can absorb wound exudates and maintain a moist wound healing environment. As wound exudates are absorbed, the silver ions released from the polyurethane foam to assist in inhabiting bacterial growth within the dressing for up to 7days, as demonstrated in vitro. The polyurethane film of dressing is waterproof and breathable which can provide a microbial barrier to prevent the microbial penetrating through it.
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)
Bench performance testing was conducted including Appearance, Size, Water absorbency (BS EN 13726-1), pH Value (USP pH), Silver content, MVTR (BS EN 13726-2), Waterproofness (BS EN 13726-3), Microbial barrier, EO and ECH residuals (ISO 10993-7), Antibacterial effectiveness (Modified AATCC TM100), and Sterility (ISO 11737-2).
Biocompatibility testing included Cytotoxicity (ISO 10993-5:2009), Intracutaneous Reactivity (ISO 10993-10:2010), Sensitization (ISO 10993-10:2010), Acute Systemic toxicity (ISO 10993-11:2017), Material-mediated pyrogenicity (USP ), Sub chronic toxicity (ISO 10993-11:2017), and Implantation (ISO 10993-6:2016). The device was determined to be safe for its intended use.
An Animal Study (Porcine Wound Healing Study) was conducted, and the device did not affect normal wound healing.
No clinical studies were 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.
No reference devices were used in this submission.
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 of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2023
Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan R&D Engineer North Shangxia Road Dongjiang Hi-Tech Industry Park Huizhou, Guangdong 516005 China
Re: K223359
Trade/Device Name: LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: April 13, 2023 Received: April 13, 2023
Dear Guosheng Tan:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
510(k) Number (if known) K223359
Device Name
LUOFUCON® Ag+ Foam Dressing LUOFUCON® Ag+ Antibacterial Foam Dressing
Indications for Use (Describe)
Prescription Use:
LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, superficial second-degree burns, donor sites, surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.
I. SUBMITTER:
Huizhou Foryou Medical Devices Co., Ltd.
| Address: | North Shangxia Rd. Dongjiang Hi-tech Industry Park, 516005,
Huizhou, PEOPLE'S REPUBLIC OF CHINA | | |
|-----------------|----------------------------------------------------------------------------------------------------|--|--|
| Phone: | +86-0752-5302185 | | |
| Contact Person: | Guosheng Tan | | |
| Date Prepared: | November 3, 2022 | | |
II. SUBJECT DEVICE
| Trade/Proprietary Names: | LUOFUCON® Ag+ Foam Dressing (Prescription use), |
|---|---|
| LUOFUCON® Ag+ Antibacterial Foam Dressing (OTC use) | |
| Common Name: | Dressing, Wound, Drug |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |
III.PREDICATE DEVICE:
Primary Predicated Device :
| 510(k) Number: | K140954 |
|---|---|
| Product Name: | LUOFUCON® Silver PU Antibacterial Foam Dressing |
| Manufacturer: | Huizhou Foryou Medical Devices Co., Ltd. |
Secondary Predicated Device:
4
510(k) Number: K083133 Product Name: X AFD Dressings Manufacturer: Andover Healthcare, Inc.
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION:
LUOFUCON® Aq+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is a sterile, single-use wound dressing. The device has a single or multi-layer structure and its foam layer is containing 0.40mg/cm² maximum content of ionic silver. According to the different composition of product structure, the device provides three models: Easy, Backing and Adhesive.
- (a) The first model, Easy, consist of a single exudate absorption layer (Polyurethane foam containing silver compound).
- (b) The second model, Backing, consist of a backing layer (Polyurethane film); an exudate absorption layer (Polyurethane foam containing silver compound).
- (c) The third model, Adhesive, consist of a self-adhesive layer (Adhesive tape); an exudate absorption layer (Polyurethane foam containing silver compound); a release liner covers on the adhesive tape.
Depending on its exudate absorption layer, the device can absorb wound exudates and maintain a moist wound healing environment. As wound exudates are absorbed, the silver ions released from the polyurethane foam to assist in inhabiting bacterial growth within the dressing for up to 7days, as demonstrated in vitro. The polyurethane film of dressing is waterproof and breathable which can provide a microbial barrier to prevent the microbial penetrating through it.
V. INDICATIONS FOR USE:
Prescription Use:
LUOFUCON® Aq+ Foam Dressing is indicated for exudate absorption and the
5
management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial second- degree burns, donor sites, surgical wounds, lacerations and abrasions.
OTC Use:
LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
LUOFUCON® Ag+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing is Compared with the Predicate Devices in terms of technological characteristics. The following table shows their similarities and differences.
| Item | Subject Device | Primary Predicate Device
(K140954) | Secondary Predicate
Device (K083133) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Intended Use | Prescription:
LUOFUCON® Ag+ Foam
Dressing is indicated for
exudate absorption and the
management of partial to full
thickness wounds, including
leg and foot ulcers, pressure
ulcers, diabetic foot ulcers,
superficial second- degree
burns, donor sites, surgical
wounds, lacerations and
abrasions.
OTC:
LUOFUCON® Ag+
Antibacterial Foam Dressing
is indicated for first aid
management of minor
abrasions, minor cuts, minor | Prescription:
LUOFUCON® Silver PU
Antibacterial Foam Dressing
is indicated for exudate
absorption and the
management of partial to full
thickness wound, including
leg ulcers, pressure ulcers,
diabetic foot ulcers, 2nd
degree burns, donor sites,
post-operative wound and
skin abrasions. | Prescription:
CoFlex-X AFD® and the
CoFlex-X AFD® Pad contact
wound dressings are
indicated for use in light to
heavy exuding partial and full
thickness wounds, including
decubitus and diabetic ulcers,
1st and 2nd degree bums,
and donor sites. These
dressings may also be used
over debrided and partial
thickness wounds.
OTC:
PowerFlex NL-X AFD® and
CoFlex-X AFD® First Aid
contact wound dressings are
indicated for first aid |
| Item | Subject Device | Primary Predicate Device
(K140954) | Secondary Predicate
Device (K083133) |
| | lacerations, minor scrapes,
minor scalds and minor
burns. | | management of minor
abrasions, cuts, scrapes,
scalds and bums. |
| Prescription
/OTC | Prescription/OTC | Prescription | Prescription/OTC |
| Mechanism | Polyurethane foam for
exudate absorption and
wound care, silver ion in the
foam for antibacterial effect;
polyurethane film is
waterproof and breathable
which can provide a microbial
barrier. Adhesive tape for
self-adhesive and holding the
dressing tightly to the
wound. | Polyurethane foam for
exudate absorption and
wound care, silver ion in the
foam for antibacterial effect. | Polyurethane foam for
exudate absorption and
wound care, metallic silver in
the foam for antibacterial
effect; Polyurethane film
provided Waterproof and
breathable function; Bandage
holds the dressing tightly to
the wound. |
| Design
/Material | Polyurethane foam
containing silver chloride,
Polyurethane film,
non-woven adhesive tape | Polyurethane foam
containing silver chloride,
Polyurethane film,
non-woven adhesive tape | Polyurethane foam
containing metallic silver with
x-static fiber, Polyurethane
film, cohesive elastic
bandage |
| Antibacterial
Duration | 7 days | 7 days | N/A |
| Antibacterial
Activity | Broad spectrum | Broad spectrum | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | EtO
SAL:10-6 | Radiation
SAL:10-6 | EtO |
6
K223359
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Bench performance testing
- Appearance
- Size
- Water absorbency: conducted with BS EN 13726-1 ●
7
- pH Value: conducted with USP pH.
- Silver content
- MVTR: conducted with BS EN 13726-2
- Waterproofness: conducted with BS EN 13726-3
- Microbial barrier
- EO and ECH residuals: conducted with ISO 10993-7 ●
- Antibacterial effectiveness: conducted with Modified AATCC TM100.
- Sterility: conducted with ISO 11737-2
Biocompatibility testing
The subject device raised no new safety concerns for biocompatibility. Based on Table A.1 of ISO 10993-1 and Table A.1 of "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1_Evaluation and testing within a risk management process", the subject is categorized as surface devices for breached or compromised surface with prolonged duration. The device has been demonstrated to safe for its intended use. The series of testing included the following tests:
- Cytotoxicity - ISO 10993-5:2009
- Intracutaneous Reactivity - ISO 10993-10:2010
- Sensitization - ISO 10993-10:2010
- Acute Systemic toxicity - ISO 10993-11:2017
- Material-mediated pyrogenicity - USP
- Sub chronic toxicity - ISO 10993-11:2017
- Implantation - ISO 10993-6:2016
Animal Study
A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study,
8
LUOFUCON® Ag+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing did not affect normal wound healing.
Clinical Study
No clinical studies were conducted for the subject device.
VIII. CONCLUSIONS
Based on the comparison of intended use and technological characteristics with the predicate devices, dthe subject d device, LUOFUCON® Ag+ Foam Dressing/LUOFUCON® Ag+ Antibacterial Foam Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, LUOFUCON® Silver PU Antibacterial Foam Dressing (K140954) and X AFD Dressings (K083133), with respect of safety and performance.