(413 days)
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, 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.
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.
This is a 510(k) premarket notification for a medical device called LUOFUCON® Ag+ Foam Dressing and LUOFUCON® Ag+ Antibacterial Foam Dressing. It is important to understand that a 510(k) submission seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to set new performance criteria or conduct studies proving superiority. Therefore, the information provided focuses on showing that the new device is as safe and effective as existing ones.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of explicit acceptance criteria with numerical targets alongside reported device performance in the way one might expect for a diagnostic AI device. Instead, the performance data provided are primarily bench performance tests and biocompatibility tests, which largely demonstrate the physical and biological characteristics of the wound dressing and confirm it meets established standards for such devices. The "acceptance criteria" are implied by the standards chosen (e.g., BS EN 13726-1 for water absorbency, ISO 10993 for biocompatibility).
Here's a breakdown based on the provided text:
| Acceptance Criteria Category (Implied by Test) | Reported Device Performance (Summary) | Relevant Standard/Method |
|---|---|---|
| Physical/Chemical Bench Tests | ||
| Appearance | Not specified beyond "conformant" | Not specified |
| Size | Not specified beyond "conformant" | Not specified |
| Water absorbency | Performed | BS EN 13726-1 |
| pH Value | Performed | USP <791> pH |
| Silver content | 0.40mg/cm² maximum content of ionic silver (in foam layer) | Not specified, but a specific value is mentioned |
| MVTR (Moisture Vapor Transmission Rate) | Performed | BS EN 13726-2 |
| Waterproofness | Performed | BS EN 13726-3 |
| Microbial barrier | Performed (polyurethane film provides microbial barrier) | Not specified |
| EO and ECH residuals | Performed | ISO 10993-7 |
| Antibacterial effectiveness | Demonstrated effectiveness for up to 7 days in vitro | Modified AATCC TM100 |
| Sterility | Performed (SAL: 10-6 via EtO) | ISO 11737-2 |
| Biocompatibility Tests | ||
| Cytotoxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-5:2009 |
| Intracutaneous Reactivity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-10:2010 |
| Sensitization | No new safety concerns; Demonstrated safe for intended use | ISO 10993-10:2010 |
| Acute Systemic toxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-11:2017 |
| Material-mediated pyrogenicity | No new safety concerns; Demonstrated safe for intended use | USP <151> |
| Sub chronic toxicity | No new safety concerns; Demonstrated safe for intended use | ISO 10993-11:2017 |
| Implantation | No new safety concerns; Demonstrated safe for intended use | ISO 10993-6:2016 |
| Animal Study | ||
| Wound Healing | Did not affect normal wound healing | Porcine Wound Healing Study |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (wound dressing), not an AI/software device. Therefore, the concepts of "test set" and "data provenance" (e.g., country of origin, retrospective/prospective) are not directly applicable in the same way they would be for an AI algorithm.
- The "test set" for the bench performance tests would be samples of the LUOFUCON® Ag+ Foam Dressing itself. The number of samples tested for each bench test is not specified, but it would typically follow the requirements of the respective ISO/EN standards.
- The "test set" for the animal study was a cohort of pigs. The number of animals used is not specified.
- There's no mention of human clinical data or patient data "test sets" for evaluation in this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the device is a wound dressing, not an AI diagnostic system requiring expert interpretation for ground truth establishment. The performance is assessed against established physical, chemical, and biological standards.
4. Adjudication Method for the Test Set
Not applicable for a physical medical device like a wound dressing. Adjudication methods like "2+1" or "3+1" are typical for establishing ground truth in image interpretation studies for AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable as this is not an algorithm or AI device.
7. The Type of Ground Truth Used
- Bench Performance Tests: The "ground truth" is defined by specific quantitative and qualitative criteria outlined in international and national standards (e.g., BS EN, USP, ISO). These are objective measurements.
- Biocompatibility Tests: The "ground truth" is based on the absence of adverse biological reactions as defined by ISO 10993 standards.
- Animal Study: The "ground truth" for wound healing was based on observations and measurements within a porcine model, comparing the effect of the device to control or normal healing processes. The precise metrics are not detailed but generally involve macroscopic and microscopic evaluation of wound closure, inflammation, and tissue regeneration.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The manufacturing process of the wound dressing is well-established, and its characteristics are determined by its materials and design, not by learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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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).
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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
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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."
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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:
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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
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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 PredicateDevice (K083133) |
|---|---|---|---|
| Regulatory Class | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Intended Use | Prescription:LUOFUCON® Ag+ FoamDressing is indicated forexudate absorption and themanagement of partial to fullthickness wounds, includingleg and foot ulcers, pressureulcers, diabetic foot ulcers,superficial second- degreeburns, donor sites, surgicalwounds, lacerations andabrasions.OTC:LUOFUCON® Ag+Antibacterial Foam Dressingis indicated for first aidmanagement of minorabrasions, minor cuts, minor | Prescription:LUOFUCON® Silver PUAntibacterial Foam Dressingis indicated for exudateabsorption and themanagement of partial to fullthickness wound, includingleg ulcers, pressure ulcers,diabetic foot ulcers, 2nddegree burns, donor sites,post-operative wound andskin abrasions. | Prescription:CoFlex-X AFD® and theCoFlex-X AFD® Pad contactwound dressings areindicated for use in light toheavy exuding partial and fullthickness wounds, includingdecubitus and diabetic ulcers,1st and 2nd degree bums,and donor sites. Thesedressings may also be usedover debrided and partialthickness wounds.OTC:PowerFlex NL-X AFD® andCoFlex-X AFD® First Aidcontact wound dressings areindicated for first aid |
| Item | Subject Device | Primary Predicate Device(K140954) | Secondary PredicateDevice (K083133) |
| lacerations, minor scrapes,minor scalds and minorburns. | management of minorabrasions, cuts, scrapes,scalds and bums. | ||
| Prescription/OTC | Prescription/OTC | Prescription | Prescription/OTC |
| Mechanism | Polyurethane foam forexudate absorption andwound care, silver ion in thefoam for antibacterial effect;polyurethane film iswaterproof and breathablewhich can provide a microbialbarrier. Adhesive tape forself-adhesive and holding thedressing tightly to thewound. | Polyurethane foam forexudate absorption andwound care, silver ion in thefoam for antibacterial effect. | Polyurethane foam forexudate absorption andwound care, metallic silver inthe foam for antibacterialeffect; Polyurethane filmprovided Waterproof andbreathable function; Bandageholds the dressing tightly tothe wound. |
| Design/Material | Polyurethane foamcontaining silver chloride,Polyurethane film,non-woven adhesive tape | Polyurethane foamcontaining silver chloride,Polyurethane film,non-woven adhesive tape | Polyurethane foamcontaining metallic silver withx-static fiber, Polyurethanefilm, cohesive elasticbandage |
| AntibacterialDuration | 7 days | 7 days | N/A |
| AntibacterialActivity | Broad spectrum | Broad spectrum | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | EtOSAL:10-6 | RadiationSAL:10-6 | EtO |
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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 ●
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- pH Value: conducted with USP <791> 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 <151>
- 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,
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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.
N/A