(293 days)
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- · Ulcers (venous, arterial, diabetic)
- Pressure Sores
- · Donor Sites
- · Surgical Incisions
- · Surgical Excisions
- · Burns (1st and 2nd degree)
Luofucon Silver Foam Dressing is a sterile, single-use dressing composed of polyurethane and silver particles, which absorbs wound exudate and releases silver ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The polyurethane material consists of metallic silver that provides effective protection of the dressing material (not wound) against bacterial contamination. The silver is a preservative that protects the dressing material (not wound) from a broad spectrum of bacteria over three days, based on in vitro laboratory testing.
All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.
The silver foam dressing in this submission consists of four variants:
The basic model, dressing without backing, is a sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth, elastic and breathable Polyurethane foam encapsulated with silver particles as an antimicrobial barrier. The product line is available in different sizes.
A second variant, non adhesive PU backing variant, has a two-layered structure: a thick layer of soft, smooth elastic and breathable Polyurethane foam encapsulated with silver particles, and a thin layer (0.025±0.005 mm thick) of non porous breathable Polyurethane film (backing film) laminated on the outer side (non-wound contacting side) of the thick layer. The thin backing has the same area as the thick soft Polyurethane layer and is for cosmetic purpose. The product line is available in different sizes.
A third adhesive variant, bordered PU adhesive backing variant, has a three-layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of Poly(ethylene terephthalate) (PET) (0.04±0.005 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The backing polyurethane layer and PET layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
A fourth adhesive variant, bordered non-woven adhesive backing variant, is similar to the third variant and also has a three layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of non-woven material (0.28±0.02 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The non woven material is made from viscose rayon fiber and poly(ethylene terephthalate) fiber. The backing polyurethane layer and non woven layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
The dressing has white appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size and backing.
This document is a 510(k) premarket notification for the "Luofucon Silver Foam Dressing." It describes the device, its intended use, and provides a comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of acceptance criteria and the reported device performance
| Description | Acceptance Criteria (Our Device) | Reported Device Performance (Our Device) | Predicate Device (K110062) Performance |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | No Toxic Effect (ISO 10993-5) | No Toxic Effect | Biocompatible (implicit) |
| Skin Irritation and Sensitization | No Effect (ISO 10993-10) | No Effect | Biocompatible |
| Systematic Toxicity | No Effect (ISO 10993-11) | No Effect | Biocompatible (implicit) |
| Antimicrobial Performance | |||
| Antibacterial Activity | Broad spectrum protection | Broad spectrum protection | Broad spectrum protection |
| Antibacterial Duration | At least 3 days (based on predicate) | 3 days (4 log reduction in 6 bacteria) | 5-7 days |
| Physical/Chemical Properties | |||
| Silver Concentration on the device | 3 ± 1 µg/cm³ silver particles | 3 ± 1 µg/cm³ silver particles | (Implicitly higher than subject device) |
| Sterilization | Validated following ISO 11135-1: 2007 | Validated following ISO 11135-1: 2007 | Sterile |
Note: The document explicitly states acceptance criteria for biocompatibility (conformance to specific ISO standards) and antibacterial activity (broad spectrum protection). For antibacterial duration, the acceptance criterion appears to be "at least 3 days" to show equivalence with the predicate for a "use case" of three days, even though the predicate performs for 5-7 days. The silver concentration is a specification, implying it was an acceptance criterion for manufacturing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For biocompatibility testing, details on the number of samples (e.g., number of test specimens, animal subjects) are not explicitly stated in this summary. It mentions compliance with ISO standards, which would typically specify sample sizes for these tests.
- For antibacterial activity, "a total of six (three Gram positive and three Gram negative) bacteria" were evaluated. This refers to the types of bacteria, not the number of physical dressing samples tested with each bacterium. The number of dressing samples per bacterial strain is not specified.
- Data Provenance: The studies were conducted for Huizhou Foryou Medical Devices Co., Ltd., which is located in Huizhou, Guangdong Province, China. The testing itself is indicated as "in vitro laboratory testing." The provenance of the actual lab where the tests were performed is not explicitly stated beyond the manufacturer's location. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document describes a medical device (wound dressing) and its performance in in vitro and biocompatibility testing. It does not involve a "test set" in the context of diagnostic or AI-driven devices that require expert-established ground truth on patient data (e.g., imaging reports). Therefore, this question is not applicable to the type of information provided. The "truth" for these tests (e.g., presence of toxicity, bacterial reduction) is determined by quantitative laboratory assays and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this summary pertains to a medical device's in vitro and biocompatibility performance, not a diagnostic algorithm requiring human adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-driven diagnostic device; it's a wound dressing. Therefore, MRMC studies are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims in this submission is established through:
- Quantitative Laboratory Assays: For antibacterial activity (4 log reduction).
- Standardized Biocompatibility Protocols: Conformance to ISO 10993 series for cytotoxicity, skin irritation/sensitization, and systematic toxicity. These standards define the methods and criteria for evaluating biological responses to the device materials.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Huizhou Foryou Medical Devices Company, Ltd. % Mr. Charles Shen Manton Business and Technology Services 853 Dorchester Lane, Unit-B Pennington, New Jersey 08534
Re: K141619
Trade/Device Name: Luofucon Silver Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 20, 2015 Received: March 24, 2015
Dear Mr. Shen:
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
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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.gov/MedicalDevices/Resourcesfor You/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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141619
Device Name Luofucon Silver Foam Dressing
Indications for Use (Describe)
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- · Ulcers (venous, arterial, diabetic)
- Pressure Sores
- · Donor Sites
- · Surgical Incisions
- · Surgical Excisions
- · Burns (1st and 2nd degree)
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary:
This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification
Huizhou Foryou Medical Devices Co., Ltd. No.1, Shangxia North Road, Dongjiang Hi-Tech Industry Park, Huizhou, Guangdong Province, China Tel: (086) 0752-5302188 Submitter's FDA Registration Number: 3007735241
US Agent and Contact Person
Charles Shen Manton Business and Technology Services 853 Dorchester Ln, Unit-B Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com
Date of Summary: March 31, 2015
| Device Name: | |
|---|---|
| Trade Name: | Luofucon Silver Foam Dressing |
| Common Name: | Silver Foam Dressing |
| Classification Name: | Dressing, wound, Drug |
| Product Code: | FRO |
| Regulation Number: | Unclassified |
| Review Panel: | General & Plastic Surgery |
Predicate Device Information:
- (1) K110062, "MediPlus-Foam AG Dressings, MediPlus-ComfortFoam AG Dressings, MediPlus-SuperFoam AG Dressings", manufactured by "MediPurpose, Pte. Ltd." located in Norcross, GA
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Device description:
Luofucon Silver Foam Dressing is a sterile, single-use dressing composed of polyurethane and silver particles, which absorbs wound exudate and releases silver ions in the presence of wound fluid. It also assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The polyurethane material consists of metallic silver that provides effective protection of the dressing material (not wound) against bacterial contamination. The silver is a preservative that protects the dressing material (not wound) from a broad spectrum of bacteria over three days, based on in vitro laboratory testing.
All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.
The silver foam dressing in this submission consists of four variants:
The basic model, dressing without backing, is a sterile highly absorbing open cell hydrophilic wound dressing composed of a thick soft, smooth, elastic and breathable Polyurethane foam encapsulated with silver particles as an antimicrobial barrier. The product line is available in different sizes.
A second variant, non adhesive PU backing variant, has a two-layered structure: a thick layer of soft, smooth elastic and breathable Polyurethane foam encapsulated with silver particles, and a thin layer (0.025±0.005 mm thick) of non porous breathable Polyurethane film (backing film) laminated on the outer side (non-wound contacting side) of the thick layer. The thin backing has the same area as the thick soft Polyurethane layer and is for cosmetic purpose. The product line is available in different sizes.
A third adhesive variant, bordered PU adhesive backing variant, has a three-layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of Poly(ethylene terephthalate) (PET) (0.04±0.005 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The backing polyurethane layer and PET layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
A fourth adhesive variant, bordered non-woven adhesive backing variant, is similar to the third variant and also has a three layered structure. A thin Polyurethane film layer (0.04±0.005 mm thick), served as backing, is laminated to the top of the thick layer of soft, breathable, and silver encapsulated Polyurethane foam. Then on top of second layer is a large thin film of non-woven material (0.28±0.02 mm thick) with pressure-sensitive adhesive to secure the dressing on patient skin surface. The non woven material is made from viscose rayon fiber and poly(ethylene terephthalate) fiber. The backing polyurethane layer and non woven layer are waterproof and semi permeable, and are used to secure the foam onto patient skin. The product line is available in different sizes.
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K141619, Page 3 of 5 The dressing has white appearance and is available in the form of pad and in different sizes packaged in pouches. All dressings have the exactly the same material, chemical, and physical properties and are different only in size and backing.
Product Information:
| Antibacterial Agent: | Silver Particles |
|---|---|
| Active Against Pathogens: | Gram positive and Gram negative bacteria |
| Spectrum of Activity: | Board spectrum antibacterial effect for Gram positive and Gramnegative bacteria |
| Concentration on the device: | Each dressing contains 3±1 µg/cm3 silver particles |
Silver serves as a preservative against bacterial growth in the dressing material
Indication for Use:
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are:
- Ulcers (venous, arterial, diabetic)
- Pressure Sores ●
- Donor Sites
- Surgical Incisions
- Surgical Excisions ●
- Burns (1st and 2nd degree) ●
Comparison to Predicate Devices
Luofucon Silver Foam Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.
- K110062, "MediPlus-Foam AG Dressings, MediPlus-ComfortFoam AG Dressings, MediPlus-SuperFoam AG Dressings", manufactured by "MediPurpose, Pte. Ltd." located in Norcross, GA
The following table shows similarities and differences of use, design, material, and processing methods between our device and the predicate devices.
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Table 5.1: Comparison of Intended Use, Design, and Material
| Description | Our Device | Predicate Device 1 (K110062) |
|---|---|---|
| Indication forUse | The Luofucon Silver Foam Dressing isindicated for exudate absorption andthe management of partial to fullthickness wounds. Some typicalwounds are:Ulcers (venous, arterial, diabetic) Pressure Sores Donor Sites Surgical Incisions Surgical Excisions Burns (1st and 2nd degree) | The MediPlus-Foam AG,MediPlus-ComfortFoam AG, andMediPlus-SuperFoam AG Dressings areindicated for exudate absorption and themanagement of partial to full thicknesswounds.Some typical wounds are:Ulcers (venous, arterial, diabetic) Pressure Sores Donor Sites Surgical Incisions Surgical Excisions Burns (1st and 2nd degree) |
| Prescription/OTC | Prescription | Same |
| Mechanism | Silver for antibacterial preservativeeffect; polyurethane foam for exudateabsorption and wound care | Same |
| Design/Material | Polyurethane foam and silver | Same |
| AntibacterialDuration | Three days | 5-7 days |
| Single Use | Yes | Yes |
| Sterile | Sterile | Sterile |
Both Luofucon Silver Foam Dressing and its predicate device (K110062) utilize silver as the antibacterial agent, and utilize polyurethane foam for the exudate absorption and wound management.
One minor difference between our device and predicate device is that predicate device uses multi-layered polyurethane structure, and our device has either single layered or double layered structure. This small difference does not impact the safety and efficacy of our devices because both devices use the silver particle as the antibacterial preservative agent and utilize polyurethane foam for the exudate absorption and wound management.
The other minor difference is the silver content. The subject device contains less silver than the predicate device, and is at the safe level based on toxicology assessment, therefore does not raise new safety concerns.
Therefore, Luofucon Silver Foam Dressing and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use.
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Table 5.2 shows similarities and differences of the performance between our device and the predicate devices.
| Description | Our Device | Predicate Device(K110062) |
|---|---|---|
| Cytotoxicity | No Toxic Effect(ISO10993-5) | |
| Skin Irritation andSensitization | No Effect(ISO 10993-10) | Biocompatible |
| Systematic Toxicity | No Effect (ISO10993-11) | |
| Antibacterial Activity | Broad spectrumprotection | Broad spectrumprotection |
| Antibacterial Duration | Three days | 5-7 days |
Table 5.2: Comparison of Biocompatibility and Performance Testing
Luofucon Silver Foam Dressing meets biocompatibility requirements per ISO 10993-5, ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by EtO using conditions validated following ISO 11135-1: 2007.
To support broad spectrum antibacterial preservative effectiveness of the Silver Foam Dressing, we evaluated a total of six (three Gram positive and three Gram negative) bacteria. Luofucon Silver Foam Dressing demonstrated a 4 log reduction in all six bacteria for three days in in vitro testing.
Therefore, the performance results are comparable to the predicate devices when the dressings are used for antibacterial purpose for three days. The product is safe and effective for its intended use.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, and performance, our Luofucon Silver Foam Dressing is substantial equivalent to its predicate devices.
N/A