(293 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing, with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The performance studies are related to biocompatibility and antibacterial activity, not algorithmic performance.
No
The device is a wound dressing that absorbs exudate and provides a moist environment for healing, as well as protecting the dressing material from bacterial contamination. It does not actively treat a disease or condition in a therapeutic manner.
No
This device is a wound dressing designed for exudate absorption, wound management, and protection against bacterial contamination of the dressing material. Its function is therapeutic and protective, not diagnostic.
No
The device is a physical wound dressing made of polyurethane and silver particles, not software.
Based on the provided information, the Luofucon Silver Foam Dressing is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the management of wounds by absorbing exudate and maintaining a moist environment. This is a direct therapeutic application to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a wound dressing applied externally. While it contains silver particles that have an antimicrobial effect on the dressing material itself (as a preservative), this is not a diagnostic function. The in vitro testing mentioned is to demonstrate the preservative effect on the dressing, not to diagnose a condition in a patient.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide information about a patient's health status or to diagnose a disease.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Luofucon Silver Foam Dressing does not fit this definition.
N/A
Intended Use / Indications 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)
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Luofucon Silver Foam Dressing demonstrated a 4 log reduction in all six bacteria for three days in in vitro testing.
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.
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/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
2
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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3
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
4
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.
5
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 Gram |
| negative 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.
6
Table 5.1: Comparison of Intended Use, Design, and Material
| Description | Our Device | Predicate Device 1 (K110062) |
|---|---|---|
| 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) | The MediPlus-Foam AG, | |
| MediPlus-ComfortFoam AG, and | ||
| MediPlus-SuperFoam AG Dressings are | ||
| 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) | ||
| Prescription/ | ||
| OTC | Prescription | Same |
| Mechanism | Silver for antibacterial preservative | |
| effect; polyurethane foam for exudate | ||
| absorption and wound care | Same | |
| Design/ | ||
| Material | Polyurethane foam and silver | Same |
| Antibacterial | ||
| Duration | 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 and
Sensitization | No Effect
(ISO 10993-10) | Biocompatible |
| Systematic Toxicity | No Effect (ISO
10993-11) | |
| Antibacterial Activity | Broad spectrum
protection | Broad spectrum
protection |
| 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.