(250 days)
Not Found
No
The device description and performance studies focus on the material properties and antibacterial activity of the wound dressing, with no mention of AI or ML.
Yes
The device is a wound dressing designed to promote healing and inhibit bacterial growth in wounds, which directly supports a therapeutic outcome.
No
The device is a wound dressing that absorbs exudate and releases silver to inhibit bacterial growth and promote healing; it does not diagnose a condition.
No
The device description clearly states it is a sterile, single-use dressing composed of physical materials (calcium alginate and silver antibacterial agent), indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the management of wounds by absorbing exudate and releasing silver for antibacterial activity. This is a therapeutic function applied directly to the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical composition and mechanism of action of a wound dressing. It describes how it interacts with the wound environment, not how it analyzes biological samples to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are used to examine specimens from the human body to provide information for diagnostic purposes. This device is a wound dressing used for treatment and management of wounds.
N/A
Intended Use / Indications for Use
Prescription: Luofucon Extra Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC: Luofucon Antibacterial Alginate Wound Dressing is first aid to help in minor cuts, lacerations, scrapes, minor scalds and burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent, which absorbs wound exudate and release silver ions in the presence of wound fluid in the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The alginate material contains silver which inhibits bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). And the silver protects the dressing from a broad spectrum of bacteria up to seven days.
All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites, minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns)
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)
The following performance tests were conducted on LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) in comparison to the predicate:
- Free Swell Absorption Capacity
- Loss on Drying
- pH Value
- Silver content
- Antibacterial Activity
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) raised no new safety concerns for biocompatibility. Assessment was carried out on the final device as per ISO 10993-1:2009 for a surface device; contacting breached or compromised skin for prolonged duration. The device has been demonstrated to safe for its intended use.
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) was evaluated for:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Implantation
- Material-mediated pyrogenicity
Modified AATCC 100-2012 was used to evaluate the antibacterial activity of the subject device. The predicate device also chooses the AATCC 100 as the test method. The subject device achieves antibacterial duration for seven days while the predicate device achieves one day.
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The test results had shown that the silver does not cause cytotoxicity in the healing period or delay normal wound healing.
Therefore, the performance results are comparable to the predicate device when the dressings are used for antibacterial purpose for seven days. The product is safe and effective for its intended use.
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2018
Huizhou Foryou Medical Devices Co., Ltd. Huida Huang Development Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, 516005 Cn
Re: K172554
Trade/Device Name: Luofucon Extra Silver Alginate Dressing (Rx Only), Luofucon Antibacterial Alginate Wound Dressing (OTC) Regulatory Class: Unclassified
Product Code: FRO Dated: March 29, 2018 Received: March 29, 2018
Dear Huida Huang:
We have reviewed vour 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K172554
Device Name
Luofucon Extra Silver Alginate Dressing (Rx Only) Luofucon Antibacterial Alginate Wound Dressing (OTC)
Indications for Use (Describe)
Prescription:
Luofucon Extra Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC:
Luofucon Antibacterial Alginate Wound Dressing is first aid to help in minor cuts, lacerations, scrapes, minor scalds and 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)
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3
510(k) Summary or 510(k) Statement Section 5
This 510(k) Summary information is being submitted in accordance with the requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K172554
1. Date of Submission:
April 25, 2018
2. Submitter Identification:
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China. Establishment Registration Number: 3007735241 Contact Person: Huida Huang Position: Development Engineer Tel: +86-0752-5302185 Fax: +86-0752-5302020 Email: hdhuang@foryougroup.com
3. Subject Device Identification:
Device Name: LUOFUCON® Extra Silver Alginate Dressing (Prescription use) LUOFUCON® Antibacterial Alginate Wound Dressing (OTC use) Common Name: Silver Alginate Dressing Classification Name: Dressing, Wound, Drug; Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery;
4. Predicate Device Identification:
510(k) Number: K120181 Product Name: LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dressing (OTC Use) Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.
5. Device Description:
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent, which absorbs wound exudate and release silver
4
ions in the presence of wound fluid in the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The alginate material contains silver which inhibits bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). And the silver protects the dressing from a broad spectrum of bacteria up to seven days.
All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
6. Intended Use Statement:
Prescription:
LUOFUCON® Extra Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.
OTC:
LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.
7. Comparison to the Predicate Device
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.
K120181, LUOFUCON® Silver Alginate Dressing (Prescription Use)/ ● LUOFUCON® Antibacterial Alginate Dressing (OTC Use), Manufactured by Huizhou Foryou Medical Devices Co., Ltd.
The following table shows similarities and differences of use, design, material, and processing methods between subject device and its predicate device.
5
| Item | Subject Device (K172554) | Predicate Device (K120181) |
|---|---|---|
| Intended Use | Prescription: | |
| LUOFUCON® Extra Silver Alginate | ||
| Dressing (Rx only) is indicated for the | ||
| management of moderate to heavily | ||
| exuding partial to full thickness | ||
| wounds, including, postoperative | ||
| wounds, trauma wounds, leg ulcers, | ||
| pressure ulcers, diabetic ulcers, graft | ||
| and donor sites. | ||
| OTC: | ||
| LUOFUCON® Antibacterial Alginate | ||
| Wound Dressing (OTC) is first aid to | ||
| help in minor abrasions, minor cuts, | ||
| lacerations, scrapes, minor scalds and | ||
| burns. | Prescription: | |
| LUOFUCON® Silver Alginate | ||
| Dressing is indicated for the | ||
| management of moderate to heavily | ||
| exuding partial to full thickness | ||
| wounds, including, postoperative | ||
| wounds, trauma wounds, leg ulcers, | ||
| pressure ulcers, diabetic ulcers, graft | ||
| and donor sites. | ||
| OTC: | ||
| LUOFUCON® Antibacterial Alginate | ||
| Dressing is first aid to help in minor | ||
| abrasions, minor cuts, lacerations, | ||
| scrapes, minor scalds and burns. | ||
| Mechanism | Alginate for absorbing liquid, silver | |
| present in the alginate for reducing | ||
| bacteria colonization in the dressing. | Alginate for absorbing liquid, silver | |
| present in the alginate for reducing | ||
| bacteria colonization in the dressing. | ||
| Material | Alginate and silver | Alginate and silver |
| Antibacterial | ||
| Duration | Seven days | One day |
| Single Use | Yes | Yes |
| Sterilization | Radiation | Radiation |
Table 5-1 Comparison of Intended Use, Design and Material
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) and its predicate device (K120181) utilize silver as the antibacterial agent and utilize alginate pad for the exudates absorption and wound So, LUOFUCON® Extra management. Silver Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) and its predicate device are made from similar materials, utilize the same antibacterial mechanism, and have the same intended use.
All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
The following performance tests were conducted on LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) in comparison to the predicate:
- Free Swell Absorption Capacity ●
6
- Loss on Drying ●
- pH Value
- Silver content
- Antibacterial Activity
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) raised no new safety concerns for biocompatibility. Assessment was carried out on the final device as per ISO 10993-1:2009 for a surface device; contacting breached or compromised skin for prolonged duration. The device has been demonstrated to safe for its intended use.
LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) was evaluated for:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Implantation
- Material-mediated pyrogenicity
Modified AATCC 100-2012 was used to evaluate the antibacterial activity of the subject device. The predicate device also chooses the AATCC 100 as the test method. The subject device achieves antibacterial duration for seven days while the predicate device achieves one day.
A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The test results had shown that the silver does not cause cytotoxicity in the healing period or delay normal wound healing.
Therefore, the performance results are comparable to the predicate device when the dressings are used for antibacterial purpose for seven days. The product is safe and effective for its intended use.
Substantial Equivalent Statement
Based on the comparison of intended use, design, materials, performance, biocompatibility, and animal study, the subject device, LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC), is determined to be Substantially Equivalent (SE) to the predicate device, LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dressing (OTC Use) (K120181), in respect of safety and effectiveness.