(230 days)
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus is a soft, conformable, sterile dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and polyethylene terephthalate fibers, 1.1% (w/w) ionic silver, and stitched with lyocell fibers. This conformable dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
The silver ions help to inhibit microbial growth in the dressing for up to seven days. Additionally, based on in vitro testing, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus also provides a barrier against bacterial penetration.
The provided text describes a medical device called "LUOFUCON® Extra Silver Gelling Fiber Dressing Plus" and "LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus" and its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria and a study proving device performance as typically understood for AI/ML-based devices, which involves metrics like sensitivity, specificity, or AUC, and clinical study details.
Instead, this document focuses on demonstrating substantial equivalence for a wound dressing through comparative performance testing against a predicate device and safety assessments (biocompatibility, antimicrobial effectiveness, and animal testing).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets the acceptance criteria in the context of typical AI/ML device performance metrics. The information available details performance and safety comparisons to a predicate device and relevant standards.
However, I can extract the closest information available, reinterpreting "acceptance criteria" as performance specifications and "study" as the testing performed.
Closest interpretation of acceptance criteria and reported device performance from the provided text:
| Acceptance Criteria (Performance Specification from Predicate/Standards) | Reported Device Performance (Subject Device) |
|---|---|
| Material Used: Silver gelling fiber non-woven pad (CMC, Ag, HDPE, PET) | Silver gelling fiber non-woven pad (CMC, Ag, HDPE, PET), plus lines of stitching composed of lyocell fibers |
| Antimicrobial Duration: Seven days | Seven days |
| Single Use: Yes | Yes |
| Sterilization: Radiation | Radiation |
| Size: Max. 300mm×200mm, Min. 50mm×50mm | Max. 300mm×200mm, Min. 50mm×50mm |
| Free Swell Absorption Capacity: ≥15g/100cm² | ≥15g/100cm² |
| pH Value: 5.0-8.0 | 5.0-8.0 |
| Silver Value: 1.1% (w/w) | 1.1% (w/w) |
| Antimicrobial effectiveness within the dressing: 4 Log Reduction within the dressing for six organisms up to 7 days (MRSA/ VRE/ Streptococcus pyogenes/ Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) | 4 Log Reduction within the dressing for eight organisms up to 7 days (MRSA/ VRE/ Streptococcus pyogenes/ Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia/ Candida albicans/ Aspergillus brasiliensis) |
Information not available or not applicable in this context:
- Sample size used for the test set and the data provenance: Not applicable in the context of device performance metrics for diagnostic or AI/ML devices. The "test set" here refers to the physical units of the wound dressing that underwent various laboratory and animal tests. No specific sample sizes are given for each individual performance test (e.g., how many dressings were tested for absorption capacity). The provenance of the testing is "Huizhou Foryou Medical Devices Co., Ltd." in China.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound dressing would typically involve laboratory measurements, histological analysis, or clinical observation in animal models, not expert consensus on diagnostic interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is a wound dressing, not an AI diagnostic/assistance device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For performance tests, the "ground truth" would be the standard measurement methods and criteria (e.g., EN 13726-1 for absorption, AATCC TM100 for antimicrobial effectiveness). For the animal study, it would be direct observation of "wound healing performance characteristic and histopathology."
- The sample size for the training set: Not applicable, this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 7, 2024
Huizhou Foryou Medical Devices Co., Ltd. Li Jiaqi R&D Engineer North Shangxia Rd. Dongjiang Hi-Tech Industry Park Huizhou, Guangdong 516005 China
Re: K240485
Trade/Device Name: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use), LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) Regulatory Class: Unclassified Product Code: FRO Dated: January 31, 2024 Received: February 20, 2024
Dear Li Jiaqi:
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"
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(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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For comprehensive regulatory information about medical devices and radiation-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,
Mustafa A. Mazher - S
For Yu-Chieh Chiu, PhD Assistant Director DHT4B: Division of 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
Enclosure
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Indications for Use
510(k) Number (if known) K240485
Device Name
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus
Indications for Use (Describe)
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
OTC:
LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for: Minor abrasions; Minor lacerations; Minor cuts; 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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1. Submitter
Huizhou Foryou Medical Devices Co., Ltd.
Address: North Shangxia Rd, Dongjiang Hi-tech Industrial Park, 516005, Huizhou,
PEOPLE'S REPUBLIC OF CHINA.
Phone: +86-0752-5302185
Contact Person: Jiaqi Li
Date Prepared: Oct 5, 2024
2. Subject Device
Trade Name: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use); LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) Common Name: Silver Gelling Fiber Dressing Classification Name: Dressing, Wound, Drug Requlatory Class: Unclassified Product Code: FRO Review Panel: General & Plastic Surgery
3. Predicate Device
510(k) Number: K210718
Product Name: LUOFUCON® Extra Silver Gelling Fiber Dressing / LUOFUCON® Silver Antibacterial Gelling Fiber Dressing
Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.
4. Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus is a soft, conformable, sterile dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and polyethylene terephthalate fibers, 1.1% (w/w) ionic silver, and stitched with lyocell fibers. This conformable dressing absorbs wound fluid and creates a soft gel,
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provides an ideal moist wound healing environment.
The silver ions help to inhibit microbial growth in the dressing for up to seven days. Additionally, based on in vitro testing, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus also provides a barrier against bacterial penetration.
5. Indications for Use
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including:
Partial thickness burns (second degree);
Diabetic foot ulcers;
Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology);
Pressure ulcers (partial and full thickness);
Donor sites;
Surgical wounds;
Traumatic wounds.
ОТС:
LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
6. Summary of Substantial Equivalence
| Items | Subject Device | Primary Predicate Device(K210718) |
|---|---|---|
| Intended Use | Prescription: | Prescription: |
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K240485
| Page | 3 | of | 6 |
|---|---|---|---|
| ------ | --- | ---- | --- |
| Under the supervision of ahealthcare professional:LUOFUCON® Extra Silver GellingFiber Dressing Plus may be usedfor the management of moderateto heavily exuding chronic andacute wounds as an effectivebarrier to bacterial penetration ofthe dressing, including:- Partial thickness burns (seconddegree);- Diabetic foot ulcers;- Leg ulcers (venous stasis ulcers,arterial ulcers and leg ulcers ofmixed etiology);- Pressure ulcers (partial and fullthickness);- Donor sites;- Surgical wounds;- Traumatic wounds.OTC:LUOFUCON® Silver AntimicrobialGelling Fiber Dressing Plus may beused for:- Minor abrasions;- Minor lacerations;- Minor cuts;- Minor scalds and burns. | Under the supervision of ahealthcare professional:LUOFUCON® Extra Silver GellingFiber Dressing may be used for themanagement of moderate toheavily exuding chronic and acutewounds as an effective barrier tobacterial penetration of thedressing, including:- Partial thickness burns (seconddegree);- Diabetic foot ulcers;- Leg ulcers (venous stasis ulcers,arterial ulcers and leg ulcers ofmixed etiology);- Pressure ulcers (partial and fullthickness);- Donor sites;- Surgical wounds;- Traumatic wounds.OTC:LUOFUCON® Silver AntibacterialGelling Fiber Dressing may be usedfor:- Minor abrasions;- Minor lacerations;- Minor cuts;- Minor scalds and burns. | |
|---|---|---|
| Prescription/OTC | Prescription and OTC | Prescription and OTC |
| Mechanism | The dressing absorbs wound fluidand creates a soft gel, whichprovides an ideal moist woundhealing environment. Based on invitro testing, the silver in thedressing inhibits microbial growthin the dressing and provides abarrier against bacterial | The dressing absorbs wound fluidand creates a soft gel, whichprovides an ideal moist woundhealing environment. Based on invitro testing, the silver in thedressing inhibits bacterial growth inthe dressing and provides a barrieragainst bacterial penetration |
| Page 4 of | ||
| penetration through the dressing for up to seven days. | through the dressing for up to seven days. | |
| Device Design | Silver gelling fiber non-woven pad with lines of stitching | Silver gelling fiber non-woven pad |
| Material Used | Silver gelling fiber non-woven pad is composed of carboxymethyl cellulose fiber, ionic silver and enhance fiber (High-density polyethylene and Polyethylene terephthalate).Lines of stitching are composed of lyocell fibers. | Silver gelling fiber non-woven pad is composed of carboxymethyl cellulose fiber, ionic silver and enhance fiber (High-density polyethylene and Polyethylene terephthalate). |
| Antimicrobial Duration | Seven days | Seven days |
| Single Use | Yes | Yes |
| Sterilization | Radiation | Radiation |
| Size | Max. 300mm×200mmMin. 50mm×50mm | Max. 300mm×200mmMin. 50mm×50mm |
| Free Swell Absorption Capacity | ≥15g/100cm² | ≥15g/100cm² |
| pH Value | 5.0-8.0 | 5.0-8.0 |
| Silver Value | 1.1% (w/w) | 1.1% (w/w) |
| Antimicrobial effectiveness within the dressing | 4 Log Reduction within the dressing for eight organisms up to 7 days (MRSA/ VRE/ Streptococcus pyogenes/ Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia/ Candida albicans/ Aspergillus brasiliensis) | 4 Log Reduction within the dressing for six organisms up to 7 days (MRSA/ VRE/ Streptococcus pyogenes/ Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia) |
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K240485
The subject device is the same as the predicate device except for the addition of sutures to the material used and the addition of test strains for antimicrobial effectiveness. The performance and biocompatibility testing have shown that these differences do not raise safety and effectiveness concern.
Summary of Performance Testing 1)
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Page 5 of 6
The following performance tests were conducted on subject device in comparison to the predicate device:
- Free Swell Absorption Capacity (EN 13726-1)
- Fluid Retention Rate ●
- Shrinkage ●
- Wet Tensile Strength
- Loss on Drying (USP <731>)
- pH Value (USP <791>)
- Silver Content
- Antimicrobial Effectiveness (AATCC TM100)
- Bacterial Barrier Effectiveness
- Bacterial Endotoxins (USP 85)
2) Summary of Biocompatibility Testing
The subject device raised no new safety concerns for biocompatibility. Based on "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 subject device was evaluated for:
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10) ●
- Irritation (ISO 10993-23) ●
- Acute systemic toxicity (ISO 10993-11) ●
- Subchronic systematic toxicity (ISO 10993-11)
- Implantation (ISO 10993-6) ●
- Pyrogenicity (USP <151>)
Summary of Animal Testing 3)
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A porcine full thickness dermal wound healing study was carried out to evaluate cytotoxicity and implantation of the subject device. The study demonstrated that there were no biologically relevant differences between subject device and predicate device (K210718) in terms of wound healing performance characteristic and histopathology after wound creation.
4) Summary of Antimicrobial Testing
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus has been shown to be effective against a variety of microorganisms, including Gram-positive and Gram-negative bacteria, yeast and mold (tested against VRE (ATCC 51299), MRSA (ATCC 43300), S. Pyogenes (ATCC 19615), P. Aeruginosa (ATCC 9027), E. Coli (ATCC 8739), Klebiella pneumoniae (ATCC 4352), C. albicans (ATCC 10231), and A. brasiliensis (ATCC 16404).
The silver ions help to inhibit microbial growth in the dressing for up to seven days. Additionally, based on in vitro testing, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus also provides a barrier against bacterial penetration.
7. Conclusions
Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Extra Silver Gelling Fiber Dressing Plus/ LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus, is determined to be Substantially Equivalent (SE) to the predicate devices, LUOFUCON® Extra Silver Gelling Fiber Dressing / LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (K210718) in respect of safety and effectiveness.
N/A