(378 days)
Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing 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 Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.
LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
The provided text describes the 510(k) submission for the LUOFUCON® Extra Silver Gelling Fiber Dressing and LUOFUCON® Silver Antibacterial Gelling Fiber Dressing. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, clinical study methodologies, sample sizes, expert involvement, and ground truth establishment are not explicitly provided in this type of regulatory document, which is primarily focused on a comparison to existing devices.
However, based on the information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document implicitly uses the performance of the predicate devices as a comparative benchmark. Explicit acceptance criteria in a quantitative sense are mentioned for some tests.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Free Swell Absorption Capacity | NA (Predicate K121275 does not explicitly list this, but the subject device states "≥15g/100cm²") | ≥15g/100cm² |
| pH Value | NA (Predicate K121275 does not explicitly list this, but the subject device states "5.0-8.0") | 5.0-8.0 |
| Silver Content | Predicate K121275: 1.2% (w/w) | 1.1% (w/w) |
| Antibacterial Effectiveness | Predicate K121275: 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/Streptococcus pyogenes/Escherichia coli/Pseudomonas aeruginosa/Klebsiella pneumonia) | 4 Log Reduction for six organisms up to 7 days (MRSA/VRE/Streptococcus pyogenes/Escherichia coli/Pseudomonas aeruginosa/Klebsiella pneumonia) |
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: Not specified for any of the performance tests.
- Data Provenance: The tests are described as "in vitro testing" and a "porcine full thickness dermal wound healing study." This indicates a mix of lab-based and animal model studies. The country of origin of the data is not specified, but the manufacturer is based in China. The studies are assumed to be prospective as they are conducted 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):
Not applicable. The document describes laboratory and animal studies, not human clinical trials that would typically involve expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study involving human readers or interpretation requiring adjudication.
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 for a wound dressing, not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is for a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the in vitro tests, the ground truth is established by the standardized methods themselves (e.g., AATCC TM100 for antibacterial effectiveness). For the porcine study, the ground truth would be based on direct observation of wound healing performance and histopathology, as assessed by the researchers conducting the study.
8. The sample size for the training set:
Not applicable. This is for a wound dressing, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is for a wound dressing, not a machine learning model.
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April 21, 2022
Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, Guangdong 516005 China
Re: K210718
Trade/Device Name: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO
Dear Junfeng Zhang:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter sent on March 23, 2022. Specifically, FDA is updating this SE Letter for an updated IFU form and no date on the SE Letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-472-6328, Julie.Morabito@fda.hhs.gov
Sincerely,
Julie A. Morabito - S
Julie Morabito Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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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Image /page/1/Picture/0 description: The image contains 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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and the word "ADMINISTRATION" in a smaller font below.
Huizhou Foryou Medical Devices Co., Ltd. Junfeng Zhang Development Engineer North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, Guangdong 516005 China
Re: K210718
Trade/Device Name: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2021 Received: December 17, 2021
Dear Junfeng Zhang:
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. 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 located 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.
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) for
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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic 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) K210718
Device Name
LUOFUCON® Extra Silver Gelling Fiber Dressing (Prescription use) LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (OTC use)
Indications for Use (Describe)
Prescription:
LUOFUCON® Extra Silver Gelling Fiber Dressing 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 Antibacterial Gelling Fiber Dressing 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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510(k) Summary
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: Junfeng Zhang
Date Prepared: March 22, 2022
2. Subject Device
Trade Name: LUOFUCON® Extra Silver Gelling Fiber Dressing (Prescription use) LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (OTC use) Common Name: Silver Gelling Fiber Dressing Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO Review Panel: General & Plastic Surgery
3. Predicate Device
510(k) Number: K121275
Product Name: Aquacel™ Ag Extra™ with Hydrofiber™ Dressing with Silver and Strengthening Fiber
Manufacturer: Convatec Inc.
510(k) Number: K183645
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Product Name: Silver High Performance Dressing Manufacturer: Advanced Medical Solutions Ltd.
4. Device Description
LUOFUCON® Extra Silver Gelling Fiber Dressing is a soft, conformable, non-woven pad or ribbon dressing composed of carboxymethyl cellulose fibers, high-density polyethylene and Polyethylene terephthalate fibers and 1.1% (w/w) ionic silver. Based on in vitro testing, the silver in the dressing inhibits bacterial growth in the dressing and provides a barrier against bacterial penetration through the dressing for up to seven days. This conformable and highly absorbent dressing absorbs wound fluid and creates a soft gel, provides an ideal moist wound healing environment.
These antibacterial claims are based on in vitro testing, no clinical studies have been conducted to support these claims.
5. Indications for Use
Prescription:
Under the supervision of a healthcare professional:
LUOFUCON® Extra Silver Gelling Fiber Dressing 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;
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Traumatic wounds.
ОТС:
LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
| Items | Subject Device | Primary Predicate Device(K121275) | Secondary Predicate Device(K183645) |
|---|---|---|---|
| Intended Use | Prescription:Under the supervision ofa healthcareprofessional:LUOFUCON® Extra SilverGelling Fiber Dressingmay be used for themanagement ofmoderate to heavilyexuding chronic andacute wounds as aneffective barrier tobacterial penetration ofthe dressing, including:Partial thickness burns(second degree);Diabetic foot ulcers;Leg ulcers (venous stasisulcers, arterial ulcers andleg ulcers of mixedetiology);Pressure ulcers (partialand full thickness);Donor sites;Surgical wounds;Traumatic wounds.OTC:LUOFUCON® SilverAntibacterial GellingFiber Dressing may beused for:Minor abrasions; | Prescription:Under the supervision of ahealthcare professional:Aquacel™ Ag Extra™ withHydrofiber™ Dressing withSilver and StrengtheningFiber may be used for themanagement of wounds asan effective barrier tobacterial penetration of thedressing as this may helpreduce infection; partialthickness (second degree)burns; diabetic foot ulcers,leg ulcers, (venous stasisulcers, arterial ulcers andleg ulcers of mixed etiology)and pressure ulcers/sores(partial & full thickness);surgical wounds left to healby secondary intention suchas dehisced surgicalincisions; surgical woundsthat heal by primary intentsuch as dermatological andsurgical incisions (e.g.orthopedic and vascular);traumatic wounds; woundsthat are prone to bleeding,such as wounds that havebeen mechanically orsurgically debrided and | Under the supervision of ahealthcare professional,Silver High PerformanceDressing can be used in themanagement of moderateto heavily exuding chronicand acute wounds. Thedressing is indicated for useon the following wounds:Pressure ulcers (partial andfull thickness);Leg ulcers (venous stasisulcers, arterial ulcers andleg ulcers of mixedetiology);Diabetic foot ulcers;Surgical wounds that healby primary intent such asdermatological and surgicalincisions;Surgical wounds left to healby secondary intention suchas dehisced surgicalincisions and donor sites;Traumatic wounds. |
| Minor lacerations;Minor cuts;Minor scalds and burns. | donor sites; oncologywounds with exudate, suchas fungoides-cutaneoustumors, fungatingcarcinoma, cutaneousmetastasis, Kaposi'ssarcoma, andangiosarcoma; painfulwounds and infected | ||
| wounds.OTC:Aquacel™ Ag Extra™ withHydrofiber™ Dressing withSilver and StrengtheningFiber may be used forabrasions, lacerations,minor cuts, minor scaldsand burns. | |||
| Prescription/OTC | Prescription and OTC | Prescription and OTC | Prescription |
| Mechanism | The dressing absorbswound fluid and createsa soft gel, whichprovides an ideal moistwound healingenvironment. Based onin vitro testing, the silverin the dressing inhibitsbacterial growth in thedressing and provides abarrier against bacterialpenetration through thedressing for up to sevendays. | The dressing absorbswound fluid and creates asoft gel, which provides anideal moist wound healingenvironment. The silver inthe dressing kills woundbacteria held in the dressingand provides a barrieragainst bacterialpenetration of the dressing. | The highly absorbentdressing absorbs exudatefrom the wound to form asoft gel that intimatelyconforms to the wound bedand aids in maintaining amoist wound environment.Silver High PerformanceDressing contains ionicsilver, and effectivelymanages and suppressescolonization andproliferation of bacteria andyeast within the dressing forup to 7 days. |
| Design/Material | Non-woven dressing,consist of carboxymethylcellulose fiber, ionicsilver and enhancefiber(High-densitypolyethylene andPolyethyleneterephthalate) | Non-woven dressing,consist of carboxymethylcellulose fiber, ionic silverand enhancefiber(regenerated cellulose) | Non-woven dressing,consist of carboxymethylcellulose fiber, alginatefiber, ionic silver andreinforcement layer (nylonfiber) |
| AntimicrobialDuration | Seven days | Seven days | Seven days |
| AntimicrobialActivity | Broad spectrum | Broad spectrum | Broad spectrum |
| Single Use | Yes | Yes | Yes |
| Sterilization | Radiation | Radiation | Radiation |
| Size | Max. 300mm×200mmMin. 50mm×50mm | Max. 300mm×200mmMin. 50mm×50mm | Ranging in area from 28cm2to 650cm2 |
6. Summary of Substantial Equivalence
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K210718
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| Free SwellAbsorptionCapacity | ≥15g/100cm² | NA | NA |
|---|---|---|---|
| pH Value | 5.0-8.0 | NA | NA |
| Silver Content | 1.1% (w/w) | 1.2% (w/w) | NA |
| AntibacterialEffectiveness | 4 Log Reduction for sixorganisms up to 7 days(MRSA/VRE/Streptococcus pyogenes/Escherichiacoli/ Pseudomonasaeruginosa/Klebsiellapneumonia) | 4 Log Reduction for sixorganisms up to 7 days(MRSA/VRE/Streptococcuspyogenes/Escherichia coli/Pseudomonas aeruginosa/Klebsiella pneumonia) | 4 Log Reduction for nineorganisms up to 7 days(MRSE/VRE/Streptococcusmutans/ Staphylococcusaureus/Enterobactercloacae/ Klebsiellapneumonia/ Serratiamarcescens/ Escherichiacoli/Candida albicans) |
The subject device and its predicate device (K121275) both utilize ionic silver as the antibacterial ingredient and utilize carboxymethyl cellulose fiber for the exudate absorption and wound management. The subject device has the similar intended use with the predicate device.
The secondary predicate device (K183645) is used for supporting the subject device's indications for use (Prescription use), and both subject device and secondary predicate device (K183645) use carboxymethyl cellulose fiber, ionic silver and enhance fiber for the antibacterial dressing.
Both subject device and predicate devices are sterilized by radiation.
The intended use, material, performance are similar to those of the predicate devices and do not raise any new issues concerning safety or effectiveness.
1) Summary of Performance Testing
The following performance tests were conducted on subject device in comparison to the predicate device:
- Free Swell Absorption Capacity (EN 13726-1)
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- Fluid Retention Rate O
- Shrinkage
- Wet Tensile Strength
- Loss on Drying (USP <731>) 0
- O pH Value (USP <791>)
- O Silver Content
- Antibacterial Effectiveness (AATCC TM100) ●
- Bacterial Barrier Effectiveness
Summary of Biocompatibility Testing 2)
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:
- 0 Cytotoxicity (ISO 10993-5)
- O Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)
- Systemic toxicity (ISO 10993-11) O
- Implantation (ISO 10993-6)
- 0 Material-mediated pyrogenicity (USP <151>)
Summary of Animal Testing 3)
A porcine full thickness dermal wound healing study was carried out to evaluate cytotoxicity of the subject device. The study demonstrated that there were no biologically relevant differences between subject device and predicate device (K121275) in terms of wound healing performance characteristics and
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histopathology after wound creation.
7. Conclusions
Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Extra Silver Gelling Fiber Dressing/ LUOFUCON® Silver Antibacterial Gelling Fiber Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, Aquacel™ Ag Extra™ with Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275) and Silver High Performance Dressing (K183645) in respect of safety and effectiveness.
N/A