(629 days)
Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing.
OTC use:
LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for: Minor abrasions: Minor lacerations; Minor cuts; Minor scalds and burns.
LUOFUCON® Silver Gelling Fiber Surgical Dressing is a sterile post-operative dressing, comprising of polyurethane film, super absorbent fiber non-woven pad, silver gelling fiber non-woven pad (wound contact) containing 1.1% (w/w) ionic silver, and silicone qel. A windowed self-adhesive silicone skin contact layer plays a role of minimizing the trauma on removal, and alleviating the leakage of exudate.
The compliance and the softness of the dressing are improved effectively by using the notched non-woven pad, thus it is easier to apply on the wounds/parts which are difficult to paste. The highly absorbent dressing has a strong exudate management. When absorbing the wound fluid, the dressing will form a soft gel to support a moist wound healing environment. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
Based on in vitro performance data, the LUOFUCON® Silver Gelling Fiber Surgical Dressing is waterproofness and breathable. The polyurethane film of dressing provides a microbial barrier to prevent the microbial penetrating through it, and the silver component prevents the growth of the bacteria within the dressing up to 7 days.
I am sorry, but the provided text describes a medical device (surgical dressing) that is not an AI/ML powered device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study details for an AI-powered device. The text does not contain information on AI/ML models, test sets, ground truth establishment, or human-in-the-loop performance.
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Huizhou Foryou Medical Devices Co., Ltd. Jie Dong R&D Engineer North Shangxia Rd, Dongjiang Hi-tech Industrial Park Huizhou, Guangdong 516005 China
Re: K221110
Trade/Device Name: LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing
Regulatory Class: Unclassified Product Code: FRO Dated: November 8, 2023 Received: December 5, 2023
Dear Jie Dong:
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" (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).
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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 QS 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.
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.
For comprehensive regulatory information about mediation-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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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
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Indications for Use
510(k) Number (if known) K221110
Device Name
LUOFUCON® Silver Gelling Fiber Surgical Dressing (Prescription use) LUOFUCON® Antibacterial Gelling Fiber Cover Dressing (OTC use)
Indications for Use (Describe)
Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the management of surgical wounds as an effective barrier to microbial penetration of the dressing.
OTC use:
LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for: Minor abrasions: Minor lacerations; Minor cuts; Minor scalds and burns.
Type of Use (Select one or both, as applicable)
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: Jie Dong
Date Prepared: December 21th, 2023
2. Subject Device
Trade Name: LUOFUCON® Silver Gelling Fiber Surgical Dressing (Prescription use); LUOFUCON® Antibacterial Gelling Fiber Cover Dressing (OTC use) Common Name: Dressing, Wound, Drug Regulatory 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. Reference Device
510(k) Number: K091034
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Product Name: Aquacel™ Ag Surgical Manufacturer: Convatec Inc.
5. Device Description
LUOFUCON® Silver Gelling Fiber Surgical Dressing is a sterile post-operative dressing, comprising of polyurethane film, super absorbent fiber non-woven pad, silver gelling fiber non-woven pad (wound contact) containing 1.1% (w/w) ionic silver, and silicone qel. A windowed self-adhesive silicone skin contact layer plays a role of minimizing the trauma on removal, and alleviating the leakage of exudate.
The compliance and the softness of the dressing are improved effectively by using the notched non-woven pad, thus it is easier to apply on the wounds/parts which are difficult to paste. The highly absorbent dressing has a strong exudate management. When absorbing the wound fluid, the dressing will form a soft gel to support a moist wound healing environment. The non-woven pad gelling properties allow intact removal without damage to the closure system e.g. sutures.
Based on in vitro performance data, the LUOFUCON® Silver Gelling Fiber Surgical Dressing is waterproofness and breathable. The polyurethane film of dressing provides a microbial barrier to prevent the microbial penetrating through it, and the silver component prevents the growth of the bacteria within the dressing up to 7 days.
6. Indications for Use
Prescription use:
Under the supervision of a healthcare professional:
LUOFUCON® Silver Gelling Fiber Surgical Dressing may be used for the
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management of surgical wounds as an effective barrier to microbial penetration of the dressing.
OTC use:
LUOFUCON® Antibacterial Gelling Fiber Cover Dressing may be used for:
Minor abrasions;
Minor lacerations;
Minor cuts;
Minor scalds and burns.
7. Summary of the conventional information
| Items | Subject Device | Predicate Device(K210718) | Reference Device(K091034) | polyethylene andPolyethyleneterephthalate) | |||
|---|---|---|---|---|---|---|---|
| Intended Use | Prescription use:Under the supervision of ahealthcare professional:LUOFUCON® Silver GellingFiber Surgical Dressingmay be used for themanagement of surgicalwounds as an effectivebarrier to microbialpenetration of thedressing. | 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; Legulcers (venous stasisulcers, arterial ulcers andleg ulcers of mixedetiology); Pressure ulcers(partial and full | Under the supervisionof a healthcareprofessional:Aquacel™ Ag Surgicalcover dressing may beused for themanagement of:Wounds healing byprimary intent (e.g.traumatic and electivepost-operativewounds/incisions) andas an effective barrierto bacterial penetrationto help reduceinfection. | AntibacterialDuration | Seven days | Seven days | Seven days |
| AntibacterialActivity | Broad spectrum | Broad spectrum | Broad spectrum | ||||
| thickness); Donor sites;Surgical wounds;Traumatic wounds. | Single Use | Yes | Yes | Yes | |||
| OTC use:LUOFUCON® AntibacterialGelling Fiber CoverDressing may be used for:Minor abrasions;Minor lacerations;Minor cuts;Minor scalds and burns. | OTC:LUOFUCON® SilverAntibacterial GellingFiber Dressing may beused for:Minor abrasions;Minor lacerations;Minor cuts;Minor scalds and burns. | Sterilization | Ethylene oxide | Radiation | Radiation | ||
| Prescription/OTC | Prescription/OTC | Prescription/OTC | Prescription | ||||
| Mechanism | Silver gelling fiber forexudate absorption andwound care, silver ion inthe non-woven pad forantibacterial effect;absorbent fiber forexudate absorption;Polyurethane film providedwaterproofness andbreathable function, as aneffective barrier tomicrobial penetration ofthe dressing;Silicone gel holds thedressing tightly to thewound. | Silver gelling fiber forexudate absorption andwound care, silver ion inthe non-woven pad forantibacterial effect, as aneffective barrier tobacterial penetration ofthe dressing; | Silver gelling fiber forexudate absorption andwound care, silver ionin the non-woven padfor antibacterial effect;Polyurethane filmprovidedwaterproofness andbreathable function, asan effective barrier tobacterial penetration ofthe dressing;Hydrocolloid holds thedressing tightly to thewound. | ||||
| Design/Material | Dressing is comprised ofpolyurethane film, siliconegel, non-woven padconsist of super absorbentfibers, non-woven padconsist of carboxymethylcellulose fiber, ionic silverand enhancefiber(High-density | Non-woven dressing,consist of carboxymethylcellulose fiber, ionic silverand enhancefiber(High-densitypolyethylene andPolyethyleneterephthalate) | Dressing is comprisedof polyurethane film,hydrocolloid,non-woven padcomposed ofcarboxymethyl cellulosefibers, ionic silver,enhance fiber |
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The subject device used the predicate device(K210718) as the wound contact layer for exudate absorption and inhibition of bacterial growth within the dressing. The subject device has the similar intended use with the predicate device. The intended use, material, performance are similar to those of the predicate device and do not raise any new issues concerning safety or performance.
The reference device (K091034) is used for understanding the structure of subject device. Both subject device and reference device are comprised of barrier Layer, bonding layer, wound-contacting layer.
8. 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 10993-10)
- Systemic toxicity (ISO 10993-11)
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- Implantation (ISO 10993-6)
- Material-mediated pyrogenicity (USP <151>)
9. Summary of Performance Testing
The following performance tests were conducted on subject device in comparison to the predicate device:
- . Appearance
- Size
- Adhesive property (ASTM D6195-03) ●
- Fluid handling capacity (EN 13726-1) ●
- Waterproofness (EN 13726-3)
- Conformability (EN 13726-4)
- Silver content
- Antibacterial effectiveness
- Sterility (USP <71>)
10. Summary of Animal Testing
A porcine partial-thickness skin 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 (K210718) in terms of wound healing performance characteristics and histopathology after wound creation.
11. Conclusions
Based on the comparison of intended use, design, materials, and performance, the subject device, LUOFUCON® Silver Gelling Fiber Surgical Dressing/ LUOFUCON® Antibacterial Gelling Fiber Cover Dressing, is determined to be
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Substantially Equivalent (SE) to the predicate device, LUOFUCON® Extra Silver Gelling Fiber Dressing/ LUOFUCON® Silver Antibacterial Gelling Fiber Dressing (K210718) in respect of safety and performance.
N/A