LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

K223360 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · Mar 27, 2024 · SU

Device Facts

• Record ID: K223360
• Device Name: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
• Applicant: Huizhou Foryou Medical Devices Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Mar 27, 2024
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Prescription Use: LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions. OTC Use: LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Device Story

Sterile, single-use multi-layer wound dressing; contains ionic silver (max 0.40mg/cm²) in foam layer for antibacterial effectiveness up to 7 days. Models include Bordered, Bordered Lite, Non-Bordered, and Transfer. Components include polyurethane film (waterproof), silver-impregnated polyurethane foam, absorbent fiber pad, and perforated silicone wound contact layer to minimize removal trauma. Used in clinical or home settings for wound management; applied by clinicians or patients. Dressing absorbs exudate while silver provides antibacterial barrier. Non-Bordered and Transfer models are cut-to-size; Transfer model used with secondary absorbent dressing. Benefits include exudate control, antibacterial protection, and atraumatic removal.

Clinical Evidence

No clinical studies conducted. Evidence provided via bench testing (adhesion, absorbency, pH, MVTR, waterproofness, EO/ECH residuals, antibacterial effectiveness, sterility) and biocompatibility testing (cytotoxicity, implantation, intracutaneous reactivity, sensitization, systemic toxicity, pyrogenicity). Porcine wound healing study demonstrated no adverse effect on normal wound healing.

Technological Characteristics

Multi-layer dressing: PU film, silver-impregnated PU foam, absorbent fiber, non-woven fabric, perforated silicone contact layer, PE release film. Ionic silver content max 0.40mg/cm². Sterilization: EtO (SAL 10^-6). Standards: ASTM D6195-03 (adhesion), BS EN 13726-1/2/3 (absorbency, MVTR, waterproofness), ISO 10993 (biocompatibility).

Indications for Use

Indicated for exudate absorption and management of partial to full-thickness wounds (leg/foot ulcers, pressure ulcers, diabetic foot ulcers, 1st/2nd degree burns, donor sites, traumatic/surgical wounds, lacerations, abrasions) for prescription use; and first aid management of minor abrasions, cuts, lacerations, scrapes, scalds, and burns for OTC use.

Predicate Devices

• LUOFUCON® Silicone Ag Foam Dressing With Border (K170077)
• X AFD Dressings (K083133)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 27, 2024

Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan R&D Engineer North Shangxia Road Dongjiang Hi-Tech Industry Park Huizhou, Guangdong 516005 China

Re: K223360

Trade/Device Name: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 28, 2024 Received: February 28, 2024

Dear Guosheng Tan:

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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mustafa A. Mazher -S

for 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

Enclosure

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## Indications for Use

510(k) Number (if known) K223360

#### Device Name

LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

#### Indications for Use (Describe)

Prescription Use:

LUOFUCON® Silicone Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

OTC Use:

LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor 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

This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.

## I. SUBMITTER:

Huizhou Foryou Medical Devices Co., Ltd.

| Address: | North Shangxia Rd. Dongjiang Hi-tech Industry Park, 516005, | | |
|-----------------|-------------------------------------------------------------|--|--|
| | Huizhou, PEOPLE'S REPUBLIC OF CHINA | | |
| Phone: | [phone] | | |
| Contact Person: | Guosheng Tan | | |
| Date Prepared: | November 3, 2022 | | |

#### II. SUBJECT DEVICE

| Trade/Proprietary Names: | LUOFUCON® Silicone Ag+ Foam Dressing<br>(Prescription use)/ LUOFUCON® Silicone Ag+<br>Antibacterial Foam Dressing (OTC use) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Silicone Silver Foam Dressing |
| Classification Name: | Dressing, Wound, Drug |
| Regulatory Class: | Unclassified |
| Product Code: | FRO |

#### III.PREDICATE DEVICE:

Primary Predicated Device:

| 510(k) Number: | K170077 |
|----------------|-------------------------------------------------|
| Product Name: | LUOFUCON® Silicone Ag Foam Dressing With Border |
| Manufacturer: | Huizhou Foryou Medical Devices Co., Ltd. |

Secondary Predicated Device:

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510(k) Number: K083133

Andover Healthcare, Inc. X AFD Dressings Product Name:

Andover Healthcare, Inc. Manufacturer:

#### IV. DEVICE DESCRIPTION:

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is a sterile, single-use dressing. The device has a multi-layer structure, and its foam layer contains 0.40mg/cm² maximum content of ionic silver. According to the different compositions of product structure, the device provides four models: Bordered, Bordered Lite, Non-Bordered, and Transfer.

- (a). The first model, Bordered, consists of a Polyurethane (hereinafter referred to as PU) Film layer, a Super Absorbent Fibre Pad layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a Polyethylene (hereinafter referred to as PE) Release Film covered on the Perforated Silicone.
- (b). The second model, Bordered Lite, consists of a PU Film layer, a Non-woven layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (c). The third model, Non-Bordered, consists of a PU Film layer, a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.
- (d). The fourth model, Transfer, consists of a Silver PU Foam layer, a Perforated Silicone layer, and a PE Release Film covered on the Perforated Silicone.

The Non-Bordered model can be freely cut as needed. The Transfer model also can be freely cut and allow using together with a secondary absorbent dressing.

Silver in the dressing is intended to provide antibacterial effectiveness within the dressing for up to 7 days, as demonstrated via in vitro testing. The Bordered, Bordered Lite, and Non-Bordered model dressings are equipped with a PU film that offers waterproofing. The self-adhesive Perforated Silicone wound contact layer plays a role in minimizing the trauma on removal.

#### V. INDICATIONS FOR USE:

Prescription Use:

LUOFUCON® Silicone Aq+ Foam Dressing is indicated for exudate absorption and the management of partial to full-thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions.

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OTC Use:

LUOFUCON® Silicone Ag+ Antibacterial Foam Wound Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

### VI.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing Compared with the Predicate Devices in terms of technological characteristics. The following table shows their similarities and differences.

| Item | Subject Device | Primary Predicate Device<br>(K170077) | Secondary Predicate<br>Device (K083133) |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | Unclassified | Unclassified | Unclassified |
| Product Code | FRO | FRO | FRO |
| Intended Use | Prescription:<br>LUOFUCON® Silicone Ag+<br>Foam Dressing is indicated<br>for exudate absorption and<br>the management of partial to<br>full thickness wounds,<br>including leg and foot ulcers,<br>pressure ulcers, diabetic foot<br>ulcers, 1st and 2nd degree<br>burns, donor sites, traumatic<br>and surgical wounds,<br>lacerations and abrasions.<br>OTC:<br>LUOFUCON® Silicone Ag+<br>Antibacterial Foam Dressing<br>is indicated for first aid<br>management of minor<br>abrasions, minor cuts, minor<br>lacerations, minor scrapes,<br>minor scalds and minor<br>burns. | Prescription:<br>LUOFUCON® Silicone Ag<br>Foam Dressing with Border is<br>indicated for the<br>management of exuding<br>wounds, such as leg and foot<br>ulcers, pressure ulcers,<br>traumatic and surgical<br>wounds, superficial and<br>partial thickness burns. | Prescription:<br>CoFlex-X AFD® and the<br>CoFlex-X AFD® Pad contact<br>wound dressings are<br>indicated for use in light to<br>heavy exuding partial and full<br>thickness wounds, including<br>decubitus and diabetic ulcers,<br>1st and 2nd degree burns,<br>and donor sites. These<br>dressings may also be used<br>over debrided and partial<br>thickness wounds.<br>OTC:<br>PowerFlex NL-X AFD® and<br>CoFlex-X AFD® First Aid<br>contact wound dressings are<br>indicated for first aid<br>management of minor<br>abrasions, cuts, scrapes,<br>scalds and burns. |
| Prescription<br>/OTC | Prescription/OTC | Prescription | Prescription/OTC |
| Mechanism | Polyurethane foam and<br>absorbent fiber pad for<br>absorbing exudates; Silver<br>compounds | Polyurethane foam and<br>absorbent fiber pad for<br>absorbing liquid; Silver<br>compounds | Polyurethane foam for<br>exudate absorption and<br>wound care, metallic silver in<br>the foam for antibacterial |

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## K223360

| Item | Subject Device | Primary Predicate Device<br>(K170077) | Secondary Predicate<br>Device (K083133) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | present in the foam for<br>reducing bacteria<br>colonization in the<br>dressing; Silicone soft<br>contact layer for<br>self-adhesive; polyurethane<br>film offers waterproofing. | present in the foam for<br>reducing bacteria<br>colonization in the<br>dressing; Silicone soft<br>contact layer for<br>self-adhesive; Backing film<br>for waterproof. | effect; Polyurethane film<br>provided Waterproof. |
| Design<br>/Material | Polyurethane film,<br>polyurethane<br>foam containing silver,<br>absorbent fiber,<br>non- woven fabrics,<br>Silicone, Release film | Polyurethane film,<br>polyurethane<br>foam containing silver,<br>absorbent fiber,<br>non- woven fabrics,<br>Silicone, Release film | Polyurethane foam<br>containing metallic silver with<br>nylon fibre, Polyurethane<br>film, cohesive elastic<br>bandage |
| Antibacterial<br>Duration | 7 days | 7 days | N/A |
| Single Use | Yes | Yes | Yes |
| Sterilization | EtO<br>SAL:10-6 | EtO<br>SAL:10-6 | EtO |

#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

## Performance testing

Performance testing was conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The performance of the subject device was tested according to the following standards.

- Adhesive property: conducted with ASTM D6195-03 ●
- Water absorbency: conducted with BS EN 13726-1
- pH Value: conducted with USP <791> pH.
- MVTR: conducted with BS EN 13726-2
- Waterproofness: conducted with BS EN 13726-3
- EO and ECH residuals: conducted with ISO 10993-7
- Antibacterial effectiveness: in vitro simulated use testing. ●
- Sterility: conducted with ISO 11737-2:2019

## Biocompatibility testing

Based on FDA Guidance Document "Use of International Standard ISO 10993-1, Biological evaluation of medical devices-Part 1_Evaluation and testing within a risk

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## K223360

management process", and series of ISO 10993 standards, the subject is categorized as surface devices for breached or compromised surface with prolonged duration. The relevant standards for biocompatibility testing of subject device are listed below.

- Cytotoxicity ISO 10993-5:2009 ●
- Implantation - ISO 10993-6:2016
- Intracutaneous Reactivity - ISO 10993-10:2010
- Sensitization - ISO 10993-10:2010
- Systemic toxicity - ISO 10993-11:2017
- Material-mediated pyrogenicity - USP 41-N36<151>

#### Animal Study

A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study, LUOFUCON® Silicone Aq+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing did not affect normal wound healing.

#### Clinical Study

No clinical studies were conducted for the subject device.

#### CONCLUSIONS VIII.

Based on the comparison of intended use and technological characteristics with the predicate devices, the subject device, LUOFUCON® Silicone Ag+ Foam Dressing/LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, LUOFUCON® Silicone Ag Foam Dressing With Border(K170077) and X AFD Dressings (K083133), in respect of safety and effectiveness.