LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing

K210718 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · Mar 23, 2022 · SU

Device Facts

• Record ID: K210718
• Device Name: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
• Applicant: Huizhou Foryou Medical Devices Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Mar 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended 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; Traumatic wounds. OTC: LUOFUCON® Silver Antibacterial Gelling Fiber Dressing may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.

Device Story

Soft, conformable, non-woven pad or ribbon dressing; composed of carboxymethyl cellulose fibers, high-density polyethylene, polyethylene terephthalate fibers, and 1.1% ionic silver. Absorbs wound fluid to form a soft gel; creates moist wound healing environment. Ionic silver inhibits bacterial growth within dressing and provides barrier against bacterial penetration for up to seven days. Used in clinical settings under healthcare professional supervision (prescription) or by patients for minor wounds (OTC). Output is physical wound management and antimicrobial barrier. Benefits include exudate management and infection barrier.

Clinical Evidence

Bench testing included free swell absorption capacity, fluid retention, shrinkage, wet tensile strength, pH, silver content, and antibacterial effectiveness (AATCC TM100). Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, implantation, pyrogenicity). Animal study: Porcine full-thickness dermal wound healing study compared subject device to K121275, showing no biologically relevant differences in wound healing or histopathology.

Technological Characteristics

Non-woven pad/ribbon; materials: carboxymethyl cellulose, ionic silver (1.1% w/w), high-density polyethylene, and polyethylene terephthalate fibers. Energy source: none. Sterilization: radiation. Connectivity: none. Form factor: 50mmx50mm to 300mmx200mm.

Indications for Use

Indicated for management of moderate to heavily exuding chronic and acute wounds (prescription) or minor abrasions, lacerations, cuts, scalds, and burns (OTC). Prescription population includes patients with partial thickness burns, diabetic foot ulcers, leg ulcers, pressure ulcers, donor sites, surgical wounds, and traumatic wounds.

Predicate Devices

• Aquacel™ Ag Extra™ with Hydrofiber™ Dressing with Silver and Strengthening Fiber (K121275)
• Silver High Performance Dressing (K183645)

Submission Summary (Full Text)

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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, [e-mail]

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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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 [phone] 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: [phone]

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<br>(K121275) | Secondary Predicate Device<br>(K183645) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prescription:<br>Under the supervision of<br>a healthcare<br>professional:<br>LUOFUCON® Extra Silver<br>Gelling Fiber Dressing<br>may be used for the<br>management of<br>moderate to heavily<br>exuding chronic and<br>acute wounds as an<br>effective barrier to<br>bacterial penetration of<br>the dressing, including:<br>Partial thickness burns<br>(second degree);<br>Diabetic foot ulcers;<br>Leg ulcers (venous stasis<br>ulcers, arterial ulcers and<br>leg ulcers of mixed<br>etiology);<br>Pressure ulcers (partial<br>and full thickness);<br>Donor sites;<br>Surgical wounds;<br>Traumatic wounds.<br>OTC:<br>LUOFUCON® Silver<br>Antibacterial Gelling<br>Fiber Dressing may be<br>used for:<br>Minor abrasions; | Prescription:<br>Under the supervision of a<br>healthcare professional:<br>Aquacel™ Ag Extra™ with<br>Hydrofiber™ Dressing with<br>Silver and Strengthening<br>Fiber may be used for the<br>management of wounds as<br>an effective barrier to<br>bacterial penetration of the<br>dressing as this may help<br>reduce infection; partial<br>thickness (second degree)<br>burns; diabetic foot ulcers,<br>leg ulcers, (venous stasis<br>ulcers, arterial ulcers and<br>leg ulcers of mixed etiology)<br>and pressure ulcers/sores<br>(partial & full thickness);<br>surgical wounds left to heal<br>by secondary intention such<br>as dehisced surgical<br>incisions; surgical wounds<br>that heal by primary intent<br>such as dermatological and<br>surgical incisions (e.g.<br>orthopedic and vascular);<br>traumatic wounds; wounds<br>that are prone to bleeding,<br>such as wounds that have<br>been mechanically or<br>surgically debrided and | Under the supervision of a<br>healthcare professional,<br>Silver High Performance<br>Dressing can be used in the<br>management of moderate<br>to heavily exuding chronic<br>and acute wounds. The<br>dressing is indicated for use<br>on the following wounds:<br>Pressure ulcers (partial and<br>full thickness);<br>Leg ulcers (venous stasis<br>ulcers, arterial ulcers and<br>leg ulcers of mixed<br>etiology);<br>Diabetic foot ulcers;<br>Surgical wounds that heal<br>by primary intent such as<br>dermatological and surgical<br>incisions;<br>Surgical wounds left to heal<br>by secondary intention such<br>as dehisced surgical<br>incisions and donor sites;<br>Traumatic wounds. |
| | Minor lacerations;<br>Minor cuts;<br>Minor scalds and burns. | donor sites; oncology<br>wounds with exudate, suchas fungoides-cutaneous<br>tumors, fungating<br>carcinoma, cutaneous<br>metastasis, Kaposi's<br>sarcoma, and<br>angiosarcoma; painful<br>wounds and infected | |
| | | wounds.<br>OTC:<br>Aquacel™ Ag Extra™ with<br>Hydrofiber™ Dressing with<br>Silver and Strengthening<br>Fiber may be used for<br>abrasions, lacerations,<br>minor cuts, minor scalds<br>and burns. | |
| Prescription/<br>OTC | Prescription and OTC | Prescription and OTC | Prescription |
| Mechanism | The dressing absorbs<br>wound fluid and creates<br>a soft gel, which<br>provides an ideal moist<br>wound healing<br>environment. Based on<br>in vitro testing, the silver<br>in the dressing inhibits<br>bacterial growth in the<br>dressing and provides a<br>barrier against bacterial<br>penetration through the<br>dressing for up to seven<br>days. | The dressing absorbs<br>wound fluid and creates a<br>soft gel, which provides an<br>ideal moist wound healing<br>environment. The silver in<br>the dressing kills wound<br>bacteria held in the dressing<br>and provides a barrier<br>against bacterial<br>penetration of the dressing. | The highly absorbent<br>dressing absorbs exudate<br>from the wound to form a<br>soft gel that intimately<br>conforms to the wound bed<br>and aids in maintaining a<br>moist wound environment.<br>Silver High Performance<br>Dressing contains ionic<br>silver, and effectively<br>manages and suppresses<br>colonization and<br>proliferation of bacteria and<br>yeast within the dressing for<br>up to 7 days. |
| Design/<br>Material | Non-woven dressing,<br>consist of carboxymethyl<br>cellulose fiber, ionic<br>silver and enhance<br>fiber(High-density<br>polyethylene and<br>Polyethylene<br>terephthalate) | Non-woven dressing,<br>consist of carboxymethyl<br>cellulose fiber, ionic silver<br>and enhance<br>fiber(regenerated cellulose) | Non-woven dressing,<br>consist of carboxymethyl<br>cellulose fiber, alginate<br>fiber, ionic silver and<br>reinforcement layer (nylon<br>fiber) |
| Antimicrobial<br>Duration | Seven days | Seven days | Seven days |
| Antimicrobial<br>Activity | Broad spectrum | Broad spectrum | Broad spectrum |
| Single Use | Yes | Yes | Yes |
| Sterilization | Radiation | Radiation | Radiation |
| Size | Max. 300mm×200mm<br>Min. 50mm×50mm | Max. 300mm×200mm<br>Min. 50mm×50mm | Ranging in area from 28cm2<br>to 650cm2 |

# 6. Summary of Substantial Equivalence

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# K210718

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K210718

| Free Swell<br>Absorption<br>Capacity | ≥15g/100cm² | NA | NA |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| pH Value | 5.0-8.0 | NA | NA |
| Silver Content | 1.1% (w/w) | 1.2% (w/w) | NA |
| Antibacterial<br>Effectiveness | 4 Log Reduction for six<br>organisms up to 7 days<br>(MRSA/VRE/Streptococc<br>us pyogenes/Escherichia<br>coli/ Pseudomonas<br>aeruginosa/Klebsiella<br>pneumonia) | 4 Log Reduction for six<br>organisms up to 7 days<br>(MRSA/VRE/Streptococcus<br>pyogenes/Escherichia coli/<br>Pseudomonas aeruginosa<br>/Klebsiella pneumonia) | 4 Log Reduction for nine<br>organisms up to 7 days<br>(MRSE/VRE/Streptococcus<br>mutans/ Staphylococcus<br>aureus/Enterobacter<br>cloacae/ Klebsiella<br>pneumonia/ Serratia<br>marcescens/ Escherichia<br>coli/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.