LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing

K172554 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · May 1, 2018 · SU

Device Facts

• Record ID: K172554
• Device Name: LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
• Applicant: Huizhou Foryou Medical Devices Co., Ltd.
• Product Code: FRO · SU
• Decision Date: May 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Prescription: LUOFUCON® Extra Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites. OTC: LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Device Story

Sterile, single-use wound dressing composed of calcium alginate and silver antibacterial agent; absorbs wound exudate to form gel, maintaining moist healing environment; releases silver ions to inhibit bacterial growth within dressing for up to seven days. Used in clinical or home settings; applied by clinicians or patients. Protects against broad spectrum of Gram-positive and Gram-negative bacteria. Facilitates intact removal of dressing. Benefits include infection control and optimal wound healing environment.

Clinical Evidence

Bench testing included free swell absorption, loss on drying, pH, silver content, and antibacterial activity (modified AATCC 100-2012). Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, irritation, systemic toxicity, implantation, and material-mediated pyrogenicity. Porcine wound healing study evaluated silver cytotoxicity; results showed no delay in normal wound healing.

Technological Characteristics

Materials: Calcium alginate and silver antibacterial agent. Form factor: Alginate pad. Sterilization: Radiation (ISO 11137-2:2013). Antibacterial duration: 7 days.

Indications for Use

Indicated for management of moderate to heavily exuding partial to full thickness wounds (postoperative, trauma, leg/pressure/diabetic ulcers, graft/donor sites) for prescription use; and first aid for minor abrasions, cuts, lacerations, scrapes, scalds, and burns for OTC use.

Predicate Devices

• LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dressing (OTC Use) (K120181)

Submission Summary (Full Text)

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May 1, 2018

Huizhou Foryou Medical Devices Co., Ltd. Huida Huang Development Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou, 516005 Cn

Re: K172554

Trade/Device Name: Luofucon Extra Silver Alginate Dressing (Rx Only), Luofucon Antibacterial Alginate Wound Dressing (OTC) Regulatory Class: Unclassified

Product Code: FRO Dated: March 29, 2018 Received: March 29, 2018

Dear Huida Huang:

We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172554

#### Device Name

Luofucon Extra Silver Alginate Dressing (Rx Only) Luofucon Antibacterial Alginate Wound Dressing (OTC)

# Indications for Use (Describe)

Prescription:

Luofucon Extra Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including: postoperative wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

#### OTC:

Luofucon Antibacterial Alginate Wound Dressing is first aid to help in minor cuts, lacerations, scrapes, 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 or 510(k) Statement Section 5

This 510(k) Summary information is being submitted in accordance with the requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172554

#### 1. Date of Submission:

April 25, 2018

#### 2. Submitter Identification:

Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd., Dongjiang Hi-tech Industry Park, 516005, Huizhou, P. R. China. Establishment Registration Number: 3007735241 Contact Person: Huida Huang Position: Development Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

### 3. Subject Device Identification:

Device Name: LUOFUCON® Extra Silver Alginate Dressing (Prescription use) LUOFUCON® Antibacterial Alginate Wound Dressing (OTC use) Common Name: Silver Alginate Dressing Classification Name: Dressing, Wound, Drug; Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery;

# 4. Predicate Device Identification:

510(k) Number: K120181 Product Name: LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dressing (OTC Use) Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

# 5. Device Description:

LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is a sterile, single-use dressing composed of calcium alginate and silver antibacterial agent, which absorbs wound exudate and release silver

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ions in the presence of wound fluid in the dressing. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The alginate material contains silver which inhibits bacterial growth within the dressing. Based on in vitro laboratory testing, the silver has been shown to protect the dressing against both Gram positive and Gram negative bacteria, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant Enterococcus (VRE). And the silver protects the dressing from a broad spectrum of bacteria up to seven days.

All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

# 6. Intended Use Statement:

#### Prescription:

LUOFUCON® Extra Silver Alginate Dressing (Rx only) is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

#### OTC:

LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is first aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

### 7. Comparison to the Predicate Device

LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.

K120181, LUOFUCON® Silver Alginate Dressing (Prescription Use)/ ● LUOFUCON® Antibacterial Alginate Dressing (OTC Use), Manufactured by Huizhou Foryou Medical Devices Co., Ltd.

The following table shows similarities and differences of use, design, material, and processing methods between subject device and its predicate device.

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| Item | Subject Device (K172554) | Predicate Device (K120181) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prescription:<br>LUOFUCON® Extra Silver Alginate<br>Dressing (Rx only) is indicated for the<br>management of moderate to heavily<br>exuding partial to full thickness<br>wounds, including, postoperative<br>wounds, trauma wounds, leg ulcers,<br>pressure ulcers, diabetic ulcers, graft<br>and donor sites.<br>OTC:<br>LUOFUCON® Antibacterial Alginate<br>Wound Dressing (OTC) is first aid to<br>help in minor abrasions, minor cuts,<br>lacerations, scrapes, minor scalds and<br>burns. | Prescription:<br>LUOFUCON® Silver Alginate<br>Dressing is indicated for the<br>management of moderate to heavily<br>exuding partial to full thickness<br>wounds, including, postoperative<br>wounds, trauma wounds, leg ulcers,<br>pressure ulcers, diabetic ulcers, graft<br>and donor sites.<br>OTC:<br>LUOFUCON® Antibacterial Alginate<br>Dressing is first aid to help in minor<br>abrasions, minor cuts, lacerations,<br>scrapes, minor scalds and burns. |
| Mechanism | Alginate for absorbing liquid, silver<br>present in the alginate for reducing<br>bacteria colonization in the dressing. | Alginate for absorbing liquid, silver<br>present in the alginate for reducing<br>bacteria colonization in the dressing. |
| Material | Alginate and silver | Alginate and silver |
| Antibacterial<br>Duration | Seven days | One day |
| Single Use | Yes | Yes |
| Sterilization | Radiation | Radiation |

Table 5-1 Comparison of Intended Use, Design and Material

LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) and its predicate device (K120181) utilize silver as the antibacterial agent and utilize alginate pad for the exudates absorption and wound So, LUOFUCON® Extra management. Silver Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) and its predicate device are made from similar materials, utilize the same antibacterial mechanism, and have the same intended use.

All dressings are sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

The following performance tests were conducted on LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) in comparison to the predicate:

- Free Swell Absorption Capacity ●

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- Loss on Drying ●
- pH Value
- Silver content
- Antibacterial Activity

LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) raised no new safety concerns for biocompatibility. Assessment was carried out on the final device as per ISO 10993-1:2009 for a surface device; contacting breached or compromised skin for prolonged duration. The device has been demonstrated to safe for its intended use.

LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC) was evaluated for:

- Cytotoxicity
- Sensitization
- Irritation
- Systemic toxicity
- Implantation
- Material-mediated pyrogenicity

Modified AATCC 100-2012 was used to evaluate the antibacterial activity of the subject device. The predicate device also chooses the AATCC 100 as the test method. The subject device achieves antibacterial duration for seven days while the predicate device achieves one day.

A porcine wound healing study was carried out to evaluate the silver cytotoxicity of subject device. The test results had shown that the silver does not cause cytotoxicity in the healing period or delay normal wound healing.

Therefore, the performance results are comparable to the predicate device when the dressings are used for antibacterial purpose for seven days. The product is safe and effective for its intended use.

#### Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, performance, biocompatibility, and animal study, the subject device, LUOFUCON® Extra Silver Alginate Dressing (Rx only)/LUOFUCON® Antibacterial Alginate Wound Dressing (OTC), is determined to be Substantially Equivalent (SE) to the predicate device, LUOFUCON® Silver Alginate Dressing (Prescription Use)/ LUOFUCON® Antibacterial Alginate Dressing (OTC Use) (K120181), in respect of safety and effectiveness.