LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING

K140954 · Huizhou Foryou Medical Devices Co., Ltd. · FRO · Mar 23, 2015 · SU

Device Facts

• Record ID: K140954
• Device Name: LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
• Applicant: Huizhou Foryou Medical Devices Co., Ltd.
• Product Code: FRO · SU
• Decision Date: Mar 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, second-degree burns, donor sites, postoperative wounds and skin abrasions.

Device Story

Sterilized, single-use wound dressing; composed of soft, elastic polyurethane (PU) foam with antibacterial coating containing polyvinyl alcohol (PVA) and ionic silver particles. Silver acts as preservative within dressing. Device absorbs exudate and manages partial to full thickness wounds. Available in multiple sizes. Applied by healthcare providers to wound sites. Silver ions provide antibacterial efficacy against gram-positive and gram-negative bacteria for up to 7 days. Benefits include exudate management and bacterial reduction in wound environment.

Clinical Evidence

Bench testing only. Testing included in vitro cytotoxicity (ISO 10993-5), irritation and sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), and antibacterial preservative efficacy (demonstrating >4log reduction for 7 days against various gram-positive and gram-negative bacteria). Packaging integrity verified via seal strength (ASTM F88) and internal pressurization (ASTM F1140). Sterility validated to SAL 10^-6 per ISO 11137-2.

Technological Characteristics

Materials: Polyurethane foam, Polyvinyl Alcohol (PVA), silver sulfate, silver chloride. Ionic silver content: 10.4-12.0 mg/100cm² (3mm thickness) or 17.3-20.1 mg/100cm² (5mm thickness). Form factor: Foam dressing in various dimensions. Sterilization: Radiation (SAL 10^-6). Standards: ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 11137-2, ASTM F88/F88M-09, ASTM F1140-07, USP <85>.

Indications for Use

Indicated for exudate absorption and management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.

Predicate Devices

• Biatain Ag Foam Dressings (K100218)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 23, 2015

Huizhou Foryou Medical Devices Company, Ltd. % Ms. Diana Hong Mid-Link Consulting Company, Ltd. P.O. Box 120-119 200120 Shanghai China

Re: K140954

Trade/Device Name: LUOFUCON® Silver PU Antibacterial Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 9, 2015 Received: March 13, 2015

Dear Ms. Hong:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K140954

Device Name

LUOFUCON® Silver PU Antibacterial Foam Dressing

Indications for Use (Describe)

LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, second-degree burns, donor sites, postoperative wounds and skin abrasions.

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)

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## 510(k) Summary

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

The assigned 510(k) Number: K140954

- 1. Date of Submission: 03/18/2015
- 2. Sponsor 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: Wei Lu Position: Development Engineer Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. Proposed Device Identification
Proposed Device Name: LUOFUCON® Silver PU Antibacterial Foam Dressing Proposed Device Common Name: Silver Containing Wound Dressing

Regulatory Information: Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery;

Intended Use Statement:

LUOFUCON® Silver PU Antibacterial Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, diabetic foot ulcers, second-degree burns, donor sites, post-operative wounds and skin abrasions.

- న్. Predicate Device Identification
510(k) Number: K100218 Product Name: Biatain Ag Foam Dressings Manufacturer: Coloplast A/S

- 6. Device Description
The proposed device, LUOFUCON® Silver PU Antibacterial Foam Dressing, is a sterilized, single-use dressing composed of soft, elastic PU foam and antibacterial coating including PVA and ionic silver particles, indicated for exudate absorption and the management of partial to full thickness wounds. The proposed device includes multiple sizes, which are listed in the following Table 1.

| Table 1 Device Sizes List | | | |
|---------------------------|---------------------------|-----------------|---------------------------|
| Product Code | Size | Product Code | Size |
| SD050050AENG101 | $50\times50\times3$ mm | SD050050BENG101 | $50\times50\times5$ mm |
| SD100100AENG101 | $100\times100\times3$ mm | SD100100BENG101 | $100\times100\times5$ mm |
| SD120100AENG101 | $120\times100 \times3$ mm | SD120100BENG101 | $120\times100 \times5$ mm |
| SD120120AENG101 | $120\times120 \times3$ mm | SD120120BENG101 | $120\times120 \times5$ mm |
| SD150150AENG101 | $150\times150 \times3$ mm | SD150150BENG101 | $150\times150 \times5$ mm |
| SD200150AENG101 | $200\times150 \times3$ mm | SD200150BENG101 | $200\times150 \times5$ mm |

Table 1 Device Sizes List

The silver is only present as a preservative within the dressing. And the content of ionic silver of

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proposed device is 10.4~12.0 mg/100cm² for 3mm thickness. 17.3~20.1 mg/100cm² for 5mm thickness.

The antibacterial preservative efficacy of proposed device is tested by gram-positive bacteria and gram-negative bacteria, including Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus faecalis, Klebsiella pneumonia, and Streptococcus pyogenes. The results showed that bacterial reduction of proposed device is greater than 4log for 7 days.

They are provided sterilized with Sterility Assurance Level (SAL) of 10-6.

- 7. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

ISO 10993-11:2006/(R)2010, Biological Evaluation Of Medical Devices -- Part 11: Tests For Systemic Toxicity.

ISO11137-2: 2012, Sterilization of healthcare products-Radiation-Part2: Establishing the sterilization dose.

ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.

ASTM F1140-07 (Reapproved 2012), Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages.

USP 36-NF 31: 2013 <85>Bacterial Endotoxins Test.

- 8. Substantially Equivalent (SE) Conclusion
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device | Predicate Device |
|--------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Product Code | FRO | FRO |
| Class | Unclassified | Unclassified |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| Intended Use | LUOFUCON® Silver PU Antibacterial<br>Foam Dressing is indicated for exudate<br>absorption and the management of partial | Biatain Ag Foam Adhesive &<br>Non-Adhesive Dressings are |

Table 2 Comparison of Technology Characteristics

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| | to full thickness wounds, including leg<br>ulcers, pressure ulcers, diabetic foot ulcers,<br>second-degree burns, donor sites,<br>post-operative wounds and skin abrasions. | indicated for use in the management<br>of moderately to highly exuding leg<br>ulcers and pressure sores. The<br>dressing can also be used for 2nd<br>degree burns, donor sites, post<br>operative wounds and skin abrasions.<br>Biatain Ag Foam Non-Adhesive<br>Dressings are additionally indicated<br>for diabetic foot ulcers. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Configuration | Foam dressing and<br>antibacterial coating | Foam dressing and<br>antibacterial coating |
| | Single Use | Yes |
| Antibacterial | Silver ion | Silver ion |
| Antibacterial<br>Time | 7 days | 7 days |
| Main Material | Polyurethane foam, Polyvinyl Alcohol,<br>Silver sulfate, silver chloride | Polyurethane foam and silver<br>compounds |
| | Biocompatibility | Comply with ISO 10993-5, ISO 10993-10,<br>and ISO 10993-11. |
| Sterilization | | Method: Radiation<br>SAL: 10-6 |

#### Intended Use

Both of proposed device and predicate device are silver containing wound dressing, with function of wound management including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, post-operative wounds and skin abrasions. The difference of intended use is only expression difference. Therefore, the difference is considered not to affect the safety and effectiveness.

#### Material

The material of proposed device and predicate device are different. But both of them comply with ISO 10993-5, ISO 10993-10, and ISO 10993-11. Therefore, this difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.

#### Conclusion

The proposed device, LUOFUCON® Silver PU Antibacterial Foam Dressing, is determined to be Substantially Equivalent (SE) to the predicate device, Biatain Ag Foam Dressings (K100218), in respect of safety and effectiveness.