LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING

• K Number: K140954
• Device Name: LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSING
• Manufacturer: HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd.
• Date Cleared: 2015-03-23 ( 343 days)
• Product Code: FRO
• Regulation Number: N/A

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 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.

Predicate Devices

K100218

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and biological compatibility of a wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

Yes
The device is a dressing indicated for wound management, including exudate absorption and treatment of partial to full thickness wounds, which are therapeutic functions.

Diagnostic

No
Explanation: The device is a wound dressing designed for exudate absorption and wound management, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical dressing composed of foam and antibacterial coating, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for "exudate absorption and the management of partial to full thickness wounds." This describes a device used directly on the body for wound care, not for testing samples taken from the body to diagnose or monitor a condition.
• Device Description: The description details a "sterilized, single-use dressing composed of soft, elastic PU foam and antibacterial coating." This is a physical dressing applied to a wound.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic tests.
• Performance Studies: The performance studies mentioned are related to biocompatibility, sterilization, and packaging integrity, which are relevant for a wound dressing, not an IVD.

Therefore, the LUOFUCON® Silver PU Antibacterial Foam Dressing is a medical device used for wound management, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

FRO

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.

The silver is only present as a preservative within the dressing. And the content of ionic silver of proposed device is 10.412.0 mg/100cm² for 3mm thickness. 17.320.1 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 Bacterial Endotoxins Test.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100218

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

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

1

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.

☑ 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)

3

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 10.412.0 mg/100cm² for 3mm thickness. 17.320.1 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 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
Foam Dressing is indicated for exudate
absorption and the management of partial	Biatain Ag Foam Adhesive &
Non-Adhesive Dressings are

Table 2 Comparison of Technology Characteristics

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