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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the LUOFUCON® Silver PU Antibacterial Foam Dressing. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials. Therefore, the document does not contain details about acceptance criteria for a study proving device performance, nor does it describe a stand-alone study, MRMC study, or the comprehensive information requested regarding sample sizes, expert ground truth establishment, or adjudication methods.

However, it does describe the non-clinical tests conducted to support substantial equivalence. Here's a breakdown of the information that can be extracted, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of a clinical performance study with specific metrics like sensitivity, specificity, etc. Instead, it details non-clinical tests to establish biocompatibility and sterility, and an antibacterial efficacy test.

Test Type	Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Biocompatibility:		Complies with:
In Vitro Cytotoxicity (ISO 10993-5)	Meet the requirements of ISO 10993-5	ISO 10993-5: 2009
Irritation/Skin Sensitization (ISO 10993-10)	Meet the requirements of ISO 10993-10	ISO 10993-10: 2010
Systemic Toxicity (ISO 10993-11)	Meet the requirements of ISO 10993-11	ISO 10993-11:2006/(R)2010
Sterility:
Sterilization Dose (ISO 11137-2)	Meet the requirements of ISO 11137-2	ISO11137-2: 2012 (Sterility Assurance Level (SAL) of 10⁻⁶)
Bacterial Endotoxins Test (USP 36-NF 31: 2013 <85>)	Meet the requirements of USP 36-NF 31: 2013 <85>	USP 36-NF 31: 2013 <85>
Packaging Integrity:
Seal Strength (ASTM F88/F88M-09)	Meet the requirements of ASTM F88/F88M-09	ASTM F88/F88M-09
Internal Pressurization Failure Resistance (ASTM F1140-07)	Meet the requirements of ASTM F1140-07	ASTM F1140-07 (Reapproved 2012)
Antibacterial Efficacy:	Demonstrate antibacterial preservative efficacy	Bacterial reduction of proposed device is greater than 4log for 7 days against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Enterococcus faecalis, Klebsiella pneumonia, and Streptococcus pyogenes.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for the non-clinical tests mentioned (e.g., number of samples for cytotoxicity, irritation, or antibacterial tests). These are typically laboratory-based tests with controls.
Data provenance: The document is a submission from Huizhou Foryou Medical Devices Co., Ltd. in P. R. China to the US FDA. The tests are non-clinical, so "country of origin for data" would refer to where the tests were performed, which is implicitly China based on the company's location. The tests are reported as part of a regulatory submission, indicating they were conducted to support the device's clearance. They are laboratory tests, not clinical studies, so the categories "retrospective or prospective" do not directly apply in the usual sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the non-clinical tests described. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not part of these physical/biological material tests. The "ground truth" for these tests would be the established scientific standards and methods outlined in the ISO and ASTM guidelines.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to the non-clinical tests described. Adjudication methods are relevant for human interpretation or clinical outcomes, not for laboratory assays confirming material properties or antibacterial activity.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This document is for a medical dressing, not an AI-powered diagnostic device, and therefore this type of study is entirely irrelevant to its submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical dressing, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by adherence to recognized international standards (ISO, ASTM, USP) for biocompatibility, sterility, packaging, and general laboratory practices for antibacterial efficacy. There is no expert consensus, pathology, or outcomes data used as ground truth for these material-based tests.

8. The sample size for the training set

Not applicable. Training sets are used for machine learning models. This document describes a physical medical device.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

☑ 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
1. 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: 86 752 5302013 Fax: 86 752 5302020 Email: wlu@foryougroup.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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1. 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
1. 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.

1. 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.

1. 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 AntibacterialFoam Dressing is indicated for exudateabsorption 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 legulcers, pressure ulcers, diabetic foot ulcers,second-degree burns, donor sites,post-operative wounds and skin abrasions.	indicated for use in the managementof moderately to highly exuding legulcers and pressure sores. Thedressing can also be used for 2nddegree burns, donor sites, postoperative wounds and skin abrasions.Biatain Ag Foam Non-AdhesiveDressings are additionally indicatedfor diabetic foot ulcers.
Configuration	Foam dressing andantibacterial coating	Foam dressing andantibacterial coating
	Single Use	Yes
Antibacterial	Silver ion	Silver ion
AntibacterialTime	7 days	7 days
Main Material	Polyurethane foam, Polyvinyl Alcohol,Silver sulfate, silver chloride	Polyurethane foam and silvercompounds
	Biocompatibility	Comply with ISO 10993-5, ISO 10993-10,and ISO 10993-11.
Sterilization		Method: RadiationSAL: 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.

Regulation Number and Section

N/A