LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

Device Description

LUOFUCON® Silicone Ag Foam Dressing with Border has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mg/cm² silver ions, a supper absorbent fibre pad, a vapor permeable waterproof film, and release PE films. LUOFUCON® Silicone Ag Foam Dressing with Border can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silicone Ag Foam Dressing with Border). It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner you've requested (e.g., performance metrics with statistical significance, sample sizes for test sets, expert ground truth adjudication).

This document is a regulatory submission focused on demonstrating equivalence to already approved devices, not necessarily a detailed report of a new clinical or performance study with acceptance criteria listed in a typical research format.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Cytotoxicity	No Toxic Effect (ISO 10993-5)	No Toxic Effect (ISO10993-5)
Skin Irritation	No Effect (ISO 10993-10)	No Effect (ISO 10993-10)
Skin Sensitization	No Effect (ISO 10993-10)	No Effect (ISO 10993-10)
Systemic Toxicity	No Effect (ISO 10993-11)	No Effect (ISO 10993-11)
Antibacterial Activity	>4 log reduction for seven days for six bacteria (implied a standard for silver dressings)	>4 log reduction for seven days for all six bacteria
Antibacterial Duration	Seven days (comparable to predicate devices)	Seven days
Sterilization	Validated using ISO 11135:2014	Sterilized by EO using conditions validated following ISO 11135:2014
Physical Performance	Meets pre-defined acceptance criteria and intended use (general statement)	Meets the requirements of its pre-defined acceptance criteria and intended use (general statement)

Missing: Specific quantitative acceptance limits for "physical performance" are not detailed. The criteria are largely based on meeting established ISO standards for biocompatibility and demonstrating comparable antibacterial activity to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "Modified ASTM E2149-13a was used to evaluate the antibacterial preservative activity of the subject device." However, it does not state the number of samples used in this testing.
Data Provenance: The antibacterial testing was likely conducted in a lab environment in China by Huizhou Foryou Medical Devices Co., Ltd., given the manufacturer's location. The document does not specify if the testing involved human data or was purely laboratory-based. Given the nature of the device (dressing) and the tests mentioned (biocompatibility, antibacterial activity), it's highly probable these are laboratory tests, not human trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not specified. This document describes laboratory performance testing (biocompatibility, antibacterial activity), not a clinical study requiring expert ground truth for a test set.

4. Adjudication method for the test set

Not applicable / Not specified. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of results by multiple experts. This document describes laboratory testing against established standards, not human interpretation.

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

Not applicable. This device is a wound dressing, not an AI-powered diagnostic tool that would involve human readers or AI assistance.

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

Not applicable. This device is a wound dressing, not an algorithm.

7. The type of ground truth used

For Biocompatibility: Defined by ISO standards (ISO 10993-5, 10993-10, 10993-11). The "ground truth" is adherence to these normative documents.
For Antibacterial Activity: Defined by the ASTM E2149-13a standard and achieving a specified log reduction (>4 log reduction) over a specific duration (seven days). This is a laboratory-based 'ground truth.'

8. The sample size for the training set

Not applicable. This document describes a physical medical device (wound dressing) and its performance testing, not a machine learning model that requires a training set.

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

Not applicable. As above, no training set for a machine learning model is involved.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

March 30, 2017

Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer North Shangxia Rd. Dongjiang Hi-tech Industry Park Huizhou. Guangdong 516005 China

Re: K170077

Trade/Device Name: LUOFUCON Silicone Ag Foam Dressing with Border Regulatory Class: Unclassified Product Code: FRO Dated: January 6, 2017 Received: January 9, 2017

Dear Guosheng Tan:

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 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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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/Resourcesfor You/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,

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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Premarket Notification 510(k) Submission Section 4: Indication for Use Staement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

Project #: GY-002

510(k) Number (if known)

Device Name

LUOFUCON® Silicone Ag Foam Dressing with Border

Indications for Use (Describe)

LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the management of exuding wounds, such as leg and foot ulcers,pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(k) Summary or 510(k) Statement

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:

1. Date of Submission: 1/6/2017

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: Guosheng Tan

Position: Development Engineer

Tel: +86-0752-5302012

Fax: +86-0752-5302020

Email: gstan@foryougroup.com

3. Subject Device Identification:

Device Name:LUOFUCON® Silicone Ag Foam Dressing with Border Common Name: Silver Foam Dressing Classification Name: Silicone, Dressing, Wound, Drug;

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Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery;

4. Predicate Device Identification:

510(k) Number: K100029 First:

Product Name: Mepilex Border Ag Dressing

Manufacturer: Mölnlycke Health Care

Second: 510(k) Number: K160022

Product Name: LUOFUCON® Silicone Ag Foam Dressing

Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

5. Device Description:

LUOFUCON® Silicone Ag Foam Dressing with Border can absorb exudates, maintains a moist wound healing environment and has good antibacterial properties. It has been shown that antibacterial effectiveness within the dressing for up to 7 days, as demonstrated in vitro.

All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

6. Intended Use Statement:

LUOFUCON® Silicone Ag Foam Dressing with Border is indicated for the

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management of exuding wounds, such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns.

Silver compounds present in the dressing helps reduce bacterial colonization in the dressing.

7. Comparison to the Predicate Device

LUOFUCON® Silicone Ag Foam Dressing with Border is compared with the following Predicate Device in terms of intended use, design, material, specifications, and performance.

. K100029, Mepilex Border Ag Foam Dressing, Manufactured by Mölnlycke Health Care.
K160022, LUOFUCON® Silicone Ag Foam Dressing, 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 two predicate devices. These data came from commercially product labeling and 510(k) summary.

Item	Subject Device	Predicate Device 1(K100029)	Predicate Device2(K160022)
Intended Use	LUOFUCON® Silicone AgFoam Dressing withBorder is indicated for themanagement of exudingwounds, such as leg andfoot ulcers, pressureulcers, traumatic andsurgical wounds,superficial and partial	Mepilex Border Agdressing is indicated forthe management ofexuding wounds such asleg and foot ulcers,pressure ulcers,traumatic and surgicalwounds, superficial andpartial thickness burns.	LUOFUCON® Silicone Agfoam dressing is indicatedfor the management ofexuding wounds, such asleg and foot ulcers,pressure ulcers, traumaticand surgical wounds,superficial and partialthickness burns.
	thickness burns.Silver compounds presentin the dressing helpsreduce bacterialcolonization in thedressing.	Mepilex Border Ag canalso be used undercompression bandaging.Silver sulfate present inthe dressing helps reducemicrobial colonization onthe dressing.	Silver compoundspresent in the dressinghelps reduce bacterialcolonization in thedressing.
Mechanism	Polyurethane foam andsuper absorbent fibrepad for absorbing liquid,Silver compoundspresent in the foam forreducing bacteriacolonization in thedressing, Silicone softcontact layer for self-adhesive, baking film forwaterproof.	Polyurethane foam andsuper absorbent fibrepad for absorb liquid,Silver compoundspresent in the foam forreducing bacteriacolonization in thedressing, Silicone softcontact layer for self-adhesive, baking film forwaterproof.	Polyurethane foam forabsorbing liquid, Silvercompounds present inthe foam for reducingbacteria colonizationwithin the dressing.Silicone soft contact layerfor self-adhesive, bakingfilm for waterproof.
Material	Silicone, polyurethanefoam containing silver,super absorbent fibre,non- woven fabrics,polyurethane film	Silicone, polyurethanefoam containing silverand activated carbon,polyacrylate fibre, non-woven fabrics,polyurethane film	Polyurethane foamcontaining silver,Silicone and polyurethanefilm; with border versionadditional has non-wovenfabrics
AntibacterialDuration	Seven days	Seven days	Seven days
Single Use	Yes	Yes	Yes
Sterilization	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Item	Subject Device	Predicate Device 1(K100029)	Predicate Device2(K160022)
Cytotoxicity	No Toxic Effect(ISO10993-5)	Non-cytotoxic	No Toxic Effect(ISO10993-5)
Skin IrritationandSensitization	No Effect(ISO 10993-10)	Non-irritatingNon-sensitizing	No Effect(ISO 10993-10)
SystematicToxicity	No Effect(ISO 10993-11)	/	No Effect(ISO 10993-11)
AntibacterialActivity	>4 log reduction forseven days for all sixbacteria	Inactivaterepresentativebacteria up to 7 days	>4 log reduction forseven days for all sixbacteria
AntibacterialDuration	Seven days	Seven days	Seven days

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

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Premarket Notification 510(k) Submission

Section 5: 510 (k) Summary

Project #: GY-002

LUOFUCON® Silicone Ag Foam Dressing with Border and its predicate devices (K100029, K160022) utilize silver compound as the antibacterial agent, and utilize polyurethane foam and super absorbent fibre pad for the exudates absorption

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and wound management. LUOFUCON® Silicone Ag Foam Dressing with Border is modified from the border version of LUOFUCON® Silicone Ag Foam Dressing (K160022) which had no supper absorbent fibre. These differences do not impact the safety and efficacy of our subject devices, because their functions have no change.

Therefore, LUOFUCON® Silicone Aq Foam Dressing with Border and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use.

Table 5-2 Comparison of Biocompatibility and Performance Testing

LUOFUCON® Silicone Ag Foam Dressing with Border meets biocompatibility requirements per ISO 10993-5, ISO10993-10, and ISO 10993-11. Its physical performance meets the requirements of its pre-defined acceptance criteria and intended use. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014.

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Modified ASTM E2149-13a was used to evaluate the antibacterial preservative activity of the subject device. Predicate Device 1 also chooses the ASTM E2149 as the test method. Both the subject device and predicate devices can get antibacterial duration of seven days.

Therefore, the performance results are comparable to the predicate devices when the dressings are used for antibacterial preservative 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, and performance, the subject device, LUOFUCON® Silicone Ag Foam Dressing with Border, is determined to be Substantially Equivalent (SE) to the predicate devices, Mepilex Border Ag Foam Dressing (K100029) and LUOFUCON® Silicone Aq Foam Dressing(K160022), in respect of safety and effectiveness.

Regulation Number and Section

N/A