LUOFUCON® Silicone Ag foam dressing 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 has a multilayer structure, it consists of a soft silicone wound contact layer, an absorbent polyurethane foam pad containing about 0.25~0.35mq/cm² silver ions, a vapor permeable waterproof film. LUOFUCON® Silicone Ag foam dressing can absorb exudates, maintains a moist wound healing environment and has good antibacterial preservative properties within the dressing. It has been shown that antibacterial preservative effectiveness within the dressing for up to 7days, as demonstrated in vitro. All dressings are sterilized and sold after sterilization by EO using conditions validated following ISO 11135: 2014. LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants: The first variant, Non-Border Silicone Ag Foam dressing consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel. The second variant, Silicone Ag Foam dressing With Border consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (A thin non woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top film); a release liner (covered on the silicone gel). The dressing has white or light brown appearance and is available in the form of pad and in different sizes of pouch package. All dressings use the same material of backing film, foam pad, silicone gel and release film. With Border version additionally adds a thin non woven as foam auxiliary layer, but it wouldn't impact the product properties.

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the LUOFUCON® Silicone Ag Foam Dressing (K160022), primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study proving the device meets specific performance acceptance criteria for a complex diagnostic or AI-driven medical device.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or AUC) for an AI device is not applicable to this document. This submission details the physical device's characteristics, manufacturing, and basic performance features like biocompatibility and antibacterial activity.

However, I can extract the relevant information that is presented in the document concerning how this medical device demonstrates its intended function and safety.

Here's a breakdown based on the provided text, addressing your points where possible and noting when information is N/A:

Acceptance Criteria and Device Performance (as demonstrated for this type of device):

The "acceptance criteria" for this device are largely based on physicochemical properties, biocompatibility, and the in vitro antibacterial activity, demonstrating it functions similarly to its predicate devices and poses no new safety or efficacy concerns.

Acceptance Criteria (from supporting data)	Reported Device Performance (LUOFUCON® Silicone Ag Foam Dressing)
Biocompatibility:
Cytotoxicity (per ISO 10993-5)	No Toxic Effect
Skin Irritation and Sensitization (per ISO 10993-10)	No Effect
Systematic Toxicity (per ISO 10993-11)	No Effect
Antibacterial Preservative Activity:
Activity against 6 bacteria (per Modified AATCC 100-2004)	>4 log reduction for seven days for all six bacteria
Duration of antibacterial preservative effectiveness within dressing	Seven days
Sterilization Efficacy	Sterilization by EO using conditions validated following ISO 11135: 2014 (all dressings are sterilized and sold after)
Physical and Performance properties	Meets the requirements of its pre-defined acceptance criteria and intended use (general statement)

Study Details (Relevant to this device type):

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of a "test set" for clinical performance. The studies mentioned (biocompatibility, antibacterial activity) would have involved specific sample sizes as per the respective ISO and AATCC standards. These are typically in vitro or animal tests, not large patient cohorts.
- Data Provenance: The studies are in vitro (e.g., antibacterial) and in vivo (biocompatibility animal studies or in vitro cell-based tests referenced by ISO standards). The document does not specify the country of origin for the data generation, but the manufacturer is Huizhou Foryou Medical Devices Co., Ltd. from P.R. China. The studies are not described as retrospective or prospective clinical studies on human patients for efficacy, but rather laboratory-based performance and safety testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not relevant or provided for this type of device submission. Ground truth, in the context of diagnostic AI, refers to expert consensus on disease presence/absence. For a wound dressing, ground truth is established through validated laboratory methods and standardized biocompatibility testing protocols, not by expert reads of images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as this is not a diagnostic device involving human interpretation of clinical data requiring adjudication.
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:
- N/A. Not applicable. MRMC studies are for diagnostic devices, especially those that assist human readers. This is a medical dressing.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not applicable. This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For biocompatibility, ground truth is established by the results of standardized tests against ISO criteria (e.g., cell viability for cytotoxicity, skin reaction in animal models for irritation). For antibacterial activity, ground truth is based on quantitative microbial reduction against a control, as per the specified AATCC method. This is laboratory-derived ground truth, not clinical outcomes in patients.
The sample size for the training set:
- N/A. Not applicable. There is no "training set" as this is not a machine learning/AI device.
How the ground truth for the training set was established:
- N/A. Not applicable. There is no "training set."

Summary of Device Rationale for Acceptance:

The acceptance of the LUOFUCON® Silicone Ag Foam Dressing (K160022) by the FDA is based on demonstrating substantial equivalence to existing, legally marketed predicate devices (Mepilex Border Ag Dressing (K100029) and LUOFUCON® Silver PU Antibacterial Foam Dressing (K140954)). This is achieved by showing that the subject device has:

Similar intended use, design, and materials to the predicates.
Comparable performance characteristics, particularly in terms of in vitro antibacterial preservative activity (meeting the ">4 log reduction for seven days for all six bacteria" criterion) and duration (seven days).
Demonstrated biocompatibility (passing ISO 10993-5, -10, and -11 for cytotoxicity, irritation, sensitization, and systematic toxicity).
Validated sterilization process (EO in accordance with ISO 11135: 2014).

The submission argues that any minor differences (e.g., sterilization method, presence of a silicone layer) do not impact the device's safety or effectiveness compared to the predicates. The studies mentioned are primarily laboratory-based performance tests and biocompatibility assessments, not clinical trials on patient populations.

Summary

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

August 17, 2016

Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer North Shangxia Road Dongjiang Hi-Tech Industry Park Huizhou, 516005 P.R. China

Re: K160022

Trade/Device Name: Luofucon Silicone Ag Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: July 13, 2016 Received: July 18, 2016

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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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.

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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K160022

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-001

510(k) Number (if known)

Device Name

LUOFUCON® Silicone Ag foam dressing

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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:_ K160022

1. Date of Submission: 12/20/2015

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: qstan@foryougroup.com

3. Subject Device Identification:

Device Name: LUOFUCON® Silicone Ag Foam Dressing Common Name: Silver Foam Dressing Classification Name: Silicone, Dressing, Wound, Drug; Product Code: FRO; Regulation Number: Unclassified; Review Panel: General & Plastic Surgery;

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4. Predicate Device Identification:

First: 510(k) Number: K100029

Product Name: Mepilex Border Ag Dressing

Manufacturer: Mölnlycke Health Care

Second: 510(k) Number: K140954

Product Name: LUOFUCON® Silver PU Antibacterial Foam Dressing Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

5. Device Description:

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

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

LUOFUCON® Silicone Ag foam dressing in this submission consists of two variants:

The first variant, Non-Border Silicone Ag Foam dressing consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (Absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film); a wound contact layer (Perforated silicone gel adhered to the center layer); a release liner covers on the silicone gel.

The second variant, Silicone Ag Foam dressing With Border consists of a top layer (Vapor permeable waterproof polyurethane film); a center layer (A thin non woven and absorbent polyurethane antibacterial foam pad containing silver compounds adhered to the top film, and the top film remained border part); a wound contact layer (Perforated silicone gel adhered to the center layer and top

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film); a release liner (covered on the silicone gel).

The dressing has white or light brown appearance and is available in the form of pad and in different sizes of pouch package. All dressings use the same material of backing film, foam pad, silicone gel and release film. With Border version additionally adds a thin non woven as foam auxiliary layer, but it wouldn't impact the product properties.

6. Intended Use Statement:

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

7. Comparison to the Predicate Device

LUOFUCON® Silicone Ag Foam Dressing 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.
K140954, LUOFUCON® Silver PU Antibacterial 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.

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Item	Subject Device	Predicate Device 1	Predicate Device2
	(K160022)	(K100029)	(K140954)
Intended Use	LUOFUCON® Silicone Agfoam dressing is indicatedfor the management ofexuding wounds, such asleg and foot ulcers,pressure ulcers, traumaticand surgical wounds,superficial and partialthickness burns.Silver compounds presentin the dressing helpsreduce bacterialcolonization in thedressing.	Mepilex Border Agdressing is indicated forthe management ofexuding wounds such asleg and foot ulcers,pressure ulcers,traumatic and surgicalwounds, superficial andpartial thickness burns.Mepilex Border Ag canalso be used undercompression bandaging.Silver sulfate present inthe dressing helps reducemicrobial colonization onthe dressing.	LUOFUCON® Silver PUAntibacterial FoamDressing is indicated forexudates absorption andthe management ofpartial to full thicknesswounds, including legulcers, pressure ulcers,diabetic foot ulcers,second-degree burns,donor sites,postoperative woundsand skin abrasions.
Mechanism	Polyurethane foam forabsorb liquid, Silvercompounds present inthe foam for reducingbacteria within thedressing. Silicone softcontact layer for self-adhesive, baking film forwaterproof.	Polyurethane foam andnon-woven for absorbliquid, Silver compoundspresent in the foam forreducing bacteria in thedressing, Silicone softcontact layer for self-adhesive, baking film forwaterproof.	Polyurethane foam forabsorb liquid, Silvercompounds present inthe foam for reducingbacteria within thedressing.
Material	Polyurethane foamcontaining silver,Silicone andpolyurethane film; withborder version additionalhas non-woven fabrics	Silicone , polyurethanefoam containing silverand activated carbon,polyacrylate fibre, non-woven fabrics,polyurethane film	Polyurethane foamcontaining silver
AntibacterialpreservativeDuration	Seven days	Seven days	Seven days
Single Use	Yes	Yes	Yes
Sterilization	Ethylene Oxide	Ethylene Oxide	Irradiation
Item	Subject Device(K160022)	Predicate Device 1(K100029)	Predicate Device2(K140954)
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)
AntibacterialPreservativeActivity	>4 log reduction forseven days for all sixbacteria	Inactivaterepresentativebacteria up to 7 days	>4 log reduction forseven days for all sixbacteria
AntibacterialPreservativeDuration	Seven days	Seven days	Seven days

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

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LUOFUCON® Silicone Ag Foam Dressing and its predicate devices (K100029、 K140945) utilize silver compound as the antibacterial preservative agent, and utilize polyurethane foam for the exudates absorption and wound management. One difference between subject device and predicate device 1(K100029) is that the predicate device has added a super polyacrylate absorbent fibers used to enhance the product fluid absorption performance. LUOFUCON® Silicone Ag Foam Dressing is modified from LUOFUCON® Silver PU Antibacterial Foam Dressing (K140945) which had no silicone wound contact layer and sterilized with Irradiation. These differences do not impact the safety and efficacy of our subject devices, because their functions have no change.

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

Table 5-2 Comparison of Biocompatibility and Performance Testing

LUOFUCON® Silicone Ag Foam Dressing meets biocompatibility requirements per ISO 10993-5, ISO10993-10, and ISO 10993-11. It's physical and 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 AATCC 100-2004 was used to evaluate the antibacterial preservative activity of the subject device. Predicate Device 1 chooses the ASTM E2149-01 as the test method. Both the subject device and predicate devices can get antibacterial preservative 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, is determined to be Substantially Equivalent (SE) to the predicate devices, Mepilex Border Ag Foam Dressing (K100029) and LUOFUCON® Silver PU Antibacterial Foam Dressing (K140954), in respect of safety and effectiveness.

Regulation Number and Section

N/A