Prescription: Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Device Description

Luofucon Silver Alginate Dressing is a sterile, non-woven pad composed of a high G (guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing. The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

AI/ML Overview

The provided text describes two medical devices, the "Luofucon Silver Alginate Dressing (Prescription)" and the "Luofucon Antibacterial Alginate Dressing (OTC)". Both devices are essentially the same product but marketed for different intended uses (prescription vs. over-the-counter). The acceptance criteria and the study to prove the device meets these criteria are primarily focused on their antibacterial activity and biocompatibility.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biocompatibility	Meet requirements per ISO 10993-5 (Tests for in vitro cytotoxicity), ISO 10993-10 (Tests for irritation and skin sensitization), and ISO 10993-11 (Tests for systemic toxicity). The results should be comparable to predicate devices.	"Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Luofucon Silver Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices." (Same statement for Antibacterial Alginate Dressing OTC)
Antibacterial Activity	Demonstrate broad-spectrum antibacterial effectiveness against Gram-positive and Gram-negative bacteria, with a significant reduction (e.g., >99.99%) in bacterial count. The effect should be maintained for at least one day (given the instruction for daily changes). Results should be comparable to predicate devices when used as instructed.	"Luofucon Silver Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day." (Same statement for Antibacterial Alginate Dressing OTC). "The results are comparable to the predicate devices when the dressings are used for antibacterial purpose and changed daily during use."
Sterilization	Validated sterilization process.	"All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006."
Physical/Performance	Meet the requirements of its pre-defined acceptance criteria and intended uses (e.g., exudate absorption, moist wound environment, intact removal).	"It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses." (This is a general statement, specific quantitative metrics are not provided in the summary).

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for the test set regarding the antibacterial activity study (AATCC 100-2004). It mentions "six (three Gram positive and three Gram negative) bacteria" were tested, but not the number of dressing samples or replicates per bacteria.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective." However, the studies were conducted by Huizhou Foryou Medical Devices Co., Ltd. in China, so the data would likely originate from their internal testing facilities. The nature of these tests (antibacterial efficacy, biocompatibility) implies they are prospective bench studies conducted specifically for this submission, rather than retrospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the studies described. The "ground truth" for these tests (biocompatibility, antibacterial activity) is established through standardized laboratory assays (e.g., ISO, AATCC standards), not by expert consensus or clinical assessment of a test set in the way a diagnostic imaging device might require.

4. Adjudication Method for the Test Set

This is not applicable as the studies are laboratory-based and do not involve human interpretation or adjudication of results in the traditional sense of clinical trials. The results are quantitative measurements against established scientific benchmarks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the device's impact on their performance is assessed. The submitted information is for a wound dressing, and the studies focus on its physical, chemical, and biological properties, not on human interpretive performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was done in the context of the antibacterial activity and biocompatibility testing. The "device" in this instance (Luofucon Silver Alginate Dressing) was tested directly and its performance was measured independently against established standards (AATCC 100-2004 for antibacterial activity, ISO 10993 series for biocompatibility). There is no "human-in-the-loop" component to these specific performance assessments.

7. Type of Ground Truth Used

The ground truth for the studies described is based on standardized laboratory test results and existing consensus standards.

For antibacterial activity, the ground truth is defined by the AATCC 100-2004 standard, which dictates methods for quantitative bacterial reduction. The "truth" is the measured percentage reduction compared to controls.
For biocompatibility, the ground truth is defined by the ISO 10993 series of standards, which specify acceptable levels for cytotoxicity, irritation, sensitization, and systemic toxicity. The "truth" is whether the device materials pass these established safety thresholds.

8. Sample Size for the Training Set

This information is not applicable. The device described is a physical medical dressing, not an AI/ML algorithm that requires a "training set" in the computational sense. The product's properties are inherent to its materials and manufacturing, not learned from data.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8.

Summary

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Section 5: 510(k) Summary:

FEB 1 4 2013

Luofucon Silver Alginate Dressing (Prescription)

This summary of 510k safety and effectiveness information is being submitted in accordance with the requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification

Huizhou Foryou Medical Devices Co., Ltd. No.1, Shangxia North Road, Dongjiang Hi-Tech Industry Park, Huizhou, Guangdong Province, China Tel: (086) 0752-5302012 Submitter's FDA Registration Number: 3007735241

US Agent and Contact Person

Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 · Email: cyshen@aol.com

Date of Summary: December 14, 2012

Device Name: Luofucon Silver Alginate Dressing (Prescription) Trade Name: Common Name: Silver Alginate Dressing Dressing, wound, Drug Classification Name: Product Code: FRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery

Predicate Device Information:

(1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions. Inc" located in Cheshire, England CW7 3PD
(2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552

Section 5: 510(K) Summary: Prescription p

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Device description:

The alginate material consists of metallic silver that provides effective protection against microbial contamination of the dressing material. Odour reduction results from the bacteria reduction effect in the dressing.

The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x 100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.

All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

Product Information:

Antibacterial Agent:	Silver Particles
Active Against Pathogens:	Gram positive and Gram negative bacteria
Spectrum of Activity:	Broad spectrum antibacterial effect for Gram positive and Gramnegative bacteria
Concentration on the device:	Each dressing contains 50ug/100 $cm^2$ silver particles

Intended Use:

Prescription:

Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including, postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites

Comparison to Predicate Devices

Luofucon Silver Alginate Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

(1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions, Inc" located in Cheshire, England CW7 3PD

(2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552

The following table shows similarities and differences of use, design, material, and processing

Section 5: 510(K) Summary: Prescription p 2

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methods between our device and the predicate devices.

Description	Our Device	Predicate Device 1(K041316)	Predicate Device 2(K023612)
Indicationfor Use	Prescription:Luofucon Silver AlginateDressing is indicated forthe management ofmoderate to heavilyexuding partial to fullthickness wounds,including, postoperativewounds, trauma wounds,leg ulcers, pressure ulcers,diabetic ulcers, graft anddonor sites	Prescription:Same as ours	Prescription:Provide an effectivebarrier to bacterialpenetration and areintended for localmanagement of partialthickness burns, incisions,skin grafts, donor sites,lacerations, abrasions, andStage I-IV dermal ulcers(vascular, venous,pressure, and diabetic).
Prescription/OTC	Prescription	Prescription	Prescription and OTC
Mechanism	Silver for antibacterialeffect; calcium alginate forexudate absorption andwound care	Same	Silver for antibacterialeffect; nylon fabric forwound care
Design/Material	Calcium alginate and silver	Calcium alginate,carboxymethylcellulose(CMC) and silver	Nylon fabric and silver
Single Use	Yes	Yes	Yes
Sterile	Sterile	Sterile	Sterile

Table 5.1: Comparison of Intended Use, Design, and Material

Both Luofucon Silver Alginate Dressing and its predicate device (K041316) utilize calcium alginate for the exudate absorption and wound management. K041316 also has small quantity of carboxymethylcellulose (CMC) while our device does not have. This slight difference is insignificant and does not affect the intended use and performance of the device.

K023612 utilizes nylon fabric for the wound care purpose, which is different from our device and K041316. However, nylon fabric permits fluid passage from wound, and similar to calcium alginate, it also helps maintaining moist environment for optimal wound heal. The difference between our device and K023612 does not change the intended use and performance of the device.

Luofucon Silver Alginate Dressing and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use.

Biocompatibility tests were conducted following procedures outlined in the respective consensus

Section 5: 510(K) Summary: Prescription 3 p

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standards, and results for Luofucon Silver Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices.

Antibacterial activity was measured following AATCC 100-2004 for total of six (three Gram positive and three Gram negative) bacteria to evaluate the broad spectrum antibacterial effectiveness. Luofucon Silver Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day.

The results are comparable to the predicate devices when the dressings are used for antibacterial purpose and changed daily during use. This is clarified in our product labeling.

K041316 has longer antibacterial duration than our product. However, we have specified in the User Instruction that daily changed is required when using our products.

In summary, Luofucon Silver Alginate Dressing meets biocompatibility requirements per ISO 10993-5, ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. The product is safe and effective for its intended use.

AATCC 100-2004 was used to evaluate the antibacterial activity of the product. This method only specifies the use of one gram positive bacteria (Staphylococcus aureus) and one gram negative bacteria (Klebsiella pneumoniae). However, we evaluated total of six (three Gram positive and three Gram negative) bacteria to evaluate broad spectrum antibacterial effectiveness of the silver alginate dressing.

Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, and performance, our Luofucon Silver Alginate Dressing is substantial equivalent to its predicate devices.

Section 5: 510(K) Summary: Prescription 4 p

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Section 5: 510(K) Summary: OTC

Section 5: 510(k) Summary:

Luofucon Antibacterial Alginate Dressing (OTC)

This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92

Submitter & Foreign Manufacture Identification

US Agent and Contact Person

Chengyu Shen Manton Business and Technology Services 5 Carey Street Pennington, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com

Date of Summary: December 14, 2012

Device Name: Trade Name: Luofucon Antibacterial Alginate Dressing (OTC) Common Name: Silver Alginate Dressing Classification Name: Dressing, wound, Drug Product Code: FRO Regulation Number: Unclassified Review Panel: General & Plastic Surgery

Predicate Device Information:

(1) K041316, "Silver Alginate II Dressing", manufactured by "Advanced Medical Solutions, Inc" located in Cheshire, England CW7 3PD (2) K023612, "Antibacterial Barrier Wound Contact Dressing", manufactured by "Argentum Medical LLC" located in Lakemont, Georgia 30552

Device description:

Luofucon Antibacterial Alginate Dressing is a sterile, non-woven pad composed of a high G

Section 5: 510(K) Summary: OTC I p

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Section 5: 510(K) Summary: OTC

K120181
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(guluronic acid) calcium alginate and metallic silver particles, which absorbs wound exudate. As wound exudate is absorbed, the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.

The dressing has an off-white appearance and is available in the form of pad and in three different sizes (50 mm x 50 mm, 100 mm x 10 mm, 200 mm x .100 mm), packaged in pouches. Additional sizes may also be manufactured per customer request. All dressings have the exactly the same material, chemical, and physical properties and are different only in size.

All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006.

Product Information:

Active Agent:	Silver Particles
Active Against Pathogens:	Gram positive and Gram negative bacteria
Spectrum of Activity:	Board spectrum protection against Gram positive and Gram negativebacteria
Concentration on the device:	Each dressing contains 50ug/100cm2 silver particles

Intended Use:

OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Comparison to Predicate Devices

Luofucon Antibacterial Alginate Dressing is compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

The following table shows similarities and differences of use, design, material, and processing methods between our device and the predicate devices.

2 p

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Description	Our Device	Predicate Device 1 (K041316)	Predicate Device 2(K023612)
Indication forUse	OTC: First aid to help inminor abrasions, minorcuts, lacerations, scrapes,minor scalds and burns.	OTC: N/AThis predicate is a prescriptionproduct.	OTC: Same as ours
Prescription/OTC	OTC	Prescription	Prescription and OTC
Mechanism	Silver provides protectionagainst bacteria; calciumalginate for exudateabsorption and wound care	Same	Silver providesprotection againstbacteria; nylon fabricfor wound care
Design/Material	Calcium alginate andsilver	Calcium alginate,carboxymethylcellulose(CMC) and silver	Nylon fabric and silver
Single Use	Yes	Yes	Yes
Sterile	Sterile	Sterile	Sterile

		Fable 5.1: Comparison of Intended Use, Design, and Material

Luofucon Antibacterial Alginate Dressing and its predicate device (K041316) utilize calcium alginate for the exudate absorption and wound management. K041316 also has small quantity of carboxymethylcellulose (CMC) while our device does not have. This slight difference is insignificant and does not affect the intended use and performance of the device.

Luofucon Antibacterial Alginate Dressing and its predicate devices are made from similar materials, utilize same antibacterial mechanism, and have similar intended use.

Biocompatibility tests were conducted following procedures outlined in the respective consensus standards, and results for Luofucon Antibacterial Alginate Dressing met all relevant requirements in the test standards, and are comparable to the predicate devices.

Protection against bacteria was measured following AATCC 100-2004 for total of six (three Gram positive and three Gram negative) bacteria to evaluate the broad spectrum effectiveness. Luofucon Antibacterial Alginate Dressing is effective (>99.99% reduction) for all 6 bacteria and effect lasts for one day.

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Section 5: 510(K) Summary: OTC

The results are comparable to the predicate devices when the dressings are changed daily during use. This is clarified in our product labeling.

K041316 has longer protection duration than our product. However, we have specified in the User Instruction that daily changed is required when using our products.

In summary, Luofucon Antibacterial Alginate Dressing meets biocompatibility requirements per ISO 10993-5, ISO 10993-10, and ISO 10993-11. It's physical and performance meets the requirements of its pre-defined acceptance criteria and intended uses. All dressings are sterilized and sold directly to users after sterilization by radiation using conditions validated following ISO 11137-2: 2006. The product is safe and effective for its intended use.

AATCC 100-2004 was used to evaluate the protection against bacteria of the product. This method only specifies the use of one gram positive bacteria (Staphylococcus aureus) and one gram negative bacteria (Klebsiella pneumoniae). However, we evaluated total of six (three Gram positive and three Gram negative) bacteria to evaluate broad spectrum effectiveness of this alginate dressing.

Substantial Equivalent Statement

Based on the comparison of intended use, design, materials, and performance, our Luofucon Antibacterial Alginate Dressing is substantial equivalent to its predicate devices.

4 p

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three branches instead of one.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Huizhou Foryou Medical Devices Company, Limited % Manton Business and Technology Services Chengyu Shen 5 Carey Street Pennington, New Jersey 08534

Re: K120181

Trade/Device Name: Luofucon Antibacterial Alginate Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 14, 2012 Received: January 03, 2013

Dear Chengyu Shen:

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. Ilsting 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.

February 14, 2013

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Page 2 - Chengyu Shen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Peter 🇿Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indication for Use: OTC

Section 4: Indication for Use Statement

Luofucon Antibacterial Alginate Dressing (OTC)

510(k) Number (if known): K120181

Device Name: Luofucon Antibacterial Alginate Dressing

Indications for Use:

OTC: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyounggyang

(Division Sign-Off) Division of Surgical Devices 510(k) Number K120181

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Section 4: Indication for Use: Prescription

K120181
p2/2

Section 4: Indication for Use Statement

Luofucon Silver Alginate Dressing (Prescription)

510(k) Number (if known): K120181

Device Name: Luofucon Silver Alginate Dressing

Indications for Use:

Prescription:

Luofucon Silver Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, pressure ulcers, diabetic ulcers, graft and donor sites.

Prescription Use X-(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiyo ying Dang

(Division Sign-Off) Division of Surgical Devices 510(k) Number K120181

Section 4: Indications for Use: Prescription p 1

Regulation Number and Section

N/A