Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.

Device Description

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is a sterile, water-based amorphous gel composed of hydrophilic polymer and silver compound. The gel helps to maintain a moist wound environment. The silver compound acts as a preservative to inhibit the growth of microorganisms in the gel during shelf storage.

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

AI/ML Overview

The provided document is a 510(k) summary for the LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Based on the content, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with numerical targets for clinical performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various physical, chemical, and biological properties, as well as general performance attributes relevant to wound care gels.

The table below summarizes the comparative data presented, which implicitly serves as "acceptance criteria" by showing the subject device is comparable to the predicate/reference devices for key properties and performance aspects.

Item	Predicate Device (K083103)	Reference Device (K140483)	Subject Device (K211123)	Interpretation (Acceptance/Performance)
Device Name	AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B / OTC: AcryDerm Wound Gel Model #B	ASAP OTC Wound Dressing Gel	LUOFUCON® Silver Wound Gel / LUOFUCON® Silver Antimicrobial Wound Gel	Subject device name aligns with product type.
Classification Regulation	Unclassified	Unclassified	Unclassified	Acceptance: Matches predicate and reference.
Product Code	FRO	FRO	FRO	Acceptance: Matches predicate and reference.
Indications for Use (Rx)	Management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.	N/A	Management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.	Acceptance: Substantially equivalent to predicate Rx indications.
Indications for Use (OTC)	Management of minor abrasions, cuts, lacerations, and scalds.	Topical management of minor cuts, lacerations, abrasions, 1st and 2nd degree burns, and skin irritations.	Topical management of minor abrasions, minor cuts, minor lacerations and minor burns.	Acceptance: Similar to both predicate and reference OTC indications, covering common minor wound types. Minor burns are explicitly included, aligning with the reference device, while the predicate mentioned "scalds." This is considered substantially equivalent.
Composition	Hydrophilic polymers and silver salt	Carbopol ETD 2020, triethanolamine, proprietary silver hydrosol suspension	Purified water, Carbopol, glycerol, polyethylene oxide, polyvinyl alcohol, silver compound	Acceptance: While ingredients differ, the overall functional components (hydrophilic polymer, silver compound) are present, supporting a "substantially equivalent" determination based on performance and safety rather than identical formulation.
Mechanism	Hydrophilic polymer for maintaining high moisture content, ionic silver for reducing microorganism colonization within the dressing during shelf storage.	Hydrophilic polymer for maintaining high moisture content, silver for reducing microorganism colonization within the dressing during shelf storage.	Hydrophilic polymer for maintaining high moisture content, ionic silver for reducing microorganism colonization within the dressing during shelf storage.	Acceptance: Matches predicate and reference mechanism of action.
Antimicrobial Agent	Silver compound	Element silver	Silver compound	Acceptance: All use silver in some form as the antimicrobial agent.
Appearance	Slightly cloudy	Clear to golden yellow translucent gel	Colorless to light yellow, transparent to slightly cloudy	Performance: Visually similar, within the range of established devices.
pH Value	N/A	6.5-8.0	5.0-7.5	Performance: Within a physiologically appropriate range for topical applications, comparable to the reference device's range. Implicit acceptance is that it's within a safe and effective range.
Silver Content	N/A	24 ppm	0.007%-0.012% w/w (which is approximately 70-120 ppm if density is 1g/mL)	Performance: This is a key difference in concentration from the reference device, but the "substantial equivalence" is based on overall performance (e.g., antimicrobial effectiveness, biocompatibility, and non-inhibition of wound healing) rather than exact silver concentration matching.
Moisture Donation	N/A	Greater than 5%	≥10%	Performance: Subject device meets or exceeds the reference device's performance for moisture donation. Implicit acceptance is that higher or comparable donation is favorable.
Moisture Absorption	N/A	Greater than 5%	<10%	Performance: This appears to be a comparative value but the "Greater than 5%" for the reference device and "<10%" for the subject device needs context. Typically, wound gels donate moisture more than they absorb, so a lower absorption for the gel itself is plausible.
Preservative Performance	USP <25> preservative assurance testing	USP <51>	USP <51> preservative effectiveness testing	Acceptance: Performance demonstrated via recognized USP standards, aligning with the reference device's standard.
Sterilized	N/A	Not provided sterile	Sterile	Acceptance: Provides sterility, which is an advantage over the reference device and aligns with the general expectations for wound care products for significant wounds (Rx).

The document states: "Performance tests were conducted to demonstrate that the subject device is as effective as its predicate device." The "acceptance criteria" for these performance tests are implicitly met if the test results demonstrate comparable performance attributes to the predicate/reference devices, supporting the claim of substantial equivalence.

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 detail specific sample sizes for the performance tests listed (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness). These are typically bench tests or in vitro studies, not requiring human patient test sets.

For the Animal Study (Porcine Wound Healing Study):

Sample Size: Not explicitly stated.
Data Provenance: Not explicitly stated (e.g., country or retrospective/prospective). This was an animal study, not human clinical data.

For Clinical Studies:

Sample Size: "No clinical study was conducted."
Data Provenance: Not applicable, as no human clinical data was used for direct performance evaluation of this device.

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 this submission. The device is a wound care gel, not an AI or diagnostic medical device that requires expert adjudication for a test set. The efficacy (or non-inhibition of wound healing) was assessed in an animal model and through comparative performance testing.

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

This information is not applicable. As mentioned above, this is not an AI/diagnostic device that relies on expert adjudication for ground truth.

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

This information is not applicable. An MRMC study is relevant for AI/diagnostic imaging devices. This submission concerns a wound care gel.

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

This information is not applicable. This question refers to AI algorithm performance.

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

For the various performance tests (Appearance, Fluid Affinity, Loss on Drying, pH Value, Preservative Effectiveness):

Ground Truth: These properties are determined through standardized laboratory testing methods (e.g., EN 13726-1, USP <731>, USP <791>, USP <51>). The "ground truth" is the quantitative or qualitative result obtained from these validated methods.

For the Biocompatibility Testing:

Ground Truth: Compliance with ISO 10993 standards. The "ground truth" is the biological response (or lack thereof) observed in standardized in vitro and in vivo biocompatibility tests, interpreted by toxicologists or biologists.

For the Animal Study (Porcine Wound Healing Study):

Ground Truth: Histological and macroscopic assessment of wound healing, and observation for adverse biological reactions. This ground truth is established by veterinary pathologists or researchers.

8. The sample size for the training set

This information is not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

This information is not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

April 22, 2022

Huizhou Foryou Medical Devices CO., Ltd. Huiqi Huang R&D Engineer North Shangxia Rd., Dongjiang Hi-tech Industry Park Huizhou. Guangdong 516005 China

Re: K211123

Trade/Device Name: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel Regulatory Class: Unclassified Product Code: FRO Dated: January 24, 2022 Received: February 2, 2022

Dear Huiqi Huang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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) K211123

Device Name

LUOFUCON® Silver Wound Gel (Prescription use) LUOFUCON® Silver Antimicrobial Wound Gel (OTC use)

Indications for Use (Describe)

Prescription:

LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.

OTC:

LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor cuts, minor lacerations and minor burns.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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K211123 Page 1 of 7

510(k) Summary

This 510(k) Summary information is being submitted in accordance with Title 21, CFR Section 807.92.

1. SUBMITTER:

Huizhou Foryou Medical Devices Co., Ltd.

Address: No.1 Shangxia North Road., Dongjiang Hi-tech Industry Park, Huizhou,

Guangdong, China. Phone: +86-0752-5302185 Fax: +86-0752-5302020 Contact Person: Huiqi Huang Date Prepared: April 12th, 2021

2. SUBJECT DEVICE

Device Name: LUOFUCON® Silver Wound Gel (Prescription use), LUOFUCON® Silver Antimicrobial Wound Gel (OTC use) Common Name or Usual Name: Silver Wound Gel Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO

3. PREDICATE DEVICE:

510(k) Number: K083103

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K211123 Page 2 of 7

Product Name: AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B, OTC: AcryDerm Wound Gel Model #B Manufacturer: AcryMed, Inc.

4. REFERENCE DEVICE:

510(k) Number: K140483 Product Name: ASAP OTC Wound Dressing Gel Manufacturer: ABL Medical, LLC

5. DEVICE DESCRIPTION:

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

6. INDICATIONS FOR USE:

Prescription:

LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears,

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K211123 Page 3 of 7

surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC:

LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns.

7. COMPARISON WITH THE PREDICATE DEVICE

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel and the predicate device/reference device consist of different ingredients. However, they have the same intended use, similar designs and performance, and meet the biocompatibility requirements.

The table below compares the subject device to the predicate and reference devices.

Item	Subject Device(K211123)	Predicate Device(K083103)	Reference Device(K140483)
Device name	LUOFUCON® SilverWound Gel /LUOFUCON® SilverAntimicrobial WoundGel	AcryDerm AntimicrobialSilver Gel Model #B /OTC: AcryDerm WoundGel Model #B	ASAP OTC WoundDressing Gel
ClassificationRegulation	Unclassified	Unclassified	Unclassified
Product Code	FRO	FRO	FRO
Indications forUse (Rx)	LUOFUCON® SilverWound Gel is underthe medicalsupervision of ahealthcare professionalfor the management of	Under the supervisionof a healthcareprofessional, AcryDermSilver AntimicrobialWound Gel Model #Bis indicated for the	N/A
	1st and 2nd degreeburns, wounds such asstasis ulcers, pressureulcers, diabetic ulcers,lacerations, abrasions,skin tears, surgicalincision sites, deviceinsertion site wounds,graft sites, and donorsites.	management of 1st and2nd degree burns,wounds such as stasisulcers, pressure ulcers,diabetic ulcers,lacerations, abrasions,skin tears, surgicalincision sites, deviceinsertion site wounds,graft sites, and donorsites.
Indications forUse (OTC)	LUOFUCON® SilverAntimicrobial WoundGel is indicated for thetopical management ofminor abrasions, minorcuts, minor lacerationsand minor burns.	AcryDerm Wound GelModel #B is indicatedfor the management ofminor abrasions, cuts,lacerations and scalds.	ASAP OTC WoundDressing Gel isindicated for thetopical managementof minor cuts,lacerations,abrasions, 1st and2nd degree burns,and skin irritations.
Composition	Purified water,Carbopol, glycerol,polyethylene oxide,polyvinyl alcohol, silvercompound	Hydrophilic polymersand silver salt	Carbopol ETD 2020,triethanolamine,proprietary silverhydrosol suspension
Mechanism	Hydrophilic polymer formaintaining highmoisture content, ionicsilver for reducingmicroorganismcolonization within thedressing during shelfstorage.	Hydrophilic polymer formaintaining highmoisture content, ionicsilver for reducingmicroorganismcolonization within thedressing during shelfstorage.	Hydrophilic polymerfor maintaining highmoisture content,silver for reducingmicroorganismcolonization withinthe dressing duringshelf storage.
Antimicrobialagent	Silver compound	Silver compound	Element silver

Appearance	Colorless to light yellow, transparent to slightly cloudy	Slightly cloudy	Clear to golden yellow translucent gel
pH Value	5.0-7.5	N/A	6.5-8.0
Silver Content	$0.007%-0.012% w/w$	N/A	24ppm
Moisture Donation	≥10%	N/A	Greater than 5%
Moisture Absorption	<10%	N/A	Greater than 5%
Preservative Performance	USP <51> preservative effectiveness testing	USP <25> preservative assurance testing	USP <51>
Sterilized	Sterile	N/A	Not provided sterile

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K211123

Page 4 of 7

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K211123 Page 5 of 7

8. SUBSTANTIAL EQUIVALENCE DISCUSSION

LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe as its predicate device. The performance tests were conducted to demonstrate that the subject device is as effective as its predicate device.

Performance Testing

The following performance tests were conducted on subject devices in comparison to the predicate device and the reference device:

Appearance Fluid Affinity: EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency Loss on Drying: USP <731> Loss on Drying pH Value: USP <791> pH

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K211123 Page 6 of 7

Preservative Effectiveness: USP <51> Antimicrobial Effectiveness Testing

Biocompatibility Testing

Based on Table A.1 of ISO 10993-1 and Table A.1 of FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1_Evaluation and testing within a risk management process", the subject device is categorized as a surface device in contact with breached or compromised surface with prolonged duration. The subject device was evaluated for:

Cytotoxicity Sensitization Irritation Systemic toxicity Implantation Material-mediated pyrogenicity

Animal Study

A Porcine Wound Healing Study was conducted to evaluate the effect of the subject device on the wound healing process. Under the conditions of the study, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel did not inhibit normal wound healing and did not trigger adverse biological reactions.

Clinical Studies

No clinical study was conducted.

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FORY↓↓ MEDICAL

K211123 Page 7 of 7

9. CONCLUSIONS

Based on the comparison analysis, performance tests, biocompatibility tests and animal study provided in this submission, the subject device, LUOFUCON® Silver Wound Gel /LUOFUCON® Silver Antimicrobial Wound Gel is demonstrated to be as safe and effective as the legally marketed predicate device, AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B /OTC: AcryDerm Wound Gel Model #B (K083103). So, the subject device is considered Substantially Equivalent (SE) to the predicate device.

Regulation Number and Section

N/A