Prescription: LUOFUCON® PHMB Alginate Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, including postoperative wounds, trauma wounds, leg ulcers, diabetic ulcers, graft and donor sites.
OTC: LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Device Description

LUOFUCON® PHMB Alginate Dressing /LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is a sterile, single-use dressing consisting of calcium alginate fiber impregnated with polyhexamethylene biguanide, and the maximum polyhexamethylene biquanide content is 0.8% w/w. LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing can absorb wound exudate. As wound exudate is absorbed, the alginate forms a gel, which provide a moist wound healing environment, and allows intact removal. Based on in vitro performance data, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing has broad spectrum antibacterial effects, and the polyhexamethylene biguanide prevents colonization and proliferation of bacteria within the dressing for up to seven days.

AI/ML Overview

The provided document is an FDA 510(k) Premarket Notification for a wound dressing, not a device that relies on complex algorithms or AI. Therefore, the questions related to AI acceptance criteria, ground truth establishment, expert consensus, MRMC studies, and training/test set sample sizes are not applicable to this submission.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, indications for use, and performance testing typically associated with wound dressings, such as absorbency, pH, sterility, and antibacterial effectiveness. There is no mention of a "device" in the context of an AI/ML-driven diagnostic or analytical tool.

Here's a breakdown of the relevant information provided, and where the requested AI-related information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table between the subject device (LUOFUCON® PHMB Alginate Dressing) and two predicate devices (COPA AMD antimicrobial wound dressing K082296 and LUOFUCON® Extra Silver Alginate Dressing K172554). This table essentially outlines the "acceptance criteria" through comparison to legally marketed devices and reports the subject device's performance against these comparative standards.

Item	Subject Device (K201016)	Primary Predicate Device (K082296)	Secondary Predicate Device (K172554)
Product Code	FRO	FRO	FRO
Class	Unclassified	Unclassified	Unclassified
Indications for Use	(See full description in the document)	(See full description in the document)	(See full description in the document)
Mechanism	Alginate for absorbing liquid, PHMB for reducing bacteria colonization in dressing.	Polyurethane foam for absorbing liquid, PHMB for reducing bacteria colonization in dressing.	Alginate for absorbing liquid, silver for reducing bacteria colonization in dressing.
Material	Alginate 99.2% w/w, PHMB 0.80% w/w	Polyurethane foam 99.5% w/w, PHMB 0.50% w/w	Alginate 99.2%, Silver 0.80% w/w
Antibacterial agent	PHMB	PHMB	Silver
Dressing Use-life	Up to Seven days	Up to Seven days	Up to Seven days
Shelf-life	Two years	/	Two years
Package information	Aluminum foil or paper aluminum plastic pouch, box and Carton	Paper-plastic bag, box and Carton	Aluminum foil pouch, box and Carton
Single Use	Yes	Yes	Yes
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Size	Prescription: Max. 200mm×200mm, OTC: Max. 200mm×200mm	Prescription: Max. 20.3cm×20.3cm	Prescription: Max. 200mm×200mm, OTC: Max. 200mm×100mm
Weight per unit area	120 g/m² - 240 g/m²	N/A	120 g/m² - 240 g/m²
Free swell absorption capacity	≥12g/100cm²	N/A	≥12g/100cm²
pH value	4.0-5.0	N/A	4.0-7.0
PHMB content	0.40-0.80% w/w	0.50% w/w	N/A
Antibacterial effectiveness	4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)	4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)	4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)

The acceptance criteria for this non-AI medical device are primarily established by demonstrating substantial equivalence to existing legally marketed predicate devices in terms of:

Intended Use: The indications for use are highly similar to the predicate devices.
Design and Materials: The core components (alginate/PHMB) and their functions are comparable.
Performance: Various physical and biological tests show comparable performance characteristics. Specifically, the antibacterial effectiveness demonstrating a "4 Log Reduction for six organisms up to 7 days" is a key performance metric that aligns across all compared devices.

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

This is a wound dressing, not a data-driven AI device. Therefore, the concept of a "test set" in the context of machine learning does not apply. The performance testing refers to laboratory studies on the physical and chemical properties of the dressing and its biological effectiveness (antibacterial activity). The document does not specify sample sizes for these tests, only that they were conducted "on subject devices."

The provenance of data would be from laboratory testing conducted by the manufacturer, Huizhou Foryou Medical Devices Co., Ltd., based in Huizhou, Guangdong, China. This would be considered prospective lab testing for the purpose of this submission.

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

Not applicable. "Ground truth" in the context of expert consensus on data is irrelevant for a physical wound dressing. The "truth" here is determined by validated laboratory test methods (e.g., BS EN 13726-1, USP <731>, USP <791>, ISO 11737-2, Modified AATCC TM100, ISO 10993-1).

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

Not applicable, as there is no "test set" requiring adjudication by human experts in this context.

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 is not an AI device.

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

Not applicable. This is not an AI device.

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

For this wound dressing, the "ground truth" for its performance is established through:

Standardized performance tests: Adherence to international standards (e.g., ISO, USP, BS EN, AATCC) for physical properties (e.g., absorbency, pH, weight) and sterility.
Microbiological assays: In vitro studies demonstrating antibacterial effectiveness (4 Log Reduction) against specified organisms.
Biocompatibility testing: In vitro and in vivo (porcine wound healing study) tests to assess biological safety, following ISO 10993-1 guidelines.

8. The sample size for the training set:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

Summary

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January 28, 2021

Huizhou Foryou Medical Devices Co., Ltd. Guosheng Tan Development Engineer No. 1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516005 China

Re: K201016

Trade/Device Name: LUOFUCON® PHMB Alginate Dressing (Prescription use), LUOFUCON® PHMB Antibacterial Alginate Wound Dressing (OTC use) Regulatory Class: Unclassified Product Code: FRO Dated: April 15, 2020 Received: April 17, 2020

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. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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/cdrh-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 Kimberly Ferlin, PhD Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201016

Device Name

LUOFUCON® PHMB Alginate Dressing (Prescription use) LUOFUCON® PHMB Antibacterial Alginate Wound Dressing(OTC use)

Indications for Use (Describe) Prescription:

Prescription:

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

OTC:

LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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: Guosheng Tan Date Prepared: April 15, 2020

2. SUBJECT DEVICE

Name of Device: LUOFUCON® PHMB Alginate Dressing (Prescription use),

LUOFUCON® PHMB Antibacterial Alginate Wound Dressing (OTC use)

Common or Usual Name: PHMB Alginate Dressing Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Product Code: FRO

3. PREDICATE DEVICES:

510(k) Number: K082296 Product Name: COPA AMD antimicrobial wound dressing Manufacturer: Kendall, a Division of Tyko Healthcare Group LP

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510(k) Number: K172554

Product Name: LUOFUCON® Extra Silver Alginate Dressing (Prescription use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use) Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.

4. DEVICE DESCRIPTION:

Based on in vitro performance data, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing has broad spectrum antibacterial effects, and the polyhexamethylene biguanide prevents colonization and proliferation of bacteria within the dressing for up to seven days.

5. INDICATIONS FOR USE:

Prescription:

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ОТС:

LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is indicated for first aid to help in minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

6. COMPARISON WITH THE PREDICATE DEVICE:

LUOFUCON® PHMB Alginate Dressing/ LUOFUCON® PHMB Antibacterial Alginate Wound Dressing is Compared with the Predicate Devices in terms of intended use, design, material, specifications, and performance. The following table shows their similarities and differences.

Item	Subject Device(K201016)	Primary Predicate Device(K082296)	Secondary Predicate Device(K172554)
Product Code	FRO	FRO	FRO
Class	Unclassified	Unclassified	Unclassified
Indications for use	Prescription:LUOFUCON® PHMBAlginate Dressing isindicated for themanagement of moderateto heavily exuding partial tofull thickness wounds,including postoperativewounds, trauma wounds,leg ulcers, pressure ulcers,diabetic ulcers, graft anddonor sites.OTC:LUOFUCON® PHMBAntibacterial AlginateWound Dressing isindicated for first aid to helpin minor abrasions, minorcuts, minor lacerations,minor scrapes, minor scaldsand minor burns.	Prescription:COPA AMD Dressing areindicated for use in themanagement ofpost-surgical incisions,pressure sores, venousstasis ulcers, diabeticulcers, donor sites,abrasions, lacerations, firstand second-degree burns,dermatologic disorders,other wounds inflicted bytrauma, and as a secondarydressing or cover dressingfor packed wounds.	Prescription:LUOFUCON® Extra SilverAlginate Dressing isindicated for themanagement of moderateto heavily exuding partial tofull thickness wounds,includingpostoperative wounds,trauma wounds, leg ulcers,pressure ulcers, diabeticulcers, graft and donorsites.OTC:LUOFUCON® AntibacterialAlginate Wound Dressing isfirst aid to help in minorabrasions, minor cuts,lacerations, scrapes, minorscalds and burns.
Mechanism
Alginate for absorbing liquid, PHMB in the alginate for reducing bacteria colonization in the dressing.	Polyurethane foam for absorbing liquid, PHMB present in the Polyurethane foam for reducing bacteria colonization in the dressing.	Alginate for absorbing liquid, silver present in the alginate for reducing bacteria colonization in the dressing.
Material
Alginate 99.2% w/w, PHMB 0.80% w/w	Polyurethane foam 99.5% w/w, PHMB 0.50% w/w	Alginate 99.2%, Silver 0.80% w/w
Antibacterial agent
PHMB	PHMB	Silver
Dressing Use-life
Up to Seven days	Up to Seven days	Up to Seven days
Shelf-life
Two years	/	Two years
Package information
Aluminum foil or paper aluminum plastic pouch, box and Carton	Paper-plastic bag, box and Carton	Aluminum foil pouch, box and Carton
Single Use
Yes	Yes	Yes
Sterilization
Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Size
Prescription:Max. 200mm×200mmOTC:Max. 200mm×200mm	Prescription:Max.20.3cm×20.3cm	Prescription:Max. 200mm×200mmOTC:Max. 200mm×100mm
Weight per unit area
120 g/m² - 240 g/m²	N/A	120 g/m² - 240 g/m²
Free swell absorption capacity
≥12g/100cm²	N/A	≥12g/100cm²
pH value
4.0-5.0	N/A	4.0-7.0
PHMB content
0.40-0.80% w/w	0.50% w/w	N/A
Antibacterial effectiveness
4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)	4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)	4 Log Reduction for six organisms up to 7 days (MRSA/VRE/ Streptococcus pyogenes/Escherichia coli/ Pseudomonas aeruginosa/ Klebsiella pneumonia)

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7. SUBSTANTIAL EQUIVALENCE DISCUSSION:

LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing and its predicate devices (K082296, K172554) have the similar

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function design and are made of the similar materials. The alginate or polyurethane foam is designed for exudate absorption and wound care, and the PHMB presented in the dressing as an antimicrobial agent is used for antibacterial effectiveness. The biocompatibility of subject device is evaluated according to ISO 10993-1, and the antibacterial effectiveness of both subject device and predicate devices can achieve 4 Log Reduction. Therefore, device materials in the subject device and predicated device do not raise any different question of safety and effectiveness. The predicate device (K172554) is also used for supporting the subject device's performance and indications for use (Prescription use and OTC use), because both subject device and predicate device (K172554) use alginate as the substrate for the antibacterial dressing, both of which have similar performance, such as size, weight per unit area, free swell absorption capacity, pH value.

Performance Testing

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

Appearance
Size
Weight per unit area ●
Free Swell Absorption Capacity: conducted in accordance with BS EN ● 13726-1 Test methods for primary wound dressings-Part 1: Aspects of absorbency.
Loss on Drying: conducted in accordance with USP <731> Lost on Drying
pH Value: complied with USP <791> Ph.
PHMB content
Sterility: conducted in accordance with ISO 11737-2 Sterilization of medical ● devices- Microbiological Methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
Antibacterial effectiveness: conducted in accordance with Modified AATCC TM100.

Biocompatibility Testing

Based on Table A.1 of ISO 10993-1 and Table A.1 of "Use of International

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Standard ISO 10993-1, Biological evaluation of medical devices-Part 1 Evaluation and testing within a risk management process", the subject is categorized as surface device for breached or compromised surface with prolonged duration. The device has been demonstrated to safe for its intended use. The subject device was evaluated for:

Cytotoxicity .
Sensitization
Irritation
Systemic toxicity
Implantation
Material-mediated pyrogenicity

Pre-Clinical Studies

A porcine wound healing study was carried out to evaluate the safety for the subject device, and the study results showed that the local tissue response to subject device is addressed for implantation biocompatibility endpoint.

8. SUBSTANTIAL EQUIVALENCE CONCLUSION:

Based on the comparison of intended use, design, materials, performance and biocompatibility testing, the subject device, LUOFUCON® PHMB Alginate Dressing/LUOFUCON® PHMB Antibacterial Alginate Wound Dressing, is determined to be Substantially Equivalent (SE) to the predicate devices, COPA AMD antimicrobial wound dressing (K082296) and LUOFUCON® Extra Silver Alginate Dressing (Prescription use)/ LUOFUCON® Antibacterial Alginate Wound Dressing (OTC Use)(K172554), in respect of safety and effectiveness.

Regulation Number and Section

N/A