LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

Device Description

LUOFUCON® Silver Collagen Dressing is comprised of bovine collagen and silver chloride intended for the management of wounds. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria. LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing. LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (LUOFUCON® Silver Collagen Dressing) and describes its substantial equivalence to a predicate device. It details the device's characteristics, indications for use, and various tests performed to demonstrate its safety and performance. However, it does not explicitly state "acceptance criteria" as a set of quantified thresholds for performance, nor does it describe a study specifically designed to prove all elements of acceptance criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Puracol® Plus Ag MicroScaffold™ Wound Dressing), rather than defining and meeting specific, quantifiable acceptance criteria. The tests conducted are primarily to show that the subject device performs similarly to the predicate and meets general safety and performance standards for wound dressings.

Therefore, many of the requested fields cannot be directly extracted from the provided text in the manner specified. I will answer based on the information that is available, and indicate where information is not provided.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance outcomes. Instead, it states that "The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."

Here's an attempt to infer and summarize based on the provided "Performance Test-bench" section and the comparison table. It's important to note that the specific numerical acceptance criteria for each test are not provided in this document.

Acceptance Criteria (Inferred from tests conducted)	Reported Device Performance (Summary)
Sterilization: Sterility Assurance Level 10⁻⁶	Sterilized using Gamma radiation to SAL 10⁻⁶ per ISO 11137-1/-2.
Shelf-Life: Demonstrated stability over time	Real-time aging test conducted per FDA guidance; assumed to meet requirements.
Biocompatibility: (Various ISO 10993-1 tests)	Compliant with ISO 10993-1 standards and FDA Guidance; "raised no new safety concerns."
- Cytotoxicity	Acceptable
- Irritation	Acceptable
- Sensitization	Acceptable
- Material-mediated pyrogenicity	Acceptable
- Systemic Toxicity	Acceptable
- Genotoxicity	Acceptable
- Implantation	Acceptable
- Acute Systemic Toxicity	Acceptable
- Subchronic Systemic Toxicity	Acceptable
- Chronic toxicity	Acceptable
- Carcinogenicity (toxicological risk assessment)	Acceptable
Performance Test-bench:	All product performance requirements met; demonstrates substantial equivalence to predicate.
- Appearance	Acceptable (Implied, no specifics)
- Size	Acceptable (Implied, no specifics)
- Loss on drying	Acceptable (Implied, no specifics)
- Tensile strength	Acceptable (Implied, no specifics)
- Free swell absorption	Acceptable (Implied, no specifics)
- pH value	Acceptable (Implied, no specifics)
- Silver content	Acceptable (Implied, no specifics)
- Sterility	Acceptable (Covered under sterilization)
- Antibacterial effectiveness	"Effective against bacteria" (in vitro)
Animal-Derived Materials Safety: Compliant with FDA/ISO standards	Compliant with FDA guidance and ISO 22442 standards.

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

Sample size: Not specified. The document mentions "a series of bench tests" and "an in-vitro antibacterial effectiveness test" but does not provide the number of samples or specimens used for each test.
Data provenance: Not specified. The tests appear to be laboratory-based ("bench tests," "in-vitro") conducted by the manufacturer or a contracted lab. There is no mention of country of origin of data or whether it was retrospective or prospective in the context of clinical data, as this is a pre-market submission based on non-clinical testing.

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

Not applicable. This device is not an AI/software device that requires expert adjudication for ground truth. The "ground truth" for these tests would be the established scientific and engineering principles for material properties, sterilization efficacy, and biological safety, as defined by international standards (e.g., ISO, FDA guidance).

4. Adjudication method for the test set

Not applicable. See #3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a wound dressing, not an AI-assisted diagnostic or therapeutic device involving human readers.

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

Not applicable. See #5.

7. The type of ground truth used

For the non-clinical tests described:

Sterility: Established by documented validation methods (ISO 11137-1/-2) demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶.
Shelf-life: Established by real-time aging tests compliant with FDA guidance.
Biocompatibility: Established by adherence to ISO 10993-1 standards and FDA guidance, with specific tests conducted (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, etc.).
Performance (Physical/Chemical): Established by standard laboratory testing methodologies for properties like appearance, size, loss on drying, tensile strength, free swell absorption, pH value, and silver content.
Antibacterial effectiveness: Established by an in-vitro test.
Animal-Derived Materials Safety: Established by compliance with FDA guidance and ISO 22442 standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See #8.

Summary

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December 16, 2024

Huizhou Foryou Medical Devices Co., Ltd. Taylor Deng R&D Manager North Shangxia Rd. Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516006 China

Re: K240809

Trade/Device Name: LUOFUCON® Silver Collagen Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 15, 2024 Received: November 15, 2024

Dear Taylor Deng:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Page

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Yu-chieh Chiu -S

Yu-Chieh Chiu, Ph.D. Assistant Director DHT4B: Division of Plastic and Reconstructive 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) K240809

Device Name

LUOFUCON® Silver Collagen Dressing

Indications for Use (Describe) LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

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

Research Use (Part 21 CFR 201.3 Subject to)	Over-The-Counter Use (21 CFR 201.3 Subject to)
-------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | 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 the requirement of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(K) Number: K240809

1. Sponsor

Huizhou Foryou Medical Devices CO., Ltd. Address: No.1 North Shangxia Rd. Dongjiang Hi-tech Industry Park, 516005, Huizhou, PEOPLE'S REPUBLIC OF CHINA Phone: +86-752-5302185 Contact Person: Taylor Deng Email address: tfdeng@foryoumedical.com Date Prepared: December 11, 2024

2. Subject Device

The Name of Device: Silver Collagen Dressing Common or Usual Name: Silver Collagen Dressing Trade or Proprietary Name: LUOFUCON® Silver Collagen Dressing Classification Name: Dressing, Wound, Drug Product Code: FRO Regulatory Class: Unclassified Review Panel: General & Plastic Surgery

3. Predicate device

The subject device has been found to be substantially equivalent to the legally marketed predicate device.

Predicate device:

The Name of Device: Puracol® Plus Ag MicroScaffold™ Wound Dressing Trade name: Puracol Plus Ag Collagen Wound Dressing 510(K) Number: K071552 Submitter: Medline Industries, Inc. Manufacturer: Medskin Solutions Classification Name: Dressing, Wound, Drug Product Code: FRO Regulatory Class: Unclassified Review Panel: General & Plastic Surgery

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Device description ব

LUOFUCON® Silver Collagen Dressing is a sterile, single use, pliable, absorbent and biodegradable wound dressing. In the present of the wound exudate LUOFUCON® Silver Collagen Dressing transforms into a soft, conformable gel sheet, maintains a physically moist environment, to protect the wound and support natural healing.

LUOFUCON® Silver Collagen Dressing can be used as a primary wound dressing in direct contact with the wound, or be used in combination with other suitable secondary dressings.

5. Indication for Use

LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include:

Full thickness and partial thickness wounds ●
Pressure ulcers ●
Venous ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
First and second degree burns
Donor sites and other bleeding surface wounds
Abrasions
Trauma wounds healing by secondary intention
Dehisced wounds
Surgical wounds ●
Dehisced surgical wounds ●

Substantially Equivalent (SE) 6.

The following table summarizes the similarities and differences of the subject device, and the predicate device in terms of intended use, indications for use, technological characteristics, sterilization, and animal-derived materials safety.

Table 1 Comparison information

Item	Subject device	Predicate device
510(k) number	K240809	K071552
Product Code	FRO	FRO
Device Class	Unclassified	Unclassified
Prescription	Yes	Yes
Intended use	LUOFUCON® Silver CollagenDressing is intended for themanagement of wounds	Puracol Plus Ag CollagenWound Dressing is indicatedfor the management ofwounds
Indications foruse	Full thickness and partialthickness wounds	Full thickness and partialthickness wounds
	Pressure ulcers	Pressure ulcers
	Venous ulcers	Venous ulcers
	Ulcers caused by mixed vascularetiologies	Ulcers caused by mixedvascular etiologies
	Diabetic ulcers	Diabetic ulcers
	First and second degree burns	First and second degree burns
	Donor sites and other bleedingsurface wounds	Donor sites and other bleedingsurface wounds
	Abrasions	Abrasions
	Trauma wounds healing bysecondary intention	Trauma wounds healing bysecondary intention
	Dehisced wounds	Dehisced wounds
	Surgical woundsDehisced surgical wounds	Surgical woundsDehisced surgical wounds
Material	Collagen, Silver Chloride	Collagen, Silver Chloride
Physical structure	Porous microstructure	Porous microstructure
Mode of action	In the present of the woundexudate or sterile waterLUOFUCON® Silver CollagenDressing transforms into a soft,conformable gel sheet, maintainsa physically moist environment,Silver chloride is present toprevent bacteria colonizationwithin the dressing. An in-vitroantibacterial effectiveness testshowed that the dressing iseffective against bacteria	Puracol Plus Ag CollagenWound Dressing forms a soft,conformable moist gel sheet atthe wound surface, to providean ideal environment.Silver chloride is present toprevent bacteria colonizationwithin the dressing.
Sterilization	Terminally sterilized by	Terminally sterilized by
	radiation, SAL 10-6	radiation
Single use	Yes	Yes
Biocompatibility	Comply with ISO 10993-1	Comply with ISO 10993-1
Animal-DerivedMaterials Safety	Complied	Complied

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LUOFUCON® Silver Collagen Dressing has the same intended use, indications for use, and very similar technological characteristics to the predicate device.

Both devices are designed as single-layer, sheet form, porous microstructure, single-use, sterile product. The subject and predicate devices employ a similar mode of action in that both devices contain an absorbent nature that maintains a moist wound environment. Silver chloride is present to prevent bacteria colonization within the dressing. An in-vitro antibacterial effectiveness test showed that the dressing is effective against bacteria

Non-Clinical Data/Information 7.

The following non-clinical data and performance data were provided to demonstrate the safety and performance of the subject device for its intended use and to support a determination of substantial equivalence.

7.1 Sterilization and Shelf-Life

LUOFUCON® Silver Collagen Dressing was sterilized using Gamma radiation to a sterility assurance level of 10th. In addition to application of the VDmax-5 methodology, the method of radiation sterilization was established and validated per ISO 11137-1/-2.

Per FDA guidance on shelf life, a real-time aging test was conducted to demonstrate the shelf-life of LUOFUCON® Silver Collagen Dressing.

7.2 Biocompatibility

Based on Table A.1 of ISO 10993-1/Table A.1 of "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 surface device for breached or compromised surface with long-term duration, the relevant biocompatibility endpoints were conducted tests or evaluation as required. The results showed that LUOFUCON® Sliver Collagen Dressing meets

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biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance. The subject device raised no new safety concerns for biocompatibility to the predicate device.

The following biocompatibility tests were conducted:

Cytotoxicity ●
Irritation ●
Sensitization ●
Material-mediated pyrogenicity
Systemic Toxicity
Genotoxicity
Implantation
Acute Systemic Toxicity ●
Subchronic Systemic Toxicity
Chronic toxicity
Carcinogenicity of subject device is acceptable based on toxicological risk ● assessment

7.3 Performance Test-bench

A series of bench tests were conducted which included an evaluation of physical, chemical, and biological properties. Parts of bench test were used to compare the subject device against to the predicate device. The results of the testing confirm that the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device.

The following performance tests were conducted on subject devices:

Appearance ●
Size ●
Loss on drying
Tensile strength
Free swell absorption
pH value
Silver content
Sterility
Antibacterial effectiveness ●

7.4 Animal-Derived Materials Safety

Based on utilization of animal derived materials in LUOFUCON® Silver Collagen Dressing, the requirements of safety is compliant with FDA guidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for

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In Vitro Diagnostic Devices) and ISO 22442 standards.

8. Conclusions

Based on the data provided in this 510(K) submission as summarized above, it can be concluded that the subject device is substantially equivalent to the predicate device concerning intended use, indications for use, technological characteristics, performance data as shown in a series of performance tests and biocompatibility studies. The technological differences between the two devices raise no new issues of safety or effectiveness.

Regulation Number and Section

N/A