K Number
K213598
Device Name
LUOFUCON Collagen Wound Dressing
Date Cleared
2022-09-20

(309 days)

Product Code
Regulation Number
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.
Device Description
LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing. When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing. LUOFUCON® Collagen Wound 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. The dressing can be cut to the exact size of the wound, and can be used in multiple layers. LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
More Information

No
The description focuses on the material properties and physical function of a collagen wound dressing, with no mention of AI or ML.

No.
The device is a wound dressing whose function is to maintain a moist environment, protect the wound, and support natural healing, which are not considered therapeutic actions.

No

The device is a wound dressing designed to protect wounds and support natural healing, not to diagnose a condition.

No

The device is a physical wound dressing made of collagen, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Description and Intended Use: The description clearly states that the LUOFUCON® Collagen Wound Dressing is a wound dressing applied directly to the wound on the body. Its function is to manage wounds, absorb exudate, maintain a moist environment, and support healing. This is a therapeutic device applied in vivo (within the body or on the body surface).

The information provided focuses on the physical properties of the dressing and its application to the wound, not on analyzing biological samples for diagnostic purposes.

N/A

Intended Use / Indications for Use

LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.

The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is intended for the management of wounds.

Full thickness and partial thickness wounds
Pressure ulcers
Venous ulcers
Ulcers caused by mixed vascular etiologies
Diabetic ulcers
Partial thickness burns
Donor sites and other bleeding surface wounds
Abrasions
Traumatic wounds healing by secondary intention
Dehisced surgical incisions

Product codes (comma separated list FDA assigned to the subject device)

KGN

Device Description

LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.

When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.

LUOFUCON® Collagen Wound 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. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Data/Information:

  • Sterilization and Shelf-Life: LUOFUCON® Collagen Wound Dressing is sterilized using gamma radiation to a sterility assurance level of 10-6. The method of radiation sterilization was established and validated per ISO 11137-1/-2. A real-time aging test was conducted and the result demonstrated that the shelf-life of LUOFUCON® Collagen Wound Dressing is up to 2 years.

  • Biocompatibility: Based on Table A.1 of ISO 10993-1 and 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 permanent duration. The relevant biocompatibility endpoints were conducted tests or evaluation as required. The results showed that Collagen Wound Dressing meets 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. Biocompatibility tests included: Cytotoxicity, Irritation, Sensitization, Material-mediated pyrogenicity, Acute Systemic Toxicity, Genotoxicity, Subchronic Toxicity, Implantation, Haemolysis.

  • 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 its predicate device. 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, Weight, Loss on drying, Porosity, Tensile strength, Free swell absorption, The time of full absorbency, pH value, Heavy metal, Hydroxyproline assay, Endotoxin content, Sterility, Scanning Electron Microscope (SEM), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR), In-Vitro degradation, Degree of crosslinking, Trypsin resistance.

  • Animal-Derived Materials Safety Information: Based on utilization of animal derivative materials in LUOFUCON® collagen wound dressing, the relevant requirements of safety are compliant with FDA guidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060456

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K102946

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

N/A

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2022

Huizhou Foryou Medical Devices CO., Ltd. Taylor Deng R&D Assistant Manager No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park Huizhou, Guangdong 516000 China

Re: K213598

Trade/Device Name: LUOFUCON Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: August 5, 2022 Received: August 5, 2022

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 (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

1

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 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 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,

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213598

Device Name LUOFUCON® Collagen Wound Dressing

Indications for Use (Describe)

LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including: full thickness and partial thickness wounds, pressure ulcers, ulcers, ulcers caused by mixed vascular etiologies, diabetic ulcers, partial thickness burns, donor sites and other bleeding surface wounds, abrasions, traumatic wounds healing by secondary intention, dehisced surgical incisions.

The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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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: K213598

1. Submitter:

Huizhou Foryou Medical Devices CO., Ltd. Address: No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park, Huizhou, Guangdong, China. 516000 Phone: +86-752-5302185 Contact Person: Taylor Deng Email address: tfdeng@foryougroup.com Date Prepared: 11/05/2021

2. Subject Device:

Common or Usual Name: Collagen Wound Dressing Trade or Proprietary Name: LUOFUCON® Collagen Wound Dressing Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulatory Class: Unclassified Review Panel: General & Plastic Surgery

3. Predicate device and reference device:

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

Predicate device:

The Name of Device: Medline Collagen Wound Dressing 510(K) Number: K060456 Submitter: Medline Industries, Inc. Classification Name: Dressing, Wound, Collagen Product Code: KGN Requlatory Class: Unclassified

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Review Panel: General & Plastic Surgery

Reference device:

The Name of Device: Coreleader Colla-Pad Common Name: Collagen Wound Dressing 510(K) Number: K102946 Manufacturer: CORELEADER BIOTECH CO., LTD. Classification Name: Dressing, Wound, Collagen Product Code: KGN Requlatory Class: Unclassified Review Panel: General & Plastic Surgery

4. Device description:

LUOFUCON® Collagen Wound Dressing is comprised of a porous matrix of cross-linked bovine collagen. LUOFUCON® Collagen Wound Dressing is a sterile, single use, white or off-white, pliable, absorbent and biodegradable wound dressing.

When the wound dressing absorbs wound exudate or sterile water, LUOFUCON® Collagen Wound Dressing transforms into a soft, conformable gel sheet, maintains a moist wound environment, to protect the wound and support natural healing.

LUOFUCON® Collagen Wound 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. The dressing can be cut to the exact size of the wound, and can be used in multiple layers.

LUOFUCON® Collagen Wound Dressing is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.

5. Indication for Use:

LUOFUCON® Collagen Wound Dressing is intended for the management of wounds including:

Full thickness and partial thickness wounds Pressure ulcers

5

Venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical incisions

6. Comparison to the predicate device:

Table 5-1 summarizes the similarities and differences of the subject device and the predicate device in terms of intended use, indications for use, technological characteristics (e.q. design, material, physical structure, technology method, main process, mode of action), sterilization, and animal-derived materials safety.

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ItemSubject devicePredicate device
510(K) numberTo Be DeterminedK060456
Product CodeKGNKGN
Device ClassUnclassifiedUnclassified
Review PanelGeneral & Plastic SurgeryGeneral & Plastic Surgery
PrescriptionYesYes
Intended useLUOFUCON® Collagen Wound Dressing is intended for the management of wounds.Medline Collagen Wound Dressing is indicated for the management of wounds.
Indications for useFull thickness and partial thickness wounds,
Pressure ulcers,
Venous ulcers,
Ulcers caused by mixed vascular etiologies,
Diabetic ulcers,
Partial thickness burns,
Donor sites and other bleeding surface wounds,
Abrasions,
Traumatic wounds healing by secondary intention,
Dehisced surgical incisions.Full thickness and partial thickness wounds,
Pressure ulcers,
Venous ulcers,
Ulcers caused by mixed vascular etiologies,
Diabetic ulcers,
Partial and full thickness burns,
Donor sites and other bleeding surface wounds,
Abrasions,
Traumatic wounds healing by secondary intention,
Dehisced surgical incisions.
MaterialBovine collagenCollagen
Animal SourceBovineBovine
Physical structurePorous microstructurePorous microstructure
BiodegradableYesYes
Technology methodReconstructed from purified collagenReconstructed from purified collagen
Main processesFreeze-drying and physicalFreeze-drying and
Table 5-1 Comparison between the subject device and the predicate device

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cross-linkingcross-linking
Mode of actionLUOFUCON® Collagen
Wound Dressing absorbs
wound exudate or sterile
water transforms into a soft,
conformable gel sheet,
maintains a moist wound
environment, to protect the
wound and support natural
wound healing.Medline collagen wound
dressing is a unique,
sterile biomaterial, forms a
soft, conformable moist
gel sheet and provides a
moist microenvironment at
the wound surface,
promoting natural healing.
SterilizationTerminally sterilized by
radiation, SAL 10-6Terminally sterilized by
radiation
PackagingSingle barrierSingle barrier
Single useYesYes
Shelf life2 years3 years
BiocompatibilityComply with ISO 10993-1Comply with ISO 10993-1
Inactivation
study of VirusesPerformed, more than 6 logs
reduction of virusesComplied

LUOFUCON® Collagen Wound Dressing has the same intended use, similar indications for use, and very similar technological characteristics to the predicate device Medline Collagen Wound Dressing (K060456). Both devices are 100% collagen from bovine and are designed as single-layer, sheet form, porous microstructure, Tyvek packaging, single-use, sterile product. They are manufactured by way of freeze-drying, cross-linking, and irradiation sterilization processes. The subject and predicate devices employ the similar mode of action in that both devices contain an absorbent nature that maintains a moist wound environment to support natural wound healing.

The premarket submission of LUOFUCON® Collagen Wound Dressing is compliant with FDA guidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).

7. Non-Clinical Data/Information:

8

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

Sterilization and Shelf-Life

LUOFUCON® Collagen Wound Dressing is sterilized using gamma radiation to a sterility assurance level of 106. In addition to application of the VDmag-55 methodology, the method of radiation sterilization was established and validated per ISO 11137-1/-2.

Per FDA quidance on shelf life, a real-time aging test was conducted and the result demonstrated that the shelf-life of LUOFUCON® Collagen Wound Dressing is up to 2 years.

Biocompatibility

Based on Table A.1 of ISO 10993-1 and 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 permanent duration, the relevant biocompatibility endpoints were conducted tests or evaluation as required. The results showed that Collagen Wound Dressing meets 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.

Biocompatibility tests included:

  • Cytotoxicity
  • Irritation ●
  • Sensitization ●
  • Material-mediated pyrogenicity ●
  • Acute Systemic Toxicity
  • Genotoxicity
  • Subchronic Toxicity ●
  • Implantation ●
  • Haemolysis ●

9

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 its predicate device. 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
  • Weight ●
  • Loss on drying ●
  • Porosity ●
  • Tensile strength ●
  • Free swell absorption
  • The time of full absorbency ●
  • pH value
  • Heavy metal ●
  • Hydroxyproline assay
  • Endotoxin content
  • Sterility ●
  • Scanning Electron Microscope (SEM) ●
  • Differential Scanning Calorimetry (DSC)
  • Fourier Transform Infrared Spectroscopy (FTIR) ●
  • In-Vitro degradation ●
  • Degree of crosslinking ●
  • Trypsin resistance

Animal-Derived Materials Safety Information

Based on utilization of animal derivative materials in LUOFUCON® collagen wound dressing, the relevant requirements of safety is compliant with FDA guidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards.

10

8. Conclusions:

LUOFUCON® Collagen Wound Dressing has the same intended use, similar indications for use, and very similar technological characteristics as the predicate device, with differences in production processes, in-vitro degradation time, size, and shelf-life. The technological differences between the two devices raise no new issues of safety or effectiveness and the subject device is substantially equivalent to the legally marketed predicate device.

Based on the data provided as summarized above, it can be concluded that the subject device is substantially equivalent to the predicate device Medline collagen wound dressing (K060456) with regard to intended use, indications for use, technological characteristics, performance tests, animal-derived materials evaluation, and biocompatibility.