(309 days)
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 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.
The provided text is a 510(k) summary for the LUOFUCON® Collagen Wound Dressing, which is a medical device intended for wound management. The document states that the device is substantially equivalent to a predicate device (Medline Collagen Wound Dressing, K060456).
The document does not describe a study in the context of comparing the device to human readers or an AI algorithm, but rather a set of bench tests and biocompatibility tests to demonstrate safety and effectiveness for its intended use, and to prove substantial equivalence to a predicate device. This is typical for a 510(k) submission for a wound dressing, which is not an AI-powered diagnostic device.
Therefore, many of the requested fields are not applicable to the information provided in this document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as numerical thresholds for specific performance metrics. Instead, it states that "the subject device meets all product performance requirements for the intended use and demonstrates substantial equivalence to the predicate device."
However, we can infer some "performance requirements" that were tested:
| Criterion | Reported Device Performance |
|---|---|
| Sterilization | Sterilized using gamma radiation to a sterility assurance level of 10^-6. Confirmed per ISO 11137-1/-2. |
| Shelf-Life | 2 years (demonstrated by real-time aging test). |
| Biocompatibility | Meets biocompatibility requirements of ISO 10993-1 standard and FDA Guidance; raised no new safety concerns. |
| Physical/Chemical/Biological Properties (Bench Tests) | Meets all product performance requirements for the intended use; demonstrates substantial equivalence to the predicate device. |
| Animal-Derived Materials Safety | Compliant with FDA guidance and ISO 22442 standards; more than 6 logs reduction of viruses. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of an AI/human reader study. The document refers to "non-clinical data and performance data" and "bench tests" performed on the device itself. Specific sample sizes for these tests (e.g., number of dressings tested for tensile strength) are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no mention of a test set with ground truth established by experts, as this is not an AI diagnostic device.
4. Adjudication method for the test set
Not applicable.
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-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The type of ground truth used
Not applicable. The "ground truth" here is the physical, chemical, biological, and safety characteristics of the device being evaluated against established standards and the characteristics of the predicate device. For example, for sterility, the ground truth is "sterile at SAL 10^-6". For biocompatibility, the ground truth is "meeting ISO 10993-1 requirements".
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a machine learning model for this medical device submission.
9. How the ground truth for the training set was established
Not applicable.
{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
{2}------------------------------------------------
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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
{4}------------------------------------------------
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.
{6}------------------------------------------------
| Item | Subject device | Predicate device |
|---|---|---|
| 510(K) number | To Be Determined | K060456 |
| Product Code | KGN | KGN |
| Device Class | Unclassified | Unclassified |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery |
| Prescription | Yes | Yes |
| Intended use | LUOFUCON® Collagen Wound Dressing is intended for the management of wounds. | Medline Collagen Wound Dressing is indicated for the management of wounds. |
| Indications for use | 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. | 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. |
| Material | Bovine collagen | Collagen |
| Animal Source | Bovine | Bovine |
| Physical structure | Porous microstructure | Porous microstructure |
| Biodegradable | Yes | Yes |
| Technology method | Reconstructed from purified collagen | Reconstructed from purified collagen |
| Main processes | Freeze-drying and physical | Freeze-drying and |
| Table 5-1 Comparison between the subject device and the predicate device | |||
|---|---|---|---|
{7}------------------------------------------------
| cross-linking | cross-linking | |
|---|---|---|
| Mode of action | LUOFUCON® CollagenWound Dressing absorbswound exudate or sterilewater transforms into a soft,conformable gel sheet,maintains a moist woundenvironment, to protect thewound and support naturalwound healing. | Medline collagen wounddressing is a unique,sterile biomaterial, forms asoft, conformable moistgel sheet and provides amoist microenvironment atthe wound surface,promoting natural healing. |
| Sterilization | Terminally sterilized byradiation, SAL 10-6 | Terminally sterilized byradiation |
| Packaging | Single barrier | Single barrier |
| Single use | Yes | Yes |
| Shelf life | 2 years | 3 years |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Inactivationstudy of Viruses | Performed, more than 6 logsreduction of viruses | Complied |
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.
N/A