(266 days)
Not Found
No
The device description and performance studies focus on the physical, chemical, and biological properties of a wound dressing, with no mention of AI or ML technologies.
No.
The device is a wound dressing designed to support natural healing and prevent bacteria colonization, which is a supportive role in managing wounds rather than a direct therapeutic intervention.
No
The device is a wound dressing designed for management and healing of wounds, not for diagnosing conditions. Its description focuses on its physical and chemical properties and wound care efficacy, rather than diagnostic capabilities.
No
The device description clearly states it is a physical wound dressing comprised of bovine collagen and silver chloride. It is a sterile, single-use, pliable, absorbent, and biodegradable material. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management of wounds." This involves applying the dressing directly to the wound for healing purposes.
- Device Description: The description details the composition and function of the dressing as a wound care product. It mentions its properties like being absorbent, biodegradable, and forming a gel in the presence of exudate to support healing.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to diagnose a condition, monitor a disease, or screen for a disease. The "in-vitro antibacterial effectiveness test" mentioned is a bench test performed on the dressing itself, not a diagnostic test performed on a patient sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a therapeutic wound dressing.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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
Not Found
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
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 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.
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.
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 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.
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.
Not Found
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 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
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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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 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.
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 Collagen | |
| Dressing is intended for the | ||
| management of wounds | Puracol Plus Ag Collagen | |
| Wound Dressing is indicated | ||
| for the management of | ||
| wounds | ||
| Indications for | ||
| use | Full thickness and partial | |
| thickness wounds | Full thickness and partial | |
| thickness wounds | ||
| Pressure ulcers | Pressure ulcers | |
| Venous ulcers | Venous ulcers | |
| Ulcers caused by mixed vascular | ||
| etiologies | Ulcers caused by mixed | |
| vascular etiologies | ||
| Diabetic ulcers | Diabetic ulcers | |
| First and second degree burns | First and second degree burns | |
| Donor sites and other bleeding | ||
| surface wounds | Donor sites and other bleeding | |
| surface wounds | ||
| Abrasions | Abrasions | |
| Trauma wounds healing by | ||
| secondary intention | Trauma wounds healing by | |
| secondary intention | ||
| Dehisced wounds | Dehisced wounds | |
| Surgical wounds | ||
| Dehisced surgical wounds | Surgical wounds | |
| Dehisced surgical wounds | ||
| Material | Collagen, Silver Chloride | Collagen, Silver Chloride |
| Physical structure | Porous microstructure | Porous microstructure |
| Mode of action | In the present of the wound | |
| exudate or sterile water | ||
| LUOFUCON® Silver Collagen | ||
| Dressing transforms into a soft, | ||
| conformable gel sheet, maintains | ||
| a physically moist 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 | Puracol Plus Ag Collagen | |
| Wound Dressing forms a soft, | ||
| conformable moist gel sheet at | ||
| the wound surface, to provide | ||
| an ideal environment. | ||
| Silver chloride is present to | ||
| prevent bacteria colonization | ||
| within 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-Derived | ||
| Materials 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
8
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
9
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.