(226 days)
No
The document describes a collagen wound dressing and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for the management of wounds and supports wound healing, which falls under therapeutic use.
No
Explanation: The device is described as a wound dressing intended for the management and healing of wounds, not for diagnosing conditions. Its function is therapeutic/supportive (maintaining a moist environment for healing), not diagnostic.
No
The device description clearly states it is a "native bovine collagen wound dressing," which is a physical material, not software.
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 device directly to a wound on a patient's body to aid in healing.
- Device Description: The description details a "wound dressing" that is applied to a wound.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside of the body) to diagnose a condition, monitor a treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic wound dressing applied directly to the body.
N/A
Intended Use / Indications for Use
LUOFUCON® Collagen Particles is intended for the management of wounds including:
- · Full thickness and partial thickness wounds
- · Pressure (stage I-IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Venous stasis and diabetic ulcers
- · 1st and superficial second-degree burns
- Cuts
- Abrasions
- · Surgical wounds
Product codes
KGN
Device Description
LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles 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
Wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following non-clinical data and performance data are provided to demonstrate the safety and performance of the subject device and to support a determination of substantial equivalence.
7.1 Sterilization and Shelf-Life
LUOFUCON® Collagen Particles is sterilized using Gamma radiation to a sterility assurance level of 10-6. In addition to application of the VDmax25 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® Collagen Particles.
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 permanent duration, the relevant biocompatibility endpoints were conducted tests or risk evaluation as required. The results showed that LUOFUCON® Collagen Particles meets biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance, and it 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. Part of these tests were used to compare the subject device against its predicate device. Test results confirm that the subject device meets all product performance requirements and demonstrates substantial equivalence to the predicate device.
The following performance tests were conducted on subject devices:
- Appearance
- Weight
- Sieving rate
- Loss on drying
- Free swell absorption
- pH value
- Heavy metal
- Hydroxyproline assay
- Endotoxin content
- Sterility
- In-Vitro degradation
7.4 Animal-Derived Materials Safety
Based on utilization of animal derived materials in LUOFUCON® Collagen Particles, the requirements of safety is compliant with FDA quidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards.
The subject device has the same collagen raw materials and animal source as the reference device (K213598), and the information related to the safety of animal-derived materials had been submitted and approved by the FDA in the previous K213598 submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
April 25, 2024
Huizhou Foryou Medical Devices Co., Ltd. Taylor Deng R&D Manager No.1 Shangxia North Road, Dongjiang Hi-tech Industry Park, Huizhou. Guangdong 516000 China
Re: K232796
Trade/Device Name: LUOFUCON® Collagen Particles (Collagen Wound Dressing) Regulatory Class: Unclassified Product Code: KGN Dated: September 11, 2023 Received: September 12, 2023
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).
1
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 OS 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.
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.
2
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 Infection Control and 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
3
Indications for Use
510(k) Number (if known) K232796
Device Name
LUOFUCON® Collagen Particles (Collagen Wound Dressing)
Indications for Use (Describe)
LUOFUCON® Collagen Particles is intended for the management of wounds including:
- · Full thickness and partial thickness wounds
- · Pressure (stage I-IV) and venous ulcers
- · Ulcers caused by mixed vascular etiologies
- · Venous stasis and diabetic ulcers
- · 1st and superficial second-degree burns
- Cuts
- Abrasions
- · Surgical wounds
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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: K232796
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: 9/11/2023
2. Subject Device
Common or Usual Name: Collagen Wound Dressing Trade or Proprietary Name: LUOFUCON® Collagen Particles Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulatory Class: Unclassified Review Panel: General & Plastic Surgery
3. Predicate device and reference device
Predicate device:
The Name of Device: CoMatryx Collagen Wound Dressing 1 gram pouch 510(K) Number: K171645 Submitter: Strukmyer Medical Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulatory Class: Unclassified Review Panel: General & Plastic Surgery
5
510(K) Summary
Reference device:
The Name of Device: LUOFUCON® Collagen Wound Dressing Common Name: Collagen Wound Dressing 510(K) Number: K213598 Manufacturer: Huizhou Foryou Medical Devices CO., Ltd. Classification Name: Dressing, Wound, Collagen Product Code: KGN Regulatory Class: Unclassified Review Panel: General & Plastic Surgery
4. Device description
LUOFUCON® Collagen Particles is a native bovine collagen wound dressing that is sterile, white to off-white, absorbent and resorbable powder. LUOFUCON® Collagen Particles maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles can be applied to a wound either in the dry state or pre-hydrated with sterile saline, and can be used in conjunction with other suitable secondary dressings indicated for wound management. The device is intended for one time use.
LUOFUCON® Collagen Particles is sterilized and sold after sterilization by radiation using conditions validated following ISO 11137-2:2013.
5. Indication for Use
LUOFUCON® Collagen Particles is intended for the management of wounds including:
- Full thickness and partial thickness wounds
- Pressure(stage I-IV) and venous ulcers
- Ulcers caused by mixed vascular etiologies
- Venous stasis and diabetic ulcers
- 1st and superficial second-degree burns
- Cuts
- Abrasions
- Surgical wounds
6
6. Comparison to the predicate device
Table 1 provides a summary of the similarities and differences of the subject device and the predicate device in terms of indications for use, technological characteristics (e.g. design, material, physical structure, technology method, main process, mode of action), sterilization, bio-compatibility, and animal-derived materials safety.
| Item | Subject device | Predicate device | |
|---|---|---|---|
| 510(K) number | To Be Determined | K171645 | |
| Product Code | KGN | KGN | |
| Device Class | Unclassified | Unclassified | |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery | |
| Prescription | Yes | Yes | |
| Indications for use | Full thickness and partial thickness wounds, | ||
| Pressure(stage I-IV) and venous ulcers, | |||
| Ulcers caused by mixed vascular etiologies, | |||
| Venous stasis and diabetic ulcers, | |||
| 1st and superficial second-degree burns, | |||
| Cuts, | |||
| Abrasions, | |||
| Surgical wounds. | Full thickness and partial thickness wounds, | ||
| Pressure(stage I-IV) and venous ulcers, | |||
| Ulcers caused by mixed vascular etiologies, | |||
| Venous stasis and diabetic ulcers, | |||
| 1st and 2nd degree burns, | |||
| Cuts, | |||
| Abrasions, | |||
| Surgical wounds. | |||
| Material | Collagen | Collagen | |
| Animal Source | Bovine | Bovine | |
| Physical structure | Powder | Powder | |
| Biodegradable | Yes | Yes | |
| Technology method | Be ground to powder from collagen sheet | Be ground to powder |
| Table 1 | Comparison information |
|---|---|
| --------- | ------------------------ |
7
| Main processes | Drying and grind | Drying and grind |
|---|---|---|
| Mode of action | LUOFUCON® Collagen | |
| Particles absorb wound | ||
| exudate or sterile water | ||
| transform into a soft, | ||
| conformable gel, maintains a | ||
| moist wound environment, to | ||
| protect the wound and | ||
| support wound healing | When the dressing applied | |
| to a wound surface, | ||
| absorbs fluid and | ||
| maintains a moist wound | ||
| environment in the | ||
| management of wound | ||
| healing | ||
| Sterilization | Terminally sterilized by | |
| radiation, SAL 10-6 | Terminally sterilized by | |
| E-Beam | ||
| Packaging | Single barrier (Tyvek Pouch) | Bottle, Vial or Tyvek Pouch |
| Single use | Yes | Yes |
| Bio-compatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 |
| Animal-Derived | ||
| Materials Safety | Complied | Complied |
LUOFUCON® Collagen Particles has the similar indications for use, and very similar technological characteristics to the predicate device(K171645). Both devices are 100% collagen and are designed as powder form, Tyvek packaging, single-use, sterile product. Their main production process includes drying, grinding, and irradiation sterilization. The subject and predicate devices employ the same mode of action in that both devices contain an absorbent nature that maintains a moist wound environment to support wound healing.
LUOFUCON® Collagen Particles is compliant with FDA guidance-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).
7. Non-Clinical Data/Information
The following non-clinical data and performance data are provided to demonstrate the safety and performance of the subject device and to support a determination of substantial equivalence.
7.1 Sterilization and Shelf-Life
LUOFUCON® Collagen Particles is sterilized using Gamma radiation to a sterility assurance level of 10-6. In addition to application of the VDmax25 methodology,
8
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® Collagen Particles.
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 permanent duration, the relevant biocompatibility endpoints were conducted tests or risk evaluation as required. The results showed that LUOFUCON® Collagen Particles meets biocompatibility requirements of the ISO 10993-1 standard and FDA Guidance, and it 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. Part of these tests were used to compare the subject device against its predicate device. Test results confirm that the subject device meets all product performance requirements and demonstrates substantial equivalence to the predicate device.
The following performance tests were conducted on subject devices:
- Appearance
- Weight ●
- Sieving rate ●
- Loss on drying ●
- Free swell absorption ●
- pH value ●
- Heavy metal ●
- Hydroxyproline assay ●
- Endotoxin content
- Sterility ●
9
- In-Vitro degradation .
7.4 Animal-Derived Materials Safety
Based on utilization of animal derived materials in LUOFUCON® Collagen Particles, the requirements of safety is compliant with FDA quidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) and ISO 22442 standards.
The subject device has the same collagen raw materials and animal source as the reference device (K213598), and the information related to the safety of animal-derived materials had been submitted and approved by the FDA in the previous K213598 submission.
8. Conclusions
LUOFUCON® Collagen Particles has the similar indications for use, material composition, mode of action and very similar technological characteristic as predicate device, with differences in sterilization method, in-vitro degradation time, and packaging size.
Furthermore, the subject and reference device share a common collagen raw material. The subject device has the same processing steps except for an additional grinding process to the reference device, it is ground into powder on the basis of the reference device (collagen sheet). The safety of the reference device has been established and cleared by FDA, any potential safety risks associated with the change in shape of the reference device from sheet to powder form have been addressed through comparison and analysis.
Based on the information provided as summarized above, the minor differences between devices raise no new issues of safety or effectiveness. It can be concluded that the subject device is substantially equivalent to the predicate device(K171645) with regard to indications for use, technological characteristics, performance tests, animal-sourced material, and biocompatibility.