(171 days)
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No
The description focuses on the material composition and physical properties of a collagen wound dressing, with no mention of AI or ML technologies.
Yes
The device is clearly indicated for the management of various types of wounds, including ulcers, burns, and surgical incisions, which falls under the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
Explanation: The device, Collagen Wound Dressing, is described as an advanced wound care device for the management of exuding wounds. Its function is to provide a dressing for wounds, not to diagnose a medical condition or disease.
No
The device description clearly states it is a physical wound dressing made of collagen, 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 the device is for the "management of exuding wounds" and lists various types of wounds. This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a "topical wound dressing" made of collagen. This is a physical device applied to the body, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a wound care product, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions
Product codes
KGN
Device Description
Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound management determined by a healthcare professional.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data/Information:
Biocompatibility: Based on ISO 10993-1, relevant biocompatibility endpoints were conducted tests or evaluation as required. Results showed that Collagen Wound Dressing meets biocompatibility requirements and FDA Guidance, raising no new safety concerns. Tests included: cytotoxicity, acute systemic toxicity, subcutaneous implantation, irritation, subacute systemic toxicity, pyrogenicity, skin sensitization, and chemical characterization.
Performance Test: A series of bench tests were conducted evaluating physical, chemical, and biological properties. Results confirm the proposed device meets all product performance requirements for its intended use and demonstrates substantial equivalence to the predicate device. Tests included: Appearance, Weight, Free swell absorption, pH value, Heavy metals, Hydroxyproline assay, Bacterial Endotoxins, Sterility, Scanning Electron Microscope (SEM), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR).
Sterilization and Shelf Life: The device is provided sterile and undergoes irradiation sterilization by gamma ray to achieve a Sterility Assurance Level (SAL) of 10^-6. Validation study for radiation sterilization dose establishment is carried out according to ISO 11137-1/-2:2013, ISO11137-3:2017, ISO11737-1:2018, ISO 11737-2:2019. Shelf life is currently 1 year based on completed one-year real-time aging test, with a proposed 3-year test ongoing.
Animal-Derived Materials Safety Information: Compliant with FDA guidance document and ISO 22442 standards. Animal testing, biocompatibility testing, chemical characterization studies, and inactivation study of viruses confirmed the safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2023
Winner Medical Co., Ltd. Ziling Shangguan Regulatory Affairs Specialist Winner Industrial Park. No. 660 Bulong Road. Longhua District Shenzhen, Guangdong 518109 China
Re: K231152
Trade/Device Name: Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: September 12, 2023 Received: September 12, 2023
Dear Ziling Shangguan:
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 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.
For comprehensive regulatory information about medical devices and radiation-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
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Enclosure
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Indications for Use
510(k) Number (if known) K231152
Device Name Collagen Wound Dressing
Indications for Use (Describe) The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions
| 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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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. Date Prepared: October 12th, 2023
1. Submitter Identification
Winner Medical Co., Ltd
Address: Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China Contact Person: Ziling Shangguan Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 150639@winnermedical.com
2. Identification of Proposed Device
Common or Usual Name: Collagen Wound Dressing
Regulatory Information Device Common Name: Wound dressing, animal-derived material(s) Classification: Unclassified Product Code: KGN
Review Panel: General and Plastic Surgery
3. Identification of Predicate Device
Predicate device: Medline Collagen Wound Dressing
510(K) Number: K060456
Manufacturer: Medline Industries, Inc.
Device Common Name: Wound dressing, animal-derived material(s)
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Classification: Unclassified
Product Code: KGN
Review Panel: General and Plastic Surgery
4. Device Description
Collagen Wound Dressing is an advanced wound care device composed of pure freezedried cross-linked bovine collagen. It is a sterile, absorbent, white, porous, topical wound dressing. As a primary wound dressing, it can be cut to any size or be used in multi-layers to fit wound. It can also be used in combination with either occlusive or semi-occlusive secondary dressing. The product is biodegradable. Please reapply the dressing as needed based on the patient's wound management determined by a healthcare professional.
5. Intended Use Statement
The Collagen Wound Dressing is indicated for the management of exuding wounds including: Full thickness and partial thickness wounds Pressure and venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Partial thickness burns Donor sites and other bleeding surface wounds Abrasions Traumatic wound healing by secondary intention Dehisced surgical incisions
6. Non-Clinical Data/Information
The following non-clinical data and performance data are provided to demonstrate the safety and performance of the proposed device for its intended use and to support a
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determination of substantial equivalence.
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 proposed 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 proposed device raised no new safety concerns for biocompatibility to the predicate device.
Biocompatibility tests included: cytotoxicity, acute systemic toxicity, subcutaneous implantation, irritation, subacute systemic toxicity, pyrogenicity, skin sensitization, and chemical characterization.
Performance Test
A series of bench tests were conducted which included an evaluation of physical, chemical, and biological properties. Results of the testing confirm that the proposed 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 proposed devices: Appearance, Weight, Free swell absorption, pH value, Heavy metals, Hydroxyproline assay, Bacterial Endotoxins, Sterility, Scanning Electron Microscope (SEM), Differential Scanning Calorimetry (DSC), Fourier Transform Infrared Spectroscopy (FTIR).
Sterilization and Shelf Life
The proposed device is provided sterile and will subject to an irradiation sterilization process by gamma ray, in its final package to achieve a Sterility Assurance Level (SAL) of 10 %. The validation study for radiation sterilization dose establishment is carried out
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according ISO 11137-1/-2:2013, ISO11137-3:2017, ISO11737-1:2018, ISO 11737-2:2019. The results for the sterility testing showed that, the products achieved a SAL of 10-6 after the irradiation sterilization process.
A proposed 3 years real time aging test is being conducted per FDA guidance on shelf life. Now we have finished the one-year test. So a maximum shelf life of one (1) years should be assigned to the proposed device, when stored in when stored in a cool (below 25 °C) place, avoid excessive light and humidity (below 50%), in accordance with the manufacturer's recommendations. The shelf life is based on an assessment of the seal integrity of the sterile barrier packaging and functional testing of device. The results demonstrated that all performance indicators of the proposed device meet the requirements.
Animal-Derived Materials Safety Information
Based on utilization of animal derivative materials in 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. Animal testing, biocompatibility testing, chemical characterization studies and inactivation study of viruses confirmed the safety of proposed device.
7. Clinical Test Conclusion
No clinical study is included in this submission.
8. Substantially Equivalent (SE) Comparison
The proposed device is compared with the following predicate device in terms of intended use, indications for use, technological characteristics (e.g. design, material, physical structure, technology method, main process, mode of action), sterilization, and animal-derived materials safety. These data of predicate devices came from commercially product labeling and 510(k) summary.
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| Item | Subject device | Predicate device | |
|---|---|---|---|
| Device Name | Collagen Wound Dressing | Medline Collagen Wound | |
| Dressing | |||
| 510(k) number | K231152 | K060456 | |
| Product Code | KGN | KGN | |
| Device Class | Unclassified | Unclassified | |
| Review Panel | General & Plastic Surgery | General & Plastic Surgery | |
| Prescription | Yes | Yes | |
| Intended use | The Collagen Wound Dressing | ||
| is indicated 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 | Collagen | Collagen | |
| Animal Source | Bovine | Bovine | |
| Physical | |||
| structure | Porous microstructure | Porous microstructure | |
| Biodegradable | Yes | Yes | |
| Technology | Reconstructed from purified | ||
| collagen | Reconstructed from purified | ||
| collagen | |||
| Main processes | Freeze-drying and cross-linking | Freeze-drying and cross-linking | |
| Principle of operation | The Collagen Wound Dressing forms a biodegradable, semitransparent gel sheet, which maintains a physiologically moist microenvironment at the wound surface. | 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. | |
| Sterilization | Irradiation sterilization | Irradiation sterilization | |
| Packaging | Single barrier | Single barrier | |
| Single use | Yes | Yes | |
| Shelf life | 1 year | 3 years | |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | |
| Animal experiments | Performed, similar in the wound healing rate, no effect the normal healing of the wound. | Complied | |
| Inactivation study of Viruses | Performed, more than 6 logs reduction of viruses | Complied | |
| Chemical Characterization Study and Toxicological Risk Assessment | Performed, the toxicological risk of extractable is acceptable. | Complied |
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The Collagen Wound Dressing has the same intended use, similar indications for use, and very similar technological characteristics to the predicate device. All 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 proposed device and predicate device employ the similar mode of action in that all devices contain an absorbent nature that maintains a moist wound environment to support natural wound healing.
The premarket submission of Collagen Wound Dressing is compliant with FDA guidance document-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).
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9. Substantial Equivalence (SE) Conclusion
The Collagen Wound Dressing has the same intended use, very similar indications for use and technological characteristics as the predicate device. The differences between the devices raise no new issues of safety or effectiveness.
Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the legally marketed predicate device with regard to intended use, indications for use, technological characteristics, performance tests, animal-derived materials evaluation, and biocompatibility.