(232 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a wound dressing gel, with no mention of AI or ML technologies.
Yes
The device is described as a wound dressing intended for the management of various types of wounds, indicating a therapeutic purpose in aiding the healing process and managing symptoms.
No
The device is described as a wound dressing, a "moist amorphous gel," intended for the management of wounds rather than for identifying or diagnosing a condition. Its function is to aid in wound care and healing by maintaining a moist environment and inhibiting microbial growth.
No
The device description clearly states it is a "non-sterile, repeated-use moist amorphous gel" and describes its physical composition and packaging (HDPE tubes). This indicates it is a physical product, 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 a wound dressing for the management of various types of wounds. This is a topical application for treating the wound itself, not for diagnosing a condition or analyzing a sample taken from the body.
- Device Description: The description details the composition and function of a gel applied to the wound surface. It describes its properties related to moisture management and preservation within the gel, not the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is applied in vivo (on the body) to treat a wound.
N/A
Intended Use / Indications for Use
For Prescription Use: Under the supervision of a healthcare professional, Antibacterial Gel Wound Dressing is indicated for the management of first and superficial second degree burns, wounds such as stasis ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites,
For Over-the-Counter Use: Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject device, Antibacterial Gel Wound Dressing, is a non-sterile, repeated-use moist amorphous gel. The hydrogel consists of amorphous cellulose-based gel complex, silver ions and Benzalkonium Chloride (BZK). The silver ions and Benzalkonium Chloride (BZK) act as a preservative to inhibit the growth of microorganisms in the gel during shelf storage. The hydroxyethyl cellulose is used as thickener to modify the viscosity of the wound gel, resulting in a moist amorphous gel with the function of moisture donation and moisture absorption. The combination of allantoin and propylene glycol are used as moisturizer to prevent gel water release. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound. The hydrogel helps to maintain a moist wound environment. The hydrogel is supplied in collapsible blind ended heat sealed HDPE tubes fitted with screw caps.
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
For Prescription Use: Under the supervision of a healthcare professional
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)
Performance Testing:
- Fluid Affinity: EN 13726-1 Test methods for primary wound dressings - Part 1: Aspects of absorbency, Loss on Drying; Subject device Result: Moisture Donation >15-20% Moisture Absorption 0-10%
- Loss on Drying: USP Loss on Drying
- pH Value: USP pH; Subject device Result: 5.5-7.5
- Bioburden: USP Microbiological examination of non-sterile products-microbial enumeration tests; USP Microbiological examination of nonsterile products-tests for specified microorganisms; Subject device Result: Pass
- Preservative Effectiveness: USP Antimicrobial Effectiveness Testing; Subject device Result: Pass
Biocompatibility Testing:
- Conducted in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO - 10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'. Test results meet the requirements.
- Comply with ISO 10993-5, ISO 10993-10, ISO 10993-6 and ISO 10993-11.
Animal Study:
- A porcine wound healing study was carried out to evaluate the cytotoxicity of subject device.
- The study demonstrated that there were no biologically relevant differences between the subject devices (Antibacterial Gel Wound Dressing), and a Control Silver Antimicrobial Wound Gel (also named SILVASORB GEL®) in terms of wound healing performance characteristics.
Clinical Study:
- No clinical study was conducted.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 1, 2023
Winner Medical Co., Ltd. Yeqing Cai Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road Longhua District Shenzhen, Guangdong 518109 China
Re: K231057
Trade/Device Name: Antibacterial Gel Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 26, 2023 Received: May 26, 2023
Dear Yeqing Cai:
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 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.
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 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).
Sincerelv. 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
2
Indications for Use
510(k) Number (if known) K231057
Device Name Antibacterial Gel Wound Dressing
Indications for Use (Describe)
For Prescription Use:
Under the supervision of a healthcare professional, Antibacterial Gel Wound Dressing is indicated for the management of first and superficial second degree burns, wounds such as stasis ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites,
For Over-the-Counter Use:
Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K231057
-
- Date of Submission: April 13, 2023
2. Submitter Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No. 660 Bulong Road, Longhua District, Shenzhen City, Guangdong Province, 518109, China
Contact Person: Yeqing Cai Position: Regulatory Affairs Specialist Tel: +86-755 28138888 Fax: +86-755 28134588 Email: 152323 @winnermedical.com
3. Identification of Subject Device
Trade/Proprietary Name: Antibacterial Gel Wound Dressing Device Common Name: Dressing, Wound, Drug Classification: Unclassified Product Code: FRO Review Panel: General & Plastic Surgery
4. Identification of Predicate Device
Predicate Device: AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103) Manufacturer: AcryMed, InC.
5. Device Description
The subject device, Antibacterial Gel Wound Dressing, is a non-sterile, repeated-use moist amorphous gel. The hydrogel consists of amorphous cellulose-based gel complex, silver ions and Benzalkonium Chloride (BZK). The silver ions and Benzalkonium Chloride (BZK) act as a preservative to inhibit the growth of microorganisms in the gel during shelf storage. The hydroxyethyl cellulose is used as thickener to modify the viscosity of the wound gel, resulting in
4
a moist amorphous gel with the function of moisture donation and moisture absorption. The combination of allantoin and propylene glycol are used as moisturizer to prevent gel water release. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound. The hydrogel helps to maintain a moist wound environment. The hydrogel is supplied in collapsible blind ended heat sealed HDPE tubes fitted with screw caps.
6. Intended Use Statement
Antibacterial Gel Wound Dressing is intended for prescription (Rx) and over-the-counter (OTC) use as follows:
-
For Prescription Use:
Under the supervision of a healthcare professional, Antibacterial Gel Wound Dressing is indicated for the management of first and superficial second degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. -
· For Over-the-Counter Use:
Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds.
7. Substantially Equivalent (SE) Comparison
The subject device, Antibacterial Gel Wound Dressing, is compared with the following predicate device in terms of intended use, material components, technology, performance and etc. The data of the predicate device from commercially product labeling and 510(k) summary is as following.
- . Predicate Device, K083103, AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B, Manufactured by AcryMed, InC.
| Device
| Characteristic | Subject device | Predicate device |
|---|---|---|
| Product Code | FRO | FRO |
| Class | Unclassified | Unclassified |
| Intended Use | For Prescription Use: Under | |
| the supervision of a healthcare | ||
| professional, the Antibacterial | ||
| Gel Wound Dressing is indicated | For Prescription use: Under the | |
| supervision of a healthcare | ||
| professional, AcryDerm Silver | ||
| Antimicrobial Wound Gel Model #B | ||
| for the management of first and superficial second degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. | ||
| For Over-the-Counter Use: | ||
| Antibacterial Gel Wound Dressing is intended for the management of minor abrasions, cuts, lacerations and scalds. | is indicated for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. | |
| For Over-the-Counter Use: | ||
| AcryDerm Wound Gel Model #B is indicated for the management of minor abrasions, cuts, lacerations and scalds. | ||
| Material | ||
| Components | Hydroxyethyl cellulose, propylene glycol, allantoin, silver ions, benzalkonium chloride and purified water; | Water, hydrophilic polyacrylate absorbent microspheres, stabilized silver salt; |
| Technological | ||
| Characteristics | The Antibacterial Gel Wound Dressing is applied directly on wound site to control wound moisture levels through dual function of moisture donation and absorption. The gel contains silver ions and Benzalkonium chloride acting as a preservative for reducing microorganism colonization within the dressing during the shelf storage. | The AcryDerm Antimicrobial Silver Gel Wound Dressings incorporate proprietary stabilized silver salt to facilitate the action of antimicrobial ionic silver in the dressing and wound environment. The gel possesses both moisture donating and moisture sequestering action depending on the moisture level in the wound. |
| Antimicrobial | ||
| Agent | silver ions and Benzalkonium chloride | Stabilized silver salt |
| Preservative | ||
| Effectiveness | USP | USP |
| Single use or | ||
| Repeated use | Repeated use for a single patient | Repeated use for a single patient |
| Sterilization | Non-sterile | Non-sterile |
| Biocompatibility | Comply with ISO 10993-5, ISO 10993-10, ISO 10993-6 and ISO 10993-11. | Comply with ISO 10993-1. |
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8. Substantial Equivalence Discussion
6
Antibacterial Gel Wound Dressing has been subjected to ISO 10993 biocompatibility studies to demonstrate the device is as safe as its predicate device. The performance tests were conducted to demonstrate that the subject device is as effective as its predicate device.
Performance Testing
The following table summarized performance tests conducted on subject devices in comparison to the predicate device:
| Performance Test | Standard | Subject device Result |
|---|---|---|
| Fluid Affinity | EN 13726-1 Test methods for primary wound | |
| dressings - Part 1: Aspects of absorbency | Moisture Donation |
15-20%
Moisture Absorption
0-10% |
| | Loss on Drying | USP Loss on Drying |
| pH Value | USP pH | 5.5-7.5 |
| Bioburden | USP Microbiological examination of
non-sterile products-microbial enumeration
tests; USP Microbiological examination
of nonsterile products-tests for specified
microorganisms | Pass |
| Preservative
Effectiveness | USP Antimicrobial Effectiveness
Testing | Pass |
Biocompatibility Testing
Biocompatibility testing was conducted for this submission in accordance with the US Food and Drug Administration's guidance entitled Use of International Standard ISO - 10993: 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and test results meet the requirements.
Animal Study
A porcine wound healing study was carried out to evaluate the cytotoxicity of subject device. The study demonstrated that there were no biologically relevant differences between the subject
7
devices (Antibacterial Gel Wound Dressing), and a Control Silver Antimicrobial Wound Gel (also named SILVASORB GEL®) in terms of wound healing performance characteristics.
Clinical Study
No clinical study was conducted.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison analysis, performance tests, biocompatibility tests and animal study provided in this submission, the subject device, Antibacterial Gel Wound Dressing is demonstrated to be as safe and effective as the legally marketed predicate devices, AcryDerm Antimicrobial Silver Gel Wound Dressing Model #B (K083103). So, the subject device is considered Substantially Equivalent (SE) to the predicate device.