(412 days)
No
The device description and performance studies focus on the physical and chemical properties of a bandage, with no mention of AI or ML technologies.
Yes
The device is used for the management of minor cuts, scrapes, and burns, which aligns with the definition of a therapeutic device as it provides treatment or relief for a medical condition.
No.
The device is an antibacterial bandage for managing minor cuts, scrapes, and burns, not for diagnosing medical conditions.
No
The device description clearly outlines a physical bandage with multiple layers and materials, including an adhesive backing, an absorbent pad, and a release liner. It also mentions sterilization by Ethylene Oxide, which is a process applied to physical devices. 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 is for the topical management of minor cuts, scrapes, and burns on the skin. This is a direct application to the body for treatment/protection, not for testing samples taken from the body.
- Device Description: The description details a physical bandage with an antibacterial component, designed for external application.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) to diagnose a condition or disease. The antibacterial component is for preventing infection in the wound, not for diagnosing an infection.
- Performance Studies: The performance studies focus on wound healing, antibacterial effectiveness (reducing bacteria on the wound), and equivalence to a predicate bandage. These are all related to the device's function as a wound dressing, not as a diagnostic tool.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This antibacterial bandage does not fit that description.
N/A
Intended Use / Indications for Use
Antibacterial bandage is to be applied to the skin for management of minor cuts, minor scrapes and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns.
The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner.
Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 tests were conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the corresponding standards.
Performance Test:
- Liquid absorbency: EN 13726-1:2002 Test methods for primary wound dressing – Part 1 Aspects of absorbency
- Moisture vapor transmission rate: EN 13726-2:2002 Test methods for primary wound dressing - Part 2 Moisture vapor transmission rate of permeable film dressing
- Peel strength: ASTMD3330/D3330M Standards peel adhesion of pressure-sensitive tapes
- Antibacterial effectiveness: Modified AATCC 100 Test Method for Antibacterial Finishes on Textile Materials
The test results demonstrated that the performance characteristics of the subject device met the requirement and supported substantially equivalence between the subject device and the predicate device.
The sterile barrier package testing was performed on the subject device and the test results demonstrated that the subject device package can maintain its integrity.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Biocompatibility Tests:
The biocompatibility evaluation for the subject device was conducted in accordance with the ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process''.
The biocompatibility tests include: Cytotoxicity, Skin sensitization, Systemic toxicity and Material mediated pyrogenicity test.
The tests were conducted following these standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity.
- USP 151:2017 Pyrogen Test
- USP-NF:2021 Bacterial Endotoxins Test
Animal Studies:
A porcine wound healing study was carried out to evaluate the cytotoxicity of the subject device. The study demonstrated that there was no difference between the Test-Antibacterial Bandage (subject device), and a Control-Curad Antibacterial Bandage (predicate device) in terms of wound healing performance characteristics and local tolerance after wound creation.
Clinical Test Conclusion:
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Antibacterial Effectiveness: ≥4 Log reduction
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.
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 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.
June 21, 2023
Winner Medical Co., Ltd. Yi Fu Regulatory Affairs Specialist Winner Industrial Park, No. 660 Bulong Road, Longhua District Shenzhen, Guangdong 518109 China
Re: K221311
Trade/Device Name: Antibacterial Bandage Regulatory Class: Unclassified Product Code: FRO Dated: April 29, 2022 Received: May 5, 2022
Dear Yi Fu:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 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,
David Krause -S
for Julie A. 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) K221311
Device Name Antibacterial bandage
Indications for Use (Describe)
Antibacterial bandage is to be applied to the skin for management of minor cuts, minor scrapes and minor burns.
Type of Use (Select one or both, as applicable)
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: K221311
-
- Date of Preparation: June 14, 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: Yi Fu Position: Regulatory Affairs Specialist Tel: +86-755 28138888- 8717 Fax: +86-755 28134588 Email: 3911(@winnermedical.com
3. Identification of Subject Device
Trade/Proprietary Name: Antibacterial Bandage Regulatory Information Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO: Review Panel: General & Plastic Surgery;
4. Identification of Predicate Device
Predicate Device:
510(k) Number: K113583
Product Name: Curad Antibacterial Bandage Manufacturer: Medline Industries, Inc
Reference Device: 510(k) Number: K200821
Product Name: Anti-bacterial Bandage Manufacturer: Planet (Suzhou) Medical Product Co., Ltd
4
5. Device Description
The subject device. Antibacterial bandage, is to be applied topically to the skin for the management of minor cuts, minor scrapes and minor burns.
The subject devices are available sterile in three models. All of devices contain three layers: (1) adhesive backing layer (fabric or plastic); (2) exactly same antibacterial non-stick absorbent pad layer (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride); (3) release liner.
Each model is available in different sizes with identical materials, chemicals and physical properties, therefore, size of the device will not affect the function and performance of products. All models of subject device, Antibacterial bandage, are for single use only and sterilized by Ethylene Oxide using conditions validated following ISO 11135:2014.
6. Intended Use/Indications for Use
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
7. Substantially Equivalent (SE) Comparison
The subject device. Antibacterial Bandage, is compared with the following Predicate Device in terms of intended use, materials, principle of operation, characteristics and performance. The predicate device is K113583, Curad Antibacterial Bandage, Manufactured by Medline Industries, Inc. The reference device is K200821, Anti-bacterial Bandage, Manufactured by Planet (Suzhou) Medical Products Co., Ltd.
The following table shows comparison between subject device and predicate device and reference device. Based on the comparison and analysis, the subject devices are determined to be Substantially Equivalent (SE) to the predicate device. These data came from commercially product labeling and 510(k) summary.
Table 1. Comparison of Intended use, Design and Technological Characteristics
5
| Item | Subject Device
(K221311) | Predicate Device
(K113583) | Reference Device
(K200821) |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FRO | FRO | FRO |
| Regulation
Number | Unclassified | Unclassified | Unclassified |
| Device
Classification
Name | Dressing, wound, drug | Dressing, wound, drug | Dressing, wound, drug |
| Intended Use | Antibacterial bandages
are to be applied
topically to the skin for
management of minor
cuts, minor scrapes and
minor burns. | Antibacterial bandages
are to be applied
topically to the skin to
help prevent infection
in minor cuts, scrapes
and minor burns. | Anti-bacterial
bandages are to be
applied topically to the
skin for management
of minor cuts, minor
scrapes. |
| Components | (1) Adhesive backing
layer;
(2) Antibacterial non-
stick absorbent pad
layer;
(3) Release liner; | (1) Adhesive backing
layer;
(2) Antibacterial non-
stick absorbent pad
layer;
(3) Release liner; | (1) Adhesive backing
layer;
(2) Antibacterial non-
stick absorbent pad
layer;
(3) Release liner; |
| Principle of
operation | Benzalkonium chloride
in the absorbent pad is
to reduce bacterial
colonization within
dressing,
Backing adhesive layer
for self-adhesive and
keep the bandage in
place. | Backing adhesive layer
for self-adhesive and
keep the bandage in
place. | Benzalkonium chloride
reduce bacterial
colonization within
dressing,
Backing adhesive layer
for self-adhesive and
keep the bandage in
place. |
| Technology | Center non-woven
absorbent pad is
impregnated with
benzalkonium chloride | Center non-woven
absorbent pad is
impregnated with
benzalkonium chloride | Center non-woven
absorbent pad is
impregnated with
benzalkonium chloride |
| Antimicrobial
agent | 0.8% (w/w)
benzalkonium chloride | 0.8% (w/w)
benzalkonium chloride | 0.1%/0.8% (w/w)
benzalkonium chloride |
| Antibacterial
Effectiveness | ≥4 Log reduction | ≥4 Log reduction | ≥4 Log reduction |
| Characteristics | • Sterile
• Soft non-stick
absorbent pad as
wound contact layer
• Absorbs wound | • Sterile
• Soft non-stick
absorbent pad as
wound contact layer
• Absorbs wound | • Sterile
• Soft non-stick
absorbent pad as
wound contact layer
• Absorbs wound |
| | • Antibacterial bandage
contains
benzalkonium
chloride that reduce
bacterial colonization
within dressing
• Backing layer with
adhesive for self-
adhesive | • Backing layer with
adhesive for self-
adhesive | • Antibacterial
bandage contains
benzalkonium
chloride that reduce
bacterial colonization
within dressing
• Backing layer with
adhesive for self-
adhesive |
| Sterilization | Ethylene Oxide
Sterilization | Ethylene Oxide
Sterilization | Ethylene Oxide
Sterilization |
| Single-use | Yes | Yes | Yes |
| Biocompatibility | Complies with ISO
10993-1 for limited
contact duration on
breached/compromised
skin | Comply with
ISO 10993 | Comply with
ISO 10993 |
6
8. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the subject device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the corresponding standards.
Performance Test
Following performance tests were conducted on the subject device in comparison to the predicate device. The test results demonstrated that the performance characteristics of the subject device met the requirement and supported substantially equivalence between the subject device and the predicate device.
- Liquid absorbency: EN 13726-1:2002 Test methods for primary wound dressing – Part 1 Aspects of absorbency
- Moisture vapor transmission rate: EN 13726-2:2002 Test methods for primary wound dressing - Part 2 Moisture vapor transmission rate of permeable film dressing
- Peel strength: ASTMD3330/D3330M Standards peel adhesion of pressure-sensitive tapes
- Antibacterial effectiveness: Modified AATCC 100 Test Method for Antibacterial Finishes on Textile Materials
7
The sterile barrier package testing was performed on the subject device and the test results demonstrated that the subject device package can maintain its integrity.
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
Biocompatibility Tests
The biocompatibility evaluation for the subject device was conducted in accordance with the ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process''
The biocompatibility tests include: Cytotoxicity, Skin sensitization, Systemic toxicity and Material mediated pyrogenicity test.
The tests were conducted following these standards:
- ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices- Part 11: Tests For Systemic Toxicity.
- USP 151:2017 Pyrogen Test
- USP-NF:2021 Bacterial Endotoxins Test
Animal Studies
A porcine wound healing study was carried out to evaluate the cytotoxicity of the subject device. The study demonstrated that there was no difference between the Test-Antibacterial Bandage (subject device), and a Control-Curad Antibacterial Bandage (predicate device) in terms of wound healing performance characteristics and local tolerance after wound creation.
Clinical Test Conclusion
No clinical study is included in this submission.
8
9. Substantially Equivalent (SE) Conclusion
The subject device Antibacterial Bandage is compared to the predicate device with respect to intended use, materials, principle of operation, characteristics and performance. According to the comparison information, most of the characteristics are the same, the material components between subject device and predicate device shows slightly different, but none of them will cause new safety or effectiveness issues. Based on the comparison and analysis, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.