(412 days)
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
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.
The provided text describes a 510(k) premarket notification for an "Antibacterial Bandage" (K221311) and compares it to a predicate device (K113583) and a reference device (K200821). The submission aims to demonstrate substantial equivalence, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, a direct answer to the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of device performance metrics often expected for AI or diagnostic devices (e.g., accuracy, sensitivity, specificity, MRMC studies) cannot be fully provided from the given document.
However, I can extract the non-clinical test conclusions which serve as the basis for demonstrating substantial equivalence based on performance and biocompatibility. These tests implicitly define "acceptance criteria" through their methodologies and the successful comparison to the predicate device.
Here's a breakdown of the information that can be extracted, framed as closely as possible to the request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list numerical "acceptance criteria" with corresponding "reported device performance" in a typical clinical study outcome format like sensitivity or specificity. Instead, the "acceptance criteria" are implied by the successful completion of specified performance and biocompatibility tests, demonstrating equivalence to the predicate device or compliance with standards.
For Antibacterial Effectiveness, a specific quantitative measure is mentioned for both the subject and predicate devices:
| Acceptance Criteria (Implied by Predicate/Standard) | Reported Device Performance (Subject Device K221311) |
|---|---|
| ≥4 Log reduction (Antibacterial Effectiveness) | ≥4 Log reduction |
For other performance tests and biocompatibility, the reported "performance" is that the device "met the requirement" or "complied with the corresponding standards," or "was not different" from the control.
Here's how the other "acceptance criteria" and "reported performance" can be inferred from the non-clinical tests:
| Test/Category | Implicit Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Tests | ||
| Liquid absorbency (EN 13726-1:2002) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Moisture vapor transmission rate (EN 13726-2:2002) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Peel strength (ASTMD3330/D3330M) | Met requirements of standard/equivalent to predicate | Met the requirement |
| Sterile barrier package testing (ASTM F88/F88M-15 & ASTM F1929-15) | Package maintains integrity | Maintained its integrity |
| Biocompatibility Tests | ||
| Cytotoxicity (ISO 10993-5:2009) | Complied with standard | Complied with standard |
| Skin sensitization (ISO 10993-10:2010) | Complied with standard | Complied with standard |
| Systemic toxicity (ISO 10993-11:2017) | Complied with standard | Complied with standard |
| Material mediated pyrogenicity (USP 151:2017 & USP-NF:2021 <85>) | Complied with standard | Complied with standard |
| Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008) | Complied with standard | Complied with standard |
| Animal Study (Wound Healing) | No difference from predicate in wound healing and local tolerance | No difference observed between subject device and predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Non-Clinical Performance Tests & Biocompatibility Tests: The document does not specify sample sizes (e.g., number of bandages tested for peel strength) or the data provenance for these lab-based tests. These are typically performed in a controlled laboratory setting.
- Animal Study: A "porcine wound healing study" was carried out, indicating an animal model. The sample size for this study is not specified, nor is the country of origin of the animal data. It would be considered prospective for the animal subjects involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. The device is an antibacterial bandage, not an AI or diagnostic device that requires expert review for ground truth establishment for a diagnostic test set. The ground truth for the non-clinical and animal studies is based on objective laboratory measurements and biological observations, not expert consensus on interpretations of images or signals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in clinical studies involving human interpretation (e.g., radiologists reviewing images). The studies described here are non-clinical and animal studies.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC study was done. This type of study is relevant for AI-powered diagnostic devices, which is not the case for an antibacterial bandage.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Performance Tests: Ground truth is established by the specified test methods and standards (e.g., EN 13726-1:2002, ASTM D3330/D3330M). The "truth" is the measured physical or chemical property of the bandage.
- Biocompatibility Tests: Ground truth is defined by the biological response observed according to the specific ISO standards (e.g., presence/absence of cytotoxicity, sensitization).
- Animal Study: Ground truth is based on observed wound healing performance characteristics and local tolerance in the porcine model.
8. The sample size for the training set
This question is not applicable. The device (antibacterial bandage) does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
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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
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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
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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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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
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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
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| Item | Subject Device(K221311) | Predicate Device(K113583) | Reference Device(K200821) |
|---|---|---|---|
| Product Code | FRO | FRO | FRO |
| RegulationNumber | Unclassified | Unclassified | Unclassified |
| DeviceClassificationName | Dressing, wound, drug | Dressing, wound, drug | Dressing, wound, drug |
| Intended Use | Antibacterial bandagesare to be appliedtopically to the skin formanagement of minorcuts, minor scrapes andminor burns. | Antibacterial bandagesare to be appliedtopically to the skin tohelp prevent infectionin minor cuts, scrapesand minor burns. | Anti-bacterialbandages are to beapplied topically to theskin for managementof minor cuts, minorscrapes. |
| Components | (1) Adhesive backinglayer;(2) Antibacterial non-stick absorbent padlayer;(3) Release liner; | (1) Adhesive backinglayer;(2) Antibacterial non-stick absorbent padlayer;(3) Release liner; | (1) Adhesive backinglayer;(2) Antibacterial non-stick absorbent padlayer;(3) Release liner; |
| Principle ofoperation | Benzalkonium chloridein the absorbent pad isto reduce bacterialcolonization withindressing,Backing adhesive layerfor self-adhesive andkeep the bandage inplace. | Backing adhesive layerfor self-adhesive andkeep the bandage inplace. | Benzalkonium chloridereduce bacterialcolonization withindressing,Backing adhesive layerfor self-adhesive andkeep the bandage inplace. |
| Technology | Center non-wovenabsorbent pad isimpregnated withbenzalkonium chloride | Center non-wovenabsorbent pad isimpregnated withbenzalkonium chloride | Center non-wovenabsorbent pad isimpregnated withbenzalkonium chloride |
| Antimicrobialagent | 0.8% (w/w)benzalkonium chloride | 0.8% (w/w)benzalkonium chloride | 0.1%/0.8% (w/w)benzalkonium chloride |
| AntibacterialEffectiveness | ≥4 Log reduction | ≥4 Log reduction | ≥4 Log reduction |
| Characteristics | • Sterile• Soft non-stickabsorbent pad aswound contact layer• Absorbs wound | • Sterile• Soft non-stickabsorbent pad aswound contact layer• Absorbs wound | • Sterile• Soft non-stickabsorbent pad aswound contact layer• Absorbs wound |
| • Antibacterial bandagecontainsbenzalkoniumchloride that reducebacterial colonizationwithin dressing• Backing layer withadhesive for self-adhesive | • Backing layer withadhesive for self-adhesive | • Antibacterialbandage containsbenzalkoniumchloride that reducebacterial colonizationwithin dressing• Backing layer withadhesive for self-adhesive | |
| Sterilization | Ethylene OxideSterilization | Ethylene OxideSterilization | Ethylene OxideSterilization |
| Single-use | Yes | Yes | Yes |
| Biocompatibility | Complies with ISO10993-1 for limitedcontact duration onbreached/compromisedskin | Comply withISO 10993 | Comply withISO 10993 |
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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
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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 <85> 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.
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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.
N/A