(203 days)
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes. Anti-bacterial bandage is made of Fabric tape/polyethylene tape, and absorbent pad. Absorbent pad contains 0.1%/0.8% benzalkonium chloride. The Anti-bacterial bandage is EO sterilized, and is for single use only. Product shelf- life time: Three years
The provided text is a 510(k) summary for an Anti-bacterial Bandage. This document describes the device, its intended use, and its comparison to a legally marketed predicate device to demonstrate substantial equivalence, a process frequently used for medical devices that are not high-risk.
It's important to understand that a 510(k) submission generally focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than proving de novo safety and effectiveness through extensive clinical trials as might be required for a PMA (Pre-Market Approval). Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to support substantial equivalence, not typically a large-scale clinical efficacy study.
Here's an analysis of the provided information concerning acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the way one might expect for a clinical study comparing numerical metrics of efficacy. Instead, it describes compliance with various standards and internal requirements.
Here's how we can infer and construct this information based on the text:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Overall Design | Meets all requirements for overall design (implied: consistent with intended use and predicate device's design principles). | "The Anti-bacterial Bandage meets all the requirements for overall design... confirming that the design output meets the design inputs and specifications for the device." |
| Sterilization | Compliance with ISO 11135:2014 (Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices). | "EO sterilized... EO sterile, compliance with ISO 11135:2014" and "Sterilization Testing ISO 11135:2014...passed all the testing." |
| Biocompatibility | Compliance with ISO 10993 standards for various biological effects: Cytotoxicity, Intracutaneous reactivity, Acute system toxicity, Sensitization testing, Material mediated pyrogenicity, Endotoxin testing. | "passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence... Biocompatibility; Cytotoxicity, Intracutaneous reactivity, Acute system toxicity, Sensitization testing, Material mediated pyrogenicity, Endotoxin testing." and "Complies with ISO 10993". |
| Shelf Life | Compliance with ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices). Target shelf life: 3 years. | "Product shelf-life time: Three years" and "Shelf Life Testing ASTM F1980-16...passed all the testing." |
| Storage & Transport | Compliance with ASTM 4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems). | "Storage and Transport Testing ASTM 4169-16...passed all the testing." |
| Antibacterial Activity | Compliance with AATCC 100: 2012 (Antibacterial Finishes on Textile Materials). (Implied: Demonstrated ability of benzalkonium chloride to reduce bacterial colonization as intended.) | "AATCC 100: 2012, Antibacterial Finishes on Textile Materials...passed all the testing." (The document states the mechanism of action is: "Benzalkonium chloride reduce bacterial colonization within dressing.") |
| Substantial Equivalence | Device characteristics are sufficiently similar to the predicate device such that no new safety or effectiveness issues are raised. Specific comparisons were made for indications for use, mechanism of action, materials, antimicrobial agent, sterile methods, single-use, shelf life, regulation number, use time, packaging, anatomical location, and overall classification. | "most of the characteristics of the subject device are the same as the predicate device, some of the characteristics are similar, one is different, but none of them will cause new safety or effectiveness issues." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes (e.g., number of bandages tested) for each non-clinical test (biocompatibility, sterilization, shelf life, etc.). These numbers would typically be detailed in the full test reports, which are not included in this summary.
- Data Provenance: The device manufacturer, Planet (Suzhou) Medical Products Co., Ltd, is located in Suzhou, Jiangsu, China. The testing was conducted by or on behalf of this company. The data is retrospective in the sense that the tests were performed on finished devices to gather data for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable in the context of this 510(k) summary for an anti-bacterial bandage. The "ground truth" for non-clinical performance tests is based on the objective results of the validated test methods and established standards (e.g., ISO, ASTM, AATCC), not on expert consensus or interpretation of complex medical images or clinical outcomes. For example, a cytotoxicity test has objective pass/fail criteria based on cell viability, not expert opinion.
4. Adjudication Method for the Test Set
This information is also not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human readers interpreting complex data (e.g., radiology images) to establish a consensus ground truth. The non-clinical tests described in this document are objective laboratory tests with defined protocols and metrics for success.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study was not done. Such studies are relevant for evaluating diagnostic imaging devices where human readers interpret images with and without AI assistance. This device is an anti-bacterial wound dressing, and its performance is evaluated through laboratory-based non-clinical tests rather than human interpretation of cases.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not done in the sense of an algorithm operating independently to perform tasks. This device is a physical product (bandage) whose performance is assessed through its material properties, biological interactions, and antimicrobial effectiveness using established laboratory methods, not through an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance claims in this submission is established through:
- Compliance with validated international and national standards (ISO, ASTM, AATCC): These standards define specific test methods and acceptance criteria for various aspects of medical device performance (e.g., sterilization, biocompatibility, antimicrobial efficacy, shelf-life).
- Objective laboratory test results: The outcomes of these tests (e.g., cell viability in cytotoxicity, bacterial reduction in antimicrobial tests, physical integrity after aging) provide the factual basis for meeting the standards.
8. Sample Size for the Training Set
This concept is not applicable. "Training set" refers to data used to train machine learning algorithms. This anti-bacterial bandage is a physical medical device, not an AI/ML software device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
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October 19, 2020
Planet (Suzhou) Medical Products Co., Ltd % Van Lee Senior Consultant LinkHope medical technology Inc No. 231 science avenue Huangpu district, Guangzhou Guangzhou, GuangDong 510700 China
Re: K200821
Trade/Device Name: Anti-bacterial bandage Regulatory Class: Unclassified Product Code: FRO Dated: March 23, 2020 Received: March 30, 2020
Dear Van Lee:
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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly Ferlin, Ph.D. For Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200821
Device Name Anti-bacterial Bandage
Indications for Use (Describe)
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
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
1. Submission Sponsor
Planet (Suzhou) Medical Products Co., Ltd
No.33 Qinglian Rd Xuguan Industrial Park, Hi-tech Development Zone,
Suzhou, Jiangsu,
China 215151
Contact: Frank Zhou
Contact title: General Manager
2. Submission Correspondent
LinkHope medical technology Inc.
No. 231 science avenue Huangpu district, Guangzhou, China
Phone: 86 -13632273583
Contact: Van Lee
Title: Senior Consultant, RA
3. Date Prepared
Mar 23, 2020
4. Device Identification
Trade/Proprietary Name: Anti-bacterial Bandage
Common/Usual Name: Wound Dressing
Classification Name: unclassified
Regulation Number: NA
Product Code: FRO
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| Device Name | 510(k)No. | ProductCode | ClassificationRegulation | Manufacture |
|---|---|---|---|---|
| CuradAntibacterialBandage | K113583 | FRO | Unclassified | Medline Industries,Inc. |
5. Legally Marketed Predicate Device(s)
6. Indication for Use Statement
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
7. Device Description
7.1.1 Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes. Anti-bacterial bandage is made of Fabric tape/polyethylene tape, and absorbent pad. Absorbent pad contains 0.1%/0.8% benzalkonium chloride.
7.1.2 The Anti-bacterial bandage is EO sterilized, and is for single use only.
7.1.3 Product shelf- life time: Three years
8. Comparison of Technological Characteristics with predicate device
| Manufacturer | Planet (Suzhou) Medical Products Co., Ltd | Medline Industries, Inc. | Comparison | management of minorcuts,minor scrapes. | minor cuts, scrapes and burns. | Page 3 of 5 | Sterile methods | EO sterile, compliancewith ISO 11135:2014 | EO sterile, compliance withISO 11135:2014 | Same | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Trade Name | Anti-bacterial Bandage | Curad Antibacterial Bandage | NA | Model | 0.1% benzalkoniumchloride, fabric tape;0.8% benzalkoniumchloride, fabric tape;0.1% benzalkoniumchloride,polyethylenetape;0.8% benzalkoniumchloride,polyethylene tape | 0.8% benzalkonium chloride,fabric tape;0.8% benzalkoniumchloride,polyethylene tape | Similar | Single-Use | Yes | Yes | Same |
| 510(k) Number | K200821 | K113583 | NA | Antimicrobialagent | Benzalkonium chloride0.1% and 0.8% | Benzalkonium chloride 0.8% | Similar | Shelf Life | 3 years | 3 years | Same |
| Product Code | FRO | FRO | Same | Mechanism ofAction | Benzalkonium chloridereduce bacterialcolonization withindressing. | Benzalkonium chloride in thewound pad helps preventinfection. Helps preventinfection and protects cuts,scrapes or minor burns fromdirt and germs | Similar | Complies withISO 10993 | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11 | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-11 | Same |
| Regulation Number | NA | NA | Same | Use time | No more than 24 hours | No more than one week | Different | Packaging | medical packing paper | medical packing paper | Same |
| Device Classification Name | dressing, wound, drug | dressing, wound, drug | Same | AnatomicalLocation | For use on minor cuts,minor scrapes. | For use on minor cuts, scrapes,and burns. | Similar | ||||
| Indications for Use | Anti-bacterial bandages are to be applied topically to the skin for the | Antibacterial bandages are to be applied topically to the skin to help prevent infection in | Similar | Material | Anti-bacterial bandage ismade of Fabrictape/polyethylene tape,and absorbent pad.Absorbent pad contains0.1%/0.8% benzalkoniumchloride. | Anti-bacterial bandage is madeof Fabric/polyethylene tape,and absorbent pad. Absorbentpad contains 0.8%benzalkonium chloride. | Similar | ||||
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9. Substantial Equivalence Discussion
The Anti-bacterial Bandage is compared to the predicate device with respect to indications for use, mechanism of action, materials,antimicrobial agent, etc. According to the comparison information, most of the characteristics of the subject device are the same as the predicate device, some of the characteristics are similar, one is different, but none of them will cause new safety or effectiveness issues.
10. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of Anti-bacterial Bandage and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Planet (Suzhou) Medical Products Co., Ltd completed a number of non-clinical performance tests. The Anti-bacterial Bandage meets all the requirements for overall design, sterilization, biocompatibility, and other test results confirming that the design output meets the design inputs and specifications for the device.
The Anti-bacterial Bandage passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- Biocompatibility; .
- Cytotoxicity o
- Intracutaneous reactivity o
- 0 Acute system toxicity
- O Sensitization testing
- Material mediated pyrogenicity O
- endotoxin testing O
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- Sterilization Testing ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- . Shelf Life Testing ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
- Storage and Transport Testing . ASTM 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems
- . AATCC 100: 2012, Antibacterial Finishes on Textile Materials
11. Conclusion
Based on the above non-clinical tests and the information compared with the predicate device, the anti-bacterial bandage is as safe and as effective as the predicate device.
N/A