(203 days)
Not Found
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, an anti-bacterial bandage with benzalkonium chloride, is applied topically to the skin for the management of minor cuts and scrapes, which constitutes a therapeutic action.
No
Explanation: The device is an anti-bacterial bandage intended for wound management, not for diagnosing medical conditions. Its purpose is therapeutic (managing cuts and scrapes), not diagnostic.
No
The device description clearly states it is a physical bandage made of fabric/polyethylene tape and an absorbent pad containing benzalkonium chloride. It also mentions sterilization and physical testing, indicating it is a hardware device.
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 and scrapes. This is a direct application to the body for wound care, not for examining specimens from the body to provide information about a physiological state, health, or disease.
- Device Description: The device is a bandage with an antibacterial agent. It's a physical barrier and a delivery system for a topical antiseptic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents to detect analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens and provide diagnostic information. This device is used in vivo (on the body) for wound treatment.
N/A
Intended Use / Indications for Use
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts,minor scrapes.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
topically to the skin; For use on minor cuts, minor scrapes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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; Intracutaneous reactivity; Acute system toxicity; Sensitization testing; Material mediated pyrogenicity; endotoxin testing), Sterilization Testing (ISO 11135:2014), Shelf Life Testing (ASTM F1980-16), Storage and Transport Testing (ASTM 4169-16), AATCC 100: 2012 (Antibacterial Finishes on Textile Materials).
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/2 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, which features a stylized depiction of human figures. To the right of this symbol, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG ADMINISTRATION" is in a smaller font below it.
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
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(@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
2
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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3
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
4
| Device Name | 510(k)
No. | Product
Code | Classification
Regulation | Manufacture |
|-----------------------------------|---------------|-----------------|------------------------------|-----------------------------|
| Curad
Antibacterial
Bandage | 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 minor
cuts,minor scrapes. | minor cuts, scrapes and burns. | Page 3 of 5 | Sterile methods | EO sterile, compliance
with ISO 11135:2014 | EO sterile, compliance with
ISO 11135:2014 | Same |
|----------------------------|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|----------------------------|------------------------------------------------------------|------------------------------------------------------------|------|
| Trade Name | Anti-bacterial Bandage | Curad Antibacterial Bandage | NA | Model | 0.1% benzalkonium
chloride, fabric tape;
0.8% benzalkonium
chloride, fabric tape;
0.1% benzalkonium
chloride,polyethylene
tape;
0.8% benzalkonium
chloride,polyethylene tape | 0.8% benzalkonium chloride,
fabric tape;
0.8% benzalkonium
chloride,polyethylene tape | Similar | Single-Use | Yes | Yes | Same |
| 510(k) Number | K200821 | K113583 | NA | Antimicrobial
agent | Benzalkonium chloride
0.1% and 0.8% | Benzalkonium chloride 0.8% | Similar | Shelf Life | 3 years | 3 years | Same |
| Product Code | FRO | FRO | Same | Mechanism of
Action | Benzalkonium chloride
reduce bacterial
colonization within
dressing. | Benzalkonium chloride in the
wound pad helps prevent
infection. Helps prevent
infection and protects cuts,
scrapes or minor burns from
dirt and germs | Similar | Complies with
ISO 10993 | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-11 | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 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 | Anatomical
Location | 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 is
made of Fabric
tape/polyethylene tape,
and absorbent pad.
Absorbent pad contains
0.1%/0.8% benzalkonium
chloride. | Anti-bacterial bandage is made
of Fabric/polyethylene tape,
and absorbent pad. Absorbent
pad contains 0.8%
benzalkonium chloride. | Similar | | | | |
| | | | | | | | | | | | |
5
6
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
7
- 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.