(263 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the bandage and its antimicrobial agent, with no mention of AI or ML.
No.
The device is described as an "antibacterial bandage" for "management of minor scrapes and minor burns" and "minor cuts". The presence of an antibacterial agent (benzalkonium chloride) is for reducing bacteria, not for treating a disease or disorder, but rather for wound management. The description does not indicate treatment of disease beyond basic topical wound care.
No
The device, an antibacterial bandage, is intended for the management of minor cuts, scrapes, and burns by providing an antiseptic effect and a physical barrier. It does not perform any diagnostic function such as identifying, detecting, or measuring a medical condition or disease.
No
The device description clearly outlines physical components (backing, absorbent pad, release paper) and materials, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the topical management of minor cuts, scrapes, and burns. This is a direct application to the body for therapeutic purposes.
- Device Description: The device is a bandage with an absorbent pad containing an antibacterial agent. It is applied externally to the skin.
- Mechanism of Action: The antibacterial agent (benzalkonium chloride) acts directly on microorganisms at the wound site.
- Lack of In Vitro Testing for Diagnosis: While the description mentions "in vitro testing" to demonstrate the effectiveness of the antibacterial agent against specific microorganisms, this testing is to support the performance of the device as an antibacterial agent, not to diagnose a condition in a patient. IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied topically to the skin, not used to analyze samples taken from the body.
In summary, this device is a therapeutic device (a wound dressing with an antibacterial component) applied directly to the body, not a device used to perform tests on samples taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
Antibacterial bandage is to be applied topically to the skin for management of minor scrapes and minor burns.
Product codes
FRO
Device Description
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.
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
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
The proposed device was tested for the peel adhesion per ASTM D3330/D3330M. The test results show that the peel strength of the product is greater than 1.0 N/cm.
The proposed device was tested for the antimicrobial efficacy study and minimum effective concentration (MEC) study per ASTM AATCC-100, the test results meet the requirement of 4 log reduction.
Sterile barrier packaging testing were performed on the proposed device, which include seal strength (ASTM F88/F88-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Biocompatibility testing:
The contact level of the proposed device is breached or compromised surfaces, and the contact duration is limited contact (
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
February 5, 2021
Jiangsu Excellence Medical Supplies Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K201324
Trade/Device Name: Antibacterial Bandage Regulatory Class: Unclassified Product Code: FRO Dated: January 4, 2021 Received: January 5, 2021
Dear Diana Hong:
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,
Lixin Liu, PhD Assistant Director (Acting) 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201324
Device Name Antibacterial Bandage
Indications for Use (Describe)
Antibacterial bandage is to be applied topically to the skin for management of 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: _ K201324
-
- Date of Preparation: February 5, 2021
-
- Sponsor Identification
Jiangsu Excellence Medical Supplies Co., Ltd.
No.65 Huiling West Road, Zouqu Town, Zhonglou District, Changzhou City, Jiangsu Province, 203144, China
Establishment Registration Number: 3010138147
Contact Person: Yanhua Li Position: Deputy General Manager Tel: +86-519-83632311 Fax: +86-519-83631033 Email:lyh@hualiandressing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Antibacterial Bandage Common Name: Wound dressing
Regulatory Information
Classification Name: Dressing, Wound, Drug; Classification: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery;
Indication for Use:
Antibacterial bandage is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns.
Device Description
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. The proposed devices are available in fabric backing and plastic backing. All of devices consist of (1) backing (fabric or plastic), (2) absorbent pad (composed of Polyester fiber, viscose fiber, PE mesh, Benzalkonium chloride) and (3) release paper (composed of cellulose pulp, water, kaolin, starch, ethanol and ethylene copolymer). Each device type is available in several models. The difference between each model is the device size. This dressing contains 0.08% benzalkonium chloride which has shown effectiveness against (Staphylococcus Aureus, Pseudomonas Aeruginosa, Escherlchia coli, Enterococcus Faecalis, Klebsiella Pneumoniae, Streptococcus Pyogenes, Candida Albicans and Aspergillus Niger) for up to 24 hours, as demonstrated via in vitro testing.
-
- Identification of Predicate Device
510(k) Number: K113583 Product Name: Curad Antibacterial bandage
- Identification of Predicate Device
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
The proposed device was tested for the peel adhesion per ASTM D3330/D3330M. The test results show that the peel strength of the product is greater than 1.0 N/cm.
5
The proposed device was tested for the antimicrobial efficacy study and minimum effective concentration (MEC) study per ASTM AATCC-100, the test results meet the requirement of 4 log reduction.
Sterile barrier packaging testing were performed on the proposed device, which include seal strength (ASTM F88/F88-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 42-NF 37 |
| Shelf Life Evaluation | Peel Adhesion, Package Tests were performed on |
| aging samples to verify the claimed shelf life of | |
| the device |
Biocompatibility testing
The contact level of the proposed device is breached or compromised surfaces, and the contact duration is limited contact ( Cytotoxicity,
-
Sensitization,
-
Intracutaneous reactivity,
-
Systemic Toxicity,
-
Material-mediated Pyrogenicity
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Substantially Equivalent (SE) Comparison
| Item | Device | Predicate Device | Remark |
|---|---|---|---|
| Device | K201324 | K113583 | |
| Product Code | FRO | FRO | Same |
| Regulation Number | Unclassified | Unclassified | Same |
| Class | Unclassified | Unclassified | Same |
| Indication for Use | Antibacterial bandage is 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 burns. | Similar |
| Configuration | Backing (fabric or plastic), | ||
| Absorbent pad | |||
| Release paper | Backing | ||
| Wound pad | Difference | ||
| Single Use | Yes | Yes | Same |
| Size | Fabric(mm): 25×25, 30×30, | ||
| 38×16, 38×19, 38×38, 50×40, | |||
| 50×50, 55×19, 55×30, 55×40, | |||
| 56×22, 56×29, 57×16, 60×19, | |||
| 60×30, 60×40, 63×25, 65×19, | |||
| 65×30, 65×40, 70×18, 70×50, | |||
| 70×60, 72×19, 72×25, 72×30, | |||
| 72×50, 76×19, 76×25, 76×38, | |||
| 76×50, 76×57, 80×50, 80×60, | |||
| 80×65, 82×19, 83×60, 84×25, | |||
| 88×38, 90×60, 95×50, 100×60, | |||
| 100×80, 100×100, 101×44, | |||
| 101×50 |
Plastic(mm): 25×25, 30×30,
38×16, 38×19, 38×38, 50×40,
50×50, 55×19, 55×30, 55×40,
56×22, 56×29, 57×16, 60×19,
60×30, 60×40, 63×25, 65×19,
65×30, 65×40, 70×18, 70×50,
70×60, 72×19, 72×25, 72×30,
72×50, 76×19, 76×25, 76×38, | 3/4"×3" | Difference |
| | | | |
| | 80×65, 82×19, 83×60, 84×25,
88×38, 90×60, 95×50, 100×60,
100×80, 100×100, 101×44,
101×50, 101×76 | | |
| Antimicrobial | 0.08-0.14% Benzalkonium
chloride | 0.1% Benzalkonium
chloride | Similar |
| Material | Benzalkonium chloride
Non-woven fabric
Polyethylene omentum
Hot melt adhesive
Acrylic adhesive | Benzalkonium chloride | Similar |
| Biocompatibility | Complies with ISO 10993-1 for
limited contact duration on
breached/compromised skin | Comply with ISO 10993 | Same |
| Sterilization | EtO Sterilization | EtO Sterilization | Same |
| SAL | 10-6 | 10-6 | Same |
Table 1 Comparison of Technology Characteristics
7
9. Summary of Technological Characteristics
The Antibacterial Bandage is compared to the predicate device with respect to indications for use, size, materials, antimicrobial agent, BZK concentration, 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 different safety or effectiveness issues.
Similar-Indication for Use
The indication for use of proposed bandage and predicate bandage are very similar. The slight difference between them is expression form of indication for use, however, both of the two devices can be applied topically to the skin for management of minor cuts, minor scrapes and minor burns. In addition, the antibacterial effect study was conducted on the proposed device, and the test results meet the requirement of 4 log reduction. Therefore, this difference does not affect the safety and effectiveness of the device.
Difference- Configuration
The configuration of proposed bandage and the predicate bandage are not exactly the same. However, the proposed device and predicate device are bandages that can be adhered to the patient's skin and both of them are indicated for management of minor cuts, minor scrapes and minor burns. Therefore, this difference does not affect the safety and effectiveness of the device.
Difference- Size
8
The size of proposed bandage and predicate bandage is different. The size will not affect the device performance of the bandage. User can select appropriate size physical requirement. Therefore, this difference is considered not to affect the safety and effectiveness of the proposed device.
Similar- Antimicrobial (BZK concentration)
The BZK concentration of proposed bandage and predicate bandage are very similar. The BZK concentration of proposed bandage is more than 0.08%, and the BZK concentration of predicate bandage is 0.1%. Although there was a small difference in BZK concentration, antibacterial effect study was conducted on the sample with minimum BZK concentration and the test results meet the requirement of 4 log reduction. Therefore, this difference does not affect the safety and effectiveness of the device.
Similar - Material
The patient contact material of proposed bandage and predicate bandage are different. However, the biocompatibility test for proposed device has been conducted and the proposed device passed all the tests. Therefore, this difference is not considered to affect the safety and effectiveness of the device.
10. Substantially Equivalent (SE) Conclusion
Based on the comparison of the indications for use and device technological characteristics to the predicate above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.