(486 days)
Not Found
No
The 510(k) summary describes a simple antibacterial bandage with no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device, an antibacterial bandage, is intended for the management of minor cuts and scrapes, indicating its use for treating or alleviating a condition, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose is for "management of minor cuts, minor scrapes," and it contains antibacterial agents. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a physical bandage made of polyethylene tape, absorbent pad, and release paper, containing benzalkonium chloride. It also details physical testing like biocompatibility, sterilization, and shelf life, which are not applicable to software-only devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of minor cuts, minor scrapes" by being "applied to the skin." This is a topical application for wound care.
- Device Description: The description details a physical bandage with an absorbent pad containing an antibacterial agent. It's a physical barrier and treatment applied externally.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The information provided clearly describes a topical wound care product, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.
Product codes
FRO
Device Description
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.
Based on in vitro testing, the Benzalkonium chloride effectively reduces microbial growth within the dressing over a maximum use period of 24 hours. No clinical benefit has been studied or demonstrated regarding the Benzalkonium chloride antimicrobial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
minor cuts, minor scrapes
Indicated Patient Age Range
adults
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 as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards.
- Biocompatibility:
- A Cytotoxicity,
-
Sensitization,
-
Intracutaneous reactivity,
- A Systemic Toxicity,
- A Material-mediated Pyrogenicity
- V Endotoxin testing
- · 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 Real time ageing study was done to demonstrate the device stability under market conditions. -
Storage and Transport Testing
ASTM 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems -
AATCC 100: 2019, Antibacterial Finishes on Textile Materials
-
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 significant difference between the subject device and the predicate device in the terms of wound healing performance.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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September 29, 2023
Allmed Medical Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K221570
Trade/Device Name: Antibacterial bandage Regulatory Class: Unclassified Product Code: FRO Dated: May 31, 2022 Received: May 31, 2022
Dear Ivy Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
David Krause, Ph.D. Assistant Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K221570
Device Name Antibacterial bandage
Indications for Use (Describe)
Antibacterial bandages are to be applied to the skin for the management of minor cuts.minor scrapes. This device is only applicable to adults.
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
Image /page/3/Picture/0 description: The image shows the logo for Allmed. The logo features a stylized letter "A" in green, with a gray plus sign above it. The word "ALLMED" is written in gray below the symbol. The logo is simple and modern, and the colors are clean and professional.
510(k) Summary
K221570
Date of summary prepared: 2023-09-28
A. Applicant:
Name: Allmed Medical Products Co., Ltd. Address: No. 99, Jin Shan Road, Majiadian Town, Zhijiang City, Hubei, CHINA Contact: Vince Tian Title: General Manager of Quality Tel: +86-717-4211111 Fax: +86-717-4225499 Email: vince@allmed.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Antibacterial bandage Common Name: Wound dressing
Regulatory Information Classification Name: Dressing, Wound, Drug; Classification: unclassified Product code: FRO Regulation Number: NA Review Panel: General & Plastic Surgery
C. Predicate device: 510(k) Number: K113583 Product Name: Curad Antibacterial bandage
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Image /page/4/Picture/0 description: The image shows the logo for Allmed. The logo consists of a gray plus sign on top of a green triangle. The word "ALLMED" is written in gray letters below the triangle. A black line is underneath the word "ALLMED".
Indications for use of the device:
Antibacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes. This device is only applicable to adults.
E. Device Description:
The device, Antibacterial bandage, is to be applied topically to the skin for management of minor cuts, minor scrapes. Antibacterial bandage is made of polyethylene tape, absorbent pad and release paper. The absorbent pad contains 95±10 ug/cm2 (0.8% by weight) benzalkonium chloride. Antibacterial bandage is available in different sizes. The antibacterial bandage is EO sterilized and is for single use only.
Based on in vitro testing, the Benzalkonium chloride effectively reduces microbial growth within the dressing over a maximum use period of 24 hours. No clinical benefit has been studied or demonstrated regarding the Benzalkonium chloride antimicrobial.
F. Technological Characteristics Comparison Table
Provided below is a comparison of the subject device with the predicate device
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K221570 | K113583 | - |
| Trade Name | Antibacterial bandage | Curad Antibacterial Bandage | Similar |
| Product code | FRO | FRO | Same |
| Regulation number | NA | NA | Same |
| Device Classification name | Dressing, wound, drug | Dressing, wound, drug | Same |
| Indications for use | Antibacterial bandages are to be | ||
| applied topically to the skin for the | |||
| management of minor cuts, minor | |||
| scrapes. This device is only | |||
| applicable to adults. | Antibacterial bandages are to be | ||
| applied topically to the skin to help | |||
| prevent infection in minor cuts, | |||
| scrapes and burns. | Similar | ||
| Configuration | Backing, absorbent pad, release | ||
| paper | Backing, wound pad | Different | |
| Antimicrobial agent | Benzalkonium chloride 95±10 | ||
| ug/cm2 (0.8% by weight) | Benzalkonium chloride 0.8% | Same | |
| Material | Antibacterial bandage is made of | ||
| polyethylene tape, absorbent pad | |||
| and release paper. The absorbent | |||
| pad contains 95±10 ug/cm2 (0.8% | |||
| by weight) benzalkonium chloride. | Anti-bacterial bandage is made of | ||
| Fabric/polyethylene tape, and | |||
| absorbent pad. Absorbent pad | |||
| contains 0.8% benzalkonium | |||
| chloride. | Similar | ||
| Anatomical location | For use on minor cuts, minor | ||
| scrapes. | For use on minor cuts, scrapes, and | ||
| burns. | Similar | ||
| OTC use | Yes | Yes | Same |
| Sterile method | EO sterilization | EO sterilization | Same |
| Singe Use | Yes | Yes | Same |
| Biocompatibility | Complies with ISO 10993-1 for | Comply with ISO 10993 | Same |
Table 1 General Comparison
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Image /page/5/Picture/0 description: The image shows the logo for ALLMED. The logo consists of a stylized letter 'A' in green, with a gray triangle above it that has a white plus sign in the center. Below the symbol is the word "ALLMED" in a bold, sans-serif font, with the letters in gray.
| limited contact duration on | |||
|---|---|---|---|
| breached/compromised skin |
Substantial equivalence discussion:
The Antibacterial Bandage is compared to the predicate device with respect to indications for use, 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.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards.
- Biocompatibility:
- A Cytotoxicity,
-
Sensitization,
-
Intracutaneous reactivity,
- A Systemic Toxicity,
- A Material-mediated Pyrogenicity
- V Endotoxin testing
- · 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 Real time ageing study was done to demonstrate the device stability under market conditions. -
Storage and Transport Testing
ASTM 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems -
AATCC 100: 2019, Antibacterial Finishes on Textile Materials
-
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 significant difference between the subject device and the predicate device in the terms of wound healing performance.
H. Clinical Test Conclusion
No clinical study is included in this submission.
l. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K113583.