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K Number
K221570
Device Name
Antibacterial bandage
Manufacturer
Allmed Medical Products Co., Ltd.
Date Cleared
2023-09-29

(486 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K113583
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

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.

AI/ML Overview

The provided text describes an antibacterial bandage, not an AI device. Therefore, it does not contain information about acceptance criteria or studies related to AI device performance. The document focuses on regulatory approval (510(k)) for the antibacterial bandage based on substantial equivalence to a predicate device.

The document discusses the following for the Antibacterial bandage:

  • Acceptance Criteria (as demonstrated by testing):

    • Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic Toxicity, Material-mediated Pyrogenicity, Endotoxin testing)
    • Sterilization (EO sterilization, complying with ISO 11135:2014)
    • Shelf Life (Accelerated Aging per ASTM F1980-16, Real-time ageing study)
    • Storage and Transport (ASTM 4169-16)
    • Antibacterial Finishes (AATCC 100: 2019)
    • Wound Healing Performance (comparable to predicate device in porcine study)

  • Study Proving Acceptance Criteria:

    • Non-clinical tests: Conducted to verify the proposed device met design specifications and was safe and effective.
      • Biocompatibility tests
      • Sterilization testing
      • Shelf life testing (accelerated aging and real-time ageing)
      • Storage and transport testing
      • AATCC 100: 2019 for antibacterial finishes.
    • Animal studies: A porcine wound healing study was carried out to evaluate the cytotoxicity and wound healing performance, demonstrating no significant difference from the predicate device.

The document explicitly states: "No clinical study is included in this submission."

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device, as this information is not present in the provided text.

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