(301 days)
Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes.
The Anti-bacterial bandage is EO sterilized and is for single use only. The bandage is made of three layers: Elastic Cloth (Fabric) type (Polyethylene terephthalate) or plastic type (Polyethylene), regenerated cellulose absorbent pad, and release liner (Glassine Release Paper). The absorbent pad contains 0.8% Benzalkonium chloride. Center non-woven absorbent pad is to absorb liquid, Benzalkonium chloride present in the pad is to reduce bacterial colonization within the dressing and backing adhesive (Liquid styrene polymer with 2-methyl-1,3-butadiene, White Mineral Oil, Petroleum Resins) layer is to keep the bandage in place.
The provided text describes an FDA 510(k) summary for an "Anti-bacterial bandage" (K232333), which is a medical device and not an AI/Software as a Medical Device (SaMD). Therefore, the requested information regarding acceptance criteria for AI/SaMD performance, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or training set details, is not applicable or available in this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Curad Antibacterial Bandage K113583) through non-clinical performance tests and biocompatibility, as is typical for traditional medical devices like bandages.
Here's a breakdown of the available information relevant to traditional device performance, acknowledging that it doesn't align with the AI/SaMD specific questions:
1. A table of acceptance criteria and the reported device performance:
The document presents a comparison table (Table 1) between the proposed device and the predicate device, highlighting their technological characteristics. While not explicitly "acceptance criteria" in the sense of a numerical threshold to be met, these are the characteristics used to demonstrate substantial equivalence.
| Acceptance Criteria (Technological Characteristics) | Reported Device Performance (Proposed Device: K232333) | Predicate Device (K113583) Performance | SE Discussion |
|---|---|---|---|
| Device Classification Name | Dressing, Wound, Drug | Dressing, Wound, Drug | Same |
| Device Class | Unclassified | Unclassified | Same |
| Classification Panel | General and Plastic Surgery | General and Plastic Surgery | Same |
| Product Code | FRO | FRO | Same |
| Intended Use | Anti-bacterial bandages are to be applied topically to the skin for the management of minor cuts, minor scrapes. | Antibacterial bandages are to be applied topically to the skin to help prevent infection in minor cuts, scrapes and bums | Same |
| Indications for Use | 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. | Same |
| Mechanism of Action | Center non-woven pad for absorbing liquid, Benzalkonium chloride present in the pad for reducing bacterial colonization within dressing, Backing adhesive layer for self-adhesive and keep the bandage in place. | Center non-woven pad for absorbing liquid, Benzalkonium chloride present in the pad for reducing bacterial colonization within dressing, Backing adhesive layer for self-adhesive and keep the bandage in place. | Same |
| Antimicrobial agent | 0.8% (w/w) benzalkonium chloride | 0.8% (w/w) benzalkonium chloride | Same |
| Multi-layer structure | (1) Outer layer (fabric or plastic); (2) Antibacterial nonstick absorbent pad layer (3) Release liner; | (1) Outer layer (fabric or plastic); (2) Antibacterial nonstick absorbent pad layer (3) Release liner; | Same |
| Antibacterial Effectiveness | ≥4 Log reduction | ≥4 Log | Same |
| Anatomical Location | For use on minor cuts, minor scrapes. | For use on minor cuts, minor scrapes. | Same |
| Use time | No more than 24 hours | No more than one week | Different |
| Sterilization Method | Ethylene oxide sterilization | Ethylene oxide sterilization | Same |
| Sterilization SAL | 10^-6 | 10^-6 | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Complies with ISO 10993-1 for limited contact duration on breached/compromised skin | Complies with ISO 10993-1 for limited contact duration on breached/compromised skin | Same |
Note: The "Use time" is noted as "Different" but the overall conclusion is Substantial Equivalence based on other testing.
Specific studies and their "performance":
- Biocompatibility: The device was evaluated for Cytotoxicity, Sensitization, Irritation toxicity, Acute systemic toxicity, Material-mediated pyrogenicity, and Bacterial Endotoxins (USP-NF ). The conclusion states it "Complies with ISO 10993-1".
- Performance Bench Tests:
- Liquid absorbency: Complies with EN 13726-1-2002.
- Peel adhesion: Complies with ASTM D 3330/D3330M.
- Antimicrobial Efficacy: Complies with AATCC 100-2019 (≥4 Log reduction).
- Minimum Bacteriostatic Concentration Test: Complies with AATCC 100-2019.
Due to the nature of the device (a bandage, not AI/SaMD), the following points are not addressed in the provided text:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
Summary of what's provided for this mechanical device:
- Study Proving Device Meets Criteria: Performance bench tests and biocompatibility studies were conducted.
- Proof of Meeting Criteria: The non-clinical test results demonstrated that the proposed device met design specifications and was "as safe, as effective, and performs as well as the legally marketed predicate device." The results indicated compliance with relevant standards (EN 13726-1-2002, ASTM D 3330/D3330M, AATCC 100-2019) and ISO 10993-1 for biocompatibility.
- Clinical Studies: No clinical studies were included in this submission.
- Animal Studies: No animal studies were included in this submission.
N/A