(183 days)
(Rx Only) Atteris Antimicrobial Skin & Wound Cleanser is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
(OTC use) Atteris Antimicrobial Skin & Wound Cleanser is intended for physical cleaning and removal of dirt and debris, from skin scrapes, cuts, lacerations, minor irritations, exit sites and unbroken skin.
Atteris Antimicrobial Skin & Wound Cleanser helps in the mechanical removal of debris and foreign material from the skin, wound or application site. Atteris Antimicrobial Skin & Wound Cleanser is a pure, colorless, isotonic cleanser that is safe. The cleanser has a six month expiration due to the preservative that provides bactericidal and fungicidal properties through the action of the antimicrobial (PHMB).
A preservative, PHMB, at a concentration of 0.1% w/w is added to the product to inhibit the growth of microorganisms such as, Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and fungus Candida albicans within the product.
The provided text describes a 510(k) premarket notification for the Atteris™ Antimicrobial Skin & Wound Cleanser. This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria in the same way a new drug or novel medical device might.
Therefore, the document does not contain a study that establishes clinical acceptance criteria for the device's performance in a clinical setting (e.g., wound healing rates, infection reduction rates). Instead, the studies mentioned are to demonstrate the new device is as safe and effective as the predicate based on pre-defined regulatory and biocompatibility standards.
However, I can extract information related to the performance testing that addresses aspects of safety and effectiveness as required for substantial equivalence.
Here's an attempt to organize the information based on your request, focusing on what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating equivalence in safety, performance, and specific product characteristics compared to a predicate device, rather than meeting specific clinical efficacy endpoints with numerical benchmarks.
| Criterion Type | Acceptance Criteria (Implied by 510(k) & Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993 standards for cytotoxicity, sensitization, and irritation. | Cytotoxicity: Final GLP Report - 15-03643-G1: L929 Agar Diffusion Test (Direct Contact) - ISO (Reference 4). Performance reported as non-cytotoxic. |
| Sensitization: Final GLP Report - 15-03643-G4: Direct Buehler Sensitization Test - ISO (Reference 6). Performance reported as non-sensitizing. | ||
| Irritation: Final GLP Report - 15-03643-G2: Direct Primary Skin Irritation Test - ISO (Reference 5). Performance reported as non-irritating. | ||
| Preservation | Meets USP criteria for antimicrobial effectiveness, specifically inhibiting growth of target microorganisms within the product. | Preservative Effectiveness Testing (USP ): Results demonstrated effectiveness against Escherichia coli (ATCC No. 8739), Staphylococcus aureus (ATCC No. 6538), Pseudomonas aeruginosa (ATCC No. 27853), Staphylococcus epidermidis (ATCC No. 12228), and Candida albicans (ATCC No. 10231). |
| Shelf Life/Stability | Device expected to maintain stability and effectiveness for a defined period. | Real-time aging study: Results indicate the product is expected to be stable and effective for a shelf life of 6 months. |
| Composition/Properties | Similar physical and chemical characteristics to predicate/reference devices (e.g., aqueous, density, non-sterile, not buffered). | Composition: Aqueous, ~1.0 g/ml density, non-sterile, not buffered. (Matches predicate/reference). Contains PHMB for preservation. |
| Intended Use | Same intended use as the predicate device (mechanical cleansing and removal of debris, dirt, foreign materials, including microorganisms). | Stated Intended Use (Rx and OTC) is consistent with the predicate device for wound and skin cleansing. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify exact sample sizes for the test sets used in the biocompatibility, preservative effectiveness, or shelf-life studies. These would typically be detailed in the full study reports referenced (e.g., Toxikon reports, USP reports), but not in the 510(k) summary. For biocompatibility tests (ISO 10993), sample sizes are generally small (e.g., a few animals or cell cultures per test).
- Data Provenance: The biocompatibility studies were conducted by "Toxikon" (a contract research organization presumably based in the US or an ISO-certified lab). The USP testing is a standard methodology. Real-time aging studies are conducted on the manufacturer's product. The provenance of the data is generally from laboratory testing, which is prospective in nature for these specific tests. Country of origin for data is not explicitly stated but assumed to be from a reputable testing facility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information (experts establishing ground truth for a test set) is not applicable to this 510(k) safety and performance testing. The "ground truth" for these tests are the established standards:
- For biocompatibility: ISO 10993 standards.
- For preservative effectiveness: USP monograph.
Experts (e.g., toxicologists, microbiologists) would perform and interpret the tests according to these standards, but there isn't a "ground truth" derived from expert consensus on images or clinical outcomes in the context of this submission.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially those involving human interpretation of data (e.g., radiology reads, pathology diagnoses), to establish a consensus "ground truth." The tests performed here are laboratory-based and follow standardized protocols; outcomes are objective measurements or categorical determinations (e.g., cytotoxic/non-cytotoxic, effective/not effective).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a 510(k) clearance for an antimicrobial skin and wound cleanser, not an AI-powered diagnostic or assistive tool. No human readers or AI assistance are involved in the performance evaluation described.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims in this submission are based on:
- Standardized Laboratory Controls: For biocompatibility, the ground truth is whether the device materials elicit a toxic, irritating, or sensitizing response when compared to controls as defined by ISO 10993.
- Pharmacopoeial Standards: For preservative effectiveness, the ground truth is the reduction in microbial count defined by the USP antimicrobial effectiveness test.
- Physical/Chemical Measurements: For shelf life and other characteristics, the ground truth is the stability of physical/chemical properties over time.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
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