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The urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract.

The Haematuria Foley catheter has a spiral reinforced shaft and eliminates collapse during suctioning from the bladder. The material is exactly the same as the already approved marketed foley catheter. It is available with a variety of tips, Standard, Dufour and Couvelaire.

The provided text is a 510(k) summary for a medical device (Euromedical Haematuria Foley Catheter) seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present within this document.

Here's an explanation of why this information is missing in this context and what is typically found in a 510(k) summary:

• Substantial Equivalence: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a predicate device already on the market. This typically involves demonstrating similar technological characteristics and intended use, often through bench testing and material comparisons, rather than large-scale clinical trials designed to prove efficacy or safety against pre-defined acceptance criteria.
• Acceptance Criteria & Device Performance: The document provides a comparison table highlighting the identical materials and similar characteristics (sizes, coating, catheter material) to the predicate device. This comparison serves as a de-facto "performance" measure, indicating that because the new device is materially and functionally similar to an already approved device, its performance will be equivalent and acceptable.
• Clinical Studies: The text does not mention any clinical studies with human subjects, let alone the details of study design, sample sizes, expert ground truth, or adjudication methods. For a Class II device like a Foley catheter, substantial equivalence can often be demonstrated without such extensive clinical trials, especially if a clear predicate exists and the changes are minor or well-understood.
• Standalone Performance/Human-in-the-loop: These concepts are relevant for AI/ML-driven devices or complex diagnostic tools, which is not the case for a Foley catheter.
• Ground Truth: For a physical medical device like a catheter, "ground truth" isn't established in the same way as for diagnostic AI. Performance is typically assessed through engineering tests (e.g., burst pressure, material strength, flow rates) to ensure it meets manufacturing specifications and is safe for its intended use.

In summary, based solely on the provided text, the answer to your request is that the information regarding acceptance criteria, detailed study design, sample sizes, expert qualifications, true ground establishment, and MRMC studies is not available. The document focuses on demonstrating substantial equivalence through comparison with a predicate device.

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