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The GuardianCatheter-Infant Urinary Collection Kit is for urinary drainage and collection for use in the neonatal/pediatric patient population.

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The provided document is a 510(k) premarket notification letter from the FDA for the GuardianCatheter™-Infant Urinary Collection Kit. This type of document confirms that a device is substantially equivalent to a predicate device already on the market.

It is important to note that 510(k) submissions typically focus on demonstrating substantial equivalence to a predicate device, and often do not involve extensive new clinical studies with detailed acceptance criteria and performance metrics as might be seen for novel, high-risk devices or those requiring a PMA (Premarket Approval).

Based on the provided text, the document does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. The letter primarily confirms regulatory clearance and substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions about performance metrics and study details from the text provided. The document outlines the device's indications for use and confirms its regulatory classification, but does not present the type of clinical study data you are asking for.

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