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The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter.

The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "GuardianCatheter"-Infant Urinary Drainage Catheter. It indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

The letter mentions:

• Device Name: GuardianCatheter"-Infant Urinary Drainage Catheter
• Regulation Number: 21 CFR §876.5130
• Regulation Name: Urological catheter and accessories
• Regulatory Class: II
• Product Code: GBM
• Indications for Use: "The GuardianCatheter-Infant Urinary Drainage Catheter is a single lumen silicone urinary catheter intended to drain urine in the neonatal patient population. This catheter is NOT a Foley (balloon) type catheter."

However, it does not provide:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of information is typically found in the 510(k) submission summary or device-specific testing reports, not in the FDA's clearance letter itself.

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