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This urological catheter is intended for the infusion of Sterile solution into the b ladder to irrigate, cleanse, or drain thecontents of the bladder during surgical procedures.

Both the device in this submission and the predicate device are used to irrigate and drain the bladder. Both devices use an inflation balloon to retain the Catheter in the bladder. Both devices are 3-way foley Catheters.

The provided text describes a 510(k) premarket notification for a medical device called "MRI's All Silicone Irrigation 3-Way Foley Catheter." However, it does not contain any information about acceptance criteria, device performance testing, study design, sample sizes, ground truth establishment, or expert involvement for a study proving the device meets acceptance criteria.

The documents are a 510(k) summary and the FDA's clearance letter, which focus on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than a detailed performance study with acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided information is insufficient to answer your prompt.

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