(203 days)
The Bard X-Force™ Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy tract and for placement of the working sheath.
The Bard X-Force™ Nephrostomy catheter is composed of a dual lumen shaft with inflation and guidewire lumens and a dilation balloon on the distal end. The catheter has a band which corresponds with the distal end of the balloon's working length to radiopaque facilitate radiographic visualization and placement. A high pressure stopcock is used on the inflation lumen to maintain pressure after removal of the pressurization apparatus.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance described in a table, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.
The document is a 510(k) summary for a medical device (X-Force™ N30 Nephrostomy Balloon Dilation Catheter). It primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, general design, and fundamental scientific technology. It states: "The X-Force™ N30 Nephrostomy Balloon Dilation Catheter referenced in this submission is held to the same design, manufacture, and performance specifications as those catheters currently manufactured by Bard. The appropriate design verification and validation activities for the modifications to the device were conducted." However, it does not provide the details of these performance specifications or the results of those verification and validation activities.
N/A