(73 days)
The device is intended for ureteral dilation prior to ureteral stone manipulation, ureteroscopy, and dilating the intramural ureter.
The Pursuit Balloon Dilation Catheter is used for the ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter. The materials used to construct the balloon is nylon and polyethylene. The Pursuit Balloon Dilation Catheter will be offered in a 5FR diameter and 40cm to 100cm long catheter with a 5mm to 10mm x 4cm to 10cm balloon.
This document, a 510(k) Premarket Notification for the Pursuit Balloon Dilation Catheter, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and device performance results.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, adjudication methods, and MRMC effectiveness studies cannot be extracted from the provided text.
The document primarily states:
- Device Description: The Pursuit Balloon Dilation Catheter is used for ureteral dilation prior to ureteral stone manipulation or ureteroscopy, and dilating the intramural ureter.
- Substantial Equivalence: The manufacturer asserts that the device is substantially equivalent to predicate devices (Balloon Catheters manufactured by Bard, High Pressure Ureteral Dilatation Balloon Catheter manufactured by Microvasive, and various Cook Urological Balloon Dilation Catheters) in terms of indications for use, design, materials, and physical construction. This equivalence is the basis for its marketing clearance.
In summary, this document does not contain the information required to answer your specific questions about acceptance criteria and a study proving device performance, as it is a regulatory submission for substantial equivalence rather than a clinical or performance study report.
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).