(78 days)
The Onset Medical Pathway™ Expandable Ureteral Sheath (the Expandable Sheath) is intended to establish a working channel, admitting access to the ureter by way of the urethra and bladder, during endoscopic urological procedures.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "Pathway™ Expandable Ureteral Sheath." This document is a regulatory approval and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving device performance based on the provided input. This type of information would typically be found in the 510(k) submission itself, which is a much larger document than this clearance letter.
§ 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).