(158 days)
Both the VORTEK and BIOSOFT versions of the ureteral double loop stent are intended for the exact same use as the current silicone ureteral double loop stent. The ureteral double loop stent are intended for drainage of the upper urinary tract where indicated such as in the case of ureteral obstruction, fistula, calculus debris/fragmentation, tumor, etc. The "flush" ureteric configuration with certain models (reference numbers) is intended to flush the lithiasis to the kidney before ESWL.
VORTEK® and BIOSOFT® Ureteral Double Loop Stents
This document is a 510(k) premarket notification decision letter from the FDA regarding VORTEK and BIOSOFT Ureteral Double Loop Stents. It confirms substantial equivalence to a predicate device but does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).