(32 days)
The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal. This is in addition to the fact that it will be used for temporary drainage from the ureteropelvic junction to the bladder. Double pigtail stents have been employed to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. These stents may be placed using endoscopic, percutaneous, or even surgical techniques. The duration of the placement of these stents must not remain indwelling more than twenty-nine (29) days. This product is intended for one-time use only. If the patient's status permits, the stent may be replaced with a new stent.
The UroSurge SpiraStent Plus™ Ureteral Stent, has a reinforcing filament which increases its tensile strength, thereby minimizing the probability of the stent breaking during removal.
This FDA 510(k) summary for the UroSurge SpiraStent™ PLUS is a notification of intent to market and does not contain information on acceptance criteria, a study proving the device meets criteria, or details regarding ground truth, sample sizes, or expert qualifications for performance evaluation. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information from the provided document. The document confirms that the device is substantially equivalent for its intended use, which is for temporary drainage from the ureteropelvic junction to the bladder, with an indwelling duration not exceeding twenty-nine (29) days. It also highlights an added feature of a reinforcing filament to minimize breakage during removal. This regulatory document does not typically include detailed performance study data against specific acceptance criteria.
§ 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).