(70 days)
The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery.
The Applied Medical Ureteral Stents are substantially equivalent to predicate devices and introduce no new safety and effectiveness issues when used as instructed.
The provided text describes a 510(k) submission for Ureteral Stents and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a regulatory submission for premarket notification, establishing substantial equivalence to predicate devices, and outlines the indications for use. It does not include performance data, clinical trials, or any specific study results that would typically be used to define and evaluate acceptance criteria for a medical device's performance. Therefore, I cannot generate the requested information based on the provided input.
§ 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).