(152 days)
The Disposable ureteral stent is intended for temporary drainage from the ureteropelvic junction to the bladder of the ureter in a variety of benign, malignant and post-traumatic conditions of the ureter. These conditions include stones and/or stone fragments or other ureteral obstructions such as those associated with ureteral stricture, malignancy of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent should be placed using endoscopic surgical technique. The stent is not intended as a permanent indwelling device. The indwelling time should not exceed thirty (30) days.
The 4Fr model is intended to be used for pediatric (adolescents, children, and infants) patients.
Disposable ureteral stents are sterile, single-use devices, that are inserted into the ureter endoscopically to facilitate the drainage of urine from the kidney to the bladder and can be used for treatment of ureter blockage and stricture.
The stents are available in 4.0 to 12.0 French (Fr) diameter, with lengths ranging from 12.0 to 30.0 centimeters (cm). The device includes a polyurethane stent, a push catheter, and optional accessories - a guide wire (coated guide wire, hydrophilic guide wire, or zebra guide wire) and a guide wire sheath.
The stents include Type A, C, D, F, and H stents all of which are composed of tube bodies only. The stents are secured in the urinary tract with pigtail loops on the proximal (renal pelvis) and distal (bladder) ends.
The Disposable ureteral stents are not intended as a permanent indwelling device and is labeled for indwell time not to exceed thirty (30) days only.
The provided 510(k) clearance letter and summary are for a "Disposable Ureteral Stent" and do not describe an AI/ML medical device. The document details the device's technical specifications, non-clinical testing (bench testing, biocompatibility, sterility, shelf-life), and comparison to predicate devices, but it explicitly states that "No clinical study is included in this submission" and there is no mention of an algorithm or AI component.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth for an AI device, as the provided text relates to a traditional medical device (a ureteral stent) and not an AI/ML product.
§ 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).