(139 days)
The JFil® Ureteral Stents are used for temporary internal drainage of the ureteropelvic junction.
The stents may be placed using endoscopic techniques.
The stents are not intended as permanent indwelling devices, it is recommended that the indwelling time does not exceed 14 days.
Target population: adults only (greater than 21 years of age).
The JFil® Ureteral Stents consist of a tube-like device that is inserted into the ureter to allow the passage of the urine in the treatment of ureteral injuries and ureteral obstructions. This polyurethane stent has a single loop on the proximal tip and a polypropylene-monofilament surgical thread on the distal tip. JFil stents are 6.0 or 7.0 French (Fr) in diameter and 8 or 16 cm in specified length. The stent is provided with a 63 cm length pusher and may include a Nitinol Guidewire in the kit. The pusher consists of a radio-opaque ring connected to a tubing, and is intended to allow pushing, placing, and releasing the stent inside the patient. This stents can only be used by trained professionals in a clinic or hospitals environment. The JFil Ureteral Stents are sterile and for single use only. The stents are also available in ECO-kits which do not include a guidewire. The stents can be removed cystoscopically by gently pulling on the surgical thread.
This document describes a 510(k) premarket notification for the JFil® Ureteral Stents, not a study evaluating an AI device. As such, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence of the JFil® Ureteral Stents to legally marketed predicate devices based on intended use, technological characteristics, and performance data from bench and biocompatibility testing. The data provided only refers to in-vitro testing of a physical medical device, not an AI model.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study evaluating an AI device's performance based on the provided text.
§ 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).