(60 days)
The double loop ureteral stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
Vortek® Double Loop Ureteral Stents in this submission and both predicates. Vortek® Hydro-Coated Double Loop Ureteral Stents and Vortek® Double Loop Ureteral Stents, are implantable autostatic catheters used to maintain urine drainage and to allow for ureteral healing. They are inserted during a surgical procedure using either an antegrade or a retrograde technique or by open surgery typically using a guidewire and a pusher.
Stents are supplied in diameters between 4.8 and 8 Fr and lengths between 12 and 30 cm long. The stents can have either both tips open (0/0) or the vesical tip open and renal tip closed (0/c).
Vortek® Double Loop Ureteral Stents in this submission and the predicates are supplied in kits which include the following components:
- A double-loop ureteral stent
- A pusher
- A guide wire
And in some kits: - A ureteric catheter
The Vortek® Double Loop Ureteral Stent and accessories included in the kits are supplied sterile via ethylene oxide. The ureteral stent and each accessory are packaged and sterilized separately prior to being combined in the kit.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device called "Vortek® Double Loop Ureteral Stents." It describes the device, its intended use, comparison to predicate devices, and the testing conducted to demonstrate substantial equivalence.
However, the provided text does not contain information about an AI/ML-based medical device or its acceptance criteria, performance studies, or ground truth establishment. The document focuses on a traditional medical device (a ureteral stent) and its non-clinical performance data (biocompatibility, mechanical testing, sterilization, packaging).
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from this document. The questions you've asked are relevant for AI/ML device submissions, but this specific FDA document does not pertain to such a device.
§ 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).