(80 days)
The Fossa Double Pigtail Expanding Ureteral Stent is indicated for use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.
The Fossa Expanding Double Pigtail Ureteral Stent set consists of a flexible, Pigtail tipped, self-expanding stent with: Insertion sheath, "Pusher," and optional pre-attached suture to facilitate stent removal. The stent is offered in various diameters and working lengths. Short slits along the working length of the stent allow radial device expansion to permit fluid flow through and around the device.
The provided text does not contain information about acceptance criteria for a study, nor does it describe a study proving a device meets such criteria. Instead, it is a 510(k) summary and FDA clearance letter for a medical device called the "Fossa Expanding Double Pigtail Ureteral Stent".
The document focuses on:
- Device Description: A flexible, pigtail-tipped, self-expanding ureteral stent with an insertion sheath, "Pusher," and optional pre-attached suture. It's offered in various diameters and lengths.
- Indications for Use: For use as an indwelling ureteral catheter for drainage of urine from the kidney to the bladder.
- Safety and Performance: States that "Product performance testing has been provided in support of this 510(k) in accordance with FDA's Guidance for the Content of Premarket Notifications for Ureteral Stents." It also mentions that the materials are identical to those used in other currently marketed urinary drainage devices.
- Predicate Devices: Cook Double Pigtail Polyurethane Stent and Bard Double Pigtail Ureteral Stent.
- Conclusion: Based on indications for use, technological characteristics, performance testing, and comparison to predicate devices, the stent is deemed safe and effective.
- FDA Clearance: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as this type of information is not present in the provided text. The document is a regulatory submission for device clearance, not a detailed study report.
§ 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).