(258 days)
The Silicone Hydro-Coated Double Loop Ureteral Stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
The Silicone Hydro-Coated Double Loop Ureteral Stents, along with the predicate devices, Porges™ Silicone Double Loop Ureteral Stents, and Vortek® Hydro-coated Double Loop Ureteral Stent, 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 6 and 8 Fr and lengths between 16 and 30 cm long. The stents have both tips open (0/0) to allow for placement over a guidewire.
Silicone Hydro-Coated Double Loop Ureteral Stents in this submission and the predicates are supplied in kits. The ImaJin™ Silicone Hydro-Coated Double Loop Ureteral Stent Kits contain the following components:
- A Silicone Hydro-Coated Double Loop Ureteral Stent
- A steerable pusher
And in some kits: - A guide wire
- A ureteric catheter
The Silicone Hydro-Coated Double Loop Ureteral Stents 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.
The provided text is a 510(k) Premarket Notification from the FDA regarding a medical device, specifically a ureteral stent. It details the device description, indications for use, comparison to predicate devices, and performance data used to establish substantial equivalence.
However, the text does not contain information related to an AI/ML-driven medical device, nor does it discuss acceptance criteria, study methodologies (like MRMC or standalone performance), sample sizes for AI model training/testing, expert ground truthing, or adjudication methods. The performance data mentioned (Biocompatibility Testing, Mechanical Testing, Sterilization, Packaging and Distribution) pertains to the physical and biological characteristics of the stent itself, not to the performance of a diagnostic or assistive AI system.
Therefore, I cannot extract the requested information to fill out the table and answer the questions. The document is about a physical medical device, not an AI system.
§ 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).