(216 days)
The Flexima™ Ureteral Stent System and Flexima™ Ureteral Stent System Kit is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.
The Flexima™ Biliary Catheter System / Flexima™ Biliary Catheter System Kit / Flexima™ Biliary Catheter System with Radiopaque Marker / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip / Flexima™ Biliary Catheter System with Hydrophilic Dissolving Tip and Radiopaque Marker are intended to provide external and internal percutaneous drainage of the biliary system.
The Flexima Biliary Catheters are constructed of Flexima, a Tecoflex Polyeurethane-based resin, and selected subfamilies also have a radiopaque marker (RO) made from 65%Tungsten. The radiopaque marker is located approximately 5mm proximal to the most proximal drainage hole to aid in proper placement of the catheter. Additionally, designated Flexima Biliary Catheters are available with a biocompatible, dissolving distal tip (Temp-Tip™). This dissolvable tip facilities tracking over a guidewire for percutaneous placement and dissolves within 24 hours of placement to provide a larger drainage lumen. These biliary catheters provide external and internal percutaneous drainage of the biliary system. Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days.
The Flexima Ureteral Stent is also constructed of Tecoflex Polyeurethane-based resin. The pigtails on either end of the stent, are in opposite directions so that the proximal pigtail can form in the renal pelvis, while the distal pigtail forms in the bladder, to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. The double pigtail stent prevents upward and downward movement. Also, where longterm use is indicated, this stent is recommended not to exceed 90 days of indwelling time.
The Flexima Biliary Catheters and Flexima Ureteral Stents are provided sterile, using 100% ethylene oxide (EO) gas sterilization, and are intended for hospital and single use only. These devices utilize Glidex™ Hydrophillic Coating for the reduction of surface friction during placement.
I'm sorry, but this document does not contain the information required to fulfill your request. The provided text is a 510(k) premarket notification for Flexima™ Biliary Catheter System and Flexima™ Ureteral Stent System. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance testing related to magnetic resonance compatibility.
The document does not describe an AI/ML-based medical device. Therefore, it lacks details on:
- Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC).
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for test sets in an AI/ML context.
- Data provenance for AI/ML training or testing.
- Number of experts and their qualifications for ground truth establishment for AI/ML.
- Adjudication methods for AI/ML test sets.
- MRMC comparative effectiveness studies for AI assistance.
- Standalone performance for an AI algorithm.
- Ground truth types or sample sizes for AI training sets, or how AI training set ground truth was established.
The document entirely pertains to the physical and material properties (e.g., radiopaque markers, dissolving tips, dimensions) and the magnetic resonance compatibility of medical catheters and stents, not an algorithm.
§ 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).