(42 days)
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder.
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.
Due to the nature of the provided text, which is an excerpt from a 510(k) Premarket Notification for a medical device (AQ Hydrophilic Stent), it does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment.
The provided text focuses on:
- Submission details: Applicant, date, device name, classification.
- Predicate devices: Stating equivalence to existing devices.
- Device description: Intended use, materials, "slippery-when-wet" property due to hydrophilic coating.
- Substantial Equivalence claim: Based on indications for use, materials, physical construction, manufacturing controls, packaging, and sterilization.
This type of document for a Class II medical device (like a ureteral stent) typically relies heavily on predicate device comparison and bench testing for performance, biocompatibility, and sterilization validation, rather than large-scale clinical studies with acceptance criteria based on metrics like sensitivity, specificity, or reader performance, as would be common for AI/ML-based diagnostic devices.
Therefore, I cannot populate the table or answer the specific questions based on the provided input. The information simply isn't present in this excerpt.
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510(k) Premarket Notification AQ Hydrophilic Stent Cook Urological
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS L
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 April 15, 1996
Device
Trade Name:
AQ Hydrophilic Stent
Proposed Classification Name:
Splint, Ureteral
Predicate Devices:
The AQ Hydrophilic Stent is substantially equivalent to predicate devices in terms of indications for use, design, and materials of construction. Predicate devices include the Slipcoat™ Stent manufactured by Cook Urological, the Hydro-Plus™ manufactured by Microvasive and the Lubri-Flex™ Ureteral Stent, K905289, manufactured by Surgitek®
Device Description:
The AQ Hydrophilic Stent is used for temporary internal drainage from the ureteropelvic junction to the bladder. The hydrophilic coating will allow the stent to become 'slippery-when-wet' which will reduce friction. This device will be made from polyurethane, silicone and a hydrophilic coating.
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4961446
10
510(k) Premarket Notification AQ Hydrophilic Stent Cook Urological
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook Urological. Being similar with respect to indications for use, materials and physical construction to predicate device meets the requirements for section 510(k) substantial equivalence.
§ 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).