(106 days)
The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system.
The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system. The set contains a stent, dilators, sheaths, wire guides, needle syringe and the exchange set contains a dilator, sheath, positioner, release sleeve and wire guide. This device is intended for one-time use.
The provided text is a 510(k) summary for a medical device (Subcutaneous Urinary Diversion Stent Set) submitted in 1996. This type of document, particularly from this era, does not contain the kind of detailed information about acceptance criteria, study design, and performance metrics that you are requesting.
510(k) submissions, especially those from the 1990s, focused primarily on demonstrating "substantial equivalence" to a predicate device. This typically involved comparing indications for use, technological characteristics (materials, design), and sometimes basic performance data. They were not clinical studies in the modern sense with specific acceptance criteria, ground truth establishment, or statistical power calculations for AI performance.
Therefore, I cannot provide the information requested from the input text because it is not present. The document focuses on demonstrating equivalence to predicate devices, not on a study proving the device meets specific performance acceptance criteria.
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.III 2 4 1996
510(k) Premarket Notification Subcutaneous Urinary Diversion Stent Set Cook Urological
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ت
Submitted By:
Tammy Bacon Cook Urological 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 April 8, 1996
Device
Trade Name: Proposed Classification Name: Subcutaneous Urinary Diversion Stent Set Splint, Ureteral
Predicate Devices:
The Subcutaneous Urinary Diversion Stent Set is comprised of a stent and accessories which are equivalent to predicate devices in terms of indications for use, design, and materials of construction.
Device Description:
The Subcutaneous Urinary Diversion Stent Set and Exchange Set is used to create a new tunnel leading from the renal pelvis to the urinary bladder for the purpose of providing decompression of the renal system. The set contains a stent, dilators, sheaths, wire guides, needle syringe and the exchange set contains a dilator, sheath, positioner, release sleeve and wire guide. This device is intended for one-time use.
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, Inc. This device is similar with respect to indications for use, materials, and physical construction to predicate devices, thereby meeting the requirements for section 510(k) substantial equivalency.
§ 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).