LESE STENTS SETS

K952513 · Cook Urological, Inc. · FAD · Jun 10, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K952513
• Device Name: LESE STENTS SETS
• Applicant: Cook Urological, Inc.
• Product Code: FAD · Gastroenterology, Urology
• Decision Date: Jun 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder.

Device Story

Ureteral stent for temporary internal drainage from ureteropelvic junction to bladder; ion implantation treatment applied to reduce surface friction and enhance surface energy; used by urologists in clinical settings; provides drainage to relieve obstruction or facilitate healing; biocompatible materials ensure safety during indwelling period.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on polyurethane, silicone, and vinyl materials; results met requirements. Stainless steel and TFE biocompatibility assured via established medical use.

Technological Characteristics

Materials: stainless steel, TFE, polypropylene, polyurethane, silicone, vinyl. Surface modification: ion implantation for reduced friction/enhanced surface energy. Sterilization: consistent with existing marketed Cook Urological devices.

Indications for Use

Indicated for temporary internal drainage from the ureteropelvic junction to the bladder in patients requiring ureteral stenting.

Regulatory Classification

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.

Predicate Devices

• Cook Urological® Ureteral and Urethral Stents (preamendment)
• Cook Urological® EchoSight® Sof-Flex® Stents
• Cook Urological® SlipCoat™ Stents

Submission Summary (Full Text)

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K9525/3

510(k) Premarket Notification
LSe Stent Sets
Cook Urological®

J. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitted By:
Rick Lykins
Cook Urological®
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
May 25, 1995

JUN 10 1996

Device:
Trade Name: LSe Stent Sets
Proposed Classification Name: Splint, Ureteral 78 FAD

Predicate Devices:

The LSe Stent Sets are substantially equivalent to predicate ureteral stents in terms of indications for use, design, construction and materials equivalence. Predicate devices include:

- Cook Urological® Ureteral and Urethral Stents manufactured by Cook Urological®. Cook Urological® Ureteral and Urethral Stents are preamendment.
- Cook Urological® EchoSight® Sof-Flex® Stents manufactured by Cook Urological®.
- Cook Urological® SlipCoat™ Stents manufactured by Cook Urological®.

Device Description:

The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder. The stents have been Ion Implantation treated for reduced surface friction and enhanced surface energy. The materials used in these devices are stainless steel, TFE, polypropylene, polyurethane, silicone and vinyl. Stainless steel and TFE are widely used in the medical field and biocompatibility is assured. Biocompatibility testing has been performed on the polyurethane, silicone and vinyl and results show the materials to meet the requirements of these tests. The polypropylene does not come into contact with body tissue.

Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. These devices will undergo packaging similar to the devices currently marketed and distributed by Cook Urological®. When marketed as sterile, these devices will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological®. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.

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