(377 days)
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No
The summary describes a physical medical device (stent) with material properties and intended use, but makes no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes.
The device is used for "temporary internal drainage," which is a medical intervention intended to treat a condition by providing drainage for fluid buildup.
No
The device is described as a stent used for temporary internal drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the device is a physical stent made of materials like stainless steel, TFE, polyurethane, silicone, and vinyl, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary internal drainage from the ureteropelvic junction to the bladder." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a physical device (stent) made of various materials, designed to be implanted in the body. This is characteristic of a medical device used for treatment or support, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to provide diagnostic information.
This device is clearly a medical device used for a therapeutic purpose within the body.
N/A
Intended Use / Indications for Use
The LSe Stent Sets are used for temporary internal drainage from the ureteropelvic junction to the bladder.
Product codes
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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, polyprethane, 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
ureteropelvic junction to the bladder
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Cook Urological® Ureteral and Urethral Stents manufactured by Cook Urological® Ureteral . and Urethral Stents are preamendment., Cook Urological® EchoSight® Sof-Flex® Stents manufactured by Cook Urologica1® ., Cook Urological® SlipCoat™ Stents manufactured by Cook Urological® .
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
510(k) Premarket Notification LSe Stent Sets Cook Urological®
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS J.
Submitted By:
JUN 10 1996
Rick Lykins Cook Urological® 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 25, 1995
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® Ureteral . and Urethral Stents are preamendment.
- Cook Urological® EchoSight® Sof-Flex® Stents manufactured by Cook Urologica1® .
- 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, polyprethane, 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.