(106 days)
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No
The summary describes a physical medical device (stent set) and its components, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is used to create a new tunnel for decompression of the renal system, which is a therapeutic intervention.
No
The device is described as being used to create a new tunnel for decompression of the renal system, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists physical components such as a stent, dilators, sheaths, wire guides, needle syringe, positioner, and release sleeve, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is used to create a physical tunnel within the body to decompress the renal system. This is a surgical or interventional procedure, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Information: The intended use and device description focus on a physical intervention and do not mention any analysis of biological samples or the generation of diagnostic information.
Therefore, this device falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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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.
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
renal pelvis, urinary 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
17
.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.