(62 days)
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No
The 510(k) summary describes a physical medical device (catheter set) and its materials, with no mention of software, algorithms, or any terms related to AI or ML.
No
The device is used for temporary or permanent urinary diversion, which is a supportive rather than therapeutic function. It does not treat a disease or condition itself but rather manages a physiological process.
No
The device is described as a catheter set used for temporary or permanent urinary diversion, which is a therapeutic or palliative function, not diagnostic.
No
The device description explicitly states the materials used (silicone, polyvinylchloride, and polypropylene) and describes biocompatibility testing performed on the silicone, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures." This describes a surgical or interventional procedure performed directly on the patient's body for therapeutic purposes (diverting urine).
- Device Description: The description details a physical catheter set made of materials like silicone, polyvinylchloride, and polypropylene. It describes a device that is inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically used in a laboratory setting or at the point of care to analyze biological samples.
Therefore, the Circle Nephrostomy Catheter Set is a medical device used for a surgical/interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures.
Product codes
79 GBO
Device Description
The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are slicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the nuterial to meet the requirements of these tests. The polyvinylchloride and polypropylene do 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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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N/A
0
510(k) Premarket Notification Circle Nephrostomy Catheter Set Cook Urological, Incorporated
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS J.
Submitted By:
Rick Lykins Cook Urological, Incorporated 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 May 16, 1996
JUL 18 1995
Device:
Trade Name:
Circle Nephrostomy Catheter Set
Proposed Classification Name: Catheter, Nephrostomy, General & Plastic Surgery 79 GBO
Predicate Devices:
The Circle Nephrostomy Cathere Set is substantially equivalent to predicate circle nephrostomy catheter sets in terms of indications for use, design, construction and materials equivalence. Predicate devices include:
- . Silastic® U-Tube Nephrostomy Kit manufactured by Dow Corning Corporation.
- . Circle Nephrostomy Tube manufactured by Mentor Urology
Device Description:
The Circle Nephrostomy Catheter Set is used for temporary or permanent urinary diversion following nephrostomy, nephroureterostomy or other stenotic or obstructed UPJ procedures. The materials used in this device are slicone, polyvinylchloride and polypropylene. Biocompatibility testing has been performed on the silicone. Results show the nuterial to meet the requirements of these tests. The polyvinylchloride and polypropylene do not come into contact with body tissue.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated. This device will undergo sterilization similar to the devices currently marketed and distributed by Cook Urological, Incorporated. 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.