(80 days)
The Cook Nephrostomy Tract Balloon Dilation Catheter Set is used for one step, dilation of the musculofascial nephrostomy tract and placement of the working sheath.
The materials used to construct the balloon are Nylon and Polyethylene. The Nephrostomy Balloon Catheter Set will be offered with a 7.3 Fr. diameter, 55cm long catheter, a 32 Fr. diameter, 16cm long sheath Vinyl or TFE and an inflation gauge.
This 510(k) premarket notification for the Cook Nephrostomy Balloon Dilation Catheter Set does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The document is a submission to the FDA for substantial equivalence and focuses on comparing the new device to existing predicate devices. It states:
- Substantial Equivalence: The device is "substantially equivalent to predicate devices in terms of indication for use and design." It also states the device "meets the requirements for section 510(k) substantial equivalence" due to similarities with predicate devices in indications for use, materials, and physical construction.
- Manufacturing and Quality: "The device will 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."
Therefore, I cannot fill in the table or answer the specific questions about acceptance criteria, performance studies, sample sizes, ground truth, or expert involvement. The provided text does not describe a performance study with acceptance criteria in the way envisioned by your request, which typically applies to software/AI or diagnostic device performance. Instead, it relies on demonstrating equivalence to legally marketed predicate devices.
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