(230 days)
The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the percutaneous tract dilation).
The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).
The In-Ka® Percutaneous Balloon Dilatation Catheters are balloon catheters intended for dilation of the nephrostomy tract to create a percutaneous renal access. The catheter is a 7 Fr double lumen catheter supplied with a radiopaque Amplatz sheath. The catheter is supplied with or without an inflation device (manometer) depending on the model. Amplatz sheaths are also sold separately from the catheter. The 30 Fr balloon is equipped with a radiopaque stainless-steel ring on its distal extremity corresponding to the balloon's working length to allow radiographic visualization and positioning. Each In-Ka catheter is supplied sterile for a single use.
The provided text describes a 510(k) premarket notification for the "In-Ka® Percutaneous Balloon Dilatation Catheter and Amplatz Sheath." It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically seen with AI/ML-driven devices.
This document is a regulatory submission for a physical medical device (catheter and sheath) and primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, biocompatibility, sterilization, and shelf-life studies. It does not involve any AI components, human reader studies, or ground truth establishment in the context of diagnostic or interpretive performance.
Therefore, the requested information regarding acceptance criteria, reported device performance in those criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this specific document as it pertains to AI/ML device evaluations.
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