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The Ultra Sets are designed for drainage and infusion of PD solution during a peritoneal dialysis exchange.

The Y-shaped design of the set enables patients to initially drain the dialysis solution from the peritoneum into the attached drain bag and then to fill new dialysis solution from a solution container into the patient's peritoneum. The plastic Y-shaped configuration serves as a junction for three lengths of tubing. The first length of tubing is the patient connector and connects to the patient's transfer set via a luer lock connection. The second length of tubing has a spike connector for connection to the new solution container and an occlusion clamp which is utilized during the solution exchange. The third length of tubing has a empty drain bag and an occlusion clamp for collection of spent dialysate during the dialysis exchange.

I'm sorry, but without a clear description of the "acceptance criteria" and "device performance" in the provided text, I cannot generate the requested table and study information. The provided text is a 510(k) summary for a medical device (Peritoneal Dialysis Y-Set) and discusses its equivalence to predicate devices, safety testing (biological, sterilization, pyrogen), and functional testing, but it does not explicitly define acceptance criteria or specific device performance metrics in a quantitative way that would allow for the construction of the requested table.

The text focuses on demonstrating the device's safety and substantial equivalence to previously cleared devices through adherence to established standards and guidelines, rather than presenting a study with specific performance acceptance criteria and results against those criteria.

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