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The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device for hemodialysis, apheresis, and infusion.

The Mahurkar 8 Fr Catheter, a radiopaque polyurethane tube with two D-shaped lumina, is coated with silicone fluid. The lumina can be distinguished by the colorcoded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.

The Mahurkar 8 Fr Catheter is available in four (4) implantable lengths (9 cm, 12 cm, 15 cm, and 19.5 cm), with straight extensions or curved extensions, and is packaged in catheter kit and catheter tray configurations.

The provided text is a 510(k) summary for the Mahurkar 8 Fr Dual Lumen Catheter. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in comprehensive performance testing reports. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot extract the requested information. The text does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set or how its ground truth was established.

The document states that "Performance data for the Mahurkar 8 Fr Catheter, including biocompatibility, mechanical characteristics, dynamic flow performance, infusion flow performance, and in vitro hemolysis testing, were compared to that of the predicate devices identified in paragraph (3) of this Summary." However, it does not provide the specific acceptance criteria for these tests or the detailed results demonstrating the device met them. It only concludes that "These test results demonstrate that the device is substantially equivalent to predicate devices commercially distributed for hemodialysis, apheresis, and infusion."

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