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The NovaLine Tubing Sets for Hemodialysis - Models BL 11 and BL 12 - are sterile, single-use arterial and venous blood lines for exclusive use with the Baxter Healthcare AK98 Hemodialysis System. The blood lines serve as the extracorporeal blood circuit in patients undergoing hemodialysis treatment, by which blood is transported from the patient through a hemodialyzer and back to the patient. The pump line interfaces with a pump rotor mechanism of the hemodialysis machine which drives the flow of blood through the circuit.

The proposed devices, NovaLine Tubing Sets for Hemodialysis, mainly consists of two tubes, which are arterial line with certain components in red and venous line with certain components in blue, as well as accessory which is recirculating connector. There are two models BL 11 and BL 12, The main difference between BL 11 and BL 12 is the Drip chamber on the arterial line. There is drip chamber on the arterial line of BL 12, there is no drip chamber on the arterial line of BL 11. The BL 12 has more drip chambers than the BL 11 on the whole tubing. The proposed devices are provided in sterile condition, it is subject to e-beam radiation sterilization prior to release to achieve a Sterility Assurance Level (SAL) of 10-6.

This document does not describe an AI/ML device or its performance criteria. Instead, it is a 510(k) summary for a NovaLine Tubing Sets for Hemodialysis, a medical device used in hemodialysis treatments.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device as none are present in the provided text.

The document discusses substantial equivalence for a medical tubing set based on:

• Non-clinical tests: Verification against design specifications and compliance with standards such as ISO 8638, ISO 594-2, ASTM D4169-16, ASTM F88/F88M-15, and ASTM F1929-15.
• Biocompatibility: Conformance to ISO 10993 series standards, with the patient contact materials of the proposed device being covered by those of the predicate device.
• Sterilization: Achieves a Sterility Assurance Level (SAL) of 10-6.
• Physical performance: Comparison of tube lengths, priming volume, positive/negative pressure, and blood flow rate limitations against the predicate device, noting that both comply with relevant ISO standards.

No clinical study was included in this submission.

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