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Non-Power Injectable:

Extension Sets with an attached BD Q-Syte™ Luer Access Split Septum are intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Power Injectable:

The Power Injectable Extension Set with an attached BD Q-Syte™ Luer Access Split Septum is intended to be used with intravascular catheters to aspirate blood or administer fluids, including medications and blood or blood products. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

The Power Injectable Extension Set is also indicated for use with intravascular catheters indicated for power injection of contrast media. The Power Injectable Extension Set is suitable for use with power injectors set to a maximum pressure of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made.

The Extension Sets with BD Q-Syte™ Luer Access Split Septum consist of a length(s) of flexible non-DEHP PVC clear tubing with a non-removable slide clamp. The devices include an ISO male Luer lock connection with a protection cap on the distal end an ISO female Luer lock connection on the proximal end(s) with a removable BD Q-Syte device or end cap. The Extension Sets with BD Q-Syte™ Luer Access Split Septum are provided in lengths from 5 in (127 mm) to 21 in (533 mm) with tubing diameters ranging from 0.035 in ID (0.89 mm) x 0.094 in OD (2.40 mm) to 0.110 in ID (2.80 mm) x .161 in OD (4.10 mm). Select Extension Sets include injection sites with a permanently attached BD Q-Syte device. The BD Q-Syte device is a needleless access device provided to aid in reducing the risk of accidental needlestick injuries. The Extension Sets with BD Q-Syte™ Luer Access Split Septum do not contain natural rubber latex.

The Power Injectable Extension Set with BD Q-Syte™ Luer Access Split Septum is suitable for use with power iniectors set to a maximum of 325 psi (2,240 kPa) when the BD Q-Syte device is removed and a direct connection is made. This device has a label attached to the tubing stating "Power Injectable Max 325 PSI".

The provided document is a 510(k) Premarket Notification for "Extension Sets with BD Q-Syte™ Luer Access Split Septum." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a new study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Specifically:

• It does not present a table of acceptance criteria and reported device performance.
• It does not describe a study involving a test set, its sample size, or data provenance.
• It does not mention experts establishing ground truth, adjudication methods, or MRMC studies.
• It explicitly states that "Performance testing was conducted for the predicate devices" and that the "results of the predicate testing indicate that the subject Extension Sets... are substantially equivalent." This means new performance data for this specific device against new acceptance criteria is not presented.
• It does not detail the sample size or ground truth establishment for a training set, as it relies on predicate device data for performance.

The document's primary purpose is to justify substantial equivalence based on the similarity of the new device to existing predicate devices, implying that the performance criteria for those predicate devices are met by extension.

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