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The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient.

The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters.

This document is a 510(k) summary for an Intravascular Administration Set from July 10, 1996. It details a medical device classification and states its substantial equivalence to previously marketed devices. However, it does not provide any information about acceptance criteria, device performance metrics, clinical studies, or data provenance. The document predates many of the standardized reporting requirements for clinical performance studies, especially those involving AI or detailed efficacy metrics.

Therefore, I cannot fulfill the request for information regarding performance, study design, expert involvement, or ground truth as this information is not present in the provided text. The document focuses solely on establishing substantial equivalence based on materials, manufacturing, and general function, rather than presenting a performance study with detailed acceptance criteria.

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