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The Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direction, intermittent infusion, continuous infusion or aspiration.

The proposed device, Needleless Connector, is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The proposed device is a needleless connector which can be activated by a male luer, and the flush volume for the device is 5ml. The device can be used for less than 7 days and 100 activations.

The Needleless Connector also suitable for power injection of contrast media into the central venous system only through IV line that is also indicated for power injection at a maximum pressure of 325psi and a flow rate of 10ml/s.

The provided text is related to an FDA 510(k) premarket notification for a "Needleless Connector." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of technical characteristics, rather than a study of an AI-powered device. Therefore, the requested information regarding acceptance criteria and a study proving an AI device meets those criteria cannot be extracted from this document.

The document details the device's technical specifications, materials, and non-clinical performance tests (e.g., biocompatibility, sterility, integrity, fluid dynamics) to show it is as safe and effective as a previously cleared device. It explicitly states: "No clinical study is included in this submission."

To address your request, I would need a document describing an AI device and its associated clinical or performance study.

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