(110 days)
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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.