(21 days)
The ICU Needleless Connector is a single use , sterile, non pyrogenic Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery
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I am sorry, but the provided text is a 510(k) clearance letter for the "Y Clave Connector Will Integrated Check Valve, Model XI-3432", an intravascular administration set.
This document describes the regulatory approval of a physical medical device, not a software algorithm or AI model. Therefore, the information you're asking for, such as acceptance criteria, study details (sample sizes, ground truth, expert qualifications, etc.), MRMC studies, or standalone algorithm performance, is not contained within this regulatory letter. These types of details are typically found in the scientific studies or technical documentation submitted as part of the 510(k) application, but they are not summarized or presented in the clearance letter itself.
To answer your request, I would need a description of a study or documentation related to an AI/algorithm-based medical device.
§ 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.