(34 days)
The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products.
This document is a 510(k) summary for a medical device (Maxcess Needlefree Connector). It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include a study with acceptance criteria and device performance as would be expected for an AI/ML medical device.
Therefore, I cannot extract the requested information from the provided text because it describes a traditional hardware medical device and not a software/AI medical device. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of AI/ML algorithms, which are not relevant to this type of device submission.
§ 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.