(50 days)
The Closed Male Luer (CML) is a single use, sterile, swab-able, bi-directional valve intended for use as an accessory to an Intravascular Administration Set. The Closed Male Luer provides access for the administration of fluids from a container to a patient's vascular system through the administration needle or catheter which is inserted into the vein or artery.
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The provided text is a clearance letter from the FDA for a medical device called "Closed Male Luer" and an "Indications for Use" statement. It does not contain the acceptance criteria or a study describing the device's performance against such criteria. The document explicitly states that the FDA's substantial equivalence determination does not mean the device complies with other requirements of the Act or any Federal statutes and regulations.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the provided text. The document focuses on regulatory clearance based on substantial equivalence to a predicate device, not on presenting performance data.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or a comprehensive market submission that includes performance testing results.
§ 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.