(133 days)
The Microvolume Luer Access Device is a valve intended for the aspiration, injection, or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Microvolume Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 10ml/sec.
The Microvolume Luer Access Device (LAD) consists of a body, piston, spike/nut, and a male luer lock cover. The Microvolume LAD is a neutral displacement needleless connector intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The Microvolume LAD may be used with a power injector. The Microvolume LAD is individually packaged and supplied as a sterile, nonpyrogenic, single use disposable device.
The provided text describes a 510(k) premarket notification for a medical device (Microvolume Luer Access Device) and its comparison to a predicate device, focusing on demonstrating substantial equivalence. However, it does not contain information about the acceptance criteria and study proving device performance as requested in the prompt. The document states that the device was evaluated using "Functional performance bench testing" and "No clinical was performed" because the device does not require clinical studies to demonstrate substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample size (test or training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established, as these aspects relate to clinical studies or a more detailed performance evaluation that is not present in this 510(k) summary.
The document lists several standards and tests performed, but these are part of the bench testing to show the device meets certain functional requirements and not specifically "acceptance criteria" against which a study directly proves performance in the context of clinical outcomes or diagnostic accuracy.
§ 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.