(102 days)
The NIVTS-LACV (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve) are intended to administer IV fluids/medication to the patient's vascular system through a needle-free device system that aids in the elimination of needle-stick injury.
The Nexus Luer-Accessible One-Way Check Valve (LACV) is designed to allow fluid flow in one direction and stop or check fluid flow in the opposite direction.
Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve
I am sorry, but to answer your request, I need extensive details on "acceptance criteria" and "device performance" that are not present in the given text. The provided document is an FDA 510(k) clearance letter for a medical device (Nexus IV Tubing Sets with Luer-Accessible One-Way Check Valve). It confirms that the device is "substantially equivalent" to legally marketed predicate devices.
However, the document does NOT contain:
- Specific acceptance criteria: It doesn't list quantitative or qualitative criteria that the device had to meet (e.g., "flow rate must be X mL/min with Y% accuracy" or "check valve must prevent backflow in Z% of trials").
- Reported device performance data: It doesn't provide any tables or descriptions of how the device actually performed in any tests against such criteria.
- Details of a study: There's no mention of a clinical or non-clinical study, its design, sample sizes, data provenance, ground truth establishment, or expert evaluations. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which sometimes involves performance testing against recognized standards, but the results of those tests are not typically included in the clearance letter itself.
Therefore, I cannot fulfill your request for details about acceptance criteria and study data based on the provided text.
§ 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.