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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.

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