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This Primary Solution set is used for infusion of I.V. solutions and/or medication to a patient intravenously. This safety feature may aid in the prevention of needle stick injury.

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The provided text is a U.S. FDA 510(k) clearance letter for the "Exel Primary Solution Set," an intravascular administration set. This type of document does not contain the detailed information requested regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies that would generate the data you're asking for. The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot provide the requested information based on the given input because it is not present in this document.

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