(203 days)
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device intended for use as an accessory to an IV catheter placed in the vein or artery for intravenous administration of blood, IV drugs and IV fluids to the patient including neonatal, pediatric and immunocompromised patients. The Nexus NIS®-6P may also be safely used with power injectors at 10mL/sec and pressures up to 325 psi. The Nexus NIS®-6P has a pre-slit septum which does not require the use of a stainless steel needle and passively aids in the reduction of needlestick injuries.
The Nexus NIS®-6P is a pressure-rated, luer-activated, normally closed, bidirectional, neutral pressure device. It has a pre-slit septum which does not require the use of a stainless steel needle.
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Nexus NIS-6P". It does not contain information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement as requested in your prompt. This document primarily focuses on the FDA's regulatory review and determination of substantial equivalence for the device.
§ 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.