(70 days)
The KVO Accessory is intended to allow fluid flow in one direction and stop, or check, fluid flow in the opposite direction. The KVO Accessory is intended to be used with the I-Flow One•Step KVO infusion pump.
The KVO Accessory is simply the Supravalve Check Valve Assembly manufactured by Vernay Laboratories, Inc. The KVO Accessory housing consists of polycarbonate with a standard female luer lock connector on the inlet port and male luer connector with a locking rotating collar on the outlet port. The check valve consists of a one-piece, elastomeric duckbill which allows free flow with positive differential pressure. With negative differential pressure, backflow is checked.
The KVO Check Valve Accessory is designed to allow fluid flow in one direction and prevent backflow. The following information summarizes its acceptance criteria and the studies performed to demonstrate compliance.
1. Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Limit | Reported Performance |
|---|---|---|
| Priming/Residual Volume | = 0.1 psi | Not explicitly stated as a value, but described as "low cracking pressure to allow use of standard IV gravity drug bags" and that the "check valve performed within specification." |
| Backpressure Withstand |
§ 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.