(16 days)
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.
The EMED VersaRate™ Flow Rate Controller (K123729) is intended for use in the intravascular infusion of fluids delivered to the patient in a precise manner for no longer than 72 hours.
The device's performance was evaluated against internal product specifications and requirements, as well as by comparison to a predicate device, the Baxter Extension Set w/Flow Regulator (K890489).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | VersaRate™ Flow Rate Controller Reported Performance | Predicate Device (Baxter Extension Set w/Flow Regulator) Performance |
|---|---|---|
| Flow Rate Control Range | 5 – 230 mL/hr at 80 cm head height | 5 – 250 mL/hr |
| Residual Volume of Set |
§ 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.