(52 days)
- The Homepump C-Series is intended for continuous infusion of medications for general infusion use, including chemotherapy and pain management. Routes of administration include intravenous, subcutaneous, intramuscular and epidural.
- The KVO model of the Homepump C-Series is intended for general purpose drug and/or diluent delivery at a sufficient flow rate to maintain a patient IV line open (i.e. keep vein open). The Y-site at the distal end of the administration set allows piggy back infusions. The routes of administration include intravenous, subcutaneous and intramuscular.
The Homepump C-Series is an elastomeric infusion pump with an integrated administration set. The elastomeric membranes function as the fluid reservoir and the pressure source. The pressure that pumps the fluid comes from the strain energy of the elastomeric membranes which are forced to expand when the pump is filled. The incorporation of fixed diameter flow control tubing or glass orifice combined with the elastomeric pressure source produces the desired flow rate. Homepump C-Series models are available in fill volumes from 50 to 500 ml and flow rates from 0.5 to 10 ml/hr. The One•Step KVO models of the Homepump C-Series have an optional Y-site and optional check valve attached to the distal end of the administration set. The following accessories are available: carry case, E-clip and power ring.
Here's a summary of the acceptance criteria and the study details for the I-Flow Homepump C-Series device based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Priming/Residual Volume: | |
§ 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.