(88 days)
The Bolus Accessory Set, in combination with a positive pressure, continuous flow infusion pump, is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. Routes of administration include intravenous, epidural, intramuscular, subcutaneous, intra-operative (as the one the same and percutaneous.
The Bolus Accessory may connect to any positive pressure, continuous flow rate infusion pump with an 8 to 17 psi pressure source to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The Bolus Accessory consists of plastic housing, medication reservoir, bolus button activator and wrist bands. The bolus button allows patient controlled administration of medication as needed.
The provided document describes the I-Flow Bolus Accessory Set, a mechanical device intended to deliver fixed boluses of medication. The primary focus of the document is on the specifications and equivalence to previously marketed devices (510(k) submission).
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified refill times. | All models performed within the specified accuracy when tested at nominal conditions. (This is the reported performance for the Bolus Accessory based on testing at standard operating conditions). |
| 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.