(40 days)
The Paragon Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or healthcare provider. The routes of administration are intravenous, epidural, intramuscular and subcutaneous.
The Bolus Accessory may connect to any Paragon administration set 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 Bolus Accessory is available in 0.5 ml bolus volume. The Bolus Accessory is a mechanical device that requires no external power.
Here's a breakdown of the acceptance criteria and study information for the Paragon Bolus Accessory Set, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bolus Volume Accuracy: ±10% at 95% confidence interval at the identified lockout times. | "All models performed within the specified accuracy when tested at nominal conditions." (Implies meeting the ±10% at 95% CI for the 0.5 mL bolus volume) |
| 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.