(76 days)
To transfer and mix drugs contained in two containers into a syringe for administration to the patient.
CIStem™ is a closed reconstitution and instillation system used to deliver reconstituted drug through a catheter. This closed system is designed to prevent leakage and prevent exposure of drug to the environment, and is easy to use. The syringe is inserted into the syringe socket of the device and the drug container is inserted into the other socket. A stopcock is used to direct and control the flow between the syringe, drug container and catheter. The syringe plunger rod is pushed to deliver liquid into the drug container. Next the plunger rod is pulled back and forth until all of the drug is mixed. Then the reconstituted drug in the syringe is delivered through the catheter.
There are two variations of CIStem™. These variations provide flexibility for the type of drug container. They both have the same intended use and similar safety features.
The materials that make up the fluid contact path in CIStem™ have passed ISO 10993-1 biocompatibility testing.
The provided text is a 510(k) summary for a fluid transfer device named CIStem™. It describes the device's functions and intended use, and states its substantial equivalence to another legally marketed device. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any information typically found in a clinical study report or a validation study. The document is a regulatory submission for premarket notification, focusing on equivalence to a predicate device rather than detailed performance metrics.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study that proves the device meets them because the necessary information is not present in the provided text.
§ 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.