(31 days)
The SmartValve is a single use, sterile, non-pyrogenic pressure activated check valve system intended for use as an accessory to Intravascular administration set. The SmartValve provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The SmartValve also provides access for the withdrawal of fluids from administration set.
The SmartValve is a single use, sterile, non-pyrogenic pressure activated valve intended for use as an accessory to Intravascular administration set.
This 510(k) notification describes a medical device, the SmartValve, which is an accessory to an Intravascular administration set. The provided documents focus on the regulatory approval process and device description, and do not contain information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval, equivalence to predicate devices, and general device information like material biocompatibility, rather than performance studies with quantitative acceptance criteria.
§ 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.