(34 days)
The intended use of the Simplicity Simplex Soft Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Simplicity™ Simplex Soft Infusion Set." This document does not contain information about acceptance criteria or a study proving the device meets them. Instead, it informs the manufacturer that their device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.
The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include details on performance metrics, study designs, sample sizes, or ground truth establishment relevant to the request.
§ 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.