(27 days)
Unomedical Monica Infusion Sets are indicated for the subcutaneous infusion of medication from an external pump.
The Unomedical Monica Set is an infusion administration set, connecting to a reservoir/infusion pump and inserted in the subcutaneous tissue of a user. The administration set attaches to the reservoir by means of a "tubing connector", and subcutaneously in to the user through an indwelling catheter made of polytetrafluoroethylene (PTFE). The tubing is made of two layers: the inner layer is polyethylene; the outer is polyurethane. The indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge introducer needle (cannula) made of AISI 304 stainless steel.
This document is a 510(k) summary for the Unomedical Monica Infusion Set, which is a submission to the FDA. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. Instead, it details the device description, its intended use, and compares it to predicate devices to establish substantial equivalence for regulatory approval.
Therefore, I cannot provide the requested information based on the provided text. The submission focuses on regulatory approval based on equivalence to existing devices, not on performance against specific acceptance criteria for a new study.
§ 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.