(14 days)
The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.
Not Found
The provided text is related to a 510(k) premarket notification for a medical device called "Simplicity Soft QD II Infusion Set". This document is an FDA letter granting substantial equivalence, which means the device can be marketed.
However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about the study, as this information is not present in the provided text.
The document is purely administrative, confirming the FDA's review and substantial equivalence determination for marketing the device.
§ 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.