(22 days)
The intended use of the Simplicity Soft QD Micro Infusion Set is to provide a means to infuse insulin subcutaneously from a pump or syringe.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "Simplicity Soft QD Micro Infusion Set." It details the regulatory classification and approval process, but it does not contain any information about acceptance criteria or specific study data to prove the device meets those criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry. However, substantial equivalence typically relies on demonstrating that the new device performs as intended and is as safe and effective as a predicate device, which may involve various tests, but the results of those tests and associated acceptance criteria are not included in this document.
Therefore, I cannot provide the requested information based on the text provided.
§ 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.