(30 days)
ACCU-CHEK Ultraflex is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.
The ACCU-CHEK Ultraflex is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
This document is a 510(k) summary for the ACCU-CHEK Ultraflex Infusion Set. It states that the device meets the requirements for its intended use and is substantially equivalent to a predicate device. However, it does not contain any data, acceptance criteria, or study details about device performance.
Therefore, I cannot provide the requested information. The document explicitly states:
"Testing of the modified ACCU-CHEK Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use. The data also demonstrates that the ACCU-CHEK Ultraflex Infusion Set is substantially equivalent to the predicate device."
This is a summary statement, not a presentation of the actual data or the study design. To answer your questions, I would need access to the full test report or detailed data provided within the 510(k) submission, which is not present in the provided text.
§ 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.