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Ultraflex™ is an infusion set for the subcutaneous infusion of insulin administered with microdosage insulin pumps.

The 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 510(k) summary (K033892) for the Ultraflex Infusion Set does not contain the detailed information requested regarding acceptance criteria and study particulars.

The provided document is limited to:

• A general introduction to the device and its intended use.
• A statement that "Testing of the modified Ultraflex Infusion Set demonstrated that the device meets the requirements for its intended use."
• A statement that the device is "substantially equivalent to the predicate device."
• The FDA's letter of substantial equivalence determination.

Therefore, I cannot provide the requested table and detailed study information. The document focuses on administrative and regulatory aspects, confirming that the device was deemed substantially equivalent to a predicate device, but does not disclose the specific performance data or the methodology of the studies conducted.

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