Search Results

Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

Acta Medical, LLC Intravascular administration set is sterile/pvrogen free. non-DEHP PVC tubing with the following combination of components.

• Universal Spike.
• Drip chamber with 15 micron filter.
• Non-DEHP PVC tubing.
• Flow Regulator.
• Roller clamp.
• Slide clamp.
• Luer locks.
• Filters.
• Latex free "Y" site or pre-approved needleless "Y" site for secondary infusions or medication administration.

This document is a 510(k) premarket notification for an Intravascular Administration Set. It primarily establishes substantial equivalence to a predicate device and does not contain detailed acceptance criteria or a dedicated study report, especially concerning performance metrics typically associated with AI/ML devices. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.

The document states:
"Acta Medical, LLC Intravascular Administration Set is substantially equivalent to the predicate device, Truecare Biomedix Intravascular Administration Set (K111351). Acta Medical utilizes the same contract manufacturer and manufacturing location (Wei De Li Trade Co. Ltd) as utilized by predicate device, identical component materials, identical indication for use, identical manufacturing process, identical sterilization process & SAL. Acta Medical Intravascular Administration Sets are identical to predicate device and present no additional safety concerns as compared to the predicate device."

This statement indicates that the submission relies on the established safety and effectiveness of the predicate device due to identical characteristics, rather than presenting new performance data against specific acceptance criteria for a novel device.

Ask a specific question about this device