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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.

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An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.

Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.

The provided text describes a 510(k) summary for an "Empty EVA Solution Container" and does not contain information about an AI/ML device or its performance criteria. The document is for a Class II medical device, specifically an IV container, and focuses on demonstrating substantial equivalence to predicate devices through various physical and chemical tests.

Therefore, I cannot provide the requested information for acceptance criteria, study details, human reader improvement with AI, or standalone algorithm performance because the provided input does not pertain to such a device or study.

The document discusses tests like:

• Biocompatibility
• Material Strength
• Physical and Chemical Testing
• Leak Testing
• Stability Testing

These are tests typically performed to ensure the safety and functionality of a physical medical device, not to evaluate the performance of an AI/ML algorithm.

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