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The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, is indicated for use:

• in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care, and
• to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/intensive care.

The QUATTRO catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood.

The provided 510(k) summary for the Alsius Quattro Catheter Model IC4593 does not contain information about acceptance criteria or a study proving the device meets said criteria as would be expected for an AI/ML powered device submission.

This document is for a medical device (a catheter) with physical characteristics and indications for use, not for a software or AI-driven diagnostic or treatment system. Therefore, the questions related to AI/ML device performance (like accuracy metrics, sample sizes for AI training/testing, expert adjudication, MRMC studies) are not applicable to this submission.

The document focuses on:

• Device identification: Name, common name, classification, predicate device.
• Intended use/Indications for Use: What the device is designed to do (achieve/maintain normothermia or induce/maintain/reverse mild hypothermia).
• Technical Characteristics: Description of the catheter's design (multi-lumen, saline circulation for heat exchange).

There is no mention of an algorithm, AI, machine learning, or any computational aspect that would require the establishment of ground truth or performance metrics like sensitivity, specificity, or AUC based on expert review.

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