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The Solex 7 Intravascular Heat Exchange Catheter connected to the Coolgard/Thermogard Thermal Regulation System is indicated for use:

· In cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care. (Maximum use period: 4 days)

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care.

(Maximum use period: 4 days)

· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period: 7 days)

The Cool Line Catheter Model CL-2295A, when used with the ZOLL Thermal Regulation System, is indicated for use in fever reduction, as an adjunct to antipyretic therapy. in adult patients with cerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.

The ZOLL ICY Intravascular Heat Exchange Catheter Model IC-3893A, connected to the ZOLL Coolgard/Thermogard Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

• · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.
  The ZOLL Quattro Catheter Model IC-4593, connected to a ZOLL Thermal Regulation System, is indicated for use:

• In cardiac surgery adult patients to achieve and/or maintain normothermia during surgery and recovery/intensive care, and

• · To induce, maintain and reverse mild hypothermia in neurosurgery adult patients in surgery and recovery/intensive care.

The ZOLL Intravascular Heat Exchange Catheters (Quattro® Intravascular Heat Exchange Catheter Kit, Quattro® Intravascular Heat Exchange Catheter Premium Access Kit, Cool Line® Intravascular Heat Exchange Catheter, ICY® Intravascular Heat Exchange Catheter) are sterile, single use heparin coated flexible catheters designed for placement in the femoral, jugular, or subclavian veins. The Solex 78 Intravascular Heat Exchange Catheter Premium Access Kit is a sterile, single use 9.3F flexible catheter designed for placement in the superior vena cava from an insection site in the jugular and subclayian veins. The Cool Line catheter contains two heat exchange balloons, the ICY catheter contains three heat exchange balloons, the Quattro catheter contains four heat exchange balloons and the Solex 7® catheter consists of a serpentine balloon. The ZOLL catheters are connected to a single use, disposable Start-Up Kit (SUK), the Coolgard 3000® Console and Thermogard XP® Console. The catheters connect to the console coolant well via tubing integral to the SUK. The catheter is connected to the SUK by connecting the male outflow Luer of the SUK to the female inflow Luer of the catheter and the female inflow Luer of the SUK to the male outflow Luer of the catheter. Both SUK Luers, in turn, are connected via tubing to a heat exchange coil through which saline circulates. The coil is placed in a coolant well located in the console. The controlled temperature saline is circulated through the closed-loop circuit of the SUK and catheter using the console pump, after which the saline is then returned within the SUK to the console heater and chiller coolant well via the catheter's outflow lumen. The catheters, SUK, the Coolgard 3000® Console and the Thermogard XP® Console are supplied separately. The ZOLL Intravascular Heat Exchange System is also designed for use with an off-the-shelf temperature probe, which is supplied separately and not manufactured by ZOLL.

The provided text is a 510(k) summary for a medical device (intravascular heat exchange catheters and associated consoles). It describes the device, its intended use, a comparison to predicate devices, and nonclinical testing that was performed. However, it explicitly states that clinical evaluations were NOT performed for this change (see section V. SUMMARY OF CLINICAL TESTS PERFORMED on page 18).

Therefore, it is not possible to extract the requested information regarding acceptance criteria and studies that prove the device meets these criteria, as the submission focuses on demonstrating substantial equivalence through nonclinical testing and comparison to predicate devices, rather than a de novo clinical study with specific performance acceptance criteria.

The clinical trial information presented in the document (the table with CI, ICH, PTBI, SAH patient cohorts, and mortality percentages) is not a study performed to prove the acceptance criteria of this specific device, but rather a reference to a randomized controlled trial that influenced the FDA's decision to add a "Warning - Fever Reduction" limitation to the device's labeling. This trial evaluated the safety and effectiveness of the Cool Line Intravascular Heat Exchange Catheter generally, and its results (increased mortality in certain cohorts compared to standard of care) led to the specific warning about its use for fever reduction in patients with subarachnoid hemorrhage or primary traumatic brain injury. It does not represent a study designed to meet pre-defined acceptance criteria for the device in this 510(k) submission.

Given this, I cannot fill the table or answer the specific questions about "proving the device meets acceptance criteria" as no such study is presented in the provided document for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and nonclinical testing for "MR Conditional" labeling.

If you had a document describing a clinical study undertaken specifically to demonstrate the performance characteristics of this device against defined acceptance criteria, I would be able to provide the requested information.

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The Solex 7™ Intravascular Heat Exchange Catheter connected to the CoolGard 3000®/Thermal Regulation System is indicated for use:

· In cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive care. (Maximum use period = 4 days)

· To induce, maintain and reverse mild hypothermia in neurosurgery and recovery/intensive care. (Maximum use period = 4 days)

· In fever reduction, as an adjunct to other antipyretic therapy, in adult patients with cerebral infarcerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated. (Maximum use period = 7 days)

The Solex 7 Intravascular Heat Exchange Catheter (Solex 7 Catheter) is a sterile, single use 9.3F flexible catheter designed for placement in the Superior Vena Cava from an insertion site in the Jugular and Subclavian Veins. The Solex 7 Catheter is connected to a single use, disposable CoolGard 3000 or Thermogard XP® Start-Up Kit (SUK) and the CoolGard 30000 or Thermogard XP® Console, all of which comprise the ZOLL Intravascular Heat Exchange The Start-Up Kit (SUK) and the CoolGard 3000 or Thermogard XP Console are System. supplied separately. The ZOLL Heat Exchange System is also designed for use with an off-theshelf temperature probe. The Solex 7 Catheter is comprised of a polyurethane shaft and a serpentine shaped PET balloon at the distal end. The blood contact surfaces of the catheter incorporate a hydrophilic heparin coating.

The catheter has five lumens, two of which when connected to the Start-Up Kit, are used to circulate sterile saline in a closed loop circuit for heat exchange with the blood in the central venous system. Warmed or chilled saline is pumped through the heat exchange lumens, inflating the diameter of the serpentine balloon that interfaces with the patient's blood to warm or cool circulating blood. The inflow/outflow lumens form a closed-loop system through which the warmed or chilled saline circulates. The warmed or chilled saline is not infused into the patient.

Additional lumens of the Solex 7 Catheter consist of a 0.032" guidewire compatible lumen that can also be used as a primary infusion lumen, and two additional infusion lumens within the catheter shaft.

The document provided describes the Solex 7™ Intravascular Heat Exchange Catheter and Start-Up Kit and its substantial equivalence to predicate devices, based on nonclinical testing. This is a 510(k) premarket notification, which demonstrates a device is at least as safe and effective as a legally marketed predicate device, rather than proving effectiveness through clinical trials required for a PMA.

Therefore, the study described here is primarily a set of nonclinical tests to show that the modified device performs similarly to its predicate devices and meets its own design specifications.

Here's an analysis of the acceptance criteria and the "study" (nonclinical testing) that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document provides multiple tables (Table 3, Table 4, Table 5, Table 6, Table 7) detailing various tests, their methods, and results. These tables effectively serve as the acceptance criteria and reported device performance. I will consolidate key examples below.

• Device Design Specifications: Specific dimensional tolerances, flow rates, heat exchange power, tensile strength, burst/leak resistance, indwell life, and biocompatibility criteria defined by the manufacturer for the device.
• Human Factors Test Scenarios: User tasks designed to assess the ease and correctness of device usage as per the Instructions for Use (IFU).

8. The sample size for the training set

This section is N/A. This is not a machine learning or AI device, so there is no "training set" in the context of algorithm development.

9. How the ground truth for the training set was established

This section is N/A for the same reason as above.

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