(13 days)
The THERMOGARD XP can be used with any of the Alsius Catheters. The indications for use are specific to the catheter. Please refer to the Indications for Use statement in the catheter specific Instructions for Use.
The THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the Icy™ or Fortius™ model catheter, 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 Alsius THERMOGARD XP™ and Cool Line™ Catheter Thermal Requlation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
The THERMOGARD XP and Catheter Thermal Regulation System consists of the THERMOGARD XP, a disposable Start Up Kit used to interface between the cooling bath of the THERMOGARD XP and the intravascular Catheter. The THERMOGARD XP is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller primo. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
The technical characteristics of the Catheter are identical to the predicate device.
The Alsius THERMOGARD XP and Catheter Thermal Regulation System is indicated for fever reduction in patients with cerebral infarction and intracerebral hemorrhage who require central venous access, intubation, and sedation. It is also indicated for use in cardiac surgery patients to achieve and 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.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fever Reduction | |
| Mortality rates not significantly inferior to control for: | |
| Cerebral Infarction (CI) | Cool Line: 18.8% (3/16), Control: 21.4% (3/14). p-value: 0.74 (No significant difference) |
| Intracerebral Hemorrhage (ICH) | Cool Line: 24.2% (8/33), Control: 25.9% (7/27). p-value: 1.00 (No significant difference) |
| Primary Traumatic Brain Injury (PTBI) | Cool Line: 22.7% (10/44), Control: 10.5% (4/38). p-value: 0.24 (No significant difference, but note higher mortality in Cool Line group; device safety not demonstrated for PTBI.) |
| Subarachnoid Hemorrhage (SAH) | Cool Line: 21.3% (13/61), Control: 11.1% (7/63). p-value: 0.15 (No significant difference, but note higher mortality in Cool Line group; device safety not demonstrated for SAH.) |
| Normothermia/Hypothermia in Cardiac/Neurosurgery | The acceptance criteria for these indications are not explicitly detailed in the provided text. The document states that the system is "safe and effective when used in accordance with the Directions For Use and substantially equivalent to the predicate device" (Alsius CoolGard 3000™/Alsius THERMOGARD™ thermal regulation system). This implies the device meets the performance standards of the predicate for these indications. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): A total of 296 patients were enrolled in the randomized controlled trial for fever reduction. The breakdown per cohort is:
- Cerebral Infarction (CI): 16 (Cool Line) + 14 (Control) = 30 patients
- Intracerebral Hemorrhage (ICH): 33 (Cool Line) + 27 (Control) = 60 patients
- Primary Traumatic Brain Injury (PTBI): 44 (Cool Line) + 38 (Control) = 82 patients
- Subarachnoid Hemorrhage (SAH): 61 (Cool Line) + 63 (Control) = 124 patients
- Data Provenance: The text does not explicitly state the country of origin. The study was a "randomized controlled trial," indicating it was prospective in nature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not specify the number or qualifications of experts used to establish ground truth for morbidity/mortality outcomes in the randomized controlled trial. Mortality data appears to be objective (number of deaths).
4. Adjudication Method for the Test Set
The provided text does not specify any adjudication method for the test set outcomes. Given that the primary outcome described is mortality, it's typically an objective measure that may not require complex adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This device is a thermal regulation system, not an AI-powered diagnostic or interpretive device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study with human readers (or "AI assistance") is not applicable to this product.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (an integrated electro-mechanical heater/cooler and catheter system) that directly modifies patient temperature. It is operated by medical professionals. The concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this type of device. Its performance is intrinsically linked to its physical function in a patient setting under human supervision.
7. The Type of Ground Truth Used
For the fever reduction indication, the ground truth used was mortality data (i.e., patient outcomes).
8. The Sample Size for the Training Set
The document describes a randomized controlled trial for evaluating safety and effectiveness for fever reduction. In such a trial, the entire patient cohort (296 patients) generally serves as the "test set" to evaluate the device's performance against a control group. The concept of a separate "training set" is typically associated with machine learning or artificial intelligence models, which is not relevant here as this is a physical medical device. Therefore, there is no distinct training set as would be understood in an AI context. The study population is the performance evaluation set.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, there isn't a separate "training set" in the context of this device and study design. The ground truth (mortality) for the study population was established by observing and recording patient outcomes (death) in both the device-treated group and the control group of the randomized controlled trial.
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).