# K072234: Thermogard XP Thermal Regulation System

- Pathway: 510(k) (Special)
- Applicant: Alsius Corp.
- Decided: Aug 23, 2007 after 13 days
- Product code: NCX (System, Hypothermia, Intravenous, Cooling)
- Device class: 2
- Regulation: 21 CFR 870.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alsius CoolGard 3000/Alsius THERMOGARD thermal regulation system: named in the summary without a submission number
- (no number) Alsius THERMOGARD MT heat exchange system: named in the summary without a submission number

## Most influential descendants
- K213031: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console (2021), 2 descendants of its own
- K220008: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console (2022), 1 descendant of its own
- K223746: Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console (2023), 0 descendants of its own

## Indications for use
The Alsius THERMOGARD XP and Cool Line TM Catheter Thermal Regulation 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. Warning - Fever Reduction The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a randomized controlled trial of 296 patients. The mortality results reported in this trial, for the four patient cohorts enrolled, are presented in the table below (CI - cerebral infarction, ICH - intracerebral hemorrhage, PTBI - primary traumatic brain injury, SAH - subarrachnoid hemorrhage). Mortality by Diagnosis (ITT analysis) Cool Line Control n N % n N CI 3 16 18.8 3 14 21.4 0.74 ICH 8 33 24.2 7 27 25.9 1.00 PTBI 10 44 22.7 4 38 10.5 0.24 SAH 13 61 21.3 7 63 11.1 0.15 *Fiscber's exact test For more details on the clinical trial results please refer to Physician's Manual - "Normothermia for the Neuro-critically III stroke patient" #101416-001. The Alsius THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the IcyTM or FortiusTM 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.

Source page: https://510kreport.com/device/K072234
Methodology: https://510kreport.com/methodology