(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.
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072234
510(k) Summary or 510(k) Statement 6
510(k) SUMMARY FOR ALSIUS CORPORTATION'S THERMOGARD XP AND CATHETER THERMAL REGULATION SYSTEM
Submitter's Name, Address, Telephone Number, and Contact Person
ALSIUS CORPORATION 15770 Laguna Canyon Road, Suite 150 Irvine, CA 92618
Contact: Ken Collins Phone: (949)-453-0150 Fax: (949)-453-0250 Email: kcollins@alsius.com AUG 2 3 2007
Name of Device
The THERMOGARD XP and Catheter Thermal Regulation System.
Common or Usual Name
Central Venous Catheter (short term) and Thermal Requlating System.
Classification Name
FDA has classified the Alsius THERMOGARD XP/Alsius heat exchange catheters as Class II devices under 21 C.F.R. §§ 870.5900 - System, Hypothermia, Intravenous, Cooling. Classification Product Code: NCX.
Predicate Devices
The Alsius CoolGard 3000™/Alsius THERMOGARD™ thermal regulation system.
Indications for Use
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.
Indications for Use (K030421, K051912, K052443)
The THERMOGARD XP/Alsius Catheter Thermal Regulation System, using either the lcy™ 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
15770 Laguna Canyon Road, Suite 150 Page 25 Irvine, California 92618
Tel: 949.453.0150 FAX: 949.453.0250
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Company Confidential K07XXXX Thermogard XP
- To induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care.
Indications for Use (K014241, K051912)
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.
Warning - Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with subarachnoid 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 – subarachnoid hemorrhage).
| Cool Line | Control | ||||||
|---|---|---|---|---|---|---|---|
| n | N | % | n | N | % | p-value* | |
| 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 |
| Table 1-1. Mortality by Diagnosis (ITT) | ||
|---|---|---|
*Fischer's exact test
For more details on the results of this study please refer to Physician's Manual – "Normothermia for the Neuro-critically III Stroke Patient" #101416-001.
Technical Characteristics
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.
Page 26
ALSIUS 510k Page 26 of 213
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Image /page/2/Picture/1 description: The image shows the logo for Alsius Corporation. The logo is in black and white and features the word "Alsius" in a stylized font. Below the word "Alsius" is the word "Corporation" in a smaller, less stylized font. The logo is simple and professional.
Company Confidential
- To induce, maintain and reverse mild hypothermia in neurosurgery patients in . surgery and recovery/intensive care.
Indications for Use (K014241, K051912)
The Alsius THERMOGARD XP™ and Cool Line™ 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 subarach oid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was examined in a fandomized 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 - subarachnoid hemorrhage).
| Cool Line | Control | ||||||
|---|---|---|---|---|---|---|---|
| n | N | % | n | N | % | p-value* | |
| 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 |
| Table 1-1、Mortality by Diagnosis (ITT) | ||||
|---|---|---|---|---|
| ---------------------------------------- | -- | -- | -- | -- |
*Fischer's exact test
For more details on the results of this study please refer to Physician's Manual - "Normothermia for the Neuro-critically III Stroke Patient" #101416-001.
Technical Characteristics
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 pump. 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 predicatedevice with the exception of revisions to the software that controls the device. (
15770 Laguna Canyon Road, Suite 150
Irvine, California 92618
Page 26
Tel: 949.453.0150 FAX: 949.453.0250
ALSIUS 510k Page 26 of 213
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Image /page/3/Picture/1 description: The image shows the logo for Alsius Corporation. The logo is in black and white and features the company name in a stylized font. The word "Alsius" is in a larger font than the word "Corporation", which is located below the first word.
Company Confidential
All models of Alsius Intravascular catheters are available for use with the THERMOGARD XP.
Principles of Operation
The THERMOGARD XP system automatically adjusts the temperature of the heater/chiller saline bath to achieve the patient target temperature that has previously been set by the attending physician. This is done via data from a temperature probe in the patient that interfaces with the temperature controller. This principle of operation is identical to the predicate device.
Summary of the Basis for Finding of Substantial Equivalence
The THERMOGARD XP System is substantially equivalent to the Alsius THERMOGARD™ heat exchange system in all its specifications except that its compressor allows additional cooling power.
Conclusion
In summary, descriptive information and performance data demonstrate that the Alsius THERMOGARD XP and Catheter Thermal Regulation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The system in this revision acts as its own predicate device. The THERMOGARD XP and Catheter Thermal Regulation System is safe and effective when used in accordance with the Directions For Use and substantially equivalent to the predicate device.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alsius Corporation % Mr. Kenneth A. Collins Executive Vice President 15770 Laguna Canyon Road Suite 150 Irvine, California 92618
AUG 2 3 2007
Re: K072234
Trade/Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: August 7, 2007 Received: August 10, 2007
Dear Mr. Collins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kenneth A. Collins
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
FOR
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System
Indications For Use:
Indications For Use:
Alsius Thermogard - Indications for Use
The Alsius THERMOGARD XP and Cool Line ™ 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).
| Cool Line | Control | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| n | N | % | n | N | % | p* | |||
| 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 |
ートー【"4" 【 : . .
"Fischer'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.
| Prescription Use X | AND/OR | Over-The-Counter Use _____ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | L072234 |
|---|---|
| Page 10 of 213 | Page 1 of 2 |
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Indications for Use
510(k) Number (if known):
Device Name: Alsius THERMOGARD XP and Catheter Thermal Regulation System Indications For Use:
Fortius and Icy Catheters - Indications for Use
The Alsius 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.
Prescription Use X
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).