COOLGARD 3000

K060308 · Alsius Corp. · NCX · Apr 26, 2006 · Cardiovascular

Device Facts

• Record ID: K060308
• Device Name: COOLGARD 3000
• Applicant: Alsius Corp.
• Product Code: NCX · Cardiovascular
• Decision Date: Apr 26, 2006
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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 CoolGard® 3000 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.

Device Story

CoolGard 3000 is an integrated electro-mechanical thermal regulation system. It uses a temperature probe in the patient to monitor core temperature and a controller to adjust the temperature of a sterile saline bath. This temperature-controlled saline is circulated through an indwelling intravascular catheter (Icy, Fortius, or Cool Line models) placed percutaneously. The system is operated by clinicians in surgical or intensive care settings to manage patient body temperature. By circulating saline through the heat-exchanging catheter, the device adds or removes heat from the patient's blood to achieve a physician-set target temperature. This helps maintain normothermia or induce therapeutic hypothermia, potentially benefiting patients in neuro-critical or cardiac recovery states.

Clinical Evidence

Clinical evidence includes a randomized controlled trial of 296 patients evaluating fever reduction safety across four cohorts: cerebral infarction (CI), intracerebral hemorrhage (ICH), primary traumatic brain injury (PTBI), and subarachnoid hemorrhage (SAH). Mortality results were reported for each cohort. Due to safety concerns in specific populations, a boxed warning was mandated for PTBI and SAH patients.

Technological Characteristics

Integrated electro-mechanical heater/cooler system. Components: temperature monitor, temperature controller, heat exchanger, and roller pump. Uses disposable start-up kits and intravascular catheters for percutaneous placement. Operates by circulating temperature-controlled sterile saline. Software-controlled thermal regulation.

Indications for Use

Indicated for cardiac surgery patients (normothermia maintenance) and neurosurgery patients (mild hypothermia induction/maintenance/reversal). Also indicated for fever reduction in intubated/sedated patients with cerebral infarction or intracerebral hemorrhage. Contraindicated for fever reduction in patients with subarachnoid hemorrhage or primary traumatic brain injury.

Regulatory Classification

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.

Predicate Devices

• Alsius CoolGard 3000 and Catheter Thermal Regulation System (acts as its own predicate)

Submission Summary (Full Text)

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K0600308

Image /page/0/Picture/2 description: The image shows the logo for Alsius Corporation. The logo features the word "Alsius" in a stylized font, with the word "Corporation" in smaller letters underneath. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.

Company Confidential

CoolGard 3000 Thermal Regulation System

.

#### 510(k) Summary or 510(k) Statement 5

## 510(k) SUMMARY FOR ALSIUS CORPORTATION'S COOLGARD 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: | [e-mail] |

#### Name of Device

The Alsius CoolGard And Catheter Thermal Regulation System.

#### Common or Usual Name

Central Venous Catheter (short term) and Thermal Regulating System.

#### Classification Name

FDA has classified the Alsius CoolGard 3000/Alsius heat exchange catheters as Class Il devices under 21 C.F.R. §§ 870.5900 - System, Hypothermia, Intravenous, Cooling. Classification Product Code: NCX.

## Predicate Devices

The product acts as its own predicate. This is a modification to the software of the device.

## Indications for Use

The following Indications for Use have clearance within the USA. The COOLGARD™ 3000 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 COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the IcyTM 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
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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 CoolGard® 3000 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 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 CoolGard and Catheter Thermal Regulation System consists of the CoolGard™ 3000, a disposable Start Up Kit used in the CoolGard™ for interface with the cooling bath and patient catheter and the Intravascular Catheter. The Alsius CoolGard™ 3000 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 predicate device with the exception of revisions to the software that controls the device.

The following models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:

- 1. ICY® Catheter Kit Model IC-3585A(CO)

| 15770 Laguna Canyon Road, Suite 150 | Page 18 |
|-------------------------------------|---------|
| Irvine, California 92618 | |

Tel: [phone] FAX: 949,453.0250

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Image /page/2/Picture/0 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, sans-serif font. The logo is simple and professional.

- 2. ICY® Catheter Kit Model IC-3893A(CO)
- 3. Fortius® Catheter Kit Model FR-5093B(CO)
- 4. Cool Line® Catheter Kit Model CL 2085B(CO)
- 5. Cool Line® Catheter Kit Model CL 2295A(CO)

#### Principles of Operation

The CoolGard™ 3000 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 System in this premarket notification acts as its own predicate. There are no changes to the indications for use of the device. Revisions have been made to the software of the device for which supportive evidence is provided to establish that there are no new questions of safety or efficacy.

The System is substantially equivalent to the predicate device, the system itself.

#### Conclusion

In summary, descriptive information and performance data demonstrate that the Alsius CoolGard 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 CoolGard 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

APR 2 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alsius Corporation c/o Kenneth A. Collins, M.D. Executive Vice President 15770 Laguna Canyon Road, Suite 150 Irvine, California 92618

Re: K060308

Trade/Device Name: Alsius CoolGard 3000 and Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: February 2, 2006 Received: February 9, 2006

Dear Dr. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that the Cool Line Catheter will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling as a box warning immediately following the indications for use statement: 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).

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#### Page 2 - Kenneth A. Collins, M.D.

| | 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 |

#### 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 ill stroke patient" #101416-001.

Please note that the above labeling limitation is required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before this limitation is modified in any way or removed from the device's labeling. This limitation does not apply to the Icy & Fortius Catheters.

The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 3 - Kenneth A. Collins. M.D.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification: (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

V.C.M.

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K060308

Alsius CoolGard 3000 and Catheter Thermal Regulation System Device Name:

Indications For Use:

Indications For Use:

#### Cool Line Cathers - Indications for Use:

The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Regulation System is indicated for use in fever reduction, as an adjunct to other antipyretic therapy, in nationts 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 (C1 - cerebral infarction, ICH - intracerebral hemormage, PTBI - primary traumatic brain injury, SAH - subarrachnoid hemorrhage).

| Mortality by Diagnosis (ITT analysis) | | | | | | | | |
|---------------------------------------|-----------|----|------|--|---------|----|------|------|
| | 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 |

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 Deyise Evalua

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# Indications for Use

## 510(k) Number (if known): K060308

Alsius CoolGard 3000 and Catheter Thermal Regulation System Device Name:

Indications For Use:

## Fortius and Icy Catheters - Indications for Use:

The COOLGARD™ 3000/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.

AND/OR -Over-The-Counter Use Prescription Use _X (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)