QUATTRO CATHETER MODEL IC4593

K070161 · Alsius Corp. · NCX · Feb 15, 2007 · Cardiovascular

Device Facts

• Record ID: K070161
• Device Name: QUATTRO CATHETER MODEL IC4593
• Applicant: Alsius Corp.
• Product Code: NCX · Cardiovascular
• Decision Date: Feb 15, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, 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.

Device Story

Quattro Catheter Model IC4593 is a multi-lumen intravascular catheter used with an Alsius Catheter Thermal Regulation System. Device functions by circulating sterile saline through internal lumens to exchange heat with central venous blood. During operation, saline flow expands distal catheter portion to 5mm or 8mm diameter, where heating/cooling membranes interface with blood. Used in clinical settings (surgery, intensive care) by medical professionals to manage patient body temperature. Output is thermal regulation of patient blood supply; clinical benefit is maintenance of normothermia or induction of therapeutic hypothermia.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Multi-lumen intravascular catheter; heat exchange via circulating sterile saline; distal heating/cooling membranes expand to 5mm or 8mm nominal diameter; interfaces with central venous blood supply; Class II device.

Indications for Use

Indicated for cardiac surgery patients to achieve/maintain normothermia and neurosurgery patients to induce/maintain/reverse mild hypothermia during surgery and recovery/intensive care.

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 Icy Catheter Kit Model IC-3893A (K052443)

Submission Summary (Full Text)

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#### 510K Summary ﮧ

K070161

# 510(K) SUMMARY FOR ALSIUS CORPORTATION'S QUATTRO CATHETER MODEL IC4593

## Submitter's Name, Address, Telephone Number, and Contact Person:

ALSIUS CORPORATION 15770 Laguna Canyon Road, Suite 150 Irvine, CA 92618

FEB 1 5 2007

Contact: Ken Collins Phone: [phone] Fax: [phone] Email: [e-mail]

## Name of Device:

Quattro Catheter Model IC4593

#### Common or Usual Name:

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

#### Classification Name:

21 CFR 870.5900 System, hypothermia, intravenous, cooling

#### Predicate Device:

K052443 Alsius Icy Catheter Kit Model IC-3893A Decision Date 10/17/2005

Substantially equivalent (SE) Decision

## Indications for Use

The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, 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.

#### Technical Characteristics:

The QUATTRO catheters are multi lumen intravascular catheters in various sizes. In common across the models, the catheters have two lumens that are used to circulate sterile saline to exchange heat with the central venous blood supply. When the heat exchange feature of the catheter is in use, heated/chilled saline is pumped through the heat exchange lumen, expanding the diameter of the distal portion of the catheter to a nominal 5mm or 8mm where the heating/cooling membranes interface with the patient's circulating blood.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alsius Corporation % Kenneth A. Collins, MD Executive Vice President 15770 Laguna Canyon Road Suite 150 Irvine, California 92618

FEB 1 5 2007

Re: K070161

Trade/Device Name: Alsius Quattro Catheter Model IC4593 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: January 12, 2007 Received: January 17, 2007

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.

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

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Page 2 - Kenneth A. Collins, MD

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.

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 Ilegally marketed predicate device results in a classification for your device and thus, perroots your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (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 vours.

Mark N. Mekerson

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): K07XXXXX

Device Name:

Alsius Quattro Catheter Model IC4593

Indications for Use:

The Quattro Catheter Model IC4593, connected to an Alsius Catheter Thermal Regulation System, 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 (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restoralive, and Neurological Devices

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Neurological Devices

510(k) Number K070162

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