ICY CATHETER, MODEL IC-3893A

K052443 · Alsius Corp. · NCX · Oct 17, 2005 · Cardiovascular

Device Facts

• Record ID: K052443
• Device Name: ICY CATHETER, MODEL IC-3893A
• Applicant: Alsius Corp.
• Product Code: NCX · Cardiovascular
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/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

Intravascular multi-lumen catheter; used with CoolGard 3000 thermal regulation system. Inputs: patient temperature probe data. Operation: closed-loop circulation of sterile saline through heat exchange lumens; saline does not enter patient. Catheter balloons expand to interface with central venous blood for heat exchange. Output: automated adjustment of saline bath temperature to reach physician-set target. Used in OR/ICU by clinicians. Benefits: precise patient temperature management. Features additional infusion lumens compared to predicate; Duraflo heparin coating on blood-contact surfaces.

Clinical Evidence

No clinical data provided; substantial equivalence based on descriptive information and performance data.

Technological Characteristics

Multi-lumen intravascular catheter; 9.3 Fr shaft diameter; Duraflo heparin coating. Closed-loop heat exchange system using sterile saline. Single-use, sterile. Operates with CoolGard 3000 thermal regulation system via temperature probe feedback.

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

• Icy™ Catheter Kit Model IC-3585A (K030421)

Submission Summary (Full Text)

{0}------------------------------------------------

T 17 2005

K05x443

Page 1 of 3

Company Confidential

CoolGard and Catheter Thermal Regulation System

# 7 510K Summary

## 510(K) SUMMARY FOR ALSIUS CORPORTATION'S ICY™ CATHETER MODEL IC-3893A

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

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

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

## Name of Device:

ICY™ Catheter Model IC-3893A

### 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:

K030421 Alsius Icy™ Catheter Kit Model IC-3585A

10/23/2003 Decision Date

Substantially equivalent (SE) Decision

## Indications for Use

The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/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 ICY™ 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. The

{1}------------------------------------------------

052443

ALSIUS

Company Confidential

inflow lumen/outflow lumen forms a closed-loop system through which the heated/chilled saline circulates. The chilled saline is not infused into the patient.

Additional lumens of the Alsius Icy™ Catheter Model IC-3893A consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.

The Icy™ Catheter Model IC-3893A is the same as the predicate device, the Icy™ Model IC-3585A except that it has two extra infusion lumens with a corresponding increase in shaft diameter. The heat exchange capability of the two catheters is the same.

| | Icy™ IC-3585A | Icy™ IC-3893A |
|----------------------------|-----------------------------------------------------------------------------------------------------|---------------|
| | Predicate - K030421 | NEW |
| Saline Circuit | Same | |
| Tip Infusion Lumen | Same | |
| Mid shaft Infusion Lumen | x | ✓ |
| Lower shaft Infusion Lumen | x | ✓ |
| Length | 35cm insertion length<br>38cm tip to manifold | |
| | | |
| Shaft Diameter | 8.5 Fr | 9.3 Fr |
| Cooling Balloons | 3 Balloons of the same dimensions and at the same<br>locations down the catheter shaft from the tip | |

The Catheter blood contact surfaces are coated with Duraflo® Treatment, a heparin coating manufactured by Edwards Lifesciences Corporation.

The Alsius Catheters are supplied sterile for single-use only.

### 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 currently marketed devices.

### Summary of the Basis for Finding of Substantial Equivalence:

The CoolGard and Catheter Thermal Regulation System indication statement and intended use is identical to the predicate device. Principle of operation is the same as the predicate

Page 13

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image contains a handwritten text string that appears to be a signature or some form of identification. The text reads "Ko(244}" and is underlined with a horizontal line. The handwriting is somewhat stylized, with the numbers and letters connected in a cursive manner.

Image /page/2/Picture/1 description: The image contains the word "ALSIUS" in a stylized font. The letters are in uppercase and appear to be slightly italicized. The word is positioned above a horizontal line, which is above the word "Com".

Company Confidential

device. The technical characteristics and materials used are very similar to the predicate device.

#### Conclusion

In summary, descriptive information and performance data demonstrate that the Alsius Icy Catheter™ Model IC-3893A characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The Icy Catheter™ Model IC-3893A is substantially equivalent to the predicate device.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052443

Trade/Device Name: Alsius Icy™ Catheter Model IC-3893A Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: September 2, 2005 Received: September 8, 2005

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 for abound of 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.

{4}------------------------------------------------

## Page 2- Kenneth A. Collins, MD

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 premaince hourse device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you attire Office of Compliance at [phone]. 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 other general informational 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,

signature

سه Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

### Indications for Use

K052443 510(k) Number (if known):

Alsius Icy™ Catheter Model IC-3893A Device Name:

Indications for Use:

The Icy™ Catheter Model IC-3893A, connected to the COOLGARD™ 3000/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)

2

Page 1 of 1_

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

510(k) Number_ < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < < <