. 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 Description

"he 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 essentially identical to those of widely used multi-lumen central venous catheters except for the dedicated closed loop fluid path through the heat exchange balloons. The Alsius Catheter materials are all biocompatible polyurethanes.

Likewise, the CoolGard™ 3000 heater/cooler has the same technical features as the medical heater/cooler unit Identified as the predicate device. These common technical features include connections for recirculating coolant to and intravascular catheter and all or combinations of the following: redundant safety controls and alarms, patient monitoring and control and temperature displays for the clinician users.

Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:

1. ICY™ Catheter Kit Model IC-3585A
1. Fortius™ Catheter Kit Model FR-5093A

The ICY™ and Fortius™ catheters are multi lumen intravascular catheters in various sizes. Two of the catheter's lumens 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 where the heating/cooling membranes interface with the patient's circulating blood. The 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 Catheters consist of a standard guide wire lumen that can be used as a primary infusion lumen, and a second infusion lumen within the shaft, depending on the catheter model selected by the clinician.

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 een 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.

AI/ML Overview

The provided 510(k) summary for the Alsius CoolGard and Catheter Thermal Regulation System states that performance data demonstrate equivalence to the predicate device, but it does not specify detailed acceptance criteria or present a study proving the device met those criteria. The 510(k) summary focuses on demonstrating substantial equivalence based on identical indications for use, principle of operation, and similar technical characteristics and materials compared to the predicate devices.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This information is not present. The submission relies on equivalence to predicate devices rather than a new set of performance metrics.
Sample size used for the test set and the data provenance: No specific test set or associated data is described for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific test set or ground truth establishment is detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is a thermal regulation system, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of Basis for Substantial Equivalence (as described in the document):

The 510(k) submission's core argument for substantial equivalence is based on the following:

Identical Indications for Use: The CoolGard and Catheter Thermal Regulation System's indications for use are identical to the predicate device.
Identical Principle of Operation: The principle of operation, which involves automatically adjusting saline bath temperature based on a patient temperature probe to achieve a set target temperature, is identical to currently marketed devices (including the predicate).
Similar Technical Characteristics and Materials: The technical characteristics of the catheter (biocompatible polyurethanes, heat exchange balloons, multiple lumens, heparin coating) and the CoolGard™ 3000 heater/cooler (integrated electro-mechanical heater/cooler, temperature monitor/controller, heat exchanger, roller pump, redundant safety controls, alarms, patient monitoring, temperature displays) are described as "very similar" or "essentially identical" to the predicate devices.

Conclusion stated by the submitter:

"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 CoolGard and Catheter Thermal Regulation System is substantially equivalent to the predicate device."

In essence, the "study" demonstrating the device meets "acceptance criteria" is the comprehensive comparison of its design, function, and intended use against already legally marketed predicate devices, concluding that there are no new questions of safety or effectiveness. Specific quantitative performance metrics or studies beyond this comparative analysis are not detailed in the provided summary.

Summary

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5 510K Summary

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: kcollins@alsius.com

Name of Device:

The Alsius CoolGard And Catheter Thermal Regulation System.

Common or Usual Name:

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

Classification Name:

Venous heat exchange catheters and associated temperature control systems have not been specifically classified by the FDA. However, FDA has classified venous catheters and thermal regulating systems as Class II devices under 21 C.F.R. §§ 880.5200 and 85 870.5900 respectively.

Predicate Device:

Cardiac Surgery	K012512 SetPoint® Endovascular Temperature Managementsystem. Radiant Medical, Inc., Redwood City CA
Neurosurgery	K022366 Celsius® Endovascular Temperature Managementsystem. Innercool Therapies Inc, San Diego CA

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.

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Technical Characteristics:

Two Models of Intravascular catheters are available for use with the CoolGard and Catheter Thermal Regulation System:

1. ICY™ Catheter Kit Model IC-3585A
1. Fortius™ Catheter Kit Model FR-5093A

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:

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Summary of the Basis for Finding of Substantial Equivalence:

The CoolGard and Catheter Thermal Requlation System indication statement and intended use is identical to the predicate device. Principle of operation is the same as the predicate 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 CoolGard and Catheter Thermal Requlation System characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The CoolGard and Catheter Thermal Requlation System is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circumference of the circle.

OCT 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ken Collins, M.D. Vice President for Regulatory Affairs Alsius Corporation 15770 Laguna Canyon Road, Suite 150 Irvine, California 92618

Re: K030421

Trade/Device Name: CoolGard and Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: August 8, 2003 Received: August 11, 2003

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 vour 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 - Ken Collins, M.D.

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Mark N Mulkern

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k)Number(if known): K030421

Device Name: CoolGard and Catheter Thermal Regulation System

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.

Mark A. Milkerer

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

9(k) Number K030421

Prescription Use

Over the Counter

Regulation Number and Section

§ 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).