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 Description

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 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:

Cool Line™ Catheter Kit Model CL 2085B (2 lumens)
Cool Line™ Catheter Kit Model CL 2295A (3 lumens)

The Cool Line™ catheters are multi lumen intravascular catheters in two 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 quide wire lumen that can be used as a primary infusion lumen, and a second or third 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Alsius CoolGard™ and Cool Line™ Catheter Thermal Regulation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the results of a clinical trial related to its safety and effectiveness for fever reduction.

It does not contain information about specific "acceptance criteria" for the device's performance in a diagnostic or classification sense, nor does it describe a study designed to prove the device meets such criteria.

The document describes the results of a randomized controlled clinical trial, but this trial assesses the safety and effectiveness of the device in a clinical context (mortality rates in different patient cohorts) rather than validating specific technical performance criteria of an AI or diagnostic algorithm.

Therefore, I cannot fulfill most of your request directly from the provided text, as the information isn't present.

However, I can extract information related to the clinical trial that was conducted:

1. A table of acceptance criteria and the reported device performance

(Not Applicable): The document does not define specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI or device. Instead, it presents mortality rates from a clinical trial to demonstrate safety and effectiveness for its intended use.

Here's the clinical trial data on mortality:

Patient Cohort	Cool Line (n/N)	Cool Line (%)	Control (n/N)	Control (%)	p* value (Fischer's exact test)
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

Note: CI = cerebral infarction, ICH = intracerebral hemorrhage, PTBI = primary traumatic brain injury, SAH = subarachnoid hemorrhage. The device is indicated for CI and ICH, and the warning explicitly states safety has not been demonstrated for PTBI or SAH.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The clinical study was a randomized controlled trial of 296 patients.
The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective, beyond "randomized controlled trial". Randomized controlled trials are generally prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

(Not Applicable): This was a clinical trial assessing device safety and effectiveness (mortality rates) in patients, not a study establishing ground truth for a diagnostic algorithm based on expert review. The "ground truth" here is the clinical outcome (mortality) observed in patients.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

(Not Applicable): As above, this was a clinical trial evaluating patient outcomes, not a diagnostic accuracy study requiring adjudication of expert interpretations.

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

(Not Applicable): This document describes a clinical trial for a thermal regulation system, not an AI or diagnostic imaging device that involves human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

(Not Applicable): This is a medical device (catheter and thermal regulation system), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this clinical trial was outcomes data, specifically mortality in the enrolled patient cohorts.

8. The sample size for the training set

(Not Applicable): This document describes a clinical trial for a medical device, not the development or training of an AI algorithm. There is no mention of a "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

(Not Applicable): As above, this is not an AI algorithm development study.

Summary

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Section 4: 510(k) Summary

510(K) Summary: Alsius Corportation's CoolGard™ | Cool Line™ Catheter Thermal Regulation System

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

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

AUG 01 2003

Contact: Ken Collins Phone: 949-453-0150 Fax: 949-453-0250 Email: kcollins@alsius.com

Name of Device:

The Alsius CoolGard And Cool Line Catheter Thermal Regulation System.

Common or Usual Name:

Central Venous Catheter (short term) and Thermal Regulating 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 §§ 870.5900 respectively.

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014241

ALSIVS
CORPORATION

Company Confidential

Predicate Device(s):

Alpha Omega Dual Cooler Heater; Alpha Omega, Inc., Austin TX K001520; S.E. 11-22-2000

MTRE Allon 2001 Thermal Regulation Device; MTRE Advanced Technologies, McCordsville, IN K001546: S.E. 06-08-2000

ARROWgard Blue Quad-Lumen Central Venous Catheter Arrow International, Inc., Reading PA K962577; S.E. 08-21-1997

Arrow-Howes Large Bore Multi Lumen central venous catheter Arrow International, Inc., Reading PA K970864: S.E. 09-17-1997

Indications for Use

Warning - Fever Reduction

The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrchnoid 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

Mortality by Diagnosis (ITT analysis)

*Fischer's exact test

For more details on the clinical trial results please refer to "Physician's Manual - Fever Reduction for Patients with Cerebral Infarction and Intracerebral Hemorrhage" #101416-001.

K014241 S3

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014241 3/4

ALSIUS
CORPORATION

K014241 S3

Company Confidential

Technical Characteristics:

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

1. Cool Line™ Catheter Kit Model CL 2085B (2 lumens)
1. Cool Line™ Catheter Kit Model CL 2295A (3 lumens)

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

Page 3 of 4

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Company Confidential

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 Cool Line™ indication statements and intended use are identical to those for central venous catheters and heater/cooler units. The Cool Line™ catheter provides access to the central circulation for fluid administration. Additionally, the closed loop connections on the catheter can be attached to the heater/cooler unit for patient heating or cooling via conductive heat transfer from the temperature controlled saline. The Cool Line™ integrates venous access and temperature control which, separately, are intended uses for numerous devices.

The integration of temperature control and venous access could potentially affect safety and effectiveness in new ways that would raise new types of safety or effectiveness questions. Accepted scientific methods were used to generate performance data demonstrating the substantial equivalence of the Cool Line™ Catheters and CoolGard™ System to the predicate. In addition, the clinical study under IDE G990263 was conducted to further define safety characteristics.

Conclusion

In summary, descriptive information and performance data demonstrate that the Alsius Cool Line™ Catheter and CoolGard™ System's different technological characteristics either do not raise new questions of safety and effectiveness or, where appropriate, performance data demonstrate equivalence.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

Kenneth A. Collins, M.D. Vice President Clinical/Quality/Regulatory Alsius Corporation 15770 Laguna Canyon, Road, Suite 150 Irvine, California 92618

Re: K014241

Trade/Device Name: Alsius CoolGard and Cool Line Catheter Thermal Regulation System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NCX Dated: June 20, 2003 Received: June 20, 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). You may, therefore, market the device. subject to the general controls provisions of the Act and the limitations described below. 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 this device 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:

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

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	Z	0/0	n	N	%	p-
							value*
CI		16	18.8		14	21.4	0.74
ICH	8	33	24.2		27	25.9	1.00
PTBI	10	44	22.7	ব	38	10.5	0.24
SAH	13	61	21.3		ર્ભ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ વિદ્યારત તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામમાં પ્રાથમિક શાળા, આંગણવાડી તેમ જ દૂધ	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 - Fever Reduction for Patients with Cerebral Infarction and Intracerebral Hemorrhage" #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.

The FDA finding of substantial equivalence of your device to a legally marketed 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 (OS) 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 (301) 594-4595. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K014241

Alsius CoolGard 3000/Cool Line Catheter Heat Exchange System

Indications for Use

Prescription Use	X
Over the Counter

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number -

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).