The Alsius CoolGard® 3000 and Cool Line ™ Catheter Thermal Requlation 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.

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the lcy™ 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.

Device Description

The Alsius CoolGard And Catheter Thermal Regulation System.

AI/ML Overview

The provided text describes a 510(k) summary for the Alsius CoolGard and Catheter Thermal Regulation System, including an update to its labeling and a summary of a clinical trial used to evaluate the device. However, the document does not specify clear "acceptance criteria" for the device's performance in the typical sense of a pre-defined threshold that the device's metrics must meet to be considered effective or safe.

Instead, the document focuses on presenting the results of a randomized controlled trial and highlighting that the device's safety for fever reduction in certain patient populations (subarachnoid hemorrhage or primary traumatic brain injury) "has not been demonstrated." The mortality data is presented, but no explicit acceptance criteria or target performance values are given. The purpose of this submission appears to be related to demonstrating substantial equivalence for an MRI environment labeling change and providing information from a clinical trial, rather than proving the device meets specific pre-defined performance metrics for its primary indications.

Therefore, many of the requested elements regarding acceptance criteria and details of studies proving they were met cannot be fully extracted directly from this document.

Here's an attempt to answer the questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly defined in the provided document. The 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices and presenting clinical trial data for risk assessment and labeling. There are no pre-specified quantitative performance thresholds (e.g., "mortality rate must be below X%" or "temperature reduction must be Y degrees") presented as acceptance criteria the device needed to meet.

Reported Device Performance (Mortality by Diagnosis from the Randomized Controlled Trial):

Diagnosis	Group	n	N	% Mortality	p-value*
CI	Cool Line	3	16	18.8	0.74
CI	Control	3	14	21.4
ICH	Cool Line	8	33	24.2	1.00
ICH	Control	7	27	25.9
PTBI	Cool Line	10	44	22.7	0.24
PBT	Control	4	38	10.5
SAH	Cool Line	13	61	21.3	0.15
SAH	Control	7	63	11.1
*Fischer's exact test

Note: The document states, "The safety of this device has not been demonstrated for fever reduction in patients presenting with subarrachnoid hemorrhage or primary traumatic brain injury." This implies that while the data is presented, it does not meet an implicit safety criterion for these patient groups, even though an explicit quantitative one isn't stated.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): The randomized controlled trial involved 296 patients in total.
- Cool Line arm: 16 + 33 + 44 + 61 = 154 patients
- Control arm: 14 + 27 + 38 + 63 = 142 patients
Data Provenance: Not explicitly stated (e.g., country of origin). The study was a "randomized controlled trial," which is prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a clinical trial involving patient outcomes (mortality), not a study requiring expert labeling or adjudication of images/data for ground truth. Patient mortality is an objective outcome.

4. Adjudication Method for the Test Set

Not applicable. As described above, the outcome measured was mortality, which is an objective clinical endpoint, not something that typically requires adjudication in the context of expert consensus or labeling.

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 evaluating a thermal regulation system, not an AI-assisted diagnostic or interpretative device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This document describes a medical device (thermal regulation system) and its clinical performance. It does not refer to an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used was patient mortality data (an objective clinical outcome) in a randomized controlled trial.

8. The Sample Size for the Training Set

Not applicable. This document does not mention an algorithm or AI model that would require a training set. The clinical trial described pertains to the direct performance of the device on patients.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set for an algorithm is mentioned.

Summary

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000 1 1 2005

K05/9/2

3 510(k) 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 Regulating System.

Classification Name:

FDA has classified the Alsius CoolGard/Catheter system for various indications as a Class II device under 21 C.F.R. § 870.5900.

Pg 1 of 3

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Indications for Use

Cool Line Cathers - Indications for Use:

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 (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 -"Normothermia for the Neuro-critically III stroke patient" #101416-001.

Fortius and Icy Catheters - Indications for Use:

The COOLGARD™ 3000/Alsius Catheter Thermal Regulation System, using either the lcy™ 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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Summary of the Basis for Finding of Substantial Equivalence:

This submission relates to the addition of labeling relating to the use of the Alsius Cool Line®, Icy® and Fortius® Catheters in an MRI environment.

The predicate devices for this change in labeling are the catheters themselves as cleared under the following 510(k): K030421 (Fortius and ICY) and K014241 (Cool Line).

The labeling of these catheters is otherwise unchanged.

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 CoolGard 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 and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S." is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051912

Trade/Device Name: Alsius Cool Line, Icy & Fortius Heat Exchange Catheters Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NCX Dated: September 20, 2005 Received: September 21, 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 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 gencral 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 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)(L) 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:

OCT 11 2005

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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 III 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 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 I carted 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 clectronic 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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Qeartul

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): Device Name:

K051912 CoolGard and Catheter Thermal Regulation System

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.

Prescription Use X__________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
Page 2 of 2	(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 9	510(k) Number K051917

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Indications for Use

510(k) Number (if known):

Device Name:

K051912 CoolGard and Catheter Thermal Regulation System

Indications For Use:

Cool Line Cathers - Indications for Use:

Warning - Fever Reduction

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

*Fischer's exact test

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 (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

evice Evaluation (ODE)

Mark A. Millussen

Page 1 of 2

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

Page 8

510(k) Number K051912

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).