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 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 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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the Icy™ Catheter Model IC-3893A. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a device meets specific, pre-defined acceptance criteria through a clinical study with detailed performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI/ML-based device. The original content describes a comparison to a predicate device for regulatory approval, focusing on technical characteristics and intended use.

However, I can extract the information that is present and explain why the other requested details are not available.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported device performance in the context of an AI/ML device study. Instead, it compares the technical characteristics of the new device (Icy™ IC-3893A) to a predicate device (Icy™ IC-3585A) to demonstrate substantial equivalence.

Feature	Predicate Device (Icy™ IC-3585A)	New Device (Icy™ IC-3893A)
Saline Circuit	Same	Same
Tip Infusion Lumen	Same	Same
Mid shaft Infusion Lumen	x	✔
Lower shaft Infusion Lumen	x	✔
Length	35cm insertion length, 38cm tip to manifold	(Not explicitly stated if different, implied same unless specified)
Shaft Diameter	8.5 Fr	9.3 Fr
Cooling Balloons	3 Balloons of same dimensions and locations	Same
Heat Exchange Capability	Same	Same

Acceptance Criteria for Substantial Equivalence (implied by the 510(k) process): The device's characteristics do not raise new questions of safety and effectiveness compared to the predicate device. Performance data (not detailed in this summary) demonstrate equivalence where appropriate.

Reported Device Performance: The document states that the heat exchange capability of the two catheters is the same. The overall conclusion is that descriptive information and performance data (which are not extensively detailed in the summary but would have been part of the full 510(k) submission) demonstrate that the new catheter characteristics do not raise new questions of safety and effectiveness, and where appropriate, performance data demonstrate equivalence.

2. Sample size used for the test set and the data provenance

Not applicable. This document is a 510(k) summary for a physical medical device (catheter) based on substantial equivalence, not an AI/ML study with a test set. There is no mention of a "test set" in the context of data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. See point 2.

4. Adjudication method for the test set

Not applicable. See point 2.

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 is for a physical medical device and does not involve AI or human readers in the context of an MRMC study.

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

Not applicable. See point 5.

7. The type of ground truth used

Not applicable. As this is a physical device submission focused on substantial equivalence to a predicate, "ground truth" in the AI/ML sense is not relevant. The "truth" for this submission is based on the established safety and effectiveness of the predicate device and the physical and functional characteristics of the new device.

8. The sample size for the training set

Not applicable. See point 2.

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

Not applicable. See point 2.

In summary: The provided document is a regulatory submission (510(k) summary) for a conventional medical device (catheter) seeking market clearance based on substantial equivalence to a previously cleared predicate device. It focuses on comparing technical characteristics and intended use. The questions posed are highly specific to AI/ML device studies, which are not described or implied in this document.

Summary

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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: 949-453-0150 Fax: 949-453-0250 Email: kcollins@alsius.com

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:

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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.

	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 length38cm tip to manifold

Shaft Diameter	8.5 Fr	9.3 Fr
Cooling Balloons	3 Balloons of the same dimensions and at the samelocations 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

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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.

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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.

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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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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

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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)

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

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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).