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 SOLEX catheter is a multi lumen intravascular catheter. The catheter has 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 12.2 mm 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 Solex Catheter Model SL2593 consist of a standard guide wire lumen that can be used as a primary infusion lumen, and two additional infusion lumens within the shaft.

AI/ML Overview

The provided document is a 510(k) summary for the Alsius Solex Catheter Model SL2593, which is a submission to the FDA for market clearance based on substantial equivalence to a predicate device. This type of submission generally does not include a detailed study proving the device meets acceptance criteria in the same way a clinical trial for a novel drug or a high-risk device might. Instead, the focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, many of the requested categories (e.g., sample size for the test set, number of experts, adjudication method, MRMC study, standalone performance) are not applicable in this context, as this document is not a report of a new clinical study with acceptance criteria being met in a statistically powered trial.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of "acceptance criteria" with measured performance for the Solex Catheter in the way it would for a clinical trial endpoint. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device (Alsius Fortius Catheter Kit Model FR-5093, K030421) by comparing technical characteristics and intended use.

The "performance" is implicitly considered equivalent if the technical changes do not raise new questions of safety and effectiveness, and the basic operating principle and indications for use are the same.

Characteristic/Comparison Point	Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Comparison to Predicate)
Indications for Use	Identical to predicate device	Identical to predicate device
Principle of Operation	Same as predicate device	Same as predicate device
Technical Characteristics	Very similar to predicate device; differences should not raise new safety/effectiveness concerns	Differences noted (shorter balloon, shorter length, additional infusion lumens, different insertion site label, different PET construction OD). These differences were deemed not to raise new safety/effectiveness concerns.
Materials Used	Very similar to predicate device	Very similar (e.g., same heat exchange balloon material, Duraflo® Treatment heparin coating)
Clinical Performance (Cooling/Heating)	Not explicitly stated as a numerical criterion; assumed to be acceptable given similarity in principle and material. Shorter balloon results in reduced heat exchange power, but this is not presented as a failure to meet a criterion, but rather a characteristic.	The shorter length balloon "results in reduced heat exchange power." The document implies this is acceptable given the overall substantial equivalence determination.
Safety	No new questions of safety	No new questions of safety raised.
Effectiveness	No new questions of effectiveness	No new questions of effectiveness raised.

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

Sample Size for Test Set: Not applicable. This is not a study with a test set in the conventional sense. The submission relies on comparative analysis with a predicate device.
Data Provenance: Not applicable. The data primarily consists of engineering and design specifications for the new device and a comparison to the predicate device.

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

Number of Experts: Not applicable. Ground truth as typically established by medical experts for clinical endpoints is not part of this 510(k) submission for substantial equivalence based on technical comparison.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. There was no test set requiring expert adjudication.

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:

MRMC Study: Not applicable. This device is a catheter for thermal regulation, not an AI-assisted diagnostic device.

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

Standalone Performance: Not applicable. This device is a physical medical device (catheter) and associated system, not an algorithm. Its operation involves human medical professionals.

7. The Type of Ground Truth Used:

Type of Ground Truth: The "ground truth" implicitly used for this 510(k) submission is the established safety and effectiveness of the predicate device. The new device is compared against the predicate's characteristics and performance to demonstrate that it is "substantially equivalent." There isn't a separate, independently established ground truth for the new device's performance in a clinical setting presented in this document.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This is a medical device submission, not an AI/machine learning model submission that would require a "training set."

9. How the Ground Truth for the Training Set was Established:

How Ground Truth for Training Set was Established: Not applicable. This is a medical device submission, not an AI/machine learning model submission.

Summary

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K081936 Page 1/3

Image /page/0/Picture/1 description: The image shows the logo for "ALSIUS CORPORATION" on the left side of the image. To the right of the logo, the text "Company Confidential" is written. There is a line above and below the text "Company Confidential".

K08xxxx - Solex Catheter Model SL2593

13 510K Summary

AUG 1 3 2008

510(K) SUMMARY FOR ALSIUS CORPORTATION'S SOLEX CATHETER MODEL SL2593

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

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

Contact: John Riolo Phone: 949-453-0150 Fax: 949-453-0250 Email: jriolo@alsius.com

Name of Device:

Solex Catheter Model SL2593

Common or Usual Name:

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

Classification Name:

21 CFR 870.5900 System, hypothermia, intravenous, cooling

Predicate Device:

K030421 Alsius Fortius Catheter Kit Model FR-5093 Decision Date 10/23/2003

Decision Substantially equivalent (SE)

Indications for Use

The Solex Catheter Model SL2593, connected to an Alsius External 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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K081936

Company Confidential

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 Solex Catheter Model SL2593 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 Solex Catheter Model SL2593 is the same as the predicate device, the Fortius Model FR-5093, K030421, except that:

lt has a shorter length balloon which results in reduced heat exchange power. . As a result it has a significantly shorter length (25 cm vs 50cm).
It is labeled for insertion via the jugular vein whereas the Fortius is labeled for . femoral insertion.

	FR-5093	Solex SL2593
	Predicate - K030421	NEW
Saline Circuit	Same
Tip Infusion Lumen	Same
Mid shaft Infusion Lumen	×	✓
Lower shaft Infusion Lumen	×	✓
Length	50cm tip to manifold	25cm tip to manifold
Shaft Diameter	Same - 9.3 Fr
Heat Exchange BalloonMaterial	Same Material (PET)
Heat Exchange BalloonConstruction	Serpentine Construction.080" OD PET	Serpentine Construction.067" OD PET

It has two additional infusion lumens. .
V =Yes, present in design,

X =No, not present in design

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

15770 Laguna Canyon Road, Suite 150 Irvine, California 92618

Page 37

Tel: 949.453.0150 FAX: 949.453.0250

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ALSIUS
CORPORATION

Company Confidential

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

Principles of Operation:

The Alsius temperature control 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 indication statement and intended use is identical to the predicate device. The 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 Solex Catheter Model SL2593 characteristics do not raise new questions of safety and effectiveness. Where appropriate, performance data demonstrate equivalence. The Solex Catheter Model SL2593 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, featuring a staff with three intertwined snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2008

Alsius Corporation % Mr. John Riolo VP, RA/CA/QA 15770 Laguna Canyon Road, Suite 150 Irvine, California 92618

Re: K081936

Trade/Device Name: Alsius Solex Catheter Model SL2593 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: July 30, 2008 Received: July 31, 2008

Dear Mr. Riolo:

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 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 -- Mr. John Riolo

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276 3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

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

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K081936

Indications for Use

510(k) Number (if known): K08XXXXX

Device Name: Alsius Solex Catheter Model SL2593

Indications for Use:

The Solex Catheter Model SL2593, connected to an Alsius External 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)

Divisi

Division of General
and Neurological Devices
Page 1 of vol. 1-

Number | 1081936

Page 34 of 89 ALSIUS 510k Page 34 of 1404

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).