SOLEX CATHETER, MODEL SL2593

K081936 · Alsius Corp. · NCX · Aug 13, 2008 · Cardiovascular

Device Facts

• Record ID: K081936
• Device Name: SOLEX CATHETER, MODEL SL2593
• Applicant: Alsius Corp.
• Product Code: NCX · Cardiovascular
• Decision Date: Aug 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Solex Catheter Model SL2593 is a multi-lumen intravascular catheter used with Alsius External Thermal Regulation System. Device circulates sterile saline through internal heat exchange lumens to modulate patient blood temperature via heat exchange membranes; saline remains in closed-loop and is not infused. Catheter includes guide wire lumen, two additional infusion lumens, and heparin-coated blood contact surfaces. Used in OR and ICU settings by clinicians. System automatically adjusts saline bath temperature based on patient temperature probe feedback to reach physician-set target. Benefits include precise thermal regulation for cardiac and neurosurgical patients.

Clinical Evidence

No clinical data provided. Substantial equivalence based on descriptive information and performance data.

Technological Characteristics

Multi-lumen intravascular catheter; PET heat exchange balloon (serpentine construction); heparin-coated (Duraflo) blood contact surfaces. Closed-loop saline circulation for thermal exchange. 25cm length; 9.3 Fr shaft diameter. Sterile, single-use.

Indications for Use

Indicated for cardiac surgery patients requiring normothermia maintenance and neurosurgery patients requiring induction, maintenance, or reversal of mild hypothermia during surgery and recovery/intensive care.

Regulatory Classification

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.

Predicate Devices

• Alsius Fortius Catheter Kit Model FR-5093 (K030421)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

### 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:

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

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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 Balloon<br>Material | Same Material (PET) | |
| Heat Exchange Balloon<br>Construction | Serpentine Construction<br>.080" OD PET | Serpentine Construction<br>.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: [phone] FAX: [phone]

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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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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

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