REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

K071358 · Radiant Medical · NCX · Jun 1, 2007 · Cardiovascular

Device Facts

• Record ID: K071358
• Device Name: REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
• Applicant: Radiant Medical
• Product Code: NCX · Cardiovascular
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Device Story

Reprieve System is a thermal regulating device for neurosurgical patients; induces, maintains, and reverses mild hypothermia. System components: heparin-coated central venous catheter, heat exchange cassette, temperature probe, external controller. Catheter placed in inferior vena cava via femoral vein. Principle: closed-loop heat exchange; sterile saline circulates through balloon catheter; counter-current heat exchange with patient blood. Controller monitors patient temperature via probe; adjusts process fluid temperature to maintain target patient temperature. Used in surgery and recovery/intensive care by clinicians. Benefits: precise, automated temperature management for neurosurgical patients.

Clinical Evidence

Bench testing only. Performance testing conducted for system functionality per BS EN ISO 10555, biocompatibility per ISO 10993, sterility per ISO 11137, and electrical safety per IEC 60601.

Technological Characteristics

Closed-loop heat exchange system; heparin-coated central venous catheter; external controller; sterile saline thermal transfer fluid. Dimensions: 12 Fr introducer sheath. Standards: BS EN ISO 10555 (catheter), ISO 10993 (biocompatibility), ISO 11137 (sterility), IEC 60601 (electrical safety). Feedback-controlled thermal regulation based on patient temperature probe input.

Indications for Use

Indicated for neurosurgical patients requiring induction, maintenance, or reversal of mild hypothermia in surgical or intensive care settings.

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

• Reprieve® Endovascular Temperature Therapy System (K012512, K063405)
• Innercool Celsius Control System™ (K022366)
• Alsius CoolGard® and CoolLine® Catheter Thermal Regulation System (K030421)

Submission Summary (Full Text)

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JUN - 1 2007

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# 510(k) Summary

### Submitter Information Applicant/Owner: Radiant Medical, Inc. 250 Chesapeake Drive Redwood City, CA 94063 [phone] Scott A. Wilson, Ph.D. Contact Person: Vice President of Regulatory Affairs, Quality Assurance & Intellectual Property May 2007 Summary Date:

#### Name and Classification

| Proprietary Name: | The Reprieve® Endovascular Temperature Therapy System |
|-------------------|-------------------------------------------------------|
| Regulation Name: | Thermal regulating system |
| Regulation No.: | 870.5900 |
| Class: | II |
| Product Code: | NCX |

#### Predicate Devices

- a) The Radiant Medical Reprieve® Endovascular Temperature Therapy System cleared under K012512 (decision dated June 11, 2002) and special K063405 (decision dated January 8, 2007).
- b) The Innercool Celsius Control System™ cleared under K022366 (decision dated January 27, 2003).
- c) The Alsius CoolGard® and CoolLine® Catheter Thermal Regulation System cleared under K030421 (decision dated October 23, 2003).

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#### Indication for Use

The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Confidential This document and its contents are the property of Radiant Medical, Inc. Any use, reproduction or distribution without the written permission of Radiant Medical is prohibited.

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#### Description of Device

The Reprieve System consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an integrated temperature probe; and an external controller. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via the Cassette and extension lines. The catheter is designed for placement in the inferior vena cava via the femoral vein using a 12 Fr hemostatic introducer sheath.

#### Summary of Technological Characteristics

The Reprieve System uses established technology, materials, and construction techniques. The system employs standard heat conduction and convection technology to warm or cool the blood using circulating warm or cool sterile saline within a balloon catheter in a closed loop system. Heat exchange is achieved without direct contact between the circulating saline and the patient's blood. The saline is continuously circulated in the closed loop through the catheter, placed in the inferior vena cava via the femoral vein, thereby exchanging heat with the blood by means of counter current heat exchange with the blood flow. The saline is returned from the catheter through an insulated extension line to a disposable cassette (plugged into the controller) where the heat from the saline is exchanged across a second heat exchange surface with a thermal transfer (process) fluid circulating in the controller. The temperature of the process fluid, which governs the degree and rate of heat exchange, is controlled based on the patient's temperature. The controller continuously monitors the patient temperature by a temperature probe (K042388) placed through the guide wire lumen of the heat exchange catheter and through a feedback loop, ensuring that a patient remains at the target temperature.

#### Performance Test

The Reprieve Endovascular Temperature Therapy System has been tested for system performance substantially equivalent to the predicate devices. In addition the Catheter has been tested for functionality in accordance to BS EN ISO 10555, for biocompatibility in accordance to ISO 10993, and for sterility in accordance to ISO 11137. The controller has been tested for electrical safety in accordance to IEC 60601.

#### Conclusion

Descriptive inforamtion and appropriate performance data demonstrate that the Radiant Medical Reprieve Endovascular Temperature Therapy System performs with safety and effectiveness substantially equivalent to the predicate devices for the stated indication for use.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radiant Medical, Inc. % Scott A. Wilson, Ph.D. Vice President, Regulatory Affairs and Quality Assurance 250 Chesapeake Drive Redwood City, California 94063-4745

JUN - 1 2007

Re: K071358

Trade/Device Name: Reprieve® Endovascular Therapy System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: May 14, 2007 Received: May 16, 2007

Dear Dr. Wilson:

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

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Page 2 - Scott A. Wilson, Ph.D.

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.

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 Office of Compliance at [phone]. 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 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 A. Wilkerson

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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## Indications for Use

510(k) Number (if known): __

Device Name: Reprieve® Endovascular Temperature Therapy System

Indications for Use:

The Radiant Medical Reprieve® Endovascular Temperature Therapy System is a thermal regulating device intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark M. Wilkerson

(Division Sign-Off) Division of General, Restorative, .. ad New ological Devices

K071358

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