SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

K012512 · Radiant Medical · NCX · Jun 11, 2002 · Cardiovascular

Device Facts

• Record ID: K012512
• Device Name: SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
• Applicant: Radiant Medical
• Product Code: NCX · Cardiovascular
• Decision Date: Jun 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.

Device Story

SetPoint Endovascular Temperature Management System manages patient blood temperature; used in cardiac surgery and intensive care. System components: heparin-coated central venous catheter, heat exchange cassette, external controller, accessories. Catheter placed in inferior vena cava via femoral vein; uses counter-current heat exchange to add or remove heat from blood. Controller circulates fluid through closed-loop system; uses thermoelectric unit to adjust fluid temperature; monitors patient temperature via 400-series thermistors. Physician/clinician operates controller interface to select parameters. Output provides precise thermal regulation to achieve/maintain normothermia; benefits patient by managing body temperature during surgical procedures and recovery.

Clinical Evidence

Bench testing only. System performance testing conducted. Catheter functionality tested per BS EN ISO 10555; biocompatibility tested per ISO 10993. Controller electrical safety tested per EN 60601.

Technological Characteristics

Closed-loop endovascular heat exchange system. Components: heparin-coated central venous catheter, heat exchange cassette, microprocessor-based controller. Sensing: 400-series thermistors. Energy: thermoelectric unit for fluid temperature regulation. Connectivity: catheter-to-controller insulated lines. Standards: BS EN ISO 10555 (catheter functionality), ISO 10993 (biocompatibility), EN 60601 (electrical safety).

Indications for Use

Indicated for cardiac surgery patients requiring achievement or maintenance of normothermia 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

• MYOTherm XPTM Cardioplegia Delivery System (K003724)
• Bio-Cal 370 Temperature Control Module (K894980)
• Femoral cannula with introducer (K924642)
• Cincinnati Sub-Zero Hemotherm 400 (K811742)
• Bair Hugger® Patient Warming System (K873745)
• Medivance Artic Sun™ Temperature Management System (K010338)
• Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404)

Reference Devices

• Mallinokrodt Mon-a-Therm™ General Purpose Temperature Probe (K890484)

Submission Summary (Full Text)

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Premarket (510[k]) Notification

JUN 1 1 2002

# 510[k] Summary of Safety and Effectiveness

112

# Submitter Information

| Company: | Radiant Medical, Inc. |
|-----------------|-------------------------------------------------------------------------------|
| | 250 Chesapeake Drive |
| | Redwood City, CA 94063 |
| | [phone] |
| Contact Person: | Andrew Cleeland<br>Vice President of Regulatory, Clinical and Quality Affairs |
| Summary Date: | August 3, 2001 |

## Name and Classification

| Proprietary Name: | SetPoint® Endovascular Temperature Management System |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Cardiopulmonary bypass heat exchanger (DTR) [21 CFR 870.4240]<br>Thermal regulating system (DWJ) [21 CFR 870.5900]<br>Percutaneous catheter (DQY) [21 CFR 870.1250] |
| Class: | II |

#### Predicate Devices

The SetPoint System has the same intended use as a number of commercially available medical devices, operates within an cstablished range of temperatures, and uses existing, established technology

- a) The Medtronic cardiopulmonary bypass circuit composed of the: MYOTherm XPTM Cardioplegia Delivery System (K003724), Bio-Cal 370 Temperature Control Module (K894980), and Femoral cannula with introducer (K924642).
- b) The Cincinnati Sub-Zero Hemotherm 400 (K811742).
- c) The Augustine Medical, Inc. Bair Hugger® Patient Warming System (K873745).
- d) The Medivance Artic Sun™ Temperature Management System (K010338).
- e) The Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404).

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Image /page/1/Picture/0 description: The image shows a logo for Radiant Medical. The logo includes a stylized graphic to the left of the word "Radiant" in large, bold letters. Below "Radiant" is the word "MEDICAL" in smaller letters. Below the logo is the address "10 Chesapeake Drive" followed by "Ashland City".

The Mallinokrodt Mon-a-Therm™ General Purpose Temperature Probe (K890484) ੀ

KO12512

#### Intended Use

Reinsed

Premarket (510fk]) Notification

The intended use of the SetPoint® System is to raise, lower, and/or maintain blood temperature. The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive carc.

#### Description of Device

The SetPoint System is used to raise, lower, and/or maintain blood temperature. It consists of a single-use, heparin-coated, central venous catheter; a single-use, heat exchange cassette; an external controller; and associated accessories. The Controller unit has a user interface to select operating parameters and is connected to the Catheter via insulated lines. The catheter is designed for placement in the inforior vena cava via the femoral vein using a 10 Fr hemostatic introducer sheath. The Cassette is an integral part to the Catheter and an interface to the Controller.

# Summary of Technological Characteristics

The SetPoint System uses established technology, materials, and construction techniques. The system employs standard heat conduction technology to warm or cool the blood using circulating warm or cool fluid in a closed loop system. The SetPoint System accomplishes this heat exchange through a catheter. Jocated in the inferior vena cava, via the femoral vein, thereby adding heat to or removing heat from the blood by means of counter current heat exchange. The microprocessor based Controller circulates the fluid through the system and allows the fluid temperature to be raised or lowered as it passes over a thermoclectric unit within the Controller. Patient temperature is measured by the Controller using common 400 series thermistors.

## Performance Test

The SetPoint® Endovascular Tcmpcrature Management System has been tested for system performance. In addition the Catheter has been tested for functionality in accordance to the BS EN ISO 10555, for biocompatibility in accordance to ISO 10993. The controller has been tested for electrical safety in accordance to EN 60601.

### Conclusion

Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint® Endovascular Temperature Management System consisting performs with similar safety and effectiveness.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three parallel lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Andrew Cleeland Vice President of Regulatory, Clinical and Quality Affairs Radiant Medical, Inc. 250 Chesapeake Drive Redwood City, CA 94063

JUN 1 1 2002

Re: K012512

Trade/Device Name: SetPoint® Endovascular Temperature Management System Regulation Number: 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: May 31, 2002 Received: June 3, 2002

Dear Mr. Cleeland:

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. Andrew Cleeland

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Radiant Medical Inc.

012512

# Statement of Indications for Use

The SetPoint® System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.

Cly Witt

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

510(k) Number *k0|2512*

Strictly Confidential I his document and the data contained herein may not be reproduced, used or disclosed without the written permission of Radiant Medical Inc.