RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

K042388 · Radiant Medical · DQY · Oct 28, 2004 · Cardiovascular

Device Facts

• Record ID: K042388
• Device Name: RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
• Applicant: Radiant Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Radiant Medical Endocatheter Temperature Probe is indicated for use with the Radiant Medical Endovascular Temperature Management System to measure core body temperature.

Device Story

The Endocatheter Temperature Probe is a single-use, sterile, heparin-coated catheter designed for placement into the inferior vena cava via the guidewire lumen of an endovascular catheter. It contains two independent thermistors that measure venous blood temperature, which serves as a proxy for core body temperature. The probe connects to the SetPoint/Reprieve Controller, which processes the thermistor signals to provide temperature readings. It is intended for use by clinicians in a hospital setting to monitor patient temperature during endovascular temperature management procedures, allowing for real-time clinical assessment and adjustment of thermal therapy.

Clinical Evidence

Bench testing only. Functionality tested per BS EN ISO 10555; biocompatibility tested per ISO 10993.

Technological Characteristics

Pebax sheath with soft, straight Pebax tip; two independent thermistor circuits; heparin-coated for hemocompatibility; gamma irradiation sterilization; single-use; connects to external controller for signal processing.

Indications for Use

Indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature in patients requiring endovascular temperature management.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Radiant Medical Endovascular Temperature Probe (K024327)

Submission Summary (Full Text)

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K042388

250 Chesapeake Drive Redwood City, CA 94063-4745

> tel. [phone] toll. 888.867.5179 fax. [phone]

www.radiantmedical.com

# 510|k] Summary of Safety and Effectiveness

OCT 2 8 2004

#### Submitter Information

| Company: | Radiant Medical, Inc.<br>250 Chesapeake Drive<br>Redwood City, CA 94063<br>[phone] |
|-----------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Cleeland<br>Senior Vice President of Regulatory & Clinical Affairs |
| Summary Date: | August 31, 2004 |

# Name and Classification

| Proprietary Name: | Endocatheter Temperature Probe |
|----------------------|-----------------------------------------------|
| Classification Name: | Percutaneous catheter (DQY) [21 CFR 870.1250] |
| Class: | II |

# Predicate Device

- a) Radiant Medical Endovascular Temperature Probe (K024327)
#### Indication for Use

The Radiant Medical Endocatheter Temperature Probe is indicated for use with the Radiant Medical Endovascular Temperature Management System to measure core body temperature.

### Description of Device

The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for

Image /page/0/Picture/17 description: The image shows the logo for Radiant Medical. The logo consists of a stylized graphic above the company name. The graphic is a series of curved lines that resemble a stylized vine or abstract design. Below the graphic is the word "Radiant" in a serif font, with the word "MEDICAL" in smaller, sans-serif letters underneath.

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Image /page/1/Picture/0 description: The image shows the logo for Radiant Medical. The logo features a stylized graphic above the text. The text "Radiant" is in a larger font size than the text "MEDICAL" which is placed directly below it.

250 Chesapeake Drive Redwood City, CA 94063-4745 tel. [phone] toll. 888.867.5179 fax. [phone] www.radiantmedical.com

placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature.

The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.

#### Summary of Technological Characteristics

The Endocatheter Temperature Probe measures blood temperature in the inferior vena cava. Patient temperature is measured by the SetPoint/Reprieve Controller via the thermistors in the probe.

#### Performance Test

The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993.

#### Conclusion

Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Endovascular Temperature Probe performs with safety and effectiveness equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 8 2004

Mr. Andrew Cleeland Senior Vice President of Regulatory & Clinical Affairs Radiant Medical, Inc. 250 Chesapeake Drive Redwood Citv. CA 94063

Re: K042388

> Trade/Device Name: Endocatheter Temperature Probe Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DOY Dated: August 31, 2004 Received: September 2, 2004

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

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Page 2 - Mr. Andrew Cleeland

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/dsma/dsmamain.html

Sincerely yours.

Duna R. Kirchner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K042388

Radiant Medical Endocatheter Temperature Probe Device Name: The Radiant Medical Endocatheter Temperature Probe is Indications For Use: indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dinnar R. Lo. Jones

Onlision Sign-Off) Trasion of Cardiovascular Devices

510:x) Number_K042388

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