SETPOINT ENDOVASCULAR TEMPERATURE PROBE

K024327 · Radiant Medical · DQY · Mar 25, 2003 · Cardiovascular

Device Facts

• Record ID: K024327
• Device Name: SETPOINT ENDOVASCULAR TEMPERATURE PROBE
• Applicant: Radiant Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

The SetPoint Endovascular Temperature Probe is a single-use, heparin-coated venous catheter designed for endovascular placement in the femoral vein. It features a Pebax sheath with a soft, straight tip and contains two 400-series equivalent thermistors on independent circuits. The probe is compatible with a 4 Fr. introducer with a Touhy-Borst hemostasis valve. It functions by sensing venous blood temperature and transmitting this data to the SetPoint Controller for core body temperature measurement. The device is intended for clinical use by healthcare professionals to monitor patient temperature. By providing accurate core temperature readings, it assists clinicians in managing patient thermal status during procedures or therapy.

Clinical Evidence

Bench testing only. The device underwent functionality testing per BS EN ISO 10555 and biocompatibility testing per ISO 10993. Electrical safety was verified per EN 60601 as previously established in K012512.

Technological Characteristics

Materials: Pebax sheath, heparin coating. Sensing: Two 400-series equivalent thermistors on independent circuits. Form factor: Venous catheter, 4 Fr. compatible. Sterilization: Gamma irradiation. Standards: BS EN ISO 10555 (functionality), ISO 10993 (biocompatibility), EN 60601 (electrical safety).

Indications for Use

Indicated for use with the SetPoint Endovascular Temperature Management System to measure core body temperature via venous blood temperature in patients requiring endovascular temperature monitoring.

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

• SetPoint® Catheter and SetPoint General Purpose Temperature Probe, components of the SetPoint Endovascular Temperature Management System (K012512)
• Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Radiant Medical. The logo consists of a circular graphic on the left, followed by the word "Radiant" in a bold, serif typeface. Below "Radiant" is the word "MEDICAL" in a smaller, sans-serif font. The circular graphic appears to contain an abstract design, possibly representing a human figure or energy flow.

MAR 2 5 2003

250 Chesapeake Drive Redwood City 0) 363.8000 [phone]

# 510[k] Summary of Safety and Effectiveness

# Submitter Information

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

### Name and Classification

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

#### Predicate Devices

- a) SetPoint® Catheter and SetPoint General Purpose Temperature Probe, components of the SetPoint Endovascular Temperature Management System (K012512)
- b) The Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404).

# Indication for Use

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

# Description of Device

The SetPoint Endovascular Temperature Probe consists of a sheath containing two 400-series equivalent thermistors on separate and independent circuits. This Probe

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Image /page/1/Picture/0 description: The image shows the logo for Radiant Medical. The logo consists of a circular graphic on the left, which contains a stylized image of a human figure. To the right of the graphic is the word "Radiant" in a serif font, with the word "MEDICAL" in smaller, sans-serif letters below it.

250 Chesapeake Drive
Redwood City
Cal: 94063
Tel. .[phone]
Fax. [phone]

is intended for endovascular placement similar to other venous catheters with temperature measurement capability, including the Arrow International Inc. Multi-Lumen Central Venous Catheter (K904404). The outer sheath is Pebax and has a soft, straight Pebax tip. The Endovascular Probe is heparin-coated for hemocompatibility. It is compatible with a 4 Fr. introducer with Touhy-Borst hemostasis valve. The intended use is to measure a patient's core body temperature via venous blood temperature.

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

#### Summary of Technological Characteristics

The SetPoint Endovascular Temperature Probe measures venous blood temperature via endovascular access in the femoral vein. Patient temperature is measured by the SetPoint Controller via the 400 series-equivalent thermistors in the probe.

#### Performance Test

The SetPoint Endovascular Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993. The SetPoint Controller has been tested for electrical safety in accordance to EN 60601, as previously reported in K012512.

#### Conclusion

Based upon the successful performance tests and the comparison to the predicate devices, the SetPoint Endovascular Temperature Probe 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 and 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 design featuring three horizontal lines that curve upwards, resembling an abstract representation of a human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

Radiant Medical, Inc. c/o Mr. Andrew Cleeland 250 Chesapeake Drive Redwood City, CA 94063

Re: K024327

> SetPoint® Endovascular Temperature Probe Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 23, 2002 Received: December 26, 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.

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#### Page 2 - Mr. Andrew Cleeland

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 (OS) 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]. 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) you may obtain. 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,

l. WQelchTull

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

Enclosure

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# Statement of Indications for Use

Temperature Follar

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

N. Deaton

51

Prescription Use Only