(56 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic functionality of a temperature probe, with no mention of AI or ML.
No
Explanation: The device is a temperature probe intended to measure core body temperature and is explicitly indicated as a component of a temperature management system, not as a standalone therapeutic device.
No
The device measures core body temperature, which is a physiological parameter, not a diagnostic finding. It is intended for use with a temperature management system, implying a monitoring and control function rather than disease diagnosis.
No
The device description clearly states it is a physical probe with a sheath, thermistors, and a Pebax tip, intended for placement in the inferior vena cava. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure core body temperature" and "measure a patient's core body temperature via venous blood temperature." This is a direct physiological measurement within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue) to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a probe inserted into the inferior vena cava to measure temperature directly. It doesn't involve the analysis of a biological sample.
- Lack of IVD Characteristics: The description doesn't mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a direct physiological measurement tool.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inferior vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
250 Chesapeake Drive Redwood City, CA 94063-4745
tel. 650.363.8000 toll. 888.867.5179 fax. 650.363.2400
510|k] Summary of Safety and Effectiveness
OCT 2 8 2004
Submitter Information
| Company: | Radiant Medical, Inc.
250 Chesapeake Drive
Redwood City, CA 94063
(650) 363-8000 |
|-----------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Andrew Cleeland
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.
1
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. 650.363.8000 toll. 888.867.5179 fax. 650.363.2400 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.
2
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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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