(17 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware components and thermal regulation.
Yes.
The device is intended to induce, maintain, and reverse mild hypothermia in neurosurgical patients, which is a therapeutic intervention.
No
The device is described as a "thermal regulating device intended to induce, maintain, and reverse mild hypothermia," which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components including a catheter, cassette, temperature probe, and external controller.
Based on the provided information, the Radiant Medical Reprieve® Endovascular Temperature Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "induce, maintain, and reverse mild hypothermia in neurosurgical patients in surgery and in recovery/intensive care." This describes a therapeutic intervention performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device description details a system involving a catheter inserted into a vein, a heat exchange cassette, and an external controller. This is consistent with a device used for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Reprieve System's function is to directly alter the patient's body temperature, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / 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.
Product codes
NCX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inferior vena cava via the femoral vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
neurosurgical patients in surgery and in recovery/intensive care
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
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.
Key Metrics
Not Found
Predicate Device(s)
K012512, K063405, K022366, K030421
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5900 Thermal regulating system.
(a)
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.(b)
Classification. Class II (performance standards).
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JUN - 1 2007
Image /page/0/Picture/3 description: The image shows a handwritten alphanumeric string. The string appears to be "K071358". The characters are written in a dark ink, and the background is white. The writing style is casual and slightly slanted.
510(k) Summary
Submitter Information Applicant/Owner: Radiant Medical, Inc. 250 Chesapeake Drive Redwood City, CA 94063 (650) 363-8000 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
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.
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 (240) 276-0115. 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 (240) 276-3150 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
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