(60 days)
The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.
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.
The provided document is a 510(k) summary for the Reprieve® Endovascular Temperature Therapy System. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the way your request outlines (e.g., sensitivity, specificity, or performance against a set of statistical targets for a diagnostic device).
This document focuses on establishing substantial equivalence based on technological characteristics and the successful completion of general performance and safety tests, rather than a clinical trial demonstrating specific performance outcomes against a predefined set of acceptance criteria for diagnostic accuracy.
Here's a breakdown based on the information available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided 510(k) summary. The document states:
"The Reprieve Endovascular Temperature Therapy System has been tested for system performance." and "Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Reprieve Endovascular Temperature Therapy System performs with safety and effectiveness equivalent to the predicate device."
This indicates that some performance tests were conducted to demonstrate safety and effectiveness, but the specific acceptance criteria (e.g., target temperature range, heating/cooling rates, or a numerical accuracy metric) and the quantitative results against those criteria are not detailed in this summary. Instead, it relies on demonstrating equivalence to a predicate device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not present. The 510(k) summary refers to "performance verification tests" but does not specify the sample size, type (e.g., in-vitro, ex-vivo, clinical), or data provenance (country, retrospective/prospective) of any test sets used.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable/not present. The device is a thermal regulating system, not a diagnostic device that requires expert interpretation to establish a "ground truth" for a test set in the way a diagnostic AI would. The performance tests would likely focus on objective measurements of temperature regulation, safety, and functionality according to engineering standards.
4. Adjudication Method for the Test Set
This information is not applicable/not present for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. The Reprieve® System is a thermal regulating therapy device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this type of "standalone" evaluation aligns with the "Performance Test" section. The document states: "The Reprieve System has been tested for system performance." and details various tests for the catheter (BS EN ISO 10555), biocompatibility (ISO 10993), sterility (ISO 11137), and electrical safety of the controller (IEC 60601). These are all standalone engineering and safety tests of the device itself. The clinical performance related to achieving normothermia would also be considered a standalone function of the device's ability to heat/cool the patient.
7. The Type of Ground Truth Used
For a thermal regulating system, the "ground truth" for performance tests would involve objective, measurable physical parameters, such as:
- Temperature measurements: Verifying the device can achieve and maintain target temperatures within specified tolerances using calibrated thermometers.
- Flow rates and pressure measurements: Ensuring fluid circulation within the system meets specifications.
- Safety parameters: Confirming the device operates without adverse events (e.g., overheating, electrical hazards).
- Biocompatibility: Testing materials for biological safety rather than clinical outcomes directly.
The document refers to adherence to international standards (e.g., ISO 10555, ISO 10993, IEC 60601), which inherently define the "ground truth" or acceptable performance against which the device is tested.
8. The Sample Size for the Training Set
This information is not applicable/not present. The Reprieve® System is a hardware medical device with embedded control logic, not an AI/ML algorithm that undergoes a training phase with a distinct training dataset in the sense of modern deep learning models. Its design and performance are based on established engineering principles and validation testing, not statistical learning from a clinical dataset (training set).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not present for the same reasons as #8.
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4063405
510[k] Summary of Safety and Effectiveness
JAN - 8 2007
| Submitter Information | |
|---|---|
| Company: | Radiant Medical, Inc.250 Chesapeake DriveRedwood City, CA 94063(650) 363-8000 |
| Contact Person: | Scott A. Wilson, Ph.D.Vice President of Regulatory Affairs, Quality Assurance &Intellectual Property |
| Summary Date: | November 2006 |
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 Device
- a) Radiant Medical SetPoint® Endovascular Temperature Management System (K012512).
Indication for Use
The Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and recovery/intensive care.
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Radiant Medical, Inc.
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 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, located 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 saline through the catheter and cassette and allows the saline temperature to be raised or lowered as it passes through a heat exchanger in thermal communication with a process fluid unit within the Controller. Patient temperature is constantly measured by the Controller using a temperature probe (K042388) integrated with the catheter.
Performance Test
The Reprieve Endovascular Temperature Therapy System has been tested for system performance. 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
Based upon the successful completion of performance verification tests and the comparison to the predicate devices, the Radiant Medical Reprieve Endovascular Temperature Therapy System performs with safety and effectiveness equivalent to the predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Radiant Medical % Scott A. Wilson, Ph.D. Vice President Regulatory Affairs and Quality Assurance 250 Chesapeake Drive Redwood City, California 94063-4745
JAN - 8 2007
Re: K063405
Trade/Device Name: Reprieve® Endovascular Temperature Therapy System Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: Class II Product Code: NCX Dated: December 1, 2006 Received: December 4, 2006
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 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 - Scott A. Wilson, Ph.D.
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,
for
Mark N. Melkerson
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): K063405
Device Name: Reprieve®Endovascular Temperature Therapy System
Indications For Use: The Radiant Medical Reprieve® Endovascular Temperature Therapy System is indicated for use in cardiac surgery patients to achieve and/or maintain normothermia during surgery and 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)
Polo
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(K) Number K063405
§ 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).