(30 days)
The Reprieve Endovascular Temperature Therapy System is a thermal regulating system intended to achieve and/or maintain normothermia in cardiac surgery patients in surgery and in recovery/intensive care, and for use in fever reduction, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemorrhage who require access to the central venous circulation and who are intubated and sedated.
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This document is a 510(k) premarket notification letter from the FDA regarding the Reprieve® Endovascular Temperature Therapy System. It does not contain information about the acceptance criteria or results of a study proving the device meets those criteria.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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).