(343 days)
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.
The provided text is a 510(k) summary for a medical device called the "Gibeck, Inc. Warmbag Reusable Convective Warming Blanket." This document primarily focuses on establishing substantial equivalence to a predicate device, the "TropicAir Reusable Convective Warming Blankets." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details typically found in a clinical study report for assessing device performance.
Therefore, I cannot provide the requested information based on the input text. The document's purpose is to satisfy regulatory requirements for market approval based on equivalence, not to detail a specific performance study against defined acceptance criteria.
§ 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).