(135 days)
The Cocoon Convective Warming System is indicated for hyper or hypothermic patients or normothermic patients for whom induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Cocoon Convective Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm. The Cocoon Convective Warming System can be used with adult and pediatric patients.
The Cocoon Convective Warming system incorporates the Convective Warming Machine CWS4000, and the Cocoon Disposable Patient Warming Blankets. The Convective Warming Machine is a mains-powered, microprocessor-controlled device that delivers a continuous flow of temperature-controlled air through a flexible hose to the warming blanket. The temperature of the air delivered to the blanket can be set to one of six settings: Ambient, 34℃, 37℃, 40℃, 43ºC, or 46ºC. When a temperature of 46ºC is selected, the setting automatically drops to 43ºC after 10 minutes.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document describes a 510(k) summary for the Cocoon Convective Warming System, outlining its characteristics, intended use, and substantial equivalence to predicate devices.
Specifically, it states: "Care Essentials Pty Ltd did not conduct a clinical study as defined in the guidance for Industry Financial Disclosures by Clinical Investigators to determine substantial equivalence. Care Essentials Pty Ltd conducted performance testing with satisfactory results." This indicates that no human clinical study was performed to establish performance against acceptance criteria.
The non-clinical testing section mentions validation against "the company's specified design requirements" and conformance with voluntary standards (ANSI/AAMI/ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971). However, it does not provide specific acceptance criteria values or the results of these performance tests in a format that would allow for the table requested.
Therefore, I cannot provide the requested information.
§ 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).