(324 days)
Bisto's BT-500 is a Infant Incubator and intended to keep Premature in a warm environment in the hood for Neonatal hypothermia, Observation and Examination in newborn nurseries.
BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to themn-regulate on their own physiology.
BT-500 is not intended for transport.
BT-500 Infant Incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.
Also Heater is equipped inside of the hood to control the Skin Temperature of Infant at a fixed level as measured by the skin probe and showing, measuring and graphing the humidity, Air Temperature, Skin Temperature, Weight and SpO2
This Incubator is provided with function to control the infant's skin temperature.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the BT-500 Infant Incubator, primarily focused on demonstrating substantial equivalence to a predicate device.
While it mentions "various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff -Neonatal Transport Incubator Premarket notifications," and states "all test report attached," the specific details of these tests, their acceptance criteria, and the reported performance are not included in the provided text.
Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies based on the given information.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).