(140 days)
The Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature control in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This incubator is provided with a function to control the infant's skin temperature. Optional functions include pulse oximetry, and oxygen density controlling.
Incu i (Atom Infant Incubator Model 101) consists of a hood, a main body, a control panel and a stand with casters. A hood consists of a canopy and access doors (Snap-open access port). An Oxygen sensor, a humidity sensor and a temperature sensor which monitor the air conditions inside the hood, are connected to the sensor module. A main body consists of a mattress, a mattress platform, a conditioning chamber, a humidity chamber. A control panel and skin temperature sensors are connected to the main body. This product has 2 types of function modes; one is skin temperature control mode and another is air temperature control mode. The skin temperature control mode is called "servo control mode" also, and the air temperature control mode is called "manual control mode" also. In "servo control mode", skin temperature can be set from 34°C to 38°C (including override). In "manual control mode", air temperature inside the hood is monitored by temperature sensor of sensor module, and air temperature inside the hood is controlled according to difference between monitored air temperature inside the hood and set air temperature. The mattress platform can be tilted. X-ray cassette tray is installed under the mattress platform. The device has 6 kinds of accessories; "Skin temperature probe (sensor)", "Oxygen sensor", "Piping hose for oxygen", "Electrostatics air filter", "Access port cover" and "Oxygen calibration tool", and these 6 accessories are available separately as replacements. "SpO2 Module", "Oxygen Controller", "Weight Monitor" and "Humidifier Chamber" are components of this device, and it is optional whether they are initial attached initially or not. If they are not attached initially, they can be attached later, and then SpO2/pulse monitoring, oxygen density controlling, weight monitoring and humidifying function can be available. The 4 kinds of components can be supplied individually. The stand can be gone up and down.
The provided text does not describe acceptance criteria for a medical device or a study validating performance against such criteria. It is a 510(k) summary for the "Incu i (Atom Infant Incubator Model 101)".
Instead, it contains:
- A submission summary: Basic information like sponsor details, device name, classification, predicate devices, and a general description of the Incu i incubator.
- Intended Use Statement: The target population and common applications for the incubator.
- Comparison to Predicate Devices: A statement that the Incu i is substantially equivalent to predicate devices (Atom V-2200 and Caleo) in terms of intended use, features, appearance, temperature modes, and components.
- Testing and Conclusions: A very high-level overview of tests performed:
- Compliance with electrical safety standards (IEC60601-1, IEC60601-1-2, IEC60601-2-19).
- Biocompatibility evaluation based on ISO10993-1, stating that infant-contacting parts are identical to predicate devices.
- Software validation.
- FDA Clearance Letter: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
- Indications for Use: Reiterates the intended use statement.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document focuses on regulatory clearance through substantial equivalence, not on specific performance metrics or detailed clinical studies as might be found for diagnostic or interventional devices.
§ 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).