(93 days)
The Neo-Servo i Atom Infant Incubator Model 102 is a closed-type 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. The incubator is provided with a function to control the infant's skin temperature.
The Neo-Servo i Atom Infant incubator Model 102 consists of a hood, a main body, a control panel and is offered with or without a stand with casters. The Model 102 incorporates two (2) modes of control: air (manual control) and baby (servo control).
The Model 102 incorporates the sensors (humidity and temperature) inside the hood monitor the air conditions inside the hood. These are connected to the Sensor module. It is equipped with an incubator air temperature control function to circulate air containing the heat generated b the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. It is equipped with a skim temperature control function o maintain the infant's skin temperature at a fixed level in response to the patient's temperature as measured by the skin probe. There are optional humidity chamber and x-ray cassette tray.
There are 2 functional modes:
- Skin temperature control mode referred to as "Servo Control Mode" 1.
- Air temperature control mode referred to as "Manual Control Mode" 2.
The provided text describes the Neo-Servo i Atom Infant Incubator Model 102 and its substantial equivalence to a predicate device (Atom Model V-2200 – K061856). The information focuses on design, indications for use, and adherence to performance standards rather than a study proving the device meets specific acceptance criteria through a clinical trial or AI model evaluation.
Therefore, many of the requested categories related to AI performance, sample sizes, expert ground truth, and adjudication methods are not applicable to this document. The document primarily demonstrates substantial equivalence by comparing the device's features and compliance with recognized safety and performance standards.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a comparison to a predicate device, which implicitly defines "acceptance criteria" as meeting or exceeding the predicate's performance and complying with relevant standards.
| Feature / Criterion | Acceptance Criteria (Implicit from Predicate & Standards) | Reported Device Performance (Neo-Servo i Atom Infant Incubator Model 102) |
|---|---|---|
| Indications for Use | Intended for temperature control, observation, and critical care for newborns/premature neonates, with skin temperature control. | Identical to predicate: temperature control in neonatal hypothermia, observation/examination, prevention of body temperature drop, pre/post-operative intensive care; skin temperature control. |
| Environment of Use | Hospital, delivery suites, NICU. | Identical to predicate: Hospital, delivery suites, NICU. |
| Patient Population | Infants and neonates ≤ 10 kg. | Identical to predicate: Infants and neonates ≤ 10 kg. |
| Technology and Design | Similar to predicate (Atom V-2200). | Identical technology and design to Atom V-2200. |
| Materials (patient contact) | Similar to predicate. | Identical to predicate K061856. |
| Skin Temperature Setting Range (Servo) | 34 - 37.5 °C (override 37.6 - 38.0 °C). | Identical: 34 - 37.5 °C (override mode 37.6 - 38.0 °C). |
| Incubator Air Temperature | 23 - 39 °C (including override). | Identical: 23 - 39 °C (including override). |
| Display Range (Skin) | 30.0 - 42 °C, Accuracy ± 0.3 °C. | Identical: 30.0 - 42 °C, Accuracy ± 0.3 °C. |
| Display Range (Air) | 20.0 - 42.0 °C, Accuracy ± 0.3 °C. | Identical: 20.0 - 42.0 °C, Accuracy ± 0.3 °C. |
| Heater Output | 0 - 100% in 10 increments. | Identical: 0 - 100% in 10 increments. |
| Warm-up Time | ≤ 60 min @ 25°C. | Identical: ≤ 60 min @ 25°C. |
| Humidity Setting Range | 40 - 95% RH. | Identical: 40 - 95% RH. |
| Humidity Display | 15 - 99% RH. | Identical: 15 - 99% RH. |
| Continuous Humidity | ~ 8 hours. | Identical: ~ 8 hours. |
| Oxygen Supply (Max Concentration) | ≥ 65% @ 10 Lpm. | Identical: ≥ 65% @ 10 Lpm. |
| Environment CO2 Concentration |
§ 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).