Search Results

The Isolette® 8000 plus is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

The Isolette® 8000 plus is a neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional).

The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system.

The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154.

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Isolette® 8000 Plus Neonatal Incubator. The modification involves replacing the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. No AI/ML components are involved in this device, therefore, many of the requested fields are not applicable.

Here's a summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating that the modified device remains substantially equivalent to its predicate device (Isolette® 8000 plus, K172154) despite the change in the trolley. The acceptance criteria essentially align with the predicate device's established performance and safety standards. The performance of the modified device is reported as "Same" for nearly all specifications, with "Different – No impact on effect on safety and effectiveness" for the few physical attribute changes.

Ask a specific question about this device