Search Results

The mOm Essential Incubator is indicated for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs).

The mOm Essential Incubator is not intended for home use.

The mOm Essential Incubator, ME1, is a neonatal incubator used for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs). Power is sourced either from an external AC supply or an internal rechargeable battery.

The mOm Essential Incubator (ME1) is intended to provide a heated environment with a stable temperature for infants who require assistance with thermoregulation but do not require a humidity-controlled environment. The ME1 should only be used within healthcare settings providing neonatal and infant care, by properly trained personnel, as directed by an appropriately qualified attending physician familiar with current known risks and benefits of infant incubator use.

The mOm Essential Incubator provides a filtered air system creating a thermally controlled environment based on air temperature control. It provides incubation as well as a degree of isolation for infants who may be near others or being cared for in clinical areas. The incubator is designed to allow adequate visibility and access to the infant to deliver care.

The Infant Compartment is designed to be disassembled and packed into a compact unit for storage and transportation and must be assembled before use. It has been designed as a cost-effective alternative to traditional incubators.

The mOm Essential Incubator is made up of several key components and sub-assemblies, which are assembled by the user prior to use:

• The incubator base unit, which includes the device's electronics, fan, heating system, display and controls.
• A rigid front panel which contains a door and two portholes.
• A flexible panel that makes up the top and rear of the infant compartment – this includes an inflatable section and is supplied with a manual inflation bulb.
• A rigid top and back U-shaped panel which provide the structure for the top and rear of the infant compartment.
• Two side panels which form the ends of the infant compartment.

An infant mattress is supplied, which is inserted into the infant compartment. A skin temperature probe is also supplied. An optional cart (trolley) is available.

The provided 510(k) clearance letter pertains to the mOm Essential Incubator (ME1), a Class II medical device. It focuses on the device's technical specifications and comparison to a predicate device (Isolette® 8000 plus), as well as a range of non-clinical bench testing to demonstrate safety and effectiveness.

*Crucially, this document does not describe a study involving a test set, expert ground truth establishment, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study.

The "study" referenced in the provided text is a collection of non-clinical performance data and bench testing to demonstrate the device meets various safety and performance standards for neonatal incubators. It explicitly states: "Bench testing of the mOm Essential Incubator met all relevant requirements for neonatal incubators. Testing was performed in accordance with applicable standards, to characterize and evaluate the device, including performance testing, functional/operational testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components."

Therefore, I cannot populate the requested sections related to traditional "studies" with human readers, expert ground truth, or AI performance metrics, as this device is a physical medical device (an incubator) not a software-driven diagnostic or AI-powered system that would require such studies.

However, I can extract the acceptance criteria and the results of the non-clinical testing for critical device features based on the provided document.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Bench Testing)

The acceptance criteria for the mOm Essential Incubator (ME1) are largely aligned with international standards for medical electrical equipment and infant incubators (e.g., IEC 60601 series) and are demonstrated through direct comparison to the predicate device and specific non-clinical tests.

Ask a specific question about this device