(143 days)
The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including humidification. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The Versalet™ 7700 Care Center offers access to the infant by allowing the caregiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two Calrod (Magnesium oxide encased in Incoloy sheath) heaters that provide heat when the canopies are opened or the over head arm is raised.
In addition to providing thermal support, the Versalet™ 7700 Care Center is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. A humidification accessory is designed to operate with the Versalet™ 7700 Care Center.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The provided text is a 510(k) summary for the Versalet™ 7700 Care Center, an infant incubator. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also includes the FDA's clearance letter.
However, it does not contain any information regarding:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Details of a study conducted to demonstrate the device meets any such criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for a training set was established.
The "Performance Standards: None applicable" section likely refers to the absence of specific FDA-mandated performance standards for this type of device at the time, not to the absence of internal performance testing by the manufacturer. However, the details of any such internal testing are not provided in this public summary.
§ 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).