(266 days)
The IncuWarmer 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 through the use of radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including phototherapy capability, scale, and humidification. It is intended for in-patient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.
The IncuWarmer is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The IncuWarmer 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 IncuWarmer offers access to the infant by allowing the cargiver 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 tubular stainless steel infrared heaters that provide supplementary heat when the canopies and side panels are closed and primary heat when the canopies are opened or the over head arm is raised.
In addition to providing thermal support, the IncuWarmer is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. The IncuWarmer accessories are designed to operate with the IncuWarmer and consist of a humidification accessory, phototherapy accessory, and scale accessory for weighing the infant.
This document is a 510(k) summary for the IncuWarmer, an infant radiant warmer. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.
Therefore, the requested information cannot be extracted from the provided text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone (algorithm only) performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.