(12 days)
The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present. The system is to be operated by trained medical technical personnel. Intended use of the modified (K022876) and predicate device ( K854065) are identical.
The "Infant Life Support Module - 20" is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring is usually present.
The provided text is an FDA 510(k) clearance letter for the "Infant Life Support Module-20," a neonatal transport incubator. While it mentions the device name, regulation information, and indications for use, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
- Information regarding a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- The type of ground truth used, training set sample size, or how ground truth for a training set was established.
This document is a regulatory approval letter, confirming the device's substantial equivalence to a predicate device, and thus permitting its marketing. It does not include the technical study details that would typically be found in a performance study report or a summary thereof.
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).