(238 days)
The BiliLux phototherapy light is designed to reduce the serum bilirubin concentration in premature babies and neonates with unconjugated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
The device BiliLux is a configurable LED phototherapy light designed to reduce serum bilirubin concentration in premature babies and neonates with unconjuqated hyperbilirubinemia by means of phototherapeutic radiation. It is intended for use with patients up to 3 months of age who weigh less than 10 kg (22 lb).
The phototherapy light houses the 20 blue lights that provide therapy as well as 2 white lights used for observation. The blue light of the phototherapy light lies within the wavelength range of 460 nm to 490 nm. The front panel has a display screen and keys to control functions and change settings. There are five intensity settings (20%, 60% 80% and 100% of nominal intensity). On the user interface, the user can see session time and any software errors that may occur.
The BiliLux phototherapy light can be placed directly on an incubator hood or be combined with a spring arm and trolley. An optional radiometer is also available to measure the phototherapeutic effective irradiance produced by the phototherapy light.
The provided document is a 510(k) premarket notification for the BiliLux® Phototherapy Light. It describes the device, its intended use, and a comparison to a predicate device (NanoBlu™ 500).
However, the document explicitly states:
- "No clinical testing was performed."
- The discussion focuses on "Non-Clinical Studies," specifically bench testing and adherence to standards.
This means that there are no acceptance criteria, performance data, or studies related to clinical effectiveness or comparison with human readers as typically found in AI/ML device submissions. The document focuses on demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of an AI/ML device, as this device is a phototherapy light and was not evaluated based on AI/ML performance.
If this was a misunderstanding and you were looking for information about a different type of device or performance evaluation, please provide a different document.
§ 880.5700 Neonatal phototherapy unit.
(a)
Identification. A neonatal phototherapy unit is a device used to treat or prevent hyperbilirubinemia (elevated serum bilirubin level). The device consists of one or more lamps that emit a specific spectral band of light, under which an infant is placed for therapy. This generic type of device may include supports for the patient and equipment and component parts.(b)
Classification. Class II (performance standards).