(294 days)
The BiliCocoon™ Phototherapy System is intended for the treatment of unconjugated hyperbilirubinemia in the population of neonates and infants under 3 months old and weighing less than 10kg. It can be used in the clinical setting or in the home.
The BiliCocoon™ Phototherapy System is a phototherapy system designed to treat unconjugated hyperbilirubinemia in newborns and infants under 3 months old and weighing less than 10kg. It is a phototherapy device, which emits light in the absorption spectrum of the bilirubin, from 430 to 490 nm. A custom optic directs light from the LEDs into the fiberoptic Pad. The system is composed of a blue light electronic generator - the Light Box - and of a light emitting fabric – the Pad – which transmits the blue light to the newborn. The Pad is provided in two versions: Bag Pad. The Light Box has a user interface to set the session time and inform the user about eventual errors. The other parameters of the therapy (irradiance level, light wavelength, etc.) are fixed.
The BiliCocoon™ Phototherapy System is used with the BiliCocoon™ Disposable, a non-woven disposable designed to fit the Pad which interfaces between the newborn. The disposable is the only part which contacts the newborn skin.
The BiliCocoon™ Phototherapy System can be fixed on the BiliCocoon™ Fixation system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the BiliCocoon™ Phototherapy System (K163526).
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily proving efficacy through a clinical trial. Therefore, the information provided primarily pertains to bench testing and comparison, rather than comprehensive clinical study data as might be expected for novel devices or PMAs.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for a specific statistical endpoint (e.g., accuracy, sensitivity, specificity) relevant to a diagnostic or AI-driven device. Instead, the "acceptance criteria" are implied by the performance of the predicate device and relevant industry standards. The "reported device performance" is largely described through a comparison against the predicate and adherence to safety and performance standards.
The closest equivalent to "acceptance criteria" for a phototherapy device would be its light output specifications and safety characteristics.
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (BiliCocoon™) |
|---|---|
| Light Characteristics | |
| Peak Emission Range | Blue LED Light with peak emission between 430 and 490 nm |
| Intensity (Irradiance) average | 30 - 40 µW/cm²/nm |
| Recommended by AAP for intensive phototherapy | Meets recommendation (>30 µW/cm²/nm) |
| Safety and Electrical | |
| Leakage Current |
§ 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).