BiliWrap

The BiliWrap is a portable phototherapy system that treats neonatal jaundice (hyperbilirubinemia) in infants up to 3 months old and weighing less than 10 kg. It delivers narrow-band blue light (450-475 nm) via LEDs through a disposable pad that wraps around the infant's torso and legs, and can be used in hospitals or at home.

The BiliWrap differs from the predicate BiliTouch in several ways: it has a larger treatment surface area (1216 cm² vs 420 cm²) covering torso and legs in a 3D design rather than wrapping underneath; a slightly wider emission spectrum (450-475 nm vs 455-465 nm, both within AAP standards); preset run-time display rather than 30-minute increment controls; and AC/DC mains power only (no battery option). Both use blue LED light and disposable nonwoven pad covers.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-50, IEC 62304, IEC 62471, and ISO 10993-1. Bench testing included durability, light intensity, temperature, and alarm tests.

BiliWrap is substantially equivalent because it uses the same operating principle as BiliTouch—blue LED phototherapy to reduce bilirubin—for the identical patient population and indications. Design differences (larger treatment area, different wrap configuration, timer display, no battery) were evaluated through performance testing demonstrating equivalent safety and effectiveness. The slightly wider emission spectrum remains within AAP-recommended wavelengths (430-490 nm), and all differences were assessed to raise no new safety or effectiveness concerns.