(146 days)
For the treatment of Neonatal Hyperbilirubinemia.
The Olympic Bili-Bassinet has three phototherapy fixtures built into a bassinet.
The two identical overhead fixtures swing and lock in their up position. They are mounted on counter-balanced arms. Thier storage position is recessed into the sides of the bassinet.
The phototherapy pad is a pad/mattress, which is transparent to light. Unlike a fiberoptic pad, which used plastic optical fibers within the pad to transmit the light from the remote light box, the Bili-Bassinet light box is below the pad/mattress and shines through the pad.
All fixtures use conventional blue (type "B") fluorescent phototherapy lamps. "Daylight" and high-intensity (type BB) fluorescent lights are available for use in the overhead fixtures.
The provided document describes the Olympic Bili-Bassinet, a device intended for the treatment of Neonatal Hyperbilirubinemia using phototherapy. The submission aims to establish substantial equivalence to predicate devices rather than proving novel effectiveness. Therefore, the "acceptance criteria" discussed here relate to safety and performance specifications relative to established standards and the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate/standards) | Reported Device Performance (Olympic Bili-Bassinet) | Study/Section Proving Criterion Met |
|---|---|---|
| Electrical Safety | ||
| Ground Impedance |
§ 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).