(212 days)
BT-400 is the Phototherapy unit intended for the treatment of Neonatal Hyperbilirubinemia caused by Indirect Hyperbilirubinemia.
BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spectrum to treat Neonatal Jaundice to use in Bassinets, Incubators, Open beds or Radiant warmer and consists of Head ( Light Source ) Control box with LCD window Roll Stand ( optional)
This document describes the premarket notification (510(k)) for the BT-400 Neonatal Phototherapy device. It compares the device to a predicate device, the BILI-THERAPY Spot type (K103828), to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the sense of predefined thresholds for a study outcome. Instead, it compares the proposed device's performance to that of a legally marketed predicate device to demonstrate substantial equivalence. The "acceptance criteria" here are implied to be that the proposed device performs comparably to or better than the predicate device across key technical and functional characteristics.
| Characteristic | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (BT-400) | Predicate Device Performance (BILI-THERAPY Spot type K103828) |
|---|---|---|---|
| Light Source | Blue LEDs | Blue LEDs | Blue LEDs |
| Wavelength | Peak 450-475nm | Peak 450-475nm | Peak 450-475nm |
| Intensity | 30-40 uW/cm² at 30cm distance | 30-45 uW/cm² at 30cm distance | 30-40 uW/cm² at 30cm distance |
| Variation in intensity in 6 hrs | ±10% in Illumination area | ±10% in Illumination area | Identical |
| Effective Surface | 30x20cm | 40x20cm | 30x20cm |
| Head output over 6 hrs |
§ 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).