(76 days)
The Natus® Blue Light Phototherapy Unit is a floor-stand, mobile, phototherapy light intended for the treatment of neonatal hyperbilirubinemia. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. It emits a narrow band of blue light considered to be the most effective in the degradation of bilirubin.
The Natus Blue Light Phototherapy Unit is a floor-standing, mobile phototherapy device that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The device consists of a lightweight plastic light enclosure that can be tilted and adjusted both horizontally and vertically on a rollstand assembly. The light enclosure can be tilted to a maximum of approximately 40° up from horizontal (the resting position). The light enclosure height can be adjusted vertically along the rollstand post, as well as horizontally out from the rollstand post (proximity adjustment) to aid in positioning the device. A red target light can be briefly illuminated by the user, using a rocker switch on the front panel, to help position the device over the infant. The device can be used for infants in a bassinet, incubator, open bed, or radiant warmer. There are two intensity settings, high and low. The user selects the desired setting using a rocker switch on the front panel of the device. The light output is optimized to provide an average intensity of 35 uW/cm-/nm at the high setting and 15 uW/cm-/nm at the low setting at 30 cm (12 inches) distance from the baby. A diffuser panel provides a more uniform illumination pattern from the multiple LED light sources, and protects the user from viewing a single point source of light. The diffuser panel also protects the device from incidental debris or fluid exposure. Blue LEDs emit light in the range of 400 - 550 nm (peak wavelength 450-475 nm). This range corresponds to the spectral absorption of light by bilirubin. and is thus considered to be the most effective for the degradation of bilirubin. Blue LEDs do not emit significant energy in the ultraviolet (UV) region of the spectrum, so there is no concern about UV exposure to the infant. In addition, blue LEDs do not emit significant energy in the infrared (IR) region of the spectrum, so there is no concern about IR exposure and excessive warming of the infant. As with all phototherapy devices, protective eye shades should be used to protect the infant's eyes from excessive light exposure. LEDs have minimal light output degradation over their lifetime with proper use. Nevertheless, the user can adjust the output of the LEDs using two potentiometers located on the side of the light enclosure. Instructions for adjusting the output are included in the User Manual (see Appendix A). A drawing of the location of the location of the potentiometers is included in Appendix C. In normal operating conditions the device is expected to operate as specified approximately 10,000 hours at the low setting, and approximately 3,000 hours at the high setting. No pre-aging of the LEDs is required; the LEDs are 'burned in' at the factory. The Natus Blue Light device is mains-power operated. The power cord plugs into a receptacle at the power inlet at the back of the light enclosure. There are no single-use components or accessories for the Natus Blue Light Phototherapy device.
The Natus® Blue Light Phototherapy Unit is a medical device intended for the treatment of neonatal hyperbilirubinemia. The 510(k) summary provides details on the device's acceptance criteria and the non-clinical study conducted to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the device's performance specifications in comparison to a predicate device, the Olympic Bili-Lite™ Model 33. The acceptance criteria are implicitly derived from these performance specifications and safety standards.
| Feature | Acceptance Criteria (Natus Blue Light Phototherapy Unit) | Reported Device Performance (Natus Blue Light Phototherapy Unit) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | Meets intended use |
| Target Population | Neonates | Neonates |
| Sites of Use | Nursery, doctor's office, anywhere phototherapy is delivered | Nursery, doctor's office, anywhere phototherapy is delivered |
| Light Source Type | Light Emitting Diodes (LED) | Light Emitting Diodes (LED) |
| Light Source Number | Approx. 750 LEDs | Approx. 750 LEDs |
| Light Source Life | 10,000 hr (low setting); 3,000 hr (high setting) | Meets specification |
| Light Source Color | Blue | Blue |
| Wavelength | 400-550 nm, Peak @ 450-475 nm | Meets specification |
| Intensity (at 30 cm distance) | Low: 15 ± 2 μW/cm²/nm; High: 35 ± 3.5 μW/cm²/nm | Low: 15 μW/cm²/nm; High: 35 μW/cm²/nm (within tolerance) |
| Light Intensity Adjustment | High/Low switch adjusts between two levels of intensity | High/Low switch present |
| Operating Voltage | 85-264VAC | 85-264VAC |
| Overload Protection (fuses) | 2A @ 120V | 2A @ 120V |
| Current Leakage |
§ 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).