(88 days)
The neoBLUE cozy phototherapy light is intended for the treatment for neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinet, an open crib, a warming table or an incubator. The neoBLUE cozy system can be used in a clinical setting or in the home.
The neoBLUE cozy system is a portable phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy system is designed to vrovide phototherapy treatment from underneath the baby. The neoBLUE cozy system must be used within a patient enclosure, such as a bassinett, an open crib, a warming tat hlast or incubator.
Blue LEDs emit light in the range of 400 -- 550 nm (peak wavelength 450-470 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. As with all phototherapy lights, protective eyeshades must 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 biomedical engineer can adjust the output of the LEDs using the potentiometer located behind the filter cover at the flat end of the light enclosure. The system is expected to operate at intensities above 30 uW/cm2/nm for approximately 3.000 hours.
The neoBLUE cozy system consists of five components: the neoBLUE cozy light source (light), the mattress, the disposable mattress cover, the bumper accessory, and the power supply.
This is a 510(k) premarket notification for a medical device called the "neoBLUE cozy LED Phototherapy System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than extensive clinical efficacy studies with predefined acceptance criteria in the same way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain explicit acceptance criteria and a study proving the device meets those criteria in the traditional sense of an AI/software efficacy study. Instead, it demonstrates that the new device is as safe and effective as already legally marketed predicate devices.
However, I can extract information related to the device's performance based on the comparison provided:
1. Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a 510(k) and not a clinical trial, "acceptance criteria" are not explicitly stated as performance metrics to be met by a study. Instead, the substantial equivalence is based on comparing the new device's features and specifications to those of predicate devices. The "reported device performance" are the specifications of the new device.
| Feature | Implied "Acceptance Criteria" (from Predicate) | Reported Device Performance (Natus neoBLUE cozy LED Phototherapy System) |
|---|---|---|
| Intended Use | For the treatment of neonatal hyperbilirubinemia | For the treatment of neonatal hyperbilirubinemia |
| Treatment Method | Underbaby phototherapy (Medela BiliBed) / Overhead phototherapy (Natus Blue Light) | Underbaby phototherapy |
| Targeted Population | Neonates | Neonates |
| Sites of Use | Clinical setting, home-use (Medela BiliBed) / Clinical setting (Natus Blue Light) | Clinical setting, home-use |
| Type of Light | Blue light fluorescent (Medela BiliBed) / Blue light (LED) (Natus Blue Light) | Blue light (LED) |
| Intensity | Approx. 40-60 µW/cm²/nm or more (Medela BiliBed) / 30-35 µW/cm²/nm (Natus Blue Light) | 30-35 µW/cm²/nm |
| Dimensions (Height) | 13.0 cm (5.1 in) (Medela BiliBed) |
§ 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).