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The DUO-LITE™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levels is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible.

The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White or Blue light which needs to be set up by an engineer in advance of the treatment. The DVO-LITE™ has combined these two light sources into one housing for the convenience of the caregiver.

The DUO-LITE™ Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.

The DUO-LITE" Phototherapy System provides light output for maximum absorption by the infant's skin in order to reduce bilirubin levels. The DUO-LITE™ is designed for use in conjunction with a variety of other products. Perhaps the most common application is when placed on the hood of an incubator, or fitted to a rail system and appitioned over the hood of the incubator. The DUO-LITT:" can also be mounted to a mobile stand, thus extending its applications to use with Open Warmers and Open Bassinets.

The product is L 23 x W 10 x H 5 (inches) and weighs approximately 15 Lbs. It is available in 100, 120 and 220/240V 50/60 Hz. The DUO-LITE™ is comprised of three 75W quartz halogen bulbs. The light emitted from these bulbs is filtered through IR/UV and Dichroic filters. The output of the bulbs is dependent on the driving voltage which is regulated by the internal power supply.

The user can select the use of White light or Blue light using the selector switch on the front of the lamp housing. The different color lights give different therapeutic outputs depending on the individual needs of the patient. Adjacent to the On/Off switch is a digital counter which can be set to display exposure time and bulb life remaining.

The DU1)-LIT!:" uses quartz halogen technology since the irradiance remains constant over the life of the bulb. By way of comparison, fluorescent bulbs degrade rapidly over the course of time and as such need to be continually monitored to ensure the output is therapeutically acceptable.

The provided text describes the Air-Shields Duo-Lite™ Phototherapy System, a medical device for treating neonatal hyperbilirubinemia. The submission is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a device meets novel acceptance criteria through a clinical study. Therefore, some of the requested information, such as sample size for test and training sets, number of experts for ground truth, adjudication methods, and MRMC studies, is not applicable to this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating that the device performs comparably to predicate devices in key specifications, rather than setting specific numerical thresholds for a novel device. The Duo-Lite™ compares its performance against several predicate devices. The critical performance metric highlighted is irradiance.

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