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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.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that the submission includes "the results of testing prototype devices to specifications." However, it does not specify the exact sample size (i.e., how many prototype devices were tested) or the data provenance (e.g., country of origin, retrospective or prospective nature of data collection). This information is not detailed in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The testing described is non-clinical and focuses on device specifications and safety standards, rather than clinical efficacy studies involving expert evaluation of patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable or not provided. The testing described is non-clinical and focuses on device specifications and compliance with standards. There is no mention of a human-based adjudication process for a test set in the context of clinical evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states that it includes "the results of testing prototype devices to specifications, spectral characterization of the blue LED light source, and an analysis of the potential optical radiation hazard." This is a non-clinical evaluation focused on substantial equivalence to a predicate device, not a comparative clinical effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable as the device described is a phototherapy unit, a physical medical device, not an AI-powered algorithm. The testing described is purely engineering and performance-based to ensure the device meets its specifications and safety standards.

7. The Type of Ground Truth Used:

The "ground truth" used for this device's evaluation is primarily based on engineering specifications, physical measurements, and compliance with established safety and performance standards. This includes:

• Spectral characterization of the blue LED light source.
• Measurements of light intensity, wavelength, operating voltage, current leakage, acoustic noise, temperature, and humidity.
• Verification of compliance with electrical, mechanical, thermal, and radiation safety standards (e.g., EN 60601-1, UL 2601-1).
• Assessment of physical design features and controls against the described specifications.

There is no mention of a clinical "ground truth" such as pathology, expert consensus on patient outcomes, or other clinical efficacy data because this was a non-clinical submission.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The Natus Blue Light Phototherapy Unit is a hardware device, not an algorithm that requires a training set. The "prototype devices" mentioned in the non-clinical testing are the subject of evaluation, not a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable. As stated above, this device is not an AI/algorithm that requires a training set. The "ground truth" for the device's performance relies on engineering principles, recognized standards, and direct physical measurements.

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