(113 days)
The neoBLUE® LED Phototherapy System is indicated for the treatment of hyperbilirubinemia for neonates and infants in a hospital environment, and administered by trained, professional medical staff, on the order of a licensed medical practitioner. The light can be used with a bassinet, incubator, open bed, or radiant warmer.
The neoBLUE® Phototherapy System consists of two products – the neoBLUE LED Phototherapy light source (light) and the neoBLUE LED Phototherapy roll stand.
The neoBLUE LED Phototherapy System is a floor-standing, mobile phototherapy light that delivers a narrow band of high-intensity blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The light can be used independently of the roll stand, and can be placed directly on an incubator with a flattopped surface.
This document describes the Natus Medical Incorporated neoBLUE® LED Phototherapy System (K160305).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present acceptance criteria in a tabular format with corresponding reported device performance metrics in the way one might see for an AI algorithm's diagnostic accuracy. Instead, the document focuses on compliance with established medical device standards and functional specifications for a phototherapy unit.
However, based on the non-clinical testing section, the implicit acceptance criteria are compliance with relevant safety and performance standards for medical electrical equipment and phototherapy devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-2-50:2009-03 Edition 2 (Infant Phototherapy Equipment) | Passed all testing and complies. |
| IEC 60601-1:2005/(R)2012 and C1:2009/(R)2012 (General Requirements for Basic Safety) | Passed all testing and complies. |
| IEC 60601-1-2: 2007/(R)2012 (Electromagnetic Compatibility) | Passed all testing and complies. |
| IEC 60601-1-6:2013-10 Edition 3.1 (Usability) | Passed all testing and complies. |
| Performance Specifications | |
| Intensity Setting (High) | 35 µW/cm²/nm at 12 inches (30.5 cm) |
| Intensity Setting (Low) | 15 µW/cm²/nm at 12 inches (30.5 cm) |
| Light Emission Spectrum | Blue LEDs emit 400-550 nm (peak 450-475 nm) |
| Non-significant UV/IR emission | Reduce risk of skin damage and excessive warming |
| Equivalence to Predicate Device | |
| Therapeutic Output | Same as predicate (K022196) |
| Functional Design Considerations | Separation of light source from roll stand for independent use; addition of timer for LED working hours |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a phototherapy system and not a diagnostic AI algorithm that relies on a "test set" of patient data for performance evaluation in the typical sense. The testing performed was for compliance with electrical, safety, and performance standards, and for demonstrating substantial equivalence to a predicate device through engineering and design validation. The provenance in this context would refer to internal validation procedures and results.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This is not applicable. The device's performance is not evaluated against a "ground truth" derived from expert consensus on patient data. Instead, it is evaluated against established engineering specifications, safety standards, and functional requirements.
4. Adjudication Method
This is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment where discrepancies need to be resolved (e.g., in clinical trials or diagnostic accuracy studies involving multiple readers). This document describes the regulatory clearance of a medical device based on compliance with standards and functional testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The neoBLUE® LED Phototherapy System is a treatment device, not a diagnostic AI tool intended to assist human readers in interpreting medical images or data. Therefore, an MRMC study related to reader performance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a standalone phototherapy unit; it is not an algorithm, and its function does not involve human interpretation of its output in the way an AI diagnostic tool would.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with recognized international and national standards for medical electrical equipment and infant phototherapy.
- Engineering specifications for light intensity, wavelength, and safety.
- Demonstration of substantial equivalence to a legally marketed predicate device (K022196 Natus Blue Light Phototherapy Unit) in terms of intended use, operating principles, and therapeutic output.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm that undergoes a "training" phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable.
§ 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).