(91 days)
No
The description focuses on the light therapy mechanism and power options, with no mention of AI or ML capabilities.
Yes
The device is described as providing "therapeutic light" for the "treatment" of neonatal jaundice (hyperbilirubinemia).
No
This device is described as a treatment system for hyperbilirubinemia, not a diagnostic device. It provides therapeutic light to treat a condition, rather than identifying or assessing it.
No
The device description explicitly states it is a "battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel," indicating it is a hardware device with a light source.
Based on the provided information, the BiliBee LED Phototherapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- BiliBee's Function: The BiliBee LED Phototherapy System is a therapeutic device. It directly treats a condition (hyperbilirubinemia) by applying light to the infant's skin. It does not analyze any biological samples.
The description clearly states its purpose is "the treatment of infants diagnosed with hyperbilirubinemia" and describes how it applies light to the patient. This is a direct therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The intended use of the BiliBee LED Phototherapy System is the treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The system can be used with off-the-shelf AA battery pack for portability or an AC/DC regulated power supply. The BiliBee LED Phototherapy System can be used in a hospital or at home.
Product codes
LBI
Device Description
The BiliBee LED Phototherapy System is both a battery-operated device or AC/DC regulated power that provides therapeutic light through an LED illuminator panel for the treatment of neonatal jaundice (hyperbilirubinemia). Treatment is applied by placing the patient (neonate) on the BiliBee LED Phototherapy System panel with a disposable sheath separating the child from the panel's surface. The patient's eyes do not need to be covered during treatment. Treatment is intended to be applied 24 hours a day until the bilirubin levels have dropped sufficiently that the child no longer suffers from jaundice. Treatment time is expected to range from 3 days to 3 weeks. Phototherapy treatment of neonatal jaundice using the BiliBee LED Phototherapy System can be applied at home or in a hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infants
Intended User / Care Setting
hospital or at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Natus Medical, Inc. neoBLUE™ LED Phototherapy System (K022196), Respironics Wallaby®3 Phototherapy System (K991627), Medela, Inc. Bilibed® Phototherapy Unit (K984589)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Kφ72φ97(P.1 of 2)
OCT % 9 2007