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510(k) Data Aggregation

    K Number
    K072097
    Device Name
    BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1
    Manufacturer
    MEDICAL SELECT, INC.
    Date Cleared
    2007-10-30

    (91 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K022196,K991627,K984589
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL SELECT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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.

    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.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) summary for a medical device (Bilibee LED Phototherapy System), which primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's description and intended use.

    Specifically, the document does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about a study proving the device meets specific performance criteria.
    • Information on sample sizes for test sets or training sets.
    • Data provenance, details about experts, adjudication methods, MRMC studies, or standalone performance.
    • The type of ground truth used or how it was established.

    The document states that the device "does not raise any new safety concerns" because it uses the "same operating principle of delivery of light to degrade bilirubin" as its predicate devices. This implies that the performance aspects related to light output are expected to be similar or equivalent to established standards for phototherapy devices, but no specific performance study results, acceptance criteria, or statistical analyses are presented in this summary.

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