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    K Number
    K110550
    Device Name
    BRIGHT EMBRACE MODEL SBL60
    Manufacturer
    PHYSICIAN ENGINEERED PRODUCTS, INC.
    Date Cleared
    2012-02-03

    (343 days)

    Product Code
    LBI
    Regulation Number
    880.5700
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K974830
    Why did this record match?
    Device Name :

    BRIGHT EMBRACE MODEL SBL60

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

    The Bright Embrace Model SBL60 phototherapy light is intended for the treatment of neonatal hyperbilirubinemia. It is designed to provide phototherapy treatment from underneath and around the neonate. The Bright Embrace can be used in a clinical setting or in the home.

    Device Description

    The Bright Embrace Model SBL60 is a single-patient, portable phototherapy light that was specifically designed to incorporate these features:

      1. high intensity blue light over a large body surface area as recommended by the American Academy of Pediatrics (AAP);
      1. the ability to hold the newborn during treatment;
      1. single patient use to minimize cross-contamination in hospitals and to facilitate home care logistics:

    The Bright Embrace Model SBL60 delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia, also called newborn jaundice. The Bright Embrace Model SBL60 is designed to provide phototherapy treatment from a wrap-around design that provides light from underneath, the sides and partially the front of the newborn to achieve a large body surface area of treatment.

    The blue LEDs used in the Bright Embrace Model SBL60 emit light in the range of 430-510nm (peak wavelength 480nm). This range corresponds to the spectral absorption of light by bilirubin, and is thus considered to be the most effective for the desirable degradation of bilirubin under the exposed skin. 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 newborn. As with most phototherapy devices, protective eye shades or goggles must be used to protect the newborn's eyes from excessive light exposure.

    AI/ML Overview

    The Bright Embrace Model SBL60 is a neonatal phototherapy light intended for the treatment of neonatal hyperbilirubinemia.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Irradiance
    Average irradiance ≥ 30 µW/cm²/nm (AAP recommended for "intense phototherapy")38 µW/cm²/nm (meets criteria)
    Light distribution (Ebi min / Ebi max) ≥ 0.4 (IEC 60601-2-50 standard)0.46 (meets criteria)
    Body Surface Area (BSA) Treatment
    > 20% BSA treated (desirable)28% BSA for normal-size newborn; 37% BSA for premie-size newborn (meets criteria)
    Thermal Safety
    No location touching newborn exceeds 40°C (IEC 60601-2-50 standard)Maximum temperature was 31.9°C (meets criteria)
    Environmental Storage Limits
    Device functional after storage at -5°C (23°F) and 60°C (140°F) at 90% rH for 60 daysDevice showed no visual defects, functioned normally, and irradiance readings were unchanged (meets criteria)
    Leakage Testing
    Qualified for Applied Parts Type CF (e.g., Patient leakage current
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