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510(k) Data Aggregation

    K Number
    K071024
    Device Name
    MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
    Manufacturer
    MASIMO CORPORATION
    Date Cleared
    2007-06-29

    (79 days)

    Product Code
    DQA,JKS
    Regulation Number
    870.2700
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K063140
    Why did this record match?
    Device Name :

    MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS

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

    The Rainbow Adhesive Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin (SpCO), and/or methemoglobin (SpMet) saturation. The Rainbow Achesive Sensors are indicated for use with adult, pediatric, and neonatal patients during both no motion and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.

    Device Description

    The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI-DC CO-Oximetry Sensors.

    The Rainbow Adhesive Sensors are similar in the predicate devices except for a recessed emitter. The emitter and detector assemblies are connected to the sensors have an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. The same emitters (with 8 wavelengths) are used in Rainbow Adhesive Sensors. Four sizes of Rainbow Adhesive Sensors are available for use with adult, pediatric, infant and neonatal patients. The four sensors are essentially identical except for the emitter and detector spacing and size and orientation of the patient contacting materials in the Rainbow Adhesive Sensors are the same that is used in Masimo's LNCS and LNOP single use sensor lines. The Rainbow Adhesive Sensors are supplied non-sterile for single patient use.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    ParameterAcceptance Criteria (Stated or Implied)Reported Device Performance
    SpO2 Accuracy (Adult, Pediatric, Infant)
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