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510(k) Data Aggregation

    K Number
    K081659
    Device Name
    RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
    Manufacturer
    MASIMO CORPORATION
    Date Cleared
    2008-09-09

    (89 days)

    Product Code
    DQA,DPZ,JKS
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K080238,K071024
    Why did this record match?
    Device Name :

    RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L

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

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

    Device Description

    The Rainbow Adhesive Sensors are fully compatible disposable sensor for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow DCI and Direct Connect (Reusable) Sensors in the K080238 filing and the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing.

    The Rainbow Adhesive Sensors in this filing have the same intended use/indications for use and performance specifications as the Rainbow Reusable Sensors in the K080238 filing. However, The Rainbow Adhesive Sensors in this filing are similar in construction to the Rainbow Adhesive CO-Oximetry Sensors in the K071024 filing. The main difference is that the sensors in the K071024 filing have 8wavelengths and the sensors in this filing have 12-wavelengths.

    Similar to the 8-wavelength sensors in this filing include the emitter and detector assemblies connecting to the flex circuit, and an adhesive bandage to allow the sensor to be attached to the patient's finger, hand, foot or toe. Sensor sizing for use with adult, pediatric, infant, and neonatal patients are the same for the sensors in the K071024 and for the sensors in this filing. The patient-contact materials in the Rainbow Adhesive Sensors in this filing are the same that is used in the K071024 filing. Also similar to the sensors in the K071024 filing, the Rainbow Adhesive Sensors in this filing are supplied non-sterile for single patient use.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Rainbow Adhesive Pulse CO-Oximeter Sensors (K081659):

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Implied)Reported Device PerformancePatient Population
    SpO2 Accuracy (no motion/motion)
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