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510(k) Data Aggregation

    K Number
    K100403
    Device Name
    MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
    Manufacturer
    MASIMO CORPORATION
    Date Cleared
    2010-06-23

    (127 days)

    Product Code
    DQA
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K091057
    Why did this record match?
    Reference Devices :

    K091057

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

    The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO₂), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).

    Device Description

    The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.

    AI/ML Overview

    Here's an analysis of the acceptance criteria and study details for the Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories, based on the provided text:

    Acceptance Criteria and Device Performance

    ParameterAcceptance Criteria (Specification)Reported Device Performance (Clinical Results)
    SpO2 Accuracy (Adults and Pediatrics > 30kg)70-100% ± 2%30kg)**
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