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    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
    Predicate For
    K081659
    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)< 2% SpO2 Arms in the range of 70%-100% SaO2 < 3% SpO2 Arms in the range of 60%-80% SaO2Less than 2% SpO2 Arms in the range of 70%-100% SaO2 and less than 3% SpO2 Arms in the range of 60%-80% SaO2
    SpO2 Accuracy (Neonatal)< 3% SpO2 Arms in the range of 70%-100% SaO2Less than 3% SpO2 Arms in the range of 70%-100% SaO2
    SpCO Accuracy< 3% SpCO Arms in the range of 1%-40% SaCOLess than 3% SpCO Arms in the range of 1%-40% SaCO
    SpMet Accuracy< 1% SpMet Arms in the range of 1%-15% SaMetLess than 1% SpMet Arms in the range of 1%-15% SaMet
    SpMet Accuracy (Neonatal)< 1% SpMet Arms in the range of 0%-2.5% SaMetLess than 1% SpMet Arms in the range of 0%-2.5% SaMet
    BiocompatibilityPatient contacting materials are non-toxic, non-irritating, and non-sensitizing.Test results demonstrated that the materials were non-toxic, non-irritating, and non-sensitizing.
    Environmental TestingApplicable electrical, mechanical, and environmental tests passed per Reviewers Guidance for Premarket Submissions - November 1993.All applicable tests (electrical, mechanical, environmental) performed and passed.

    2. Sample Size Used for the Test Set and Data Provenance:

    • SpO2 (Adult, Pediatric, Infant): "healthy adult volunteer subjects" - The specific sample size is not stated, but the study was prospective. Not explicitly stated, but the study implies a laboratory setting for induced hypoxia.
    • SpO2 (Neonatal): "hospitalized neonatal patients" - The specific sample size is not stated, but the study was prospective (clinical study).
    • SpCO & SpMet (Adult): "healthy adult volunteers" - The specific sample size is not stated, but the study was prospective (human blood studies).
    • SpMet (Neonatal): "hospitalized neonatal patients" - The specific sample size is not stated, but the study was prospective (clinical study).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

    The document does not provide details on the number or qualifications of experts used to establish ground truth.

    4. Adjudication Method for the Test Set:

    Not applicable. The ground truth was established through objective laboratory measurements (CO-Oximeter blood samples) rather than expert consensus on subjective interpretations.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    A MRMC comparative effectiveness study was not explicitly mentioned or performed. The study focuses on the device's accuracy against a reference standard, not its impact on human readers' performance with or without AI assistance.

    6. Standalone Performance (Algorithm only without human-in-the-loop performance):

    Yes, the studies described are for standalone performance. The device's accuracy (SpO2, SpCO, SpMet) is measured directly against a reference standard (arterial blood samples analyzed by a CO-Oximeter), without human interpretation of the device's output influencing the ground truth comparison.

    7. Type of Ground Truth Used:

    • **SpO2,
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