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510(k) Data Aggregation

    K Number
    K051572
    Device Name
    KOKO LEGEND
    Manufacturer
    PULMONARY DATA SERVICES, INC.
    Date Cleared
    2005-11-17

    (156 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K831779,K914272,K022276
    Why did this record match?
    Device Name :

    KOKO LEGEND

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

    The KoKo LEGEND is intended to be used for diagnostic use in the pulmonary function testing (PFT) with an intended use and indication for use as a configurable, non-invasive pulmonary function tester (PFT) testing system. The KoKo LEGEND is indicated for use in: pulmonary function testing.

    The KoKo LEGEND (Diagnostic Spirometer) is an Office Spirometer. It is intended as a configurable, portable, noninvasive pulmonary function tester (PFT) system. These tests are suitable for both pediatric and adult patient testing.

    Device Description

    The KoKo LEGEND is a configurable, non-invasive pulmonary function tester (PFT) testing system. It is a diagnostic spirometer.

    AI/ML Overview

    The provided text is a 510(k) summary for the KoKo LEGEND Diagnostic Spirometer and does not contain detailed information about a specific study testing the device's performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

    Instead, it declares conformity to recognized standards and lists technical specifications, which implicitly serve as acceptance criteria for a diagnostic spirometer.

    Here's an analysis based on the information available:

    1. A table of acceptance criteria and the reported device performance

    For a diagnostic spirometer, the "acceptance criteria" are primarily established by recognized performance standards. The device's "reported performance" is its technical specifications, which are implicitly stated to meet these standards.

    Acceptance Criteria (from ATS Standardization of Spirometry 1994 Update)Reported Device Performance (KoKo LEGEND)
    Appropriately calibrated (e.g., with a 3-liter syringe)3-liter calibration syringe
    Resistance
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