LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040684
    Device Name
    T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303
    Manufacturer
    SPECTROS CORPORATION
    Date Cleared
    2004-11-05

    (234 days)

    Product Code
    MUD
    Regulation Number
    870.2700
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K023938,K001842,K991823,K011869,K002231,K915857
    Why did this record match?
    Device Name :

    T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

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

    The Spectros T-Stat™ 303 Microvascular The Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states.

    The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.

    Device Description

    The Spectros T-Stat™ 303 Tissue Oximeter is a broadband, multiwavelength, Visible Light Spectroscopy (VLS) monitoring system for measuring the saturation of hemoglobin with oxygen in the microvascular tissue spaces (StQ2%).

    The complete system consists of a disposable sensor probe connected to a software-driven electronic monitor. Data collection, analysis, and display functions are provided by the monitor. Illumination of the tissue is provided by a visible light source in the sensor probe placed near, on, or into the target tissue to be studied. Reflected light is captured and returned to the monitor via a detachable connection at the monitor end of the patient probe. StO2% is estimated using differential optical diffuse reflectance spectroscopy and fitting for background scattering over a range of reflected visible wavelengths.

    AI/ML Overview

    The Spectros T-Stat™ 303 Microvascular Tissue Oximeter's acceptance criteria are not explicitly stated in the provided text as numerical thresholds for performance metrics. Instead, the document describes the device's performance in comparison to predicate devices and previously published studies to establish substantial equivalence.

    Here's an analysis of the provided information, structured around your request:

    1. Table of Acceptance Criteria and Reported Device Performance

    As specific acceptance criteria (e.g., "accuracy must be > 90%") are not detailed, this table will reflect the comparative performance statements provided in the submission.

    Performance AspectAcceptance Criteria (Implied)Reported Device Performance
    Hemoglobin Spectra & Desaturation Binding CurvesAccurate measurementAccurately measured in peer-reviewed in vitro studies.
    Bias against NIRS Predicates (StO2%)Unbiased-1% ± 5% (p=N.S.) when compared to NIRS predicates.
    Range of Normal (StO2%)Tighter range than NIRS predicates62-75% for VLS vs. 48-88% for NIRS (p
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1