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510(k) Data Aggregation

    K Number
    K162234
    Device Name
    Truscope Ultra Patient Monitor
    Manufacturer
    GUANGDONG BIOLIGHT MEDITECH CO., LTD.
    Date Cleared
    2017-01-04

    (148 days)

    Product Code
    MWI
    Regulation Number
    870.2300
    Type
    Special
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Truscope Ultra Patient Monitor

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

    Truscope Ultra Patient monitors are intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate (HR), Respiration Rate (RESP), Temperature (TEMP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Carbon dioxide (CO2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Cerebral Index (CSI), Bispectral Index (BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin (SpCO), Methemoglobin(SpMet).

    The arrhythmia detection. ST segment analysis only applied to a single adult patient.

    The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physician. It is not intended for helicopter transport, hospital ambulance, or home use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the "Truscope Ultra Patient Monitors". It primarily addresses the substantial equivalence determination for the device and its intended use. It does not contain information about acceptance criteria or specific study data to prove device performance.

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
    4. Adjudication method for the test set
    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
    6. If a standalone performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    This document is an administrative approval from the FDA, confirming that the device is substantially equivalent to a predicate device, and lists its general indications for use. It does not delve into the detailed technical studies or performance data that would typically be reviewed during the 510(k) submission process itself.

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