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510(k) Data Aggregation

    K Number
    K243268
    Device Name
    TipTraQ (TTQ001)
    Manufacturer
    PranaQ Pte. Ltd.
    Date Cleared
    2025-02-03

    (111 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K222579,K231355,K220028
    Why did this record match?
    Reference Devices :

    K222579, K231355

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

    The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.

    Device Description

    TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals.

    TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System.

    The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the TipTraQ (TTQ001) device, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: The document presents the performance results directly without explicitly stating the "acceptance criteria" as a separate, quantified threshold. However, for the SpO2 validation, it states "met the predefined acceptance criteria

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