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510(k) Data Aggregation

    K Number
    K230526
    Device Name
    TEA Device
    Manufacturer
    Transtimulation Research, Inc.
    Date Cleared
    2023-09-14

    (199 days)

    Product Code
    QHH
    Regulation Number
    876.5340
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K212377
    Why did this record match?
    Reference Devices :

    K212377

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

    The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.

    Device Description

    The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.

    AI/ML Overview

    The provided document describes the Transtimulation Research Inc.'s Transcutaneous Electrical Applicator (TEA) Device (Model: SNM-FDC01) and its substantial equivalence to a predicate device, the IB-Stim.

    The acceptance criteria are derived from the special controls for devices under 21 CFR 876.5340, as well as general performance requirements for medical devices. The study provided focuses on the clinical effectiveness of the device.

    Here's a breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance
    BiocompatibilityPatient-contacting components must be demonstrated to be biocompatible (ISO 10993-1, G95-1).Biocompatibility evaluation conducted (Cytotoxicity, Irritation tests). The TEA pads and Device were evaluated for skin contact for prolonged use (>24 hours to 30 days). Outcome: Testing demonstrated compliance.
    Electrical Safety & EMCElectromagnetic compatibility, electrical, mechanical, and thermal safety testing must be performed (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2).Electrical safety and EMC testing conducted. Outcome: The system complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 for safety and IEC 60601-1-2 for EMC.
    Battery SafetyBattery evaluation must be performed (IEC 62133-2).Battery evaluation conducted. Outcome: Compliance demonstrated to IEC 62133-2.
    Wireless/Radio TestingRadio and wireless testing (FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27).Compliance demonstrated to FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27 for radio and wireless testing. Outcome: Compliance demonstrated.
    Electrical PerformanceElectrical performance testing of the device and electrodes must be conducted to validate specified electrical output and duration of stimulation."The TEA Device and its components were tested to validate the safety and effectiveness of the device. The TEA Device has equivalent performance specifications when compared to the predicate device." "The Model SNM-FDC01 has been previously cleared under K212377 with the identical design and performance specification." Outcome: Implicitly satisfied through testing and previous clearance of a device with identical design/performance.
    Software Verification & ValidationSoftware verification, validation, and hazard analysis must be performed (FDA Guidance for Industry and FDA Staff).Software verification and validation testing conducted, documentation provided. Outcome: Software considered "moderate" level of concern and testing performed as per guidance satisfied requirements.
    Shelf LifeShelf-life testing of the electrode pad must be performed to demonstrate continued package integrity and device functionality over labeled shelf life.Shelf life of the TEA electrode pad demonstrated to be 2 years. Outcome: Satisfied.
    Clinical Efficacy (for Indication of Use)Reduction of functional abdominal pain and constipation associated with IBS.Complete Spontaneous Bowel Movements (CSBMs) per week: TEA group tripled (2.8 ± 2.2) vs. sham (0.9 ± 0.9), P
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