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510(k) Data Aggregation

    K Number
    K240946
    Device Name
    Gastric Alimetry
    Manufacturer
    Alimetry Ltd.
    Date Cleared
    2024-07-03

    (89 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The Gastric Alimetry System is indicated for patients 12 years and older.
    Device Description
    The Gastric Alimetry System is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The device is used to acquire and digitize gastric myoelectrical data and movement artifacts using the Alimetry Reader connected to a single use Gastric Alimetry Array which includes electrodes on an adhesive patch used for recording the myoelectrical data from the skin surface. The Gastric Alimetry App runs on an iPad mini and is used to set up the device and capture patient-reported symptom data. The Gastric Alimetry Report is provided to the clinicians at the end of the test and includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array. The Alimetry Cloud acts as a secure website portal for physicians to access Gastric Alimetry Reports. The Gastric Alimetry Dock (Accessory) is used to guide alignment of the Array and Reader during the setup procedure and charge the Reader. The Gastric Alimetry System is non-invasive and used in healthcare facilities.
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    K Number
    K232925
    Device Name
    Gastric Alimetry System
    Manufacturer
    Alimetry Ltd.
    Date Cleared
    2023-11-17

    (59 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various qastric disorders.
    Device Description
    The Gastric Alimetry System is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The device is used to acquire and digitize gastric myoelectrical data and movement artifacts using an array with recording electrodes on an adhesive patch, which is used for recording the myoelectrical data from the skin surface. An App is used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the end of the test which includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array.
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    K Number
    K223398
    Device Name
    Gastric Alimetry System
    Manufacturer
    Alimetry Ltd.
    Date Cleared
    2023-04-27

    (170 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
    Device Description
    The Gastric Alimetry System is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The device is used to acquire and digitize gastric myoelectrical data and movement artifacts using an array with recording electrodes on an adhesive patch. which is used for recording the myoelectrical data from the skin surface. An App is used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the test which includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array. In the modified Gastric Alimetry System, the following minor updates are introduced in order to provide additional data summaries within the Report: - Addition of four post-processing data summary metrics: - Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range - 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI <35) - Gastric Alimetry Rhythm Index a calculated measure of the stability of the gastric о rhythm - fed:fasted Amplitude Ratio a calculated ratio showing the change in the gastric o myoelectrical amplitude after a meal stimulus. - Addition of a 'Symptom Burden' tracking bar to the front page of the Report. This is a ● calculated average of the patient-reported symptom data already shown in the Report, and is provided as a summary next to the spectral plot as a convenience for clinicians. - Addition of data tables to the Supplementary Report. These provide hour by hour read ● outs of the symptom logs and summary metrics provided in the main Report, and are made available in Table form as a convenient reference for clinicians. - Some minor Report rearrangements, with the 'signal strength' and 'best 8 channel' plots . moved from the main Report to the Supplementary Report. The four additional metrics are equivalent to other metrics widely applied in the EGG literature, and are included in the Reference Device, with only minor updates that address recognized inaccuracies that may affect performance.
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    K Number
    K213924
    Device Name
    Gastric Alimetry System
    Manufacturer
    Alimetry Ltd.
    Date Cleared
    2022-06-03

    (170 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
    Device Description
    The Gastric Alimetry is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The device is used to acquire and digitize the myoelectrical data and movement artifacts through an array with recording electrodes on an adhesive patch which is used for recording the myoelectrical data from the skin surface. An App used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the end of the test which displays myoelectrical data.
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    K Number
    K212954
    Device Name
    G-Tech Wireless Patch System (WPS)
    Manufacturer
    G-Tech Medical
    Date Cleared
    2022-01-10

    (116 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
    Device Description
    The G-Tech System is a non-invasive wireless gastrointestinal monitoring system for use by the physician or staff in the hospital setting, clinic, or physician's office. The device is intended for use while the patient is under direct supervision (e.g., in hospital or clinic) as well as after discharge to home or to intermediate setting. The device is for prescription use only. The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS application, a secure cloud storage server and computer-based data analysis algorithms. The G-Tech Patch is a single use, wearable electrode patch that reads the electrical signals of the gastrointestinal tract from the abdominal skin surface. The Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch Monitor. The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient interface to allow the patient to manual enter events such as meals, bowel movements, pain or the taking of medications. Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines. These measurements are made available to physicians for aid in clinical evaluation of their patient.
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    K Number
    K014269
    Device Name
    POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102
    Manufacturer
    MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S
    Date Cleared
    2002-11-21

    (329 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PolygrafID with POLYGRAM NET™ ElectroGastroGraphy Application is intended to record, store, process and view gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
    Device Description
    The system is a stationary electrogastrography system for use in the evaluation of gastrointestinal motility disorders. The system measures the myoelectrical activity of the gastrum using sensors situated on the skin. The parameters measured are presented on a computer screen during the capture and are also stored for later display, review, analysis and reporting.
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    K Number
    DEN990005
    Device Name
    THE 3PM EGG MACHINE
    Manufacturer
    3PM CO., INC.
    Date Cleared
    1999-08-20

    (39 days)

    Product Code
    MYE
    Regulation Number
    876.1735
    Why did this record match?
    Product Code :

    MYE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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