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510(k) Data Aggregation
K Number
K240946Device Name
Gastric Alimetry
Manufacturer
Alimetry Ltd.
Date Cleared
2024-07-03
(89 days)
Product Code
MYE
Regulation Number
876.1735Why did this record match?
Applicant Name (Manufacturer) :
Alimetry Ltd.
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
K232925Device Name
Gastric Alimetry System
Manufacturer
Alimetry Ltd.
Date Cleared
2023-11-17
(59 days)
Product Code
MYE
Regulation Number
876.1735Why did this record match?
Applicant Name (Manufacturer) :
Alimetry Ltd.
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
K223398Device Name
Gastric Alimetry System
Manufacturer
Alimetry Ltd.
Date Cleared
2023-04-27
(170 days)
Product Code
MYE
Regulation Number
876.1735Why did this record match?
Applicant Name (Manufacturer) :
Alimetry Ltd.
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
K213924Device Name
Gastric Alimetry System
Manufacturer
Alimetry Ltd.
Date Cleared
2022-06-03
(170 days)
Product Code
MYE
Regulation Number
876.1735Why did this record match?
Applicant Name (Manufacturer) :
Alimetry Ltd.
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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