Gastric Alimetry System
Device Facts
| Record ID | K223398 |
|---|---|
| Device Name | Gastric Alimetry System |
| Applicant | Alimetry , Ltd. |
| Product Code | MYE · Gastroenterology, Urology |
| Decision Date | Apr 27, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1735 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K223398 · Apr 27, 2023 | Gastric Alimetry System | Alimetry , Ltd. | Post-market clinical study data | The sponsor used a retrospective analysis of post-market data from 86 subjects to demonstrate that four new software metrics in the modified device are highly correlated with equivalent metrics from a reference device. | Post-market data; Software validation; Comparative analysis |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Retrospective comparative analysis | 43 patients with chronic nausea and vomiting syndromes, gastroparesis, and functional dyspepsia, and 43 healthy matched controls; Sample Size: 86 | Reference Device (Medtronic Polygram NET EGG System) | Correlation of four post-processing data summary metrics (Principal Gastric Frequency, BMI-Adjusted Amplitude, Gastric Alimetry Rhythm Index, fed:fasted Amplitude Ratio) |
Indications for 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 Story
Gastric Alimetry is a non-invasive electrogastrography (EGG) system. It uses a 64-channel electrode array patch on the abdomen to record gastric myoelectrical activity and an accelerometer to track motion artifacts. A tablet app manages device setup, patient-reported symptom logging, and data acquisition. Data is processed to generate clinical reports containing myoelectrical signal waveforms, spectral plots, and computed metrics (Principal Gastric Frequency, BMI-Adjusted Amplitude, Rhythm Index, fed:fasted Amplitude Ratio). Clinicians use these outputs to assess gastric rhythm stability and myoelectrical response to meals, aiding in the diagnosis of gastric disorders like gastroparesis and functional dyspepsia. The system is intended for use by medical professionals in clinical settings.
Clinical Evidence
Performance testing utilized post-market data from 86 subjects (43 patients with chronic nausea/vomiting, gastroparesis, or functional dyspepsia; 43 healthy controls). The four new data summary metrics were compared against equivalent metrics from the reference device (Medtronic Polygram NET). Results showed high correlations (r>0.91; p<0.0001) for all four metrics, confirming substantial equivalence.
Technological Characteristics
EGG system; 64-channel disposable adhesive electrode array (ANSI/AAMI EC12:2000 compliant); 4 Hz sampling frequency; DC-2 Hz frequency range; accelerometer for motion sensing; battery-powered; tablet-based app for control/display; cloud and local data storage. Software performs automated spectral analysis via Fourier-transform and noise detection. Non-sterile; reader/dock reprocessed via wipes.
Indications for Use
Indicated for patients 18 years and older with suspected gastric disorders to aid in diagnosis via recording and processing of gastric myoelectrical activity.
Regulatory Classification
Identification
An electrogastrography system (EGG) is a device used to measure gastric myoelectrical activity as an aid in the diagnosis of gastric motility disorders. The device system includes the external recorder, amplifier, skin electrodes, strip chart, cables, analytical software, and other accessories.
Special Controls
*Classification.* Class II (Special Controls). The special controls are as follows:(1) The sale, distribution and use of this device are restricted to prescription use in accordance with § 801.109 of this chapter. (2) The labeling must include specific instructions: (i) To describe proper patient set-up prior to the start of the test, including the proper placement of electrodes; (ii) To describe how background data should be gathered and used to eliminate artifact in the data signal; (iii) To describe the test protocol (including the measurement of baseline data) that may be followed to obtain the EGG signal; and (iv) To explain how data results may be interpreted. (3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal. (4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.
In addition to the general controls of the act, the 3CPM EGG Machine is subject to the following special controls: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include specific instructions (a) to describe proper patient set-up prior to the start of the test, including the proper placement of electrodes; (b) to describe how background data should be gathered and used to eliminate artifact in the data signal; (c) to describe the test protocol (including the measurement of baseline data) which may be followed to obtain the EGG signal; and (d) to explain how data results may be interpreted. (3) The device design should ensure that the EGG signal is distinguishable from background noise that may interfere with the true gastric myoelectric signal. (4) Data should be collected to demonstrate that the device has adequate precision and the EGG signal is reproducible and is interpretable.
Predicate Devices
- Gastric Alimetry (K213924)
Reference Devices
- Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269)
Submission Summary (Full Text)
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April 27, 2023
Alimetry Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19115
Re: K223398
Trade/Device Name: Gastric Alimetry Regulation Number: 21 CFR§ 876.1735 Regulation Name: Electrogastrography System Regulatory Class: II Product Code: MYE Dated: March 27, 2023 Received: March 27, 2023
Dear Janice Hogan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K223398
Device Name Gastric Alimetry
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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#### 510(k) SUMMARY Alimetry's Gastric Alimetry
#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Alimetry Ltd.
Phone: +64 27 609 1886 Facsimile: -Contact Person: Yaara Yarmut, Chief Regulatory Officer. Date Prepared: November 8, 2022
#### Name of Device and Name/Address of Sponsor
Trade Name: Gastric Alimetry
Manufacturer: Alimetry
Address: 70 Symonds St. Grafton Auckland 1010 New Zealand
Common Name: Gastric Alimetry System
#### Classification Name:
Electrogastrography system, 21 CFR 876.1735, Product code: MYE
Class II
#### Predicate and Reference Devices
- 1. Trade Name: Gastric Alimetry (K213924) (primary predicate) Manufacturer: Alimetry Ltd.
- 2. Trade Name: Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269) (reference device) Manufacturer: Medtronic A/S
#### Intended Use / Indications for Use
The Gastric Alimetry 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.
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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.
### Technological Characteristics / Substantial Equivalence
The Gastric Alimetry device has the same intended use and indications for use and technological characteristics as the primary predicate. Both devices are intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
| Item | Subject Device | Primary Predicate Device | Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Gastric Alimetry System | Gastric Alimetry System | |
| Manufacturer / K# | Alimetry Ltd. | Alimetry Ltd. / K213924 | |
| Item | Subject Device | Primary Predicate Device | Discussion |
| Intended Use and<br>indication for use | To record, store, view and<br>process gastric myoelectrical<br>activity as an aid to the<br>diagnosis of various gastric<br>disorders. | To record, store, view and<br>process gastric myoelectrical<br>activity as an aid to the<br>diagnosis of various gastric<br>disorders. | Same as the predicate. |
| User Population | Medical professionals to set up<br>and use the system<br>Patients 18 years and older<br>Specialist GI physicians | Medical professionals to set up<br>and use the system<br>Patients 18 years and older<br>Specialist GI physicians | Same as the predicate. |
| Accessories | | | |
| Setup and<br>Charging Dock | Gastric Alimetry Dock for<br>charging and user convenience | Gastric Alimetry Dock for<br>charging and user convenience | Same as the predicate. |
| Electrodes | Disposable; same components<br>as ECG electrodes.<br>Peel-and-stick patch. | Disposable; same components<br>as ECG electrodes.<br>Peel-and-stick patch. | Same as the predicate. |
| Technological Characteristics | | | |
| Sampling<br>Frequency | 4 Hz | 4 Hz | Same as the predicate. |
| Low Frequency<br>Range | DC | DC | Same as the predicate. |
| High frequency<br>range | 2 Hz | 2 Hz | Same as the predicate. |
| Number of<br>channels | 64 (+2 reference) | 64 (+2 reference) | Same as the predicate. |
| Electrode to<br>recorder interface | Reader located on the Array and<br>directly connected to it. | Reader located on the Array and<br>directly connected to it. | Same as the predicate. |
| Screen | Dedicated tablet for system<br>operation | Dedicated tablet for system<br>operation | Same as the predicate. |
| Motion Sensor | Accelerometer | Accelerometer | Same as the predicate. |
| Data Storage | On data acquisition device and<br>cloud server | On data acquisition device and<br>cloud server | Same as the predicate. |
| Weight of device<br>on patient | 225 grams – Reader and Array | 225 grams – Reader and Array | Same as the predicate. |
| ltem | Subject Device | Primary Predicate Device | Discussion |
| Power Source | Battery powered | Battery powered | Same as the predicate. |
| Software | Setup (including clinical data),<br>device control, data acquisition<br>software and system checks via<br>App running on a tablet. | Setup (including clinical data),<br>device control, data acquisition<br>software and system checks via<br>App running on a tablet. | Same as the predicate. |
| Patient Symptom<br>Logging | Available on App interface.<br>Presented as plot with times. | Available on App interface.<br>Presented as plot with times. | Same as the predicate. |
| Skin Preparation | Yes. Shave, measure, skin prep<br>with abrasive conductive gel<br>Additional array template<br>marking step for convenience. | Yes. Shave, measure, skin prep<br>with abrasive conductive gel<br>Additional array template<br>marking step for convenience. | Same as the predicate. |
| Sterilization | Electrodes are disposable, non-<br>sterile.<br>Reader and Dock are<br>reprocessed, not supplied<br>sterile. Cleaning and disinfection<br>instructions using wipes<br>provided. | Electrodes are disposable, non-<br>sterile.<br>Reader and Dock are<br>reprocessed, not supplied<br>sterile. Cleaning and disinfection<br>instructions using wipes<br>provided. | Same as the predicate. |
| Safety Features | | | |
| System Checks | Impedance monitor and<br>connectivity check displayed<br>prior to recordings. | Impedance monitor and<br>connectivity check displayed<br>prior to recordings. | Same as the predicate. |
| Instructions to<br>Patient | Yes. User instructs patient to<br>limit movement, talking and<br>sleeping.<br>Additional step of displaying<br>these instructions to patient via<br>App as an added safety<br>measure. | Yes. User instructs patient to<br>limit movement, talking and<br>sleeping.<br>Additional step of displaying<br>these instructions to patient via<br>App as an added safety<br>measure. | Same as the predicate. |
| Reporting Features | | | |
| Visualization of<br>myoelectrical<br>waveforms | Yes, all channels. | Yes, all channels. | Same as the predicate. |
| Automated<br>Spectral Analysis | Yes, by Fourier-transform | Yes, by Fourier-transform | Same as the predicate. |
| Item | Subject Device | Primary Predicate Device | Discussion |
| Artifact<br>Evaluation | By manual identification of noise<br>in waveforms and with reference<br>to motion sensor.<br><br>Additionally provides automated<br>noise detection for convenience. | By manual identification of noise<br>in waveforms and with reference<br>to motion sensor.<br><br>Additionally provides automated<br>noise detection for convenience. | Same as the predicate. |
| Dominant<br>Frequency and<br>Amplitude of<br>Myoelectrical<br>Activity | Yes, data tables, and<br>visualization by spectral graphs<br>and myoelectrical waveforms. | Yes, data tables, and<br>visualization by spectral graphs<br>and myoelectrical waveforms. | Same as the predicate. |
| Other<br>Myoelectrical<br>Parameters | Measures of % time in<br>frequency ranges, changes in<br>signal power over time, and<br>cross-channel coupling (wave<br>propagation across the<br>stomach) are available by visual<br>inspection of spectral maps and<br>waveforms.<br><br>Additionally processes these<br>outputs as tables for<br>convenience. | Measures of % time in<br>frequency ranges, changes in<br>signal power over time, and<br>cross-channel coupling (wave<br>propagation across the<br>stomach) are available by visual<br>inspection of spectral maps and<br>waveforms.<br><br>No additional processing of<br>these metrics. | Equivalent. Same plots<br>available for visual<br>inspection as the<br>predicate. Additional<br>spectral metric outputs<br>equivalent to<br>technological<br>reference.<br><br>See substantial<br>equivalence<br>discussion. |
| Symptom<br>Outputs | Yes. Arranged in time plots for<br>convenience. | Yes. Arranged in time plots for<br>convenience | Same as the predicate. |
| Technical /<br>recording quality<br>outputs | Yes. Impedance, motion.<br><br>Additionally shows Array<br>position and spatial distribution<br>of amplitude for user<br>convenience. | Yes. Impedance, motion.<br><br>Additionally shows Array<br>position and spatial distribution<br>of amplitude for user<br>convenience. | Same as the predicate. |
| Standards with which the Device Complies | | | |
| Electrodes | ANSI/AAMI EC12:2000 –<br>compliance with relevant<br>requirements. | ANSI/AAMI EC12:2000 –<br>compliance with relevant<br>requirements. | Same as the predicate. |
| Medical Electrical<br>Equipment | IEC 60601-1 | IEC 60601-1 | Same as the predicate. |
| Electromagnetic<br>Compatibility | IEC 60601-1-2 | IEC 60601-1-2 | Same as the predicate. |
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## Performance Data
The four data summary metrics included in the modified Gastric Alimetry System are technically equivalent to those used in the Reference Device (Medtronic Polygram NET EGG
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System). Minor technical updates were made to the four metrics to address issues that have been recognized to affect the performance of these metrics in the vears since the Reference Device was approved. Therefore, additional performance testing was conducted to confirm that substantial equivalence was maintained as compared to the Reference Device.
These analyses were performed using post-market data from a study of 86 subjects, being 43 patients with chronic nausea and vomiting syndromes, gastroparesis, and functional dyspepsia, and 43 healthy matched controls. Each of the four metrics included in the modified Gastric Alimetry System were subjected to direct comparison with the equivalent Reference Device metrics, using this comparison cohort. In all four comparisons, high correlations were demonstrated (r>0.91; p<0.0001), confirming the substantial equivalence of all metrics.
#### Substantial Equivalence
The modified Gastric Alimetry System has the same intended uses and the same indications, technological characteristics, and principles of operation as its predicate device, the Gastric Alimetry System. The minor technological differences between the Gastric Alimetry and its predicate devices do not raise different questions of safety or effectiveness. In addition, performance testing based on post-market data analysis in patients with various gastric disorders and matched controls showed that the four additional metrics in the modified Gastric Alimetry System remained highly correlated to their equivalent metrics in the Reference Device after minor updates to correct recognized performance issues. Therefore the modified Gastric Alimetry System is shown to be substantially equivalent.
