Gastric Alimetry System
Device Facts
| Record ID | K232925 |
|---|---|
| Device Name | Gastric Alimetry System |
| Applicant | Alimetry , Ltd. |
| Product Code | MYE · Gastroenterology, Urology |
| Decision Date | Nov 17, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.1735 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
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 System is an electrogastrography (EGG) device for non-invasive measurement of gastric myoelectrical activity. Input: 64-channel surface electrode array on adhesive patch; accelerometer for motion artifacts. Operation: Array records signals from skin surface; data digitized and transmitted to tablet App; App captures patient-reported symptoms. Processing: Fourier-transform spectral analysis; automated noise detection; correlation analysis between symptom severity and gastric amplitude. Output: Clinical report with myoelectrical waveforms, spectral maps, symptom summary panels, and gut-brain wellbeing questionnaire results. Used in clinical settings by GI physicians to aid diagnosis of gastric disorders. Benefits: Provides objective data on gastric rhythm and amplitude to correlate with patient symptoms, assisting in clinical decision-making.
Clinical Evidence
No clinical data. Bench testing only. Previous bench testing remains applicable; array electrical performance testing was repeated to confirm consistency with prior design iterations.
Technological Characteristics
Electrogastrography system; 64-channel electrode array (ANSI/AAMI EC12 compliant); accelerometer; 250 Hz raw sampling; 4 Hz logging; 0-2 Hz frequency range. Battery-powered; tablet-based App interface; cloud-server data storage. Software includes data acquisition, spectral analysis, and reporting. Reprocessed reader/dock; disposable electrodes. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).
Indications for Use
Indicated for patients 18 years and older to record, store, view, and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. Used by medical professionals and specialist GI physicians.
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 (K223398)
Submission Summary (Full Text)
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November 17, 2023
Alimetry Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street. Floor 23 Philadelphia, Pennsylvania 19115
Re: K232925
Trade/Device Name: Gastric Alimetry System Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography System Regulatory Class: Class II Product Code: MYE Dated: September 19, 2023 Received: September 19, 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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. 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known) K232925
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 qastric disorders.
Type of Use (Select one or both, as applicable)
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 27 622 2306
Contact Person: Yaara Yarmut, Chief Regulatory Officer. Date Prepared: September 19, 2023
# 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 (K223398) (primary predicate) Manufacturer: Alimetry Ltd.
# 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 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.
In the modified Gastric Alimetry System, the following updates are introduced:
- Modifications to the patient report to include additional information, as follows:
- Inclusion of Symptom Summary panel in the Gastric Alimetry Report to provide a O visual summary of the overall symptom severities currently displayed by the Symptom Graph.
- Inclusion of Symptom Correlation Analysis panel in the Gastric Alimetry Report O to provide a visual summary of the correlation between symptom severity and gastric amplitude.
- Inclusion of Gut-Brain Wellbeing questions panel in the Gastric Alimetry Report o to display the results of ten optional wellbeing questions presented to the patient via the Gastric Alimetry App.
- Update to the design of the Reader's Enclosure
- The labeling has been updated to include normative range data to provide reference ● information for the clinician.
In addition, the following minor updates were introduced:
- 0 Minor firmware changes for efficiency
- 0 Gastric Alimetry App:
- Cybersecurity updates o
- Update to the user interface of the App to include additional symptom logging O
- Alimetry Cloud: ●
- O Updated to health professional dashboard available to include the session number
- Addition of multi-factor authentication for user login. O
- Minor Algorithm fixes O
# 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. / K223398 | |
| 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 | Medical professionals to set up<br>and use the system | Same as the predicate. |
| | Patients 18 years and older | Patients 18 years and older | Same as the predicate. |
| | Specialist GI physicians | 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. | Disposable; same components<br>as ECG electrodes. | Same as the predicate. |
| | Peel-and-stick patch. | Peel-and-stick patch. | Same as the predicate. |
| Technological Characteristics | | | |
| Sampling | raw sampling: 250 Hz | raw sampling: 250 Hz | Same as the predicate. |
| Frequency | logging: 4 Hz | logging: 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>These instructions are displayed<br>to the patient via an App as an<br>added safety measure. | Yes. User instructs patient to<br>limit movement, talking and<br>sleeping.<br>These instructions are displayed<br>to the patient via an App as an<br>added safety 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. |
| Artifact<br>Evaluation | By manual identification of noise<br>in waveforms and with reference<br>to motion sensor. | By manual identification of noise<br>in waveforms and with reference<br>to motion sensor. | Same as the predicate. |
| Item | Subject Device | Primary Predicate Device | Discussion |
| | Additionally provides automated<br>noise detection for convenience. | Additionally provides automated<br>noise detection for convenience. | |
| Frequency,<br>Amplitude, and<br>Rhythm Stability<br>of 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 and changes<br>in signal power over time are<br>available by visual inspection of<br>spectral maps and waveforms. | Measures of % time in<br>frequency ranges and changes<br>in signal power over time are<br>available by visual inspection of<br>spectral maps and waveforms. | Same as the predicate. |
| Symptom<br>Outputs | Each symptom severity and<br>symptom event is shown as a<br>function of time. The total<br>symptom burden score is<br>displayed in a table.<br>The average symptom severity<br>for each symptom is shown in a<br>radar plot. The total symptom<br>burden score and symptom<br>event counts are shown using<br>summary bar graphs.<br>The gastric amplitude and<br>symptom severities are shown<br>on a shared axis, normalized so<br>that they can be visually<br>compared. The corresponding<br>correlation coefficients are<br>displayed as a bar graph.<br>Questions are presented to the<br>patient on the App. Patient<br>responses are captured and<br>provided to the clinician in the<br>Gastric Alimetry Report. | Each symptom severity and<br>symptom event is shown as a<br>function of time. The total<br>symptom burden score is<br>displayed in a table.<br>Gut-brain wellbeing questions<br>asked by clinician during patient<br>consultation. | The Subject Device<br>contains additional<br>visualizations of data<br>presented by the<br>Predicate Device<br>without removing or<br>altering any of the<br>existing outputs. Refer<br>discussion above on<br>symptom visualization<br>and correlation<br>analysis.<br>The addition of the gut-<br>brain wellbeing<br>questions into the app<br>and report does not<br>impact the<br>performance of the<br>device. |
| Technical /<br>recording quality<br>outputs | Yes. Impedance, motion.<br>Additionally shows Array<br>position and spatial distribution<br>of amplitude for user<br>convenience. | Yes. Impedance, motion.<br>Additionally shows Array<br>position and spatial distribution<br>of amplitude for user<br>convenience. | Same as the predicate. |
| | | | |
| Electrodes | ANSI/AAMI EC12–compliance<br>with relevant requirements. | ANSI/AAMI EC12–compliance<br>with relevant 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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#### Standards with which the Device Complies
#### Performance Data
The modifications to the device since the prior clearances, namely additional Symptom Summary panel, Symptom Correlation Analysis panel, additional Gut-Brain Wellbeing questions, and an update to the Reader's enclosure, were minimal and did not significantly impact the safety or performance of the device as reflected in the previously performed bench testing, the testing submitted in the prior 510(k) notice remains applicable. For completeness, the company repeated the array electrical performance testing on the final version of the device with the thinner gel that was incorporated into the device design addressed in K213924.
No clinical studies were required.
# 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 device do not raise different questions of safety or effectiveness. Therefore the modified Gastric Alimetry System is shown to be substantially equivalent.
