Gastric Alimetry

K240946 · Alimetry , Ltd. · MYE · Jul 3, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K240946
• Device Name: Gastric Alimetry
• Applicant: Alimetry , Ltd.
• Product Code: MYE · Gastroenterology, Urology
• Decision Date: Jul 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1735
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 Story

Non-invasive electrogastrography (EGG) system; records gastric myoelectrical activity via 64-channel adhesive array on abdomen. System includes Alimetry Reader (data acquisition), Gastric Alimetry Array (electrodes), Gastric Alimetry App (iPad mini for setup/symptom capture), and Alimetry Cloud (physician portal). Used in healthcare facilities by medical professionals. Device digitizes myoelectrical signals and movement artifacts; processes data to provide spectral analysis, BMI-adjusted amplitude plots, and symptom correlation reports. Clinicians use output to assess gastric myoelectrical patterns and patient-reported symptoms to aid diagnosis of gastric disorders. Benefits include objective, non-invasive assessment of gastric function.

Clinical Evidence

No new clinical trials performed. Substantial equivalence supported by previously submitted bench testing and systematic review of medical literature/research evaluations confirming comparable performance in the adolescent population (12+).

Technological Characteristics

64-channel EGG system; disposable peel-and-stick electrode array (ANSI/AAMI EC12:2000 compliant); battery-powered reader; accelerometer for motion artifact detection. Connectivity via iPad mini app and secure cloud portal. Software performs Fourier-transform spectral analysis. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients 12 years and older as an aid in the diagnosis of various gastric disorders.

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.

Predicate Devices

• Gastric Alimetry (K232925)

Submission Summary (Full Text)

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July 3, 2024

Alimetry Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K240946

Trade/Device Name: Gastric Alimetry Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography System Regulatory Class: Class II Product Code: MYE Dated: April 5, 2024 Received: April 5, 2024

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.

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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" (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 QS 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 ([e-mail]) or phone [phone] 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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## Indications for Use

510(k) Number (if known) K240946

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.

The Gastric Alimetry System is indicated for patients 12 years and older.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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### 510(K) SUMMARY Alimetry's Gastric Alimetry

#### Submitter

Alimetry Ltd.

Address: 70 Symonds St. Grafton Auckland 1010 New Zealand

Phone: [phone]

Contact Person: Yaara Yarmut, Chief Regulatory Officer.

Date Prepared: April 5, 2024

Name of Device: Gastric Alimetry

Common or Usual Name: Gastric Alimetry System

Classification Name: Electrogastrography system, 21 CFR 876.1735

Regulatory Class: Class II

Product Code: MYE

#### Predicate Devices

Trade Name: Gastric Alimetry (K232925) (primary predicate)

Manufacturer: Alimetry Ltd.

#### 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

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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.

The device is mostly unchanged compared to the previously cleared Gastric Alimetry System, apart for the following modifications:

Labelling:

- Inclusion of adolescent patient population age 12 years and over in the indications for use । statement and associated labeling.
- -Inclusion of a report interpretation guide and phenotyping patterns diagram to provide information to the clinician.

Modification to the report:

- -Inclusion of the normative reference intervals
- -Updated Gut-Brain Wellbeing Survey
- -Adding a Gut-Brain Wellbeing Total Score
- -Updated Amplitude plot to BMI-Adjusted Amplitude' plot

Additional minor updates were made to the cloud, algorithm, app, labels and packaging.

#### Intended Use / 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.

The Gastric Alimetry System is indicated for use in patients 12 years and older.

The modified Gastric Alimetry System that is the submission is "intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders". There are no changes to the intended use in comparison to the predicate Gastric Alimetry System (K232925) which has an identical intended use, being "intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders".

The modified Gastric Alimetry System is indicated for patients 12 years and older. This is a modification from the predicate Gastric Alimetry System which is indicated for patients 18 years and older. Systematic review of the extensive general medical literature, together with real-world and structured research evaluations specific to the Gastric Alimetry System, show comparable device performance in adolescents with no new questions of safety and efficacy.

#### Technological Characteristics / Substantial Equivalence

At a high level, the subject and predicate devices are based on the same technological elements: Both the modified Gastric Alimetry system and the Gastric Alimetry system use identical hardware (Alimetry Reader for recording the myoelectrical activity from the patient), identical accessories (Gastric Alimetry Array for recording the myoelectrical activity from the patient and the Gastric Alimetry Dock for device setup and charging), identical dedicated tablet device (i.e. a commercial off-the-shelf iPad mini that is supplied with the system and running on a mobile device management system) and equivalent secure Alimetry Cloud.

The following technological differences exist between the subject and predicate devices:

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- Updating the Amplitude plot to a BMI-adjusted Amplitude plot. .
- . Updating the spectral analysis section to include normative ranges.
- . Updating the Gut-Brain Wellbeing survey responses presentation and adding a total score.

A table comparing the key features of the subject and predicate devices is provided below.

| | Gastric Alimetry System | Gastric Alimetry System<br>(predicate) | Discussion |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To record, store, view and process gastric myoelectrical activity as an aid to the diagnosis of various gastric disorders. | To record, store, view and process gastric myoelectrical activity as an aid to the diagnosis of various gastric disorders. | Same as the predicate. |
| Indications for Use | Patients 12 years and older | Patients 18 years and older | Different. The subject device is indicated for patients 12 years and older whereas the predicate is indicated for patients 18 years and older. This difference in use population does not raise different questions of safety or effectiveness. See discussion above the indications for use. |
| User Population | Medical professionals to set up and use the system<br>Patients 12 years and older<br>Specialist GI physicians | Medical professionals to set up and use the system<br>Patients 18 years and older<br>Specialist GI physicians | Different. See above. |
| Technological Characteristics | | | |
| Setup and Charging Dock | Gastric Alimetry Dock for charging and user convenience | Gastric Alimetry Dock for charging and user convenience | Same as the predicate. |
| Electrodes | Disposable; same components as ECG electrodes.<br>Peel-and-stick patch. | Disposable; same components as ECG electrodes.<br>Peel-and-stick patch. | Same as the predicate. |
| Weight of device on patient | 225 grams - Reader and Array | 225 grams - Reader and Array | Same as the predicate. |
| | Gastric Alimetry System | Gastric Alimetry System<br>(predicate) | Discussion |
| Sampling<br>Frequency | raw sampling: 250 Hz<br>logging: 4 Hz | raw sampling: 250 Hz<br>logging: 4 Hz | Same as the<br>predicate. |
| Low Frequency<br>Range | DC | DC | Same as the<br>predicate. |
| High frequency<br>range | 2 Hz | 2 Hz | Same as the<br>predicate. |
| Number of<br>channels | 64 (+2 reference) | 64 (+2 reference) | Same as the<br>predicate. |
| Electrode to<br>recorder interface | Reader located on the Array<br>and directly connected to it. | Reader located on the Array<br>and directly connected to it. | Same as the<br>predicate. |
| Screen | Dedicated tablet for system<br>operation | Dedicated tablet for system<br>operation | Same as the<br>predicate. |
| Motion Sensor | Accelerometer | Accelerometer | Same as the<br>predicate. |
| Power Source | Battery powered | Battery powered | Same as the<br>predicate. |
| Reporting<br>Features | | | |
| Visualization of<br>myoelectrical<br>waveforms | Yes, all channels. | Yes, all channels. | Same as the<br>predicate. |
| Automated<br>Spectral Analysis | Yes, by Fourier-transform | Yes, by Fourier-transform | Same as the<br>predicate. |
| Artifact<br>Evaluation | By manual identification of<br>noise in waveforms and with<br>reference to motion sensor.<br>Additionally provides<br>automated noise detection for<br>convenience. | By manual identification of<br>noise in waveforms and with<br>reference to motion sensor.<br>Additionally provides<br>automated noise detection for<br>convenience. | Same as the<br>predicate. |
| Dominant<br>Frequency and<br>Amplitude of<br>Myoelectrical<br>Activity | Yes, data tables, and<br>visualization by spectral<br>graphs and myoelectrical<br>waveforms.<br>Amplitude presented as 'BMI-<br>Adjusted Amplitude'. | Yes, data tables, and<br>visualization by spectral<br>graphs and myoelectrical<br>waveforms. | Similar. The subject device presents 'BMI-Adjusted Amplitude' instead of 'Amplitude'. See discussion above on updating the Amplitude plot. |
| | Gastric Alimetry System | Gastric Alimetry System<br>(predicate) | Discussion |
| 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<br>visual inspection of spectral<br>maps and waveforms.<br>Additionally processes these<br>outputs as tables for<br>convenience.<br>Spectral analysis table<br>includes normative ranges. | 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<br>visual inspection of spectral<br>maps and waveforms.<br>Additionally processes these<br>outputs as tables for<br>convenience. | This update<br>does not impact<br>the performance<br>or safety of the<br>device.<br><br>The subject<br>device includes<br>normative<br>ranges for the<br>spectral<br>analysis<br>parameters.<br>See discussion<br>above on<br>updating the<br>spectral<br>analysis. This<br>update does not<br>impact the<br>performance or<br>safety of the<br>device. |
| Symptom 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<br>a radar plot. The total<br>symptom burden score and<br>symptom event counts are<br>shown using summary bar<br>graphs.<br>The gastric amplitude and<br>symptom severities are shown<br>on a shared axis, normalized<br>so that they can be visually<br>compared. The corresponding<br>correlation coefficients are<br>displayed as a bar graph.<br>Ten questions are presented<br>to the patient on the App<br>during the test. The Patient's<br>response is captured and<br>provided to the clinician in the<br>Gastric Alimetry Report. The<br>responses are grouped under<br>'depressive symptoms', 'stress<br>symptoms', and 'anxiety | 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<br>severity for each symptom is<br>shown in a radar plot. The<br>total symptom burden score<br>and symptom event counts<br>are shown using summary<br>bar graphs.<br>The gastric amplitude and<br>symptom severities are<br>shown on a shared axis,<br>normalized so that they can<br>be visually compared. The<br>corresponding correlation<br>coefficients are displayed as<br>a bar graph.<br>Ten questions are presented<br>to the patient on the App<br>during the test. The Patient's<br>response is captured and<br>provided to the clinician in the<br>Gastric Alimetry Report. | The Subject<br>Device groups<br>the mental<br>wellbeing<br>responses<br>under 3 groups.<br>Refer<br>discussion<br>above on<br>updating the<br>Gut-Brain<br>Wellbeing<br>survey<br>responses. This<br>update does not<br>impact the<br>performance or<br>safety of the<br>device. |
| | Gastric Alimetry System | Gastric Alimetry System<br>(predicate) | Discussion |
| | symptoms'. Gut-Brain<br>Wellbeing Total Score<br>included. | | |
| 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<br>distribution of amplitude for<br>user convenience. | Same as the<br>predicate. |
| Safety Features | | | |
| Biocompatibility | Array and Reader in contact<br>with the patient. | Array and Reader in contact<br>with the patient. | Same as the<br>predicate. |
| Software | Setup (including clinical data),<br>device control, data acquisition<br>software and system checks<br>via App running on a tablet. | Setup (including clinical<br>data), device control, data<br>acquisition software and<br>system checks via App<br>running on a tablet. | Same as the<br>predicate. |
| 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<br>predicate. |
| Skin Preparation | Yes. Shave, measure, skin<br>prep with abrasive conductive<br>gel<br>Additional array template<br>marking step for convenience. | Yes. Shave, measure, skin<br>prep with abrasive conductive<br>gel<br>Additional array template<br>marking step for<br>convenience. | Same as the<br>predicate.…