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.

AI/ML Overview

This FDA 510(k) clearance document for the Gastric Alimetry System states that no new clinical studies were required for this submission. The submission relies on prior clearances and bench testing, as the modifications introduced were considered minimal and did not significantly impact safety or performance.

Therefore, the document does not contain the detailed information usually found in a study proving a device meets acceptance criteria, such as:

A table of acceptance criteria and reported device performance (for a new study).
Sample size used for a test set or data provenance.
Number of experts or their qualifications for ground truth establishment.
Adjudication methods.
MRMC comparative effectiveness study details.
Standalone algorithm performance.
Type of ground truth used (for a new study).
Training set sample size or how its ground truth was established.

Based only on the provided document, here's what can be inferred / what is explicitly stated:

The document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (Gastric Alimetry System, K223398) due to minor modifications.

Here's a breakdown of the requested information, referencing the document's content:

A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria table for this submission's performance study is provided. The document states: "The modifications to the device since the prior clearances... 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."
- The "Technological Characteristics / Substantial Equivalence" table (pages 5-6) compares the subject device to the predicate across various parameters (e.g., sampling frequency, number of channels, power source, software features). For almost all parameters, the "Subject Device" and "Primary Predicate Device" columns state identical characteristics, followed by "Same as the predicate." This implicitly means the performance characteristics are expected to be the same as the predicate and were deemed acceptable based on the predicate's clearance.
- For "Symptom Outputs", the subject device adds visualizations without removing or altering existing outputs, and the addition of gut-brain wellbeing questions does not impact device performance.
Sample sizes used for the test set and the data provenance:
- Not applicable. No new clinical "test set" was used for this 510(k) submission. "No clinical studies were required."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical "test set" for which ground truth needed to be established for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new clinical "test set" for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done for this submission. The device (Gastric Alimetry System) is an electrogastrography (EGG) device intended to "record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders." It provides "myoelectrical signal data for manual analysis, together with computed data summaries and plots." It is not described as an "AI assistance" device for human readers in the context of interpretive diagnostic imaging.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated for this submission. The device provides data for "manual analysis" by clinicians. The document focuses on the equivalence of the data acquisition and reporting features, not on a standalone diagnostic algorithm's performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for this submission. No new clinical study was conducted where such ground truth would be established. The device is an EGG system, aiding in diagnosis by presenting myoelectrical activity data. The "ground truth" for its function would relate to how accurately it records and processes these physiological signals, which is addressed through technical and bench testing described in previous submissions, not a comparative diagnostic outcome study in this document.
The sample size for the training set:
- Not applicable for this submission. This document describes minor modifications to an already cleared device and does not detail a new AI model with a training set. The "Minor Algorithm fixes" mentioned on page 5 suggests iterative improvements, but no new large-scale training is implied or detailed.
How the ground truth for the training set was established:
- Not applicable. See point 8.

In summary, the provided document explicitly states, "No clinical studies were required," for this 510(k) clearance due to the minor nature of the changes. The acceptance criteria and performance proof are based on the prior clearance of the predicate device (K223398) and repeated bench testing for specific components (array electrical performance).

Summary

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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

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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 andindication for use	To record, store, view andprocess gastric myoelectricalactivity as an aid to thediagnosis of various gastricdisorders.	To record, store, view andprocess gastric myoelectricalactivity as an aid to thediagnosis of various gastricdisorders.	Same as the predicate.
User Population	Medical professionals to set upand use the system	Medical professionals to set upand 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 andCharging Dock	Gastric Alimetry Dock forcharging and user convenience	Gastric Alimetry Dock forcharging and user convenience	Same as the predicate.
Electrodes	Disposable; same componentsas ECG electrodes.	Disposable; same componentsas 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 FrequencyRange	DC	DC	Same as the predicate.
High frequencyrange	2 Hz	2 Hz	Same as the predicate.
Number ofchannels	64 (+2 reference)	64 (+2 reference)	Same as the predicate.
Electrode torecorder interface	Reader located on the Array anddirectly connected to it.	Reader located on the Array anddirectly connected to it.	Same as the predicate.
Screen	Dedicated tablet for systemoperation	Dedicated tablet for systemoperation	Same as the predicate.
Motion Sensor	Accelerometer	Accelerometer	Same as the predicate.
Data Storage	On data acquisition device andcloud server	On data acquisition device andcloud server	Same as the predicate.
Weight of deviceon 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),device control, data acquisitionsoftware and system checks viaApp running on a tablet.	Setup (including clinical data),device control, data acquisitionsoftware and system checks viaApp running on a tablet.	Same as the predicate.
Patient SymptomLogging	Available on App interface.Presented as plot with times.	Available on App interface.Presented as plot with times.	Same as the predicate.
Skin Preparation	Yes. Shave, measure, skin prepwith abrasive conductive gelAdditional array templatemarking step for convenience.	Yes. Shave, measure, skin prepwith abrasive conductive gelAdditional array templatemarking step for convenience.	Same as the predicate.
Sterilization	Electrodes are disposable, non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning and disinfectioninstructions using wipesprovided.	Electrodes are disposable, non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning and disinfectioninstructions using wipesprovided.	Same as the predicate.
Safety Features
System Checks	Impedance monitor andconnectivity check displayedprior to recordings.	Impedance monitor andconnectivity check displayedprior to recordings.	Same as the predicate.
Instructions toPatient	Yes. User instructs patient tolimit movement, talking andsleeping.These instructions are displayedto the patient via an App as anadded safety measure.	Yes. User instructs patient tolimit movement, talking andsleeping.These instructions are displayedto the patient via an App as anadded safety measure.	Same as the predicate.
Reporting Features
Visualization ofmyoelectricalwaveforms	Yes, all channels.	Yes, all channels.	Same as the predicate.
AutomatedSpectral Analysis	Yes, by Fourier-transform	Yes, by Fourier-transform	Same as the predicate.
ArtifactEvaluation	By manual identification of noisein waveforms and with referenceto motion sensor.	By manual identification of noisein waveforms and with referenceto motion sensor.	Same as the predicate.
Item	Subject Device	Primary Predicate Device	Discussion
	Additionally provides automatednoise detection for convenience.	Additionally provides automatednoise detection for convenience.
Frequency,Amplitude, andRhythm Stabilityof MyoelectricalActivity	Yes, data tables, andvisualization by spectral graphsand myoelectrical waveforms.	Yes, data tables, andvisualization by spectral graphsand myoelectrical waveforms.	Same as the predicate.
OtherMyoelectricalParameters	Measures of % time infrequency ranges and changesin signal power over time areavailable by visual inspection ofspectral maps and waveforms.	Measures of % time infrequency ranges and changesin signal power over time areavailable by visual inspection ofspectral maps and waveforms.	Same as the predicate.
SymptomOutputs	Each symptom severity andsymptom event is shown as afunction of time. The totalsymptom burden score isdisplayed in a table.The average symptom severityfor each symptom is shown in aradar plot. The total symptomburden score and symptomevent counts are shown usingsummary bar graphs.The gastric amplitude andsymptom severities are shownon a shared axis, normalized sothat they can be visuallycompared. The correspondingcorrelation coefficients aredisplayed as a bar graph.Questions are presented to thepatient on the App. Patientresponses are captured andprovided to the clinician in theGastric Alimetry Report.	Each symptom severity andsymptom event is shown as afunction of time. The totalsymptom burden score isdisplayed in a table.Gut-brain wellbeing questionsasked by clinician during patientconsultation.	The Subject Devicecontains additionalvisualizations of datapresented by thePredicate Devicewithout removing oraltering any of theexisting outputs. Referdiscussion above onsymptom visualizationand correlationanalysis.The addition of the gut-brain wellbeingquestions into the appand report does notimpact theperformance of thedevice.
Technical /recording qualityoutputs	Yes. Impedance, motion.Additionally shows Arrayposition and spatial distributionof amplitude for userconvenience.	Yes. Impedance, motion.Additionally shows Arrayposition and spatial distributionof amplitude for userconvenience.	Same as the predicate.

Electrodes	ANSI/AAMI EC12–compliancewith relevant requirements.	ANSI/AAMI EC12–compliancewith relevant requirements.	Same as the predicate.
Medical ElectricalEquipment	IEC 60601-1	IEC 60601-1	Same as the predicate.
ElectromagneticCompatibility	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.

Regulation Number and Section

§ 876.1735 Electrogastrography system.

(a)
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.(b)
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.