K Number

Device Name

Gastric Alimetry System

Manufacturer

Alimetry Ltd.

Date Cleared

2023-11-17

(59 days)

Product Code

MYE

Regulation Number

876.1735

Intended Use

The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various qastric disorders.

Device Description

The Gastric Alimetry System is an electrogastrography (EGG) device, used for non-invasively measuring the myoelectrical activity of the stomach at the surface of the abdomen. The Gastric Alimetry System is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders. The device is used to acquire and digitize gastric myoelectrical data and movement artifacts using an array with recording electrodes on an adhesive patch, which is used for recording the myoelectrical data from the skin surface. An App is used to set up the device and capture patient-reported symptom data. A report is provided to the clinicians at the end of the test which includes myoelectrical signal data for manual analysis, together with computed data summaries and plots. A Supplementary Report is also routinely available to clinicians that includes signal data from all 64 channels on the array.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K223398

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard signal processing and data summaries, with no mention of AI or ML techniques for analysis or diagnosis.

Therapeutic

No
The device is described as an aid in the diagnosis of gastric disorders, not as a treatment device.

Diagnostic

Yes

The device "is intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders."

SaMD (Software as a Medical Device)

The device description explicitly mentions hardware components like an "array with recording electrodes on an adhesive patch" used for acquiring and digitizing data, indicating it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Gastric Alimetry System is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Gastric Alimetry System measures electrical activity on the surface of the body (in vivo) using electrodes on an adhesive patch.
The device description explicitly states it's an electrogastrography (EGG) device, which is a non-invasive method of measuring electrical activity. This is consistent with an in vivo measurement, not an in vitro one.
The intended use describes recording and processing gastric myoelectrical activity as an aid in diagnosis. This activity is measured directly from the patient's body.

Therefore, the Gastric Alimetry System falls under the category of a medical device that performs measurements on the body, rather than analyzing samples from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes

MYE

Device Description

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 visual summary of the overall symptom severities currently displayed by the Symptom Graph.
- Inclusion of Symptom Correlation Analysis panel in the Gastric Alimetry Report 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 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:

Minor firmware changes for efficiency
Gastric Alimetry App:
- Cybersecurity updates
- Update to the user interface of the App to include additional symptom logging
Alimetry Cloud:
- Updated to health professional dashboard available to include the session number
- Addition of multi-factor authentication for user login.
- Minor Algorithm fixes

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

stomach, abdomen

Indicated Patient Age Range

Patients 18 years and older

Intended User / Care Setting

Medical professionals to set up and use the system; Specialist GI physicians

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K223398

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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"

(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).

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

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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FORM FDA 3881 (6/20)

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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

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
indication for 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.
User Population	Medical professionals to set up
and use the system	Medical professionals to set up
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
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.	Disposable; same components
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
Range	DC	DC	Same as the predicate.
High frequency
range	2 Hz	2 Hz	Same as the predicate.
Number of
channels	64 (+2 reference)	64 (+2 reference)	Same as the predicate.
Electrode to
recorder interface	Reader located on the Array and
directly connected to it.	Reader located on the Array and
directly connected to it.	Same as the predicate.
Screen	Dedicated tablet for system
operation	Dedicated tablet for system
operation	Same as the predicate.
Motion Sensor	Accelerometer	Accelerometer	Same as the predicate.
Data Storage	On data acquisition device and
cloud server	On data acquisition device and
cloud server	Same as the predicate.
Weight of device
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),
device control, data acquisition
software and system checks via
App running on a tablet.	Setup (including clinical data),
device control, data acquisition
software and system checks via
App running on a tablet.	Same as the predicate.
Patient Symptom
Logging	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 prep
with abrasive conductive gel
Additional array template
marking step for convenience.	Yes. Shave, measure, skin prep
with abrasive conductive gel
Additional array template
marking step for convenience.	Same as the predicate.
Sterilization	Electrodes are disposable, non-
sterile.
Reader and Dock are
reprocessed, not supplied
sterile. Cleaning and disinfection
instructions using wipes
provided.	Electrodes are disposable, non-
sterile.
Reader and Dock are
reprocessed, not supplied
sterile. Cleaning and disinfection
instructions using wipes
provided.	Same as the predicate.
Safety Features
System Checks	Impedance monitor and
connectivity check displayed
prior to recordings.	Impedance monitor and
connectivity check displayed
prior to recordings.	Same as the predicate.
Instructions to
Patient	Yes. User instructs patient to
limit movement, talking and
sleeping.
These instructions are displayed
to the patient via an App as an
added safety measure.	Yes. User instructs patient to
limit movement, talking and
sleeping.
These instructions are displayed
to the patient via an App as an
added safety measure.	Same as the predicate.
Reporting Features
Visualization of
myoelectrical
waveforms	Yes, all channels.	Yes, all channels.	Same as the predicate.
Automated
Spectral Analysis	Yes, by Fourier-transform	Yes, by Fourier-transform	Same as the predicate.
Artifact
Evaluation	By manual identification of noise
in waveforms and with reference
to motion sensor.	By manual identification of noise
in waveforms and with reference
to motion sensor.	Same as the predicate.
Item	Subject Device	Primary Predicate Device	Discussion
	Additionally provides automated
noise detection for convenience.	Additionally provides automated
noise detection for convenience.
Frequency,
Amplitude, and
Rhythm Stability
of Myoelectrical
Activity	Yes, data tables, and
visualization by spectral graphs
and myoelectrical waveforms.	Yes, data tables, and
visualization by spectral graphs
and myoelectrical waveforms.	Same as the predicate.
Other
Myoelectrical
Parameters	Measures of % time in
frequency ranges and changes
in signal power over time are
available by visual inspection of
spectral maps and waveforms.	Measures of % time in
frequency ranges and changes
in signal power over time are
available by visual inspection of
spectral maps and waveforms.	Same as the predicate.
Symptom
Outputs	Each symptom severity and
symptom event is shown as a
function of time. The total
symptom burden score is
displayed in a table.
The average symptom severity
for each symptom is shown in a
radar plot. The total symptom
burden score and symptom
event counts are shown using
summary bar graphs.
The gastric amplitude and
symptom severities are shown
on a shared axis, normalized so
that they can be visually
compared. The corresponding
correlation coefficients are
displayed as a bar graph.
Questions are presented to the
patient on the App. Patient
responses are captured and
provided to the clinician in the
Gastric Alimetry Report.	Each symptom severity and
symptom event is shown as a
function of time. The total
symptom burden score is
displayed in a table.
Gut-brain wellbeing questions
asked by clinician during patient
consultation.	The Subject Device
contains additional
visualizations of data
presented by the
Predicate Device
without removing or
altering any of the
existing outputs. Refer
discussion above on
symptom visualization
and correlation
analysis.
The addition of the gut-
brain wellbeing
questions into the app
and report does not
impact the
performance of the
device.
Technical /
recording quality
outputs	Yes. Impedance, motion.
Additionally shows Array
position and spatial distribution
of amplitude for user
convenience.	Yes. Impedance, motion.
Additionally shows Array
position and spatial distribution
of amplitude for user
convenience.	Same as the predicate.

Electrodes	ANSI/AAMI EC12–compliance
with relevant requirements.	ANSI/AAMI EC12–compliance
with relevant requirements.	Same as the predicate.
Medical Electrical
Equipment	IEC 60601-1	IEC 60601-1	Same as the predicate.
Electromagnetic
Compatibility	IEC 60601-1-2	IEC 60601-1-2	Same as the predicate.

Standards with which the Device Complies

Performance Data

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.