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 patients 12 years and older.

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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Gastric Alimetry system. It details modifications made to an already cleared device (K232925, Gastric Alimetry) and argues for substantial equivalence. The summary emphasizes that the changes are minor and do not significantly impact the safety or performance of the device.

Here's an analysis of the acceptance criteria and study information, based only on the provided text. It's important to note that this document is a summary and therefore may not contain all the detailed information of the full 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria or reported device performance in the typical format of a standalone clinical study. Instead, it asserts substantial equivalence to a predicate device (K232925) based on the minimal nature of the modifications and the applicability of previously performed bench testing.

The device's intended use and indications for use are considered the primary "performance" criteria for comparison to the predicate.

Acceptance Criteria (Derived from Substantial Equivalence Claim)	Reported Device Performance (as stated for the modified device)
Intended Use: 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 (modified from predicate)	Indicated for patients 12 years and older. (Previous predicate was 18 years and older). This difference "does not raise different questions of safety or effectiveness."
Technological Characteristics: Similar to predicate (e.g., hardware, sampling frequency, number of channels, reporting features) with minor modifications.	Modifications include: - Updating Amplitude plot to BMI-adjusted Amplitude plot. - Updating spectral analysis section to include normative ranges. - Updating the Gut-Brain Wellbeing survey responses presentation and adding a total score. These updates are stated to "not impact the performance or safety of the device."
Safety Features: Biocompatibility, software, system checks, skin preparation, instructions to patient, sterilization.	Same as the predicate.
Compliance with Standards: ANSI/AAMI EC12:2000, IEC 60601-1, IEC 60601-1-2.	Same as the predicate.

2. Sample Size for Test Set and Data Provenance:

The document explicitly states: "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 submitted in the prior 510(k) notice remains applicable."

This implies that no new test set (clinical data) was used or required for this specific 510(k) submission (K240946) due to the nature of the modifications. The submission relies on the existing performance data of the predicate device (K232925).

Therefore, specific sample size, country of origin, or retrospective/prospective nature for a new test set are not provided in this document. The decision is based on asserting that the changes do not warrant new clinical performance data.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable for this submission. As stated above, no new clinical test set was presented or required to demonstrate performance for these minor modifications. The modifications relate to presentation of existing data (BMI-adjusted amplitude, normative ranges, survey presentation) and an expanded age indication supported by a systematic review of literature and real-world data, rather than a new performance claim verified by expert interpretation of new cases.

4. Adjudication Method for Test Set:

Not applicable for this submission, as no new clinical test set was presented.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done for this submission. The provided text does not mention any comparative effectiveness study, with or without AI assistance, or any effect size of human reader improvement. The focus of this 510(k) is on the safety and performance of the device as a diagnostic aid, specifically justifying minor changes and an expanded age indication based on existing data and prior clearance.

6. Standalone (Algorithm Only) Performance:

The document describes the device as a "diagnostic aid" that records, stores, views, and processes data for clinicians to analyze. It mentions "manual analysis" alongside "computed data summaries and plots." This suggests that the device's outputs are intended for interpretation by a clinician, rather than providing a definitive automated diagnosis (standalone performance).

The "modifications to the report" include "normative reference intervals" and "BMI-Adjusted Amplitude plot," which are tools to aid clinician interpretation, not to replace it with a standalone algorithmic decision.

7. Type of Ground Truth Used:

For the justification of the expanded age indication (12 years and older), the document states: "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."

This suggests that the "ground truth" for affirming comparable performance in the adolescent population was based on:

Systematic review of general medical literature: Implies accepted medical knowledge and established diagnostic criteria.
Real-world and structured research evaluations specific to the Gastric Alimetry System: This would likely involve data from previous deployments or studies, where clinical outcomes or established diagnostic methods would serve as ground truth for evaluating the device's measurements. However, no specifics are provided in this summary.

For the changes to reporting features (BMI-adjusted amplitude, normative ranges, Gut-Brain Wellbeing survey), the ground truth is implicitly related to accepted physiological measurements and clinical utility in presenting information to clinicians.

8. Sample Size for Training Set:

The document does not provide details of a training set sample size for this specific submission because it's focused on modifications to an already cleared device. Any training data would have been part of the original K232925 submission.

9. How Ground Truth for Training Set was Established:

Not specified in the provided text, as this submission focuses on modifications to an existing device rather than initial development and training. This information would refer to the predicate device's initial development.

Summary

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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 (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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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)

☑ 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

Alimetry Ltd.

Address: 70 Symonds St. Grafton Auckland 1010 New Zealand

Phone: +64 27 622 2306

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

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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(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 systemPatients 12 years and olderSpecialist GI physicians	Medical professionals to set up and use the systemPatients 18 years and olderSpecialist 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.Peel-and-stick patch.	Disposable; same components as ECG electrodes.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(predicate)	Discussion
SamplingFrequency	raw sampling: 250 Hzlogging: 4 Hz	raw sampling: 250 Hzlogging: 4 Hz	Same as thepredicate.
Low FrequencyRange	DC	DC	Same as thepredicate.
High frequencyrange	2 Hz	2 Hz	Same as thepredicate.
Number ofchannels	64 (+2 reference)	64 (+2 reference)	Same as thepredicate.
Electrode torecorder interface	Reader located on the Arrayand directly connected to it.	Reader located on the Arrayand directly connected to it.	Same as thepredicate.
Screen	Dedicated tablet for systemoperation	Dedicated tablet for systemoperation	Same as thepredicate.
Motion Sensor	Accelerometer	Accelerometer	Same as thepredicate.
Power Source	Battery powered	Battery powered	Same as thepredicate.
ReportingFeatures
Visualization ofmyoelectricalwaveforms	Yes, all channels.	Yes, all channels.	Same as thepredicate.
AutomatedSpectral Analysis	Yes, by Fourier-transform	Yes, by Fourier-transform	Same as thepredicate.
ArtifactEvaluation	By manual identification ofnoise in waveforms and withreference to motion sensor.Additionally providesautomated noise detection forconvenience.	By manual identification ofnoise in waveforms and withreference to motion sensor.Additionally providesautomated noise detection forconvenience.	Same as thepredicate.
DominantFrequency andAmplitude ofMyoelectricalActivity	Yes, data tables, andvisualization by spectralgraphs and myoelectricalwaveforms.Amplitude presented as 'BMI-Adjusted Amplitude'.	Yes, data tables, andvisualization by spectralgraphs and myoelectricalwaveforms.	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(predicate)	Discussion
OtherMyoelectricalParameters	Measures of % time infrequency ranges, changes insignal power over time, andcross-channel coupling (wavepropagation across thestomach) are available byvisual inspection of spectralmaps and waveforms.Additionally processes theseoutputs as tables forconvenience.Spectral analysis tableincludes normative ranges.	Measures of % time infrequency ranges, changes insignal power over time, andcross-channel coupling (wavepropagation across thestomach) are available byvisual inspection of spectralmaps and waveforms.Additionally processes theseoutputs as tables forconvenience.	This updatedoes not impactthe performanceor safety of thedevice.The subjectdevice includesnormativeranges for thespectralanalysisparameters.See discussionabove onupdating thespectralanalysis. Thisupdate does notimpact theperformance orsafety of thedevice.
Symptom Outputs	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 ina radar plot. The totalsymptom burden score andsymptom event counts areshown using summary bargraphs.The gastric amplitude andsymptom severities are shownon a shared axis, normalizedso that they can be visuallycompared. The correspondingcorrelation coefficients aredisplayed as a bar graph.Ten questions are presentedto the patient on the Appduring the test. The Patient'sresponse is captured andprovided to the clinician in theGastric Alimetry Report. Theresponses are grouped under'depressive symptoms', 'stresssymptoms', and 'anxiety	Each symptom severity andsymptom event is shown as afunction of time. The totalsymptom burden score isdisplayed in a table.The average symptomseverity for each symptom isshown in a radar plot. Thetotal symptom burden scoreand symptom event countsare shown using summarybar graphs.The gastric amplitude andsymptom severities areshown on a shared axis,normalized so that they canbe visually compared. Thecorresponding correlationcoefficients are displayed asa bar graph.Ten questions are presentedto the patient on the Appduring the test. The Patient'sresponse is captured andprovided to the clinician in theGastric Alimetry Report.	The SubjectDevice groupsthe mentalwellbeingresponsesunder 3 groups.Referdiscussionabove onupdating theGut-BrainWellbeingsurveyresponses. Thisupdate does notimpact theperformance orsafety of thedevice.
	Gastric Alimetry System	Gastric Alimetry System(predicate)	Discussion
	symptoms'. Gut-BrainWellbeing Total Scoreincluded.
Technical /recording qualityoutputs	Yes. Impedance, motion.Additionally shows Arrayposition and spatial distributionof amplitude for userconvenience.	Yes. Impedance, motion.Additionally shows Arrayposition and spatialdistribution of amplitude foruser convenience.	Same as thepredicate.
Safety Features
Biocompatibility	Array and Reader in contactwith the patient.	Array and Reader in contactwith the patient.	Same as thepredicate.
Software	Setup (including clinical data),device control, data acquisitionsoftware and system checksvia App running on a tablet.	Setup (including clinicaldata), device control, dataacquisition software andsystem checks via Apprunning on a tablet.	Same as thepredicate.
System Checks	Impedance monitor andconnectivity check displayedprior to recordings.	Impedance monitor andconnectivity check displayedprior to recordings.	Same as thepredicate.
Skin Preparation	Yes. Shave, measure, skinprep with abrasive conductivegelAdditional array templatemarking step for convenience.	Yes. Shave, measure, skinprep with abrasive conductivegelAdditional array templatemarking step forconvenience.	Same as thepredicate.
Instructions toPatient	Yes. User instructs patient tolimit movement, talking andsleeping.Additional step of displayingthese instructions to patient viaApp as an added safetymeasure.	Yes. User instructs patient tolimit movement, talking andsleeping.Additional step of displayingthese instructions to patientvia App as an added safetymeasure.	Same as thepredicate.
Sterilization	Electrodes are disposable,non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning anddisinfection instructions usingwipes provided.	Electrodes are disposable,non-sterile.Reader and Dock arereprocessed, not suppliedsterile. Cleaning anddisinfection instructions usingwipes provided.	Same as thepredicate.
Standards withwhich the DeviceComplies			Same as thepredicate.
	Gastric Alimetry System	Gastric Alimetry System(predicate)	Discussion
Electrodes	ANSI/AAMI EC12:2000 -compliance with relevantrequirements.	ANSI/AAMI EC12:2000 -compliance with relevantrequirements.	Same as thepredicate.
Medical ElectricalEquipment	IEC 60601-1	IEC 60601-1	Same as thepredicate.
ElectromagneticCompatibility	IEC 60601-1-2	IEC 60601-1-2	Same as thepredicate.

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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 submitted in the prior 510(k) notice remains applicable.

Conclusions

The modified Gastric Alimetry System is as safe and effective as the Gastric Alimetry System. The Gastric Alimetry System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the modified Gastric Alimetry System and its predicate device raise no new issues of safety or effectiveness.

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.