(89 days)
No
The summary describes a system for recording and processing myoelectrical activity, but there is no mention of AI or ML being used for analysis or interpretation of the data. The report provides data for "manual analysis" and "computed data summaries," which does not imply AI/ML.
No.
The device is described as an aid in diagnosis and does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "an aid in the diagnosis of various gastric disorders," indicating its role in the diagnostic process.
No
The device description explicitly mentions hardware components such as the Alimetry Reader, Gastric Alimetry Array (electrodes on an adhesive patch), and the Gastric Alimetry Dock (Accessory). While it includes software components (Gastric Alimetry App, Alimetry Cloud), it is a system that integrates both hardware and software.
Based on the provided text, the Gastric Alimetry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Gastric Alimetry System Function: The Gastric Alimetry System measures myoelectrical activity of the stomach non-invasively from the surface of the abdomen using electrodes on an adhesive patch. It does not involve the collection or analysis of specimens taken from the body.
The device is an electrogastrography (EGG) device, which is a type of in vivo diagnostic device, as it measures physiological activity directly within the living body.
N/A
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 patients 12 years and older.
Product codes
MYE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Electrogastrography (EGG)
Anatomical Site
Stomach (myoelectrical activity on the surface of the abdomen)
Indicated Patient Age Range
12 years and older
Intended User / Care Setting
Medical professionals to set up and use the system, Specialist GI physicians.
Healthcare facilities.
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 submitted in the prior 510(k) notice remains applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
3
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
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
5
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 system
Patients 12 years and older
Specialist GI physicians | Medical professionals to set up and use the system
Patients 18 years and older
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.
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 |
| Sampling
Frequency | raw sampling: 250 Hz
logging: 4 Hz | raw sampling: 250 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. |
| Power Source | Battery powered | Battery powered | 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.
Additionally provides
automated noise detection for
convenience. | By manual identification of
noise in waveforms and with
reference to motion sensor.
Additionally provides
automated noise detection for
convenience. | Same as the
predicate. |
| Dominant
Frequency and
Amplitude of
Myoelectrical
Activity | Yes, data tables, and
visualization by spectral
graphs and myoelectrical
waveforms.
Amplitude presented as 'BMI-
Adjusted Amplitude'. | Yes, data tables, and
visualization by spectral
graphs and myoelectrical
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
(predicate) | Discussion |
| Other
Myoelectrical
Parameters | Measures of % time in
frequency ranges, changes in
signal power over time, and
cross-channel coupling (wave
propagation across the
stomach) are available by
visual inspection of spectral
maps and waveforms.
Additionally processes these
outputs as tables for
convenience.
Spectral analysis table
includes normative ranges. | Measures of % time in
frequency ranges, changes in
signal power over time, and
cross-channel coupling (wave
propagation across the
stomach) are available by
visual inspection of spectral
maps and waveforms.
Additionally processes these
outputs as tables for
convenience. | This update
does not impact
the performance
or safety of the
device.
The subject
device includes
normative
ranges for the
spectral
analysis
parameters.
See discussion
above on
updating the
spectral
analysis. This
update does not
impact the
performance or
safety of the
device. |
| 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.
Ten questions are presented
to the patient on the App
during the test. The Patient's
response is captured and
provided to the clinician in the
Gastric Alimetry Report. The
responses are grouped under
'depressive symptoms', 'stress
symptoms', and 'anxiety | 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.
Ten questions are presented
to the patient on the App
during the test. The Patient's
response is captured and
provided to the clinician in the
Gastric Alimetry Report. | The Subject
Device groups
the mental
wellbeing
responses
under 3 groups.
Refer
discussion
above on
updating the
Gut-Brain
Wellbeing
survey
responses. This
update does not
impact the
performance or
safety of the
device. |
| | Gastric Alimetry System | Gastric Alimetry System
(predicate) | Discussion |
| | symptoms'. Gut-Brain
Wellbeing Total Score
included. | | |
| 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. |
| Safety Features | | | |
| Biocompatibility | Array and Reader in contact
with the patient. | Array and Reader in contact
with the patient. | 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. |
| System Checks | Impedance monitor and
connectivity check displayed
prior to recordings. | Impedance monitor and
connectivity check displayed
prior to recordings. | 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. |
| Instructions to
Patient | Yes. User instructs patient to
limit movement, talking and
sleeping.
Additional step of displaying
these instructions to patient via
App as an added safety
measure. | Yes. User instructs patient to
limit movement, talking and
sleeping.
Additional step of displaying
these instructions to patient
via App as an added safety
measure. | 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. |
| Standards with
which the Device
Complies | | | Same as the
predicate. |
| | Gastric Alimetry System | Gastric Alimetry System
(predicate) | Discussion |
| Electrodes | ANSI/AAMI EC12:2000 -
compliance with relevant
requirements. | ANSI/AAMI EC12:2000 -
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. |
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9
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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.