(170 days)
Not Found
No
The summary describes an electrogastrography (EGG) device that records, stores, views, and processes myoelectrical data. While it mentions an "artifact detection algorithm," there is no explicit mention of AI, ML, deep learning, or any related terms. The performance studies focus on comparing the device's frequency measurement and artifact detection algorithm to a predicate device and manual marking, not on validating an AI/ML model's performance.
No.
The device is described as aiding in the diagnosis of various gastric disorders by recording, storing, viewing, and processing gastric myoelectrical activity, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended to aid in the diagnosis of various gastric disorders by recording, storing, viewing, and processing gastric myoelectrical activity, which directly relates to diagnosing medical conditions.
No
The device description explicitly mentions hardware components like an "array with recording electrodes on an adhesive patch" used for recording myoelectrical data from the skin surface. While there is an App involved, the system includes physical hardware for data acquisition.
Based on the provided information, the Gastric Alimetry System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The Gastric Alimetry System measures myoelectrical activity on the surface of the abdomen. It does not analyze blood, urine, tissue, or other samples removed from the patient.
- The device description and intended use focus on measuring a physiological signal. It records and processes electrical activity from the stomach, which is a physiological measurement, not an analysis of a biological specimen.
- The output is a report of myoelectrical data. This data is derived from the surface measurement, not from the analysis of a biological sample.
Therefore, the Gastric Alimetry System falls under the category of a non-invasive diagnostic device that measures physiological parameters, rather than an In Vitro Diagnostic device.
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.
Product codes
MYE
Device Description
The Gastric Alimetry 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 the myoelectrical data and movement artifacts through an array with recording electrodes on an adhesive patch which is used for recording the myoelectrical data from the skin surface. An App 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 displays myoelectrical data.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach (surface of the abdomen)
Indicated Patient Age Range
18 and over
Intended User / Care Setting
clinicians
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
A prospective clinical study was undertaken on a total of 25 patients aged 18 and over with various qastric disorders. This was a simultaneous head-to-head comparison to the predicate to evaluate the mean of the frequency of the raw data recorded from the predicate electrode channels vs identically positioned channels recorded simultaneously with the Gastric Alimetry System. The results demonstrate that the Gastric Alimetry System detects and measures gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device within a cohort of patients with various gastric disorders who form the target population for the device in clinical practice. Minimal adverse events were observed, with all reported events being minor and transient and predominantly related to irritation at the site of the electrodes.
Additional clinical study data was used to evaluate the sensitivity and specificity of the artifact detection algorithm against manual marking of artifacts by clinicians. These data demonstrated that the automated artifact detection algorithm is comparable to manual marking.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective Clinical Study
Sample Size: 25 patients
Key Results: The Gastric Alimetry System detects and measures gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device within a cohort of patients with various gastric disorders who form the target population for the device in clinical practice. Minimal adverse events were observed, with all reported events being minor and transient and predominantly related to irritation at the site of the electrodes. The automated artifact detection algorithm is comparable to manual marking.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
sensitivity and specificity (for artifact detection algorithm)
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.
0
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 seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
June 3, 2022
Alimetry Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19115
Re: K213924
Trade/Device Name: Gastric Alimetry System Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography system Regulatory Class: Class II Product Code: MYE Dated: December 15, 2021 Received: December 15, 2021
Dear Ms. 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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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, 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
2
Indications for Use
510(k) Number (if known) K213924
Device Name Gastric Alimetry System
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 gastric 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY Alimetry's Gastric Alimetry
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Alimetry Ltd.
Phone: +64 27 609 1886 Facsimile: -Contact Person: Yaara Yarmut, Chief Regulatory Officer. Date Prepared: December 15, 2021
Name of Device and Name/Address of Sponsor
Gastric Alimetry Trade name:
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 Devices
Trade Name: Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269) Manufacturer: Medtronic A/S
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
The Gastric Alimetry 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 the myoelectrical data and movement artifacts through an array with recording electrodes on an adhesive patch which is used for recording the myoelectrical data from the skin surface. An App used to set up the device and capture patient-reported symptom data.
4
A report is provided to the clinicians at the end of the test which displays myoelectrical data.
Technological Characteristics / Substantial Equivalence
The Gastric Alimetry device has the same intended use, and substantially similar indications for use and technological characteristics as the cleared predicate. Both devices are intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of various gastric disorders.
| Gastric Alimetry | Medtronic Polygram NET Electrogastrography (EGG) System (K014269) | |
|---|---|---|
| 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, process and view gastric myoelectrical activity as an aid to the diagnosis of gastrointestinal motility disorders |
| Electrodes | Disposable; Peel-and-stick patch. | Disposable; Placed individually. |
| Sampling Frequency | 4 Hz | 1Hz |
| Low Frequency Range | DC | DC |
| High frequency range | 2 Hz | 0.5 Hz |
| Number of channels | 8 displayed 64 (+2 reference) | 4 (+2 reference) |
| Electrode to recorder interface | Reader located on the Array and directly connected to it. | Electrodes connected to recorder with cables. |
| Screen | Dedicated tablet for system operation | Connected to a desktop computer for system operation |
| Motion Sensor | Accelerometer | Accelerometer |
| Power Source | Battery powered | Connected to the mains power supply |
| Patient Symptom Logging | Available on App interface. | Available on desktop interface. |
Performance Data
Testing was performed to verify device specifications and confirm the safety and performance of the device. In all instances, the Gastric Alimetry functioned as intended. Testing comprised:
- . Biocompatibility testing addressing cytotoxicity, sensitization, and skin irritation in accordance with ISO 10993
5
- Cleaning and disinfection validation of reusable components
- . Package validation
- Shelf life validation
- . Software verification and validation
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2014 4th edition and FCC 47 CFR Part 15 subpart C 2021.
- Electrical safety in accordance with IEC 60601-1:2005 + A1:2012
- . Human factors evaluation by medical professional to address placement of the array and comprehension of the report
A prospective clinical study was undertaken on a total of 25 patients aged 18 and over with various qastric disorders. This was a simultaneous head-to-head comparison to the predicate to evaluate the mean of the frequency of the raw data recorded from the predicate electrode channels vs identically positioned channels recorded simultaneously with the Gastric Alimetry System. The results demonstrate that the Gastric Alimetry System detects and measures gastric myoelectrical frequency across pre-prandial and postprandial periods in an equivalent manner to the predicate device within a cohort of patients with various gastric disorders who form the target population for the device in clinical practice. Minimal adverse events were observed, with all reported events being minor and transient and predominantly related to irritation at the site of the electrodes.
Additional clinical study data was used to evaluate the sensitivity and specificity of the artifact detection algorithm against manual marking of artifacts by clinicians. These data demonstrated that the automated artifact detection algorithm is comparable to manual marking.
Substantial Equivalence
The Gastric Alimetry has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Gastric Alimetry and its predicate devices do not raise different questions of safety or effectiveness. Performance data demonstrate that the Gastric Alimetry is as safe and effective as the Polygraf ID with Electrogastrography System. Thus, the Gastric Alimetry is substantially equivalent to the predicate.