(170 days)
Gastric Alimetry (K213924)
No
The description focuses on signal processing and calculation of standard metrics, with no mention of AI or ML algorithms. The performance study compares calculated metrics to a reference device, not the performance of an AI/ML model.
No
The device is described as an aid in the diagnosis of various gastric disorders by recording and processing gastric myoelectrical activity, not for treating any condition.
Yes
The device is described as "an aid in the diagnosis of various gastric disorders," indicating its purpose is to assist in identifying or characterizing medical conditions.
No
The device description explicitly mentions hardware components like an "array with recording electrodes on an adhesive patch" used for acquiring data from the skin surface. While there is an App (software) involved, it is part of a larger system that includes physical hardware for data acquisition.
Based on the provided information, the Gastric Alimetry System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Gastric Alimetry System Function: The Gastric Alimetry System measures myoelectrical activity at the surface of the abdomen. It does not analyze biological specimens taken from the body. It's a non-invasive external measurement device.
- Intended Use: The intended use is to record and process gastric myoelectrical activity as an aid in diagnosis, but this is based on external physiological signals, not analysis of bodily fluids or tissues.
Therefore, the Gastric Alimetry System falls under the category of a medical device that measures physiological signals externally, rather than an IVD.
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 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 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 minor updates are introduced in order to provide additional data summaries within the Report:
- Addition of four post-processing data summary metrics:
- Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range
- 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI 0.91; p0.91; p
§ 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
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April 27, 2023
Alimetry Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19115
Re: K223398
Trade/Device Name: Gastric Alimetry Regulation Number: 21 CFR§ 876.1735 Regulation Name: Electrogastrography System Regulatory Class: II Product Code: MYE Dated: March 27, 2023 Received: March 27, 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 (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 Federal statutes and regulations administered by other Federal agencies.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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-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
2
Indications for Use
510(k) Number (if known) K223398
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 gastric disorders.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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: November 8, 2022
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
-
- Trade Name: Gastric Alimetry (K213924) (primary predicate) Manufacturer: Alimetry Ltd.
-
- Trade Name: Polygraf ID with POLYGRAM NET ElectroGastroGraphy Application Software (K014269) (reference device) 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 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.
4
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 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 minor updates are introduced in order to provide additional data summaries within the Report:
- Addition of four post-processing data summary metrics:
- Principal Gastric Frequency showing the frequency of myoelectrical activity o occurring within the gastric range
- 'BMI-Adjusted Amplitude' calculated amplitude for BMI up to the recommended O device limit (BMI 0.91; p