(116 days)
No
The description mentions "computer-based data analysis algorithms" and "data processing algorithms" but does not use terms like AI, ML, deep learning, or neural networks. The focus is on extracting rhythmic motor activity signals and spectral analysis, which are traditional signal processing techniques.
No
The device is described as a diagnostic tool used to measure gastrointestinal myoelectrical activity to aid in the diagnosis and evaluation of gastrointestinal disorders. It does not provide treatment or therapy.
Yes.
Justification: The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis and evaluation of gastrointestinal disorders."
No
The device description explicitly states that the system consists of hardware components (G-Tech Patch, G-Tech Patch Monitor) in addition to the software (iOS application, cloud storage, data analysis algorithms).
Based on the provided information, the G-Tech Patch System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device provides "gastrointestinal myoelectrical activity measurements" to "aid in the diagnosis and evaluation of gastrointestinal disorders." This involves measuring electrical signals from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a system that uses a wearable patch to read electrical signals from the abdominal skin surface. This is a non-invasive method of measuring physiological activity.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVDs.
- Focus on Physiological Measurement: The core function of the device is to measure electrical activity within the gastrointestinal tract, which is a physiological measurement, not an in vitro analysis.
In summary, the G-Tech Patch System is a device that measures physiological signals from the body to aid in diagnosis, which falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
Product codes (comma separated list FDA assigned to the subject device)
MYE
Device Description
The G-Tech System is a non-invasive wireless gastrointestinal monitoring system for use by the physician or staff in the hospital setting, clinic, or physician's office. The device is intended for use while the patient is under direct supervision (e.g., in hospital or clinic) as well as after discharge to home or to intermediate setting.
The device is for prescription use only.
The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS application, a secure cloud storage server and computer-based data analysis algorithms.
The G-Tech Patch is a single use, wearable electrode patch that reads the electrical signals of the gastrointestinal tract from the abdominal skin surface. The Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch Monitor.
The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient interface to allow the patient to manual enter events such as meals, bowel movements, pain or the taking of medications.
Data analysis algorithms process the uploaded data to measure and report myoelectrical activity for the stomach and intestines. These measurements are made available to physicians for aid in clinical evaluation of their patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, abdominal skin surface, stomach, small intestine, colon
Indicated Patient Age Range
pediatric populations, adult
Intended User / Care Setting
Physician or Clinical User, hospital setting, clinic, physician's office.
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)
Software Verification and Validation Testing: The G-Tech Patch System uses software to acquire and process the myoelectrical signals and generate a report for the Physician. Software documentation for the G-Tech Patch System was developed in consideration of FDA's guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices" and is provided.
Mechanical Strength Testing: Mechanical Strength testing that includes wear adhesion test and tensile strength test are presented. Additionally, impact test, drop test and shock and vibration tests, conducted for compliance to 60101-1-11 that assesses requirements of medical electrical equipment for Home Healthcare, is presented. The testing demonstrates that the G-Tech Wireless Patch System device should perform as intended in the specified use conditions and maintain the safety profile of the predicate system.
Bench Performance Study: Functional bench testing performed to demonstrate the performance and efficiency of the patch system and algorithms that calculate myoelectrical activity of the Stomach and Intestines are presented. Known signals that have realistic background, artifact and noise characteristics to the system were applied to the system both directly and through a phantom, to assess how the system will perform when the signals are real and not known a priori. The study demonstrated that the G-Tech Patches are reliable and provide consistent electrical measurement devices, and that the data processing algorithms are efficient engines for extracting rhythmic motor activity signals.
Animal Study: Data from a study undertaken to compare simultaneous measurements between G-Tech Wireless Patches and multi-element electrodes sutured to serosal surfaces of stomach, small intestine, and colon of adolescent Yucatan mini-pigs is presented. The data demonstrate that the slow wave signals associated with the three major GI organs as observed with internal electrodes are detectable at the skin surface with the G-Tech Wireless Patches and have fidelity to the internally measured signals in frequency and spectral shape.
Clinical Studies: G-Tech Medical has studied its technology under several nonsignificant risk IRB-approved studies and well-documented case histories. These studies have focused on understanding the measurement capabilities and potential clinical utility of the technology.
The primary evidence includes simultaneous measurements between G-Tech Wireless Patches and antroduodenal and colonic manometry that demonstrates that the non-invasive patch system records signals that can be identified as being from the Stomach, Duodenum/Jejunum and Colon by the concordance with frequency and time, of spectral analysis of high-resolution manometry data. Similarly, concordance in frequency and time observed between G-Tech Wireless Patch measurements and Smart Pill measurements is presented that corroborates the findings from the manometry study.
The supplemental evidence provided are four peer-reviewed publications listed below. Three of these demonstrate correlation between the G-Tech Wireless Patch Measurements and clinical markers of postoperative recovery in adult and pediatric populations. A fourth peer reviewed publication demonstrates reproducibility of the gastric and intestinal myoelectrical profile over multi-year periods and the sensitivity of the measurements to in external stimulus in specific examples.
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.
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.
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
§ 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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2022
G-Tech Medical Steve Axelrod President and CEO 2495 Hospital Drive, Suite 300 Mountain View, CA 94040
Re: K212954
Trade/Device Name: G-Tech Wireless Patch System (WPS) Regulation Number: 21 CFR 876.1735 Regulation Name: Electrogastrography System Regulatory Class: Class II Product Code: MYE Dated: September 14, 2021 Received: September 16, 2021
Dear Steve Axelrod:
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. 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
1
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-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 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,
for
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) K212954
Device Name The G-Tech Wireless Patch System (WPS)
Indications for Use (Describe)
The intended use for the G-Tech Patch System is to serve as a tool that provides gastrointestinal myoelectrical activity measurements to be used at the discretion of the Physician or Clinical User to aid in the diagnosis and evaluation of gastrointestinal disorders.
| 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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3
K212954 Page 1 of 4
510(k) Summary
This summary of the 510(k) premarket notification for the G-Tech Patch System is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR§807.92.
| Date: | Jan 7, 2022 |
|---|---|
| Applicant: | G-Tech Medical, Inc. |
| 2495 Hospital Drive, Suite # 300 | |
| Mountain View, CA 94040 | |
| Phone: 650-269-1479 | |
| Fax: N/A | |
| Applicant | |
| Contact Person: | Steve Axelrod, PhD |
| President and CEO, G-Tech Medical, Inc. | |
| 2495 Hospital Drive, Suite # 300 | |
| Mountain View, CA 94040 | |
| Phone: 650-269-1479 | |
| Fax: N/A | |
| Email: steve.axelrod@gtechhealth.com | |
| Device | |
| Information | Trade Name: The G-Tech Wireless Patch System (WPS) |
| Generic/Common Name: Gastrointestinal myoelectrical activity measurement | |
| system | |
| Regulation: 21 CFR 876.1735 | |
| Classification: Electrogastrography (EGG) system | |
| Product Code: MYE | |
| Predicate | |
| Device(s) | Primary predicate device #1: DEN990005 / K984637, THE 3CPM EGG |
| MACHINE | |
| Predicate device #2: K014269, Polygram Net Electrogastrography Application | |
| Software, Model 9043S0151; Polygraf Id, Model 9043G0102 | |
| Reference device: K092342, Smartpill GI Monitoring System, Version 2.0. | |
| Intended Use | The intended use for the G-Tech Patch System is to serve as a tool that provides |
| gastric and intestinal myoelectrical activity measurements to be used at the | |
| discretion of the Physician or Clinical User to aid in the diagnosis and evaluation | |
| of gastrointestinal disorders. | |
| Device | |
| Description | The G-Tech System is a non-invasive wireless gastrointestinal monitoring system |
| for use by the physician or staff in the hospital setting, clinic, or physician's | |
| office. The device is intended for use while the patient is under direct supervision | |
| (e.g., in hospital or clinic) as well as after discharge to home or to intermediate | |
| setting. | |
| The device is for prescription use only. | |
| The device consists of the G-Tech Patch, the G-Tech Patch Monitor, an iOS | |
| application, a secure cloud storage server and computer-based data analysis | |
| algorithms. | |
| The G-Tech Patch is a single use, wearable electrode patch that reads the | |
| electrical signals of the gastrointestinal tract from the abdominal skin surface. The | |
| Patch transmits the acquired electrical signals via Bluetooth to the G-Tech Patch | |
| Monitor. | |
| The G-Tech Patch Monitor receives the raw data, encrypts it, and periodically | |
| uploads it to a secure cloud server. Additionally, the Patch Monitor has a patient | |
| interface to allow the patient to manual enter events such as meals, bowel | |
| movements, pain or the taking of medications. | |
| Data analysis algorithms process the uploaded data to measure and report | |
| myoelectrical activity for the stomach and intestines. These measurements are | |
| made available to physicians for aid in clinical evaluation of their patient. | |
| Determination of | |
| Substantial | |
| Equivalence: | Indications for Use: The G-Tech Wireless Patch System and the predicate device |
| have the same indications for use and same intended population. | |
| Technology: The G-Tech WPS operates on the same fundamental principal as the | |
| predicate system by measuring myoelectrical activity with cutaneous electrodes at | |
| the abdominal skin surface. Technological improvements in the G-Tech WPS | |
| that improve on the predicate system have been evaluated to ensure that the safety | |
| and efficacy profile of the predicate device is maintained for the G-Tech Patch | |
| System. | |
| Electrical safety and electromagnetic compatibility (EMC): Electrical safety | |
| and EMC testing were conducted on the G-Tech Wireless Patch System. The G- | |
| Tech Wireless Patch System complies with the following standards | |
| • IEC 60601-1:2005 | |
| • IEC 60601-1-11:2015 | |
| • IEC 60601-1-6:2010 | |
| • IEC 60601-1-2:2014 | |
| • ANSI C63.27-2017 | |
| Biocompatibility: The biocompatibility of the G-Tech Patch System was | |
| assessed by evaluating the results of the testing recommended by ISO 10993- | |
| 1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing | |
| within a risk management. The G-Tech Patch has been assessed to be compliant | |
| for contact with intact skin for up to 30 days. |
510(k) Notification K212954
4
5
Software Verification and Validation Testing: The G-Tech Patch System uses software to acquire and process the myoelectrical signals and generate a report for the Physician. Software documentation for the G-Tech Patch System was developed in consideration of FDA's guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for the Management of Cybersecurity in Medical Devices" and is provided.
Mechanical Strength Testing: Mechanical Strength testing that includes wear adhesion test and tensile strength test are presented. Additionally, impact test, drop test and shock and vibration tests, conducted for compliance to 60101-1-11 that assesses requirements of medical electrical equipment for Home Healthcare, is presented. The testing demonstrates that the G-Tech Wireless Patch System device should perform as intended in the specified use conditions and maintain the safety profile of the predicate system.
Bench Performance Study: Functional bench testing performed to demonstrate the performance and efficiency of the patch system and algorithms that calculate myoelectrical activity of the Stomach and Intestines are presented. Known signals that have realistic background, artifact and noise characteristics to the system were applied to the system both directly and through a phantom, to assess how the system will perform when the signals are real and not known a priori. The study demonstrated that the G-Tech Patches are reliable and provide consistent electrical measurement devices, and that the data processing algorithms are efficient engines for extracting rhythmic motor activity signals.
Animal Study: Data from a study undertaken to compare simultaneous measurements between G-Tech Wireless Patches and multi-element electrodes sutured to serosal surfaces of stomach, small intestine, and colon of adolescent Yucatan mini-pigs is presented. The data demonstrate that the slow wave signals associated with the three major GI organs as observed with internal electrodes are detectable at the skin surface with the G-Tech Wireless Patches and have fidelity to the internally measured signals in frequency and spectral shape.
Clinical Studies: G-Tech Medical has studied its technology under several nonsignificant risk IRB-approved studies and well-documented case histories. These studies have focused on understanding the measurement capabilities and potential clinical utility of the technology.
The primary evidence includes simultaneous measurements between G-Tech Wireless Patches and antroduodenal and colonic manometry that demonstrates that the non-invasive patch system records signals that can be identified as being from the Stomach, Duodenum/Jejunum and Colon by the concordance with frequency and time, of spectral analysis of high-resolution manometry data. Similarly, concordance in frequency and time observed between G-Tech Wireless Patch measurements and Smart Pill measurements is presented that corroborates the findings from the manometry study.
The supplemental evidence provided are four peer-reviewed publications listed below. Three of these demonstrate correlation between the G-Tech Wireless Patch Measurements and clinical markers of postoperative recovery in adult and
6
| | pediatric populations. A fourth peer reviewed publication demonstrates
reproducibility of the gastric and intestinal myoelectrical profile over multi-year
periods and the sensitivity of the measurements to in external stimulus in specific
examples. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. Dua, M.M., Navalgund, A., Axelrod, S., Axelrod, L., Worth, P.J., Norton,
J.A., Poultsides, G.A., Triadafilopoulos, G. and Visser, B.C., 2018.
Monitoring gastric myoelectric activity after pancreaticoduodenectomy
for diet "readiness”. American Journal of Physiology-Gastrointestinal
and Liver Physiology , 315(5), pp. G743-G751. |
| | 2. Navalgund, A., Axelrod, S., Axelrod, L., Singhal, S., Tran, K., Legha, P.,
& Triadafilopoulos, G. (2019). Colon myoelectric activity measured after
open abdominal surgery with a noninvasive wireless patch system
predicts time to first flatus. Journal of Gastrointestinal Surgery , 23(5),
982-989. |
| | 3. Taylor, J.S., de Ruijter, V., Brewster, R., Navalgund, A., Axelrod, L.,
Axelrod, S., Dunn, J.C. and Wall, J.K., 2019. Cutaneous Patches to
Monitor Myoelectric Activity of the Gastrointestinal Tract in
Postoperative Pediatric Patients. Pediatric gastroenterology, hepatology
& nutrition , 22(6), pp.518-526. |
| | 4. Axelrod, L., Axelrod, S., Navalgund, A. and Triadafilopoulos, G., 2020.
Pilot Validation of a New Wireless Patch System as an Ambulatory,
Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic
and Disease Correlations. Digestive Diseases and Sciences , pp.1-11. |
| Conclusion: | The G-Tech Patch System and the predicate device have the same indications for
use. Technological improvements in the G-Tech WPS that expand the utility of
the predicate device have been evaluated to ensure that the safety and efficacy
profile of the predicate device is maintained for the G-Tech Patch System.
The biocompatibility, electrical and electromagnetic testing and hardware testing
support the safety of the device. The clinical data supports the safety and the
ability of the G-Tech Wireless Patch System to measure not just gastric but also
intestinal myoelectrical activity. The bench testing, hardware and software
verification and validation demonstrate that the G-Tech Wireless Patch System
device should perform as intended in the specified use conditions. Therefore, it is
the conclusion of G-Tech Medical that the G-Tech Patch System is substantially
equivalent to the predicate device. |