(172 days)
Not Found
No
The summary explicitly states that the device "does not make any diagnostic conclusion" and is intended as a "physiological signal monitor." There is no mention of AI, ML, or any form of automated analysis or interpretation of the EEG data beyond preparing it for review by a medical professional. The performance studies focus on safety, compatibility, and usability, not on the performance of any analytical algorithms.
No
The device is described as a "physiological signal monitor" and does not make diagnostic conclusions or provide therapy; its purpose is to capture and transmit EEG data for review.
No
The text explicitly states: "REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor."
No
The device description explicitly lists a "REMI Sensor" as a major component, which is a disposable hardware sensor placed on the patient's scalp.
Based on the provided information, the REMI Remote EEG Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the REMI System is a "physiological signal monitor" and "does not make any diagnostic conclusion about the subject's condition." IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The REMI System is monitoring electrical activity of the brain in vivo (within the living body).
- Device Description: The components described (sensor placed on the scalp, mobile application, cloud storage) are consistent with a system for capturing and transmitting physiological signals, not for analyzing biological samples.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
Therefore, the REMI Remote EEG Monitoring System falls under the category of a medical device that monitors physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI System uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
REMI System uses the REMI Mobile software application that runs on qualified commercial off-the-shelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.
REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric patients (1+ years).
Product codes (comma separated list FDA assigned to the subject device)
OMC, GXY
Device Description
REMI Sensors amplify electroencephalographic activity acquired from a patient's scalp. After amplification, the EEG data is sent to the REMI Mobile medical application running on a qualified commercial-off-the-shelf mobile computing platform. REMI Mobile combines the EEG from the REMI Sensors with corresponding patient information and relays the REMI Cloud server. REMI Cloud processes the data into a format compatible for viewing using qualified EEG viewing software (initially qualified for viewing on Persyst 14 EEG Review and Analysis Software, K182181).
The REMI System has three major components:
-
- REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
-
- REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android device (phone or smartwatch) for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to.
-
- REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform
where data is processed into a qualified EEG reviewing software format for neurological review.
- REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform
This submission provides evidence to demonstrate that:
-
- The REMI System is safe and effective for monitoring EEG of pediatric patients ages 1 through
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
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May 21, 2025
Epitel. Inc. Christopher Phillips VP, Regulatory Affairs and Quality 465 S 400 E Suite 250 Salt Lake City, Utah 84111
Re: K243185
Trade/Device Name: REMI Remote EEG Monitoring System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: February 21, 2025 Received: February 21, 2025
Dear Christopher Phillips:
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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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,
Image /page/2/Picture/3 description: The image shows the name "Jaime Raben -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible, and the name appears to be the main focus of the image.
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
REMI Remote EEG Monitoring System
Indications for Use (Describe)
The REMI Remote EEG Monitoring System is indicated for use in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted. REMI System uses single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration up to 30 days.
REMI System uses the REMI Mobile software application that runs on qualified commercial off-theshelf mobile computing platforms. REMI Mobile displays user setup information to trained medical professionals and provides notifications to medical professionals and ambulatory users. REMI Mobile receives and transmits data from connected REMI Sensors to the secure REMI Cloud where it is stored and prepared for review on qualified EEG viewing software.
REMI System does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. REMI System is indicated for use with adult and pediatric patients (1+ years).
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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Image /page/4/Picture/0 description: The image shows the word "EPITEL" in a stylized, bold, sans-serif font. The letters are a dark blue color. There is a white line drawing of a waveform inside the letter "P". The letters are slightly rounded at the corners. To the right of the letter "L" is the trademark symbol.
REMI Remote EEG Monitoring Svstem Traditional 510(k) Summary
1. Applicant Information
Epitel, Inc. 465 S 400 E, Suite 250 Salt Lake City, UT 84111
Contact Information
Christopher M. Phillips VP, Regulatory Affairs and Quality
Date Prepared
February 21, 2025
2. Subject Device Information
Name of Device: REMI Remote EEG Monitoring System Common or Usual Name: EEG System Classification Name: Electroencephalograph, Electrode, Cutaneous Regulatory Class: Class II Product Code and Regulation Number: OMC - Sec. 882.1400. GXY Sec. 882.1320
3. Predicate Devices
| Predicate Type | 510(k) Number | Name of Device | Name of Manufacturer |
|---|---|---|---|
| Primary Predicate | K230933 | REMI Remote EEG | |
| Monitoring System | Epitel, Inc. |
4. Device Description
REMI Sensors amplify electroencephalographic activity acquired from a patient's scalp. After amplification, the EEG data is sent to the REMI Mobile medical application running on a qualified commercial-off-the-shelf mobile computing platform. REMI Mobile combines the EEG from the REMI Sensors with corresponding patient information and relays the REMI Cloud server. REMI Cloud processes the data into a format compatible for viewing using qualified EEG viewing software (initially qualified for viewing on Persyst 14 EEG Review and Analysis Software, K182181).
The REMI System has three major components:
-
- REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
-
- REMI Mobile A mobile medical application that is designed to run on a qualified commercial-off-the-shelf mobile computing platform (an Android tablet for use in healthcare settings, and a portable/wearable Android device (phone or smartwatch) for use in ambulatory settings), acquire EEG data transmitted from REMI Sensors and then transmit the EEG data and associated patient information via wireless encrypted transmission to.
-
- REMI Cloud A HIPAA-compliant secure cloud storage and data processing platform
5
Image /page/5/Picture/0 description: The image shows the word "EPITEL" in a stylized, sans-serif font. The letters are a dark blue color. The "I" in "EPITEL" has a graphic of a waveform in the middle of the letter. There is a small "TM" symbol in the bottom right corner of the image.
where data is processed into a qualified EEG reviewing software format for neurological review.
This submission provides evidence to demonstrate that:
-
- The REMI System is safe and effective for monitoring EEG of pediatric patients ages 1 through