REMI Remote EEG Monitoring System

K230933 · Epitel, Inc. · OMC · Jun 30, 2023 · Neurology

Device Facts

• Record ID: K230933
• Device Name: REMI Remote EEG Monitoring System
• Applicant: Epitel, Inc.
• Product Code: OMC · Neurology
• Decision Date: Jun 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Acquisition and presentation of electroencephalographic (EEG) data.

Device Story

REMI Remote EEG Monitoring System captures single-channel EEG signals via disposable, wearable sensors placed on the patient's scalp. Sensors amplify and wirelessly transmit data to the REMI-Mobile application running on qualified Android tablets or smartwatches. REMI-Mobile relays data to the secure REMI-Cloud, which processes and formats the EEG for review on third-party viewing software. Used in healthcare and ambulatory settings by medical professionals and patients. The system provides notifications to users and clinicians. It serves as a physiological signal monitor to facilitate neurological review; it does not perform automated diagnosis. Benefits include remote, long-term (up to 30 days) EEG monitoring capability.

Clinical Evidence

Bench testing only. Testing verified end-to-end system performance: EEG signal acquisition, wireless transmission to REMI-Mobile, relay to REMI-Cloud, and compatibility with qualified EEG viewing software. Additional testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and usability/human factors. Biocompatibility was confirmed via existing data from the predicate device (K203827) for prolonged contact.

Technological Characteristics

System comprises disposable sensors (2 gold electrodes, conductive hydrogel), Android-based mobile application, and cloud platform. Sensors use primary lithium button cells. Connectivity via low-power wireless personal area network (sensor to mobile) and WiFi/cellular (mobile to cloud). Complies with IEC 60601-1, 60601-1-2, 60601-2-26, and 60601-1-11. Biocompatibility per ISO 10993-5 and 10993-10.

Indications for Use

Indicated for use in healthcare and ambulatory settings where near real-time or remote EEG is warranted. Uses single-use, disposable, wearable sensors to amplify, capture, and wirelessly transmit a single channel of brain electrical activity for up to 30 days. Intended for adult and pediatric patients (6+ years). Does not provide diagnostic conclusions; intended as a physiological signal monitor.

Regulatory Classification

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.

Predicate Devices

• REMI (K203827)

Reference Devices

• Persyst 14 EEG Review and Analysis Software (K182181)

Submission Summary (Full Text)

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June 30, 2023

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Epitel, Inc. Randy Parry Staff Regulatory Affairs Specialist 465 South 400 East. Suite 250 Salt Lake City, Utah 84111

Re: K230933

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: March 31, 2023 Received: April 3, 2023

Dear Randy Parry:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Patrick Antkowiak -S

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

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# Indications for Use

510(k) Number (if known) K230933

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 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.

The REMI System uses the REMI-Mobile software application that runs on qualified portable general purpose 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 does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|

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## REMI Remote EEG Monitoring System Traditional 510(k) Summary K230933

#### 1. Applicant Information

Epitel, Inc. 465 S 400 E Suite 250, Salt Lake City, UT 84111

### Primary Contact Information

Randy Parry Staff Regulatory Affairs Specialist Mobile: [phone] Email: [e-mail]

### Secondary Contact Information

Christopher M. Phillips VP, Regulatory Affairs and Quality Mobile: [phone] Email: [e-mail]

## Date Prepared

June 30, 2023

- 2. Subject Device Information Name of Device: REMI Remote EEG Monitoring System Common or Usual Name: EEG System Classification Name: Electroencephalograph, Regulatory Class: Class II Product Code and Regulation Number: OMC - Sec. 882.1400, GXY Sec. 882.1320
- 3. Predicate Device Name of Device: REMI 510(k) Number: K203827 Manufacturer: 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).

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The REMI System has three major components:

- 1) REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
- 2) 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 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,
- 3) 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.

This 510(k) submission includes the addition of the Android smartwatch for ambulatory use and increases the duration of monitoring to up to 30 days.

### 5. Intended Use

Acquisition and presentation of electroencephalographic (EEG) data.

### 6. Indications for Use

The REMI Remote EEG Monitoring System (REMI 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 uses single use, single patient, disposable, wearable sensors intended to amplify, capture, and wirelessly transmit a single channel of electrical activity of the brain for a duration of up to 30 days.

The 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 does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor. The REMI System is indicated for use with adult and pediatric patients (6+ years).

### 7. Substantial Equivalence

The REMI System has been developed in compliance with applicable FDA requirements and quidance as well as with recognized standards. This submission includes required documentation and testing data demonstrating substantial equivalence of the REMI System to its predicate device. The device has undergone software testing, human factors/usability testing, electromagnetic compatibility and electrical safety testing, and biocompatibility testing, which demonstrate that it is safe and effective for its intended use. The subject REM System presents no new significant risks or safety concerns, and any potential risks have been mitigated as low as reasonably possible.

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| Attribute | Subject Device K230933<br>REMI Remote EEG Monitoring System | Predicate Device K203827<br>REMI |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Acquisition and presentation of<br>electroencephalographic (EEG) data. | Acquisition and presentation of<br>electroencephalographic (EEG) data. |
| Indications for Use | The REMI Remote EEG Monitoring System is<br>indicated for use in healthcare settings where near<br>real-time and/or remote EEG is warranted and in<br>ambulatory settings where remote EEG is<br>warranted. REMI uses single use, single patient,<br>disposable, wearable sensors intended to amplify,<br>capture, and wirelessly transmit a single channel of<br>electrical activity of the brain for a duration up to 30<br>days.<br>The REMI System uses the REMI-Mobile software<br>application that runs on qualified portable general<br>purpose computing platforms. REMI-Mobile<br>displays user setup information to trained medical<br>professionals and provides notifications to medical<br>professionals and ambulatory users. REMI-Mobile<br>receives and transmits data from connected REMI<br>Sensors to the secure REMI-Cloud where it is<br>stored and prepared for review on qualified EEG<br>viewing software.<br>REMI does not make any diagnostic conclusion<br>about the subject's condition and is intended as a<br>physiological signal monitor. The REMI System is<br>indicated for use with adult and pediatric patients<br>(6+ years). (Rx only). | The REMI System is intended to be used in<br>healthcare settings where near real-time and/or<br>remote EEG is warranted. REMI uses disposable<br>Sensors – a single use, single patient, disposable,<br>wearable sensor intended to amplify, capture, and<br>wirelessly transmit a single channel of electrical<br>activity of the brain for up to 48 hours. The REMI<br>Mobile software and REMI Tablet are intended to<br>receive and transmit data from four REMI Sensors to<br>secure cloud storage for subsequent viewing and<br>reviewing of EEG on third-party software.<br>REMI does not make any diagnosis or<br>recommendations and is intended only as a<br>physiological signal monitor.<br>REMI Sensors are intended for use by trained<br>medical professionals in a professional healthcare<br>facility environment. REMI Sensors are intended for<br>use with adult and pediatric patients (6+). (Rx only). |
| Use Environment | The REMI system is intended to be used in health<br>care settings for near real time/and or remote EEG<br>signal collection.<br><br>The REMI system is intended to be used in<br>ambulatory settings for remote EEG signal<br>collection and includes home-use. | The REMI system is intended to be used in health<br>care settings for near real time/and or remote EEG<br>signal collection. |
| Software/System<br>User Interface | REMI Mobile medical application<br>The REMI Mobile application is run on qualified<br>commercial off-the-shelf Android computing<br>platforms. | REMI Mobile medical application<br>The REMI Mobile application is run on qualified<br>commercial off-the-shelf Android computing<br>platforms. |
| Qualified Computing<br>Platform Operating<br>Systems | Android 11 or higher<br>Wear OS 3.0 or higher | Android 6 |
| Sensor User<br>Interface | The REMI Sensor has a single push button<br>integrated into the sensor that serves as the user<br>interface. Some feedback about sensor status is<br>given via an onboard LED. | The REMI Sensor has a single push button<br>integrated into the sensor that serves as the user<br>interface. Some feedback about sensor status is<br>given via an onboard LED. |
| Physiological Signal<br>Acquired | EEG acquired from a patient's scalp | EEG acquired from a patient's scalp |
| Attribute | Subject Device K230933<br>REMI Remote EEG Monitoring System | Predicate Device K203827<br>REMI |
| Patient Contact | REMI-Sticker accessory contacts the patient's skin<br>(scalp). | REMI-Sticker accessory contacts the patient's skin<br>(scalp). |
| Cumulative Wear<br>Time | Up to 30 days. Prolonged contact. | Up to 48 hours. Prolonged contact. |
| Electrodes | 2 passive gold electrodes that interface with the<br>scalp through a conductive hydrogel integrated into<br>the sticker. | 2 passive gold electrodes that interface with the<br>scalp through a conductive hydrogel integrated into<br>the sticker. |
| Type of Use | REMI sensor is a non-sterile, single-use<br>disposable device. | REMI sensor is a non-sterile, single-use disposable<br>device. |
| Channels | Up to 10 | Up to 10 |
| Montage | 10/20 system – REMI Sensor can be placed<br>anywhere in the 10/20 system where each channel<br>represents a bipolar derivation approximation of<br>the 10/20 system | 10/20 system - REMI Sensor can be placed<br>anywhere in the 10/20 system where each channel<br>represents a bipolar derivation approximation of the<br>10/20 system |
| Electrical Safety and<br>EMC | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-26<br>IEC 60601-1-11:2015 /A1:2020 | IEC 60601-1,<br>IEC 60601-1-2,<br>IEC 60601-2-26 |
| Input Range<br>(sensors) | 1 mVp-p | 1 mVp-p |
| Input Noise (sensors) | 5 µVp-p | 5 µVp-p |
| Transfer of Data from<br>the sensor to REMI<br>Mobile (operating on<br>a qualified computing<br>platform) | Low power wireless personal area network | Low power wireless personal area network |
| Transfer of data from<br>REMI Mobile to REMI<br>Cloud | Secured WiFi or Cellular data connection | Secured WiFi or Cellular data connection |
| Power Source<br>(sensors) | Primary lithium button cell (not rechargeable) | Primary lithium button cell (not rechargeable) |
| Data Format (Viewer<br>software) | Common EEG data formats (e.g., lay-dat) | Common EEG data formats (e.g., lay-dat) |
| Firmware (sensors) | REMI sensors use integrated firmware to collect<br>and transmit EEG data to the REMI Mobile<br>application. | REMI sensors use integrated firmware to collect and<br>transmit EEG data to the REMI Mobile application. |
| Software (REMI<br>Cloud) | The REMI Cloud receives EEG data from the<br>REMI Mobile app and prepares it into a format for<br>viewing in the qualified EEG viewing software.<br><br>REMI Cloud also facilitates transfer and<br>subsequent receipt of EEG data for additional<br>characterization by EEG analysis module(s). | The REMI Cloud receives EEG data from the REMI<br>Mobile app and prepares it into a format for viewing<br>in the qualified EEG viewing software. |
| Attribute | Subject Device K230933<br>REMI Remote EEG Monitoring System | Predicate Device K203827<br>REMI |
| Connector | REMI Sensors are equipped with a non-standard<br>USB pinout/connector that is only used for<br>programming during production. This interface is<br>not used by the clinician or patient. | REMI Sensors are equipped with a non-standard<br>USB pinout/connector that is only used for<br>programming during production. This interface is not<br>used by the clinician or patient. |
| | Available Sizes<br>(sensor) | REMI Sensor comes in one size:<br>Width: 27 mm<br>Length: 27 mm<br>Depth: 7 mm |
| Conductive<br>Electrolyte Gel<br>(sticker) | Conductive electrolyte is in the form of a hydrogel<br>converted in a one-piece adhesive sticker as an<br>accessory to the REMI Sensor. | Conductive electrolyte is in the form of a hydrogel<br>converted in a one-piece adhesive sticker as an<br>accessory to the REMI Sensor. |
| | The sticker is replaceable<br>and single use. | The sticker is replaceable<br>and single use. |
| Biocompatibility | Biocompatibility of patient contacting components<br>verified with Irritation, Sensitization, and<br>Cytotoxicity testing per ISO 10993-5:2009 and ISO<br>10993-10:2010 for a prolonged time period. | Biocompatibility of patient contacting components<br>verified with Irritation, Sensitization, and Cytotoxicity<br>testing per ISO 10993-5:2009 and ISO 10993-<br>10:2010 for a prolonged time period. |

# 7.1. Summary of Technological Characteristics and Substantial Equivalence

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#### Performance Testing 8.

Testing verifying the performance requirements of the subject device was conduct…