REMI Remote EEG Monitoring System

{0}------------------------------------------------ June 30, 2023 Image /page/0/Picture/1 description: The image shows 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 consists of a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. 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. 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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 {2}------------------------------------------------ # 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> | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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: 801-497-6297 Email: r.parry@epitel.com ### Secondary Contact Information Christopher M. Phillips VP, Regulatory Affairs and Quality Mobile: 801-497-6297 Email: c.phillips@epitel.com ## 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). {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "epitel" in a sans-serif font. The word is in a dark blue color. There is a graphic of a waveform in the middle of the word, replacing the vertical line of the "p". 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. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for "epitel". The logo is in a dark blue color. The "e" and "p" are connected with a line that looks like an EKG reading. | 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 {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "epitel" in a bold, sans-serif font. The letters are a dark blue color. There is a stylized graphic of a waveform inside of a blue square that is placed above the "i" in "epitel". The waveform is white. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for "epitel". The logo is in a dark blue color. The "e" and "p" are connected to a square with a white line going through it. The rest of the letters are not connected. #### Performance Testing 8. Testing verifying the performance requirements of the subject device was conduct…