(88 days)
No
The summary explicitly states "REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor." and there is no mention of AI, ML, or related terms in the device description or performance studies. The system focuses on data acquisition, transmission, storage, and preparation for review by a medical professional.
No
The device is described as a "physiological signal monitor" that "does not make any diagnostic conclusion." Its primary function is to amplify, capture, and wirelessly transmit EEG data for review, rather than to treat or cure a condition.
No
The "Intended Use / Indications for Use" section explicitly states, "REMI does not make any diagnostic conclusion about the subject's condition and is intended as a physiological signal monitor."
No
The device description explicitly states that the REMI System has three major components, including a physical "REMI Sensor" which is a disposable EEG sensor. This indicates the system includes hardware components beyond just software.
Based on the provided information, the REMI Remote EEG Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- REMI's Function: The REMI system collects electrical activity from the brain (EEG) directly from the patient's scalp. This is a physiological signal collected in vivo (within the living body), not from a specimen in vitro (outside the living body).
- Intended Use: The intended use explicitly states that REMI is a "physiological signal monitor" and "does not make any diagnostic conclusion about the subject's condition." This further reinforces that it's not performing diagnostic tests on biological samples.
Therefore, the REMI Remote EEG Monitoring System is a medical device that monitors physiological signals, but it does not fit the definition of 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 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).
Product codes
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's scalp
Indicated Patient Age Range
adult and pediatric patients (6+ years)
Intended User / Care Setting
Trained medical professionals in healthcare settings where near real-time and/or remote EEG is warranted and in ambulatory settings where remote EEG is warranted.
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
Bench Testing: End to end testing was conducted to ensure that the REMI System meets its Essential Performance: to record digitized EEG data with patient-applied sensors, and transfer the data, wirelessly, to a cloud-based archive. End to end testing verified that (1) the REMI System is able to acquire EEG signals using REMI Sensors and subsequently transmit that EEG data to REMI Mobile software, (2) that REMI Mobile is able to transfer the EEG data to the REMI Cloud, and (3) the final EEG file format within REMI Cloud is viewable in qualified EEG viewing software. This testing demonstrates that the REMI System meets its Essential Performance and fulfills system requirements.
General Electrical Safety, Electromagnetic Compatibility and Ingress Protection: Testing conducted to: IEC 60601-1:2005, including Amendment 2:2021, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-2-26:2015, Particular Requirements For The Basic Safety And Essential Performance Of Electroencephalographs IEC 60601-1-11:2015 + A1:2021, Medical Electrical Equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment
Wireless Technology Testing: Wireless functionality is needed for the REMI System to achieve its Essential Performance. Because of this, comprehensive EMC testing of the REMI System has been conducted, including immunity to electromagnetic disturbance, in accordance with IEC 60601-1-2 and consistent with the requirements of IEC 60601-1-11. REMI Sensor wireless connectivity was tested with the qualified computing platform to demonstrate that wireless connections can be initiated, are stable, and are able to accurately transfer EEG signals. REMI Sensors were also tested to ensure that a wireless connection is able to be maintained for a minimum of 48 continuous hours.
Environmental/Shelf life: Accelerated aging and subsequent functional verification testing
Packaging Performance: Ship testing and subsequent functional verification testing
Biocompatibility: There are no new patient contacting components as part of this submission and no new biocompatibility testing was required. The patient contacting materials are identical to those presented in the predicate device submission (K203827). There have not been any changes to the material or tested contact type/duration.
Usability/Human Factors: Human factors/usability testing was conducted to evaluate tasks associated with use of the device.
Software Testing: REMI Mobile software has been updated compared to the predicate software hand-off an initialized session from a primary computing platform (Android tablet) to a portable/wearable computing platform (Wear OS smartwatch) in order to support portable/wearable ambulatory use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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. 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,
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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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: 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
-
- 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
-
- 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:
-
- 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 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.
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
REMI Remote EEG Monitoring System | Predicate Device K203827
REMI |
|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Acquisition and presentation of
electroencephalographic (EEG) data. | Acquisition and presentation of
electroencephalographic (EEG) data. |
| 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 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 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). (Rx only). | The REMI System is intended to be used in
healthcare settings where near real-time and/or
remote EEG is warranted. REMI uses disposable
Sensors – a single use, single patient, disposable,
wearable sensor intended to amplify, capture, and
wirelessly transmit a single channel of electrical
activity of the brain for up to 48 hours. The REMI
Mobile software and REMI Tablet are intended to
receive and transmit data from four REMI Sensors to
secure cloud storage for subsequent viewing and
reviewing of EEG on third-party software.
REMI does not make any diagnosis or
recommendations and is intended only as a
physiological signal monitor.
REMI Sensors are intended for use by trained
medical professionals in a professional healthcare
facility environment. REMI Sensors are intended for
use with adult and pediatric patients (6+). (Rx only). |
| Use Environment | The REMI system is intended to be used in health
care settings for near real time/and or remote EEG
signal collection.
The REMI system is intended to be used in
ambulatory settings for remote EEG signal
collection and includes home-use. | The REMI system is intended to be used in health
care settings for near real time/and or remote EEG
signal collection. |
| Software/System
User Interface | REMI Mobile medical application
The REMI Mobile application is run on qualified
commercial off-the-shelf Android computing
platforms. | REMI Mobile medical application
The REMI Mobile application is run on qualified
commercial off-the-shelf Android computing
platforms. |
| Qualified Computing
Platform Operating
Systems | Android 11 or higher
Wear OS 3.0 or higher | Android 6 |
| Sensor User
Interface | The REMI Sensor has a single push button
integrated into the sensor that serves as the user
interface. Some feedback about sensor status is
given via an onboard LED. | The REMI Sensor has a single push button
integrated into the sensor that serves as the user
interface. Some feedback about sensor status is
given via an onboard LED. |
| Physiological Signal
Acquired | EEG acquired from a patient's scalp | EEG acquired from a patient's scalp |
| Attribute | Subject Device K230933
REMI Remote EEG Monitoring System | Predicate Device K203827
REMI |
| Patient Contact | REMI-Sticker accessory contacts the patient's skin
(scalp). | REMI-Sticker accessory contacts the patient's skin
(scalp). |
| Cumulative Wear
Time | Up to 30 days. Prolonged contact. | Up to 48 hours. Prolonged contact. |
| Electrodes | 2 passive gold electrodes that interface with the
scalp through a conductive hydrogel integrated into
the sticker. | 2 passive gold electrodes that interface with the
scalp through a conductive hydrogel integrated into
the sticker. |
| Type of Use | REMI sensor is a non-sterile, single-use
disposable device. | REMI sensor is a non-sterile, single-use disposable
device. |
| Channels | Up to 10 | Up to 10 |
| Montage | 10/20 system – REMI Sensor can be placed
anywhere in the 10/20 system where each channel
represents a bipolar derivation approximation of
the 10/20 system | 10/20 system - REMI Sensor can be placed
anywhere in the 10/20 system where each channel
represents a bipolar derivation approximation of the
10/20 system |
| Electrical Safety and
EMC | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-26
IEC 60601-1-11:2015 /A1:2020 | IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-26 |
| Input Range
(sensors) | 1 mVp-p | 1 mVp-p |
| Input Noise (sensors) | 5 µVp-p | 5 µVp-p |
| Transfer of Data from
the sensor to REMI
Mobile (operating on
a qualified computing
platform) | Low power wireless personal area network | Low power wireless personal area network |
| Transfer of data from
REMI Mobile to REMI
Cloud | Secured WiFi or Cellular data connection | Secured WiFi or Cellular data connection |
| Power Source
(sensors) | Primary lithium button cell (not rechargeable) | Primary lithium button cell (not rechargeable) |
| Data Format (Viewer
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
and transmit EEG data to the REMI Mobile
application. | REMI sensors use integrated firmware to collect and
transmit EEG data to the REMI Mobile application. |
| Software (REMI
Cloud) | The REMI Cloud receives EEG data from the
REMI Mobile app and prepares it into a format for
viewing in the qualified EEG viewing software.
REMI Cloud also facilitates transfer and
subsequent receipt of EEG data for additional
characterization by EEG analysis module(s). | The REMI Cloud receives EEG data from the REMI
Mobile app and prepares it into a format for viewing
in the qualified EEG viewing software. |
| Attribute | Subject Device K230933
REMI Remote EEG Monitoring System | Predicate Device K203827
REMI |
| Connector | REMI Sensors are equipped with a non-standard
USB pinout/connector that is only used for
programming during production. This interface is
not used by the clinician or patient. | REMI Sensors are equipped with a non-standard
USB pinout/connector that is only used for
programming during production. This interface is not
used by the clinician or patient. |
| | Available Sizes
(sensor) | REMI Sensor comes in one size:
Width: 27 mm
Length: 27 mm
Depth: 7 mm |
| Conductive
Electrolyte Gel
(sticker) | Conductive electrolyte is in the form of a hydrogel
converted in a one-piece adhesive sticker as an
accessory to the REMI Sensor. | Conductive electrolyte is in the form of a hydrogel
converted in a one-piece adhesive sticker as an
accessory to the REMI Sensor. |
| | The sticker is replaceable
and single use. | The sticker is replaceable
and single use. |
| Biocompatibility | Biocompatibility of patient contacting components
verified with Irritation, Sensitization, and
Cytotoxicity testing per ISO 10993-5:2009 and ISO
10993-10:2010 for a prolonged time period. | Biocompatibility of patient contacting components
verified with Irritation, Sensitization, and Cytotoxicity
testing per ISO 10993-5:2009 and ISO 10993-
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 conducted and is included in this premarket notification, the results of which support substantial equivalence. A summary of the testing is included below:
The REMI System was tested to verify its safe and effective use for the intended population and use environments. Testing included the following:
| Test Type | Summary |
|---|---|
| General Electrical Safety, | |
| Electromagnetic Compatibility and | |
| Ingress Protection | Testing conducted to: |
| IEC 60601-1:2005, including Amendment 2:2021, Medical electrical | |
| equipment - Part 1: General requirements for basic safety and essential | |
| performance, | |
| IEC 60601-1-2:2015, Medical electrical equipment - Part 1-2: General | |
| requirements for basic safety and essential performance - Collateral | |
| Standard: Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-2-26:2015, Particular Requirements For The Basic Safety And | |
| Essential Performance Of Electroencephalographs | |
| IEC 60601-1-11:2015 + A1:2021, Medical Electrical Equipment - Part 1- | |
| 11: General requirements for basic safety and essential performance – | |
| Collateral Standard: Requirements for medical electrical equipment and | |
| medical electrical equipment and medical electrical systems used in the | |
| home healthcare environment | |
| Test Type | Summary |
| Wireless Technology Testing | Wireless functionality is needed for the REMI System to achieve its |
| Essential Performance. Because of this, comprehensive EMC testing of | |
| the REMI System has been conducted, including immunity to | |
| electromagnetic disturbance, in accordance with IEC 60601-1-2 and | |
| consistent with the requirements of IEC 60601-1-11. |
REMI Sensor wireless connectivity was tested with the qualified
computing platform to demonstrate that wireless connections can be
initiated, are stable, and are able to accurately transfer EEG signals.
REMI Sensors were also tested to ensure that a wireless connection is
able to be maintained for a minimum of 48 continuous hours. |
| Environmental/Shelf life | Accelerated aging and subsequent functional verification testing |
| Packaging Performance | Ship testing and subsequent functional verification testing |
| Biocompatibility | There are no new patient contacting components as part of this
submission and no new biocompatibility testing was required. The patient
contacting materials are identical to those presented in the predicate
device submission (K203827). There have not been any changes to the
material or tested contact type/duration. |
| Usability/ Human Factors | Human factors/usability testing was conducted to evaluate tasks
associated with use of the device. |
| Software Testing | REMI Mobile software has been updated compared to the predicate
software hand-off an initialized session from a primary computing platform
(Android tablet) to a portable/wearable computing platform (Wear OS
smartwatch) in order to support portable/wearable ambulatory use. |
| Bench Testing | End to end testing was conducted to ensure that the REMI System meets
its Essential Performance: to record digitized EEG data with patient-
applied sensors, and transfer the data, wirelessly, to a cloud-based
archive.
End to end testing verified that (1) the REMI System is able to acquire
EEG signals using REMI Sensors and subsequently transmit that EEG
data to REMI Mobile software, (2) that REMI Mobile is able to transfer the
EEG data to the REMI Cloud, and (3) the final EEG file format within
REMI Cloud is viewable in qualified EEG viewing software. This testing
demonstrates that the REMI System meets its Essential Performance and
fulfills system requirements. |
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The REMI Remote EEG Monitoring System met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantially equivalent performance as compared with the predicate device.
9. Substantial Equivalence Conclusion
The subject device has the same intended use, similar indications for use and incorporates the same fundamental technology as the legally marketed predicate device to which it was compared. Based on intended use, technological characteristics, and performance testing to account for differences in technological characteristics as compared to the predicate, it can be concluded that the subject device, REMI Remote EEG Monitoring System, is substantially equivalent to the identified predicate device.