(172 days)
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).
The REMI System has three major components:
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- REMI Sensor A disposable EEG sensor which is placed on the patient's scalp using a conductive REMI Sticker
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- 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.
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- 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.
The provided document is a 510(k) Pre-market Notification Summary for the REMI Remote EEG Monitoring System (K243185). This document details the device's characteristics, indications for use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (REMI Remote EEG Monitoring System, K230933).
Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily relies on comparisons to its own predicate device (K230933) and general performance testing against recognized standards. Specific quantitative acceptance criteria are not explicitly detailed in a table format within this summary, but the general assertion is that the device met all predetermined acceptance criteria derived from the listed tests.
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| General Electrical Safety, EMC, and Ingress Protection | Compliance with relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26, IEC 60601-1-11). | Testing conducted to and met the requirements of the specified IEC standards. |
| Wireless Technology Testing | Wireless connectivity can be initiated, is stable, and accurately transfers EEG signals. Connection maintained for a minimum of 48 continuous hours. | Wireless connectivity was tested (in accordance with IEC 60601-1-2 and IEC 60601-1-11 requirements) and demonstrated to initiate, maintain stability, and accurately transfer EEG signals. A wireless connection was confirmed to be maintained for a minimum of 48 continuous hours. |
| Environmental/Shelf life | Device functions as intended after accelerated aging. | Accelerated aging and subsequent functional verification testing were performed. (Outcome states "met all predetermined acceptance criteria"). |
| Packaging Performance | Device maintains integrity and function after ship testing. | Ship testing and subsequent functional verification testing were performed. (Outcome states "met all predetermined acceptance criteria"). |
| Biocompatibility | Long-term contact with intact skin is safe (non-cytotoxic, non-sensitizing, non-irritating). | Biocompatibility testing for long-term contact with intact skin was performed per ISO-10993-1, ISO 10993-10, and ISO 10993-23 for all patient-contacting components. (Outcome states "safe and effective for its intended use" and "met all predetermined acceptance criteria"). |
| Usability/Human Factors | Tasks associated with device use are safe and effective. | Human factors/usability testing was conducted to evaluate tasks associated with use of the device. (Outcome states "met all predetermined acceptance criteria"). |
| Software Verification Testing | End-to-end functionality: Acquire EEG, transmit to mobile, transmit to cloud, viewable in qualified software. Essential performance met. | End-to-end testing confirmed: (1) REMI System acquires EEG signals from REMI Sensors and transmits to REMI Mobile software, (2) REMI Mobile transfers EEG data to REMI Cloud, and (3) final EEG file format within REMI Cloud is viewable in qualified EEG viewing software. This demonstrated that the REMI System meets its Essential Performance and fulfills system requirements. |
| Clinical Performance (Extension to 1-6 years pediatric patients) | REMI System (including new hydrocolloid REMI Sticker) is safe and effective for monitoring EEG in pediatric patients aged 1 to |
§ 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).