SEM · Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

Neurology · 21 CFR 882.1360 · Class 2

Overview

Identification

The Minder System is an electroencephalographic (EEG) recording and transmitting device implanted under the scalp. It is a prescription device indicated to acquire, transmit, and store EEGs continuously from patients between 18-75 years of age with drug-resistant epilepsy who are intolerant or not indicated for more conservative monitoring tools. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. It is intended to aid in a physician's remote assessment and monitoring of the patient's condition by making EEG data available for review by a healthcare provider at a different location. The device is not intended to be implanted in brain tissue.

Classification Rationale

FDA has determined that the device can be classified in Class II with the establishment of special controls. FDA believes that Class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.

Special Controls

In combination with the general controls of the FD&C Act, the sub-scalp implanted electroencephalogram system for remote patient monitoring is subject to the following special controls: (1) In vivo performance testing must demonstrate that the device performs as intended following implantation to continuously acquire, transmit, and store electrical brain activity and evaluate all adverse effects, including tissue injury. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use for the duration of the operational life of the device. The technical specifications of the device's hardware and software must be fully characterized, such as: (i) Data acquisition testing: (A) Input dynamic range; (B) Signal/noise ratio; (C) Frequency response; (D) Accuracy and resolution of recorded signal; and (E) Quality and accessibility of continuous wireless transmission. (ii) Mechanical testing: (A) Impact testing; and (B) Integrity testing following implantation and explantation. (3) Performance testing must evaluate the compatibility of the device in a magnetic resonance environment. (4) The patient-contacting components of the device must be demonstrated to be biocompatible. (5) Performance testing must demonstrate electrical safety, thermal safety, mechanical safety, electromagnetic compatibility (EMC), and wireless coexistence of the device in the intended use environment. (6) Software verification, validation, and hazard analysis must be performed. (7) Performance testing must demonstrate the sterility of the device. (8) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf-life. (9) Performance testing must validate the reprocessing instructions for the reusable components of the device. (10) Physician and patient labeling must include the following: (i) Detailed description of the device technical parameters, explanation of all device outputs, care instructions to maintain the operation of the device, operational life and duration of device implantation, and troubleshooting options; (ii) A summary of any in vivo performance testing conducted to demonstrate device safety and performance under anticipated use conditions; (iii) Conditions of use that may impact the accuracy, reliability, or functionality of the device measurement and operation; (iv) Conditions that may preclude use and implantation of the device, such as skin integrity or thickness; (v) Magnetic resonance imaging related information; (vi) Statement that the device is not a standalone diagnostic device and does not replace clinical decision making; and (vii) A shelf-life. (11) Physician labeling must include: (i) Instructions for the preparation and implantation of the device, including recommended site of implantation and method of implantation, and explantation of the device; and (ii) Validated instructions for reprocessing of any reusable component. (12) Patient labeling must include: (i) A patient implant card, including magnetic resonance imaging related information; (ii) Information about the associated surgical procedure; and (iii) A discussion of available monitoring alternatives.

Recent Cleared Devices (1 of 1)

Top Applicants

• Epi-Minder Pty, Ltd. — 1 clearance