(a) Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:

(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.

(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.

(2) The patient-contacting components of the device must be demonstrated to be biocompatible.

(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).

(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.

(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.

(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:

(i) A detailed summary of the clinical performance testing, including any adverse events and complications.

(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.

(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.

[82 FR 50082, Oct. 30, 2017]