21 CFR 882.5806 — Computerized Behavioral Therapy Device For Migraine
Neurology (NE) · Part 882 Subpart F—Neurological Therapeutic Devices · § 882.5806
Identification
CT-132 is a prescription device indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. It is a computerized behavioral therapy device for headache, which is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.
Classification Rationale
FDA has determined that, for the previously stated indications for use, the CT-132 can be classified in class II with the establishment of special controls for class II. FDA believes that class II (special) controls provide reasonable assurance of the safety and effectiveness of the device type.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| SEE | Computerized Behavioral Therapy Device For Migraine | 2 | 1 | SaMD |
Special Controls
SEE — Computerized Behavioral Therapy Device For Migraine
(1) Clinical performance testing must be provided to fulfill the following: (i) Describe a model of behavioral therapy for the treatment of headache; and (ii) Validate the model of behavioral therapy as implemented by the device. (2) Software must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model. (3) The following labeling must be provided: (i) Patient and physician labeling must include instructions for use, including images that demonstrate how to interact with the device; (ii) Patient and physician labeling must list compatible devices; (iii) Patient and physician labeling must include a warning that the device is not intended for use as a standalone therapy if intended to be used as an adjunct therapy; (iv) Patient and physician labeling must include a warning that the device does not represent a substitution for the patient’s medication; and (v) Physician labeling must include a summary of the clinical testing with the device.
De Novo Order DEN240064
