QQC · Brain Stimulation Programming Planning Software.
Neurology · 21 CFR 882.5855 · Class 2
Overview
| Product Code | QQC |
|---|---|
| Device Name | Brain Stimulation Programming Planning Software. |
| Regulation | 21 CFR 882.5855 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In combination with the general controls of the FD&C Act, the brain stimulation programming planning software is subject to the following special controls: - 1. Software verification, validation, and hazard analysis must be performed - 2. Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. - 3. Labeling must include: - a. The implanted brain stimulators for which the device is compatible. - b. Instructions for use. - c. Instructions and explanations of all user-interface components. - d. A warning regarding use of the data with respect to not replacing clinical judgement.
*Classification.* Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed. (2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. (3) Labeling must include: (i) The implanted brain stimulators for which the device is compatible. (ii) Instructions for use. (iii) Instructions and explanations of all user-interface components. (iv) A warning regarding use of the data with respect to not replacing clinical judgment.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243520 | Bullsai Confirm | Turing Medical Technologies, Inc. | Mar 28, 2025 | SESE |
| K213930 | Brainlab Elements Guide XT, Guide 3.0 | Brainlab AG | Apr 19, 2022 | SESE |
| DEN210003 | SureTune4 Software | Medtronic Neuromodulation | Aug 23, 2021 | DENG |
Top Applicants
- Brainlab AG — 1 clearance
- Medtronic Neuromodulation — 1 clearance
- Turing Medical Technologies, Inc. — 1 clearance
