Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5855](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5855) → QQC — Brain Stimulation Programming Planning Software.

# QQC · Brain Stimulation Programming Planning Software.

_Neurology · 21 CFR 882.5855 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC

## Overview

- **Product Code:** QQC
- **Device Name:** Brain Stimulation Programming Planning Software.
- **Regulation:** [21 CFR 882.5855](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5855)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)

## 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](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC/K243520.md) | Bullsai Confirm | Turing Medical Technologies, Inc. | Mar 28, 2025 | SESE |
| [K213930](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC/K213930.md) | Brainlab Elements Guide XT, Guide 3.0 | Brainlab AG | Apr 19, 2022 | SESE |
| [DEN210003](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC/DEN210003.md) | SureTune4 Software | Medtronic Neuromodulation | Aug 23, 2021 | DENG |

## Top Applicants

- Brainlab AG — 1 clearance
- Medtronic Neuromodulation — 1 clearance
- Turing Medical Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/QQC)

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