21 CFR 868.1985 — Spinal Imaging System For Neuraxial Procedures
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1985
Identification
Spinal imaging system for neuraxial procedures. A spinal imaging system for neuraxial procedures is a sensor and software system that is used to assist in identification of the interspinous space for neuraxial procedures. The VerTouch Spinal Imaging Device is intended to provide a two-dimensional (2D) pressure map of posterior spinal anatomy to help the physician plan and approach his/her needle placement during neuraxial procedures, including lumbar punctures, neuraxial anesthesia (spinals, and combined spinal-epidurals), epidural steroid injections, and epidural blood patches.
Classification Rationale
Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QXD | Spinal Imaging System For Neuraxial Procedures | 2 | 1 | SaMD |
Special Controls
QXD — Spinal Imaging System For Neuraxial Procedures
In combination with the general controls of the FD&C Act, the spinal imaging system for neuraxial procedures is subject to the following special controls:
De Novo Order DEN220009
