21 CFR 868.1980 — Ultrasound Guided Nerve Block Assist
Anesthesiology (AN) · Part 868 Subpart B—Diagnostic Devices · § 868.1980
Identification
ScanNav Anatomy Peripheral Nerve Block is a software medical device that assists qualified healthcare professionals in the identification and labeling of anatomical structures in live ultrasound images in preparation for ultrasound-guided regional anesthesia (UGRA) prior to needle insertion for patients 18 years of age or older. It provides real-time interpretation and enhanced visualization by highlighting anatomical landmarks. The device is an accessory to compatible general-purpose diagnostic ultrasound systems and supports the following anatomical regions: Axillary level brachial plexus, Erector spinae plane, Interscalene level brachial plexus, Popliteal level sciatic nerve, Rectus sheath plane, Sub-sartorial femoral triangle/Adductor canal, Superior trunk of brachial plexus, Supraclavicular level brachial plexus, and Longitudinal suprainguinal fascia iliaca plane.
Classification Rationale
Class II (special controls). The device is classified as Class II because the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QRG | Ultrasound Guided Nerve Block Assist | 2 | 3 | SaMD |
Special Controls
QRG — Ultrasound Guided Nerve Block Assist
In combination with the general controls of the FD&C Act, the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia is subject to the following special controls:
De Novo Order DEN220024
