ScanNav Anatomy Peripheral Nerve Block
Intelligent Ultrasound LimitedScanNav Anatomy Peripheral Nerve Block is a software that assists healthcare professionals in identifying and labeling anatomical structures in real-time ultrasound images during preparation for ultrasound-guided regional anesthesia. It uses deep learning AI to highlight key nerve block anatomical regions, improving procedural accuracy and safety.
Intended Use
To assist qualified healthcare professionals to identify and label relevant anatomy in live ultrasound images during preparation for ultrasound guided regional anesthesia prior to needle insertion for patients 18 years or older.
Technology
The device receives real-time ultrasound images from a compatible ultrasound machine and processes them using deep learning AI algorithms to highlight relevant anatomical structures. Highlighting is displayed on a separate panel PC, leaving the original ultrasound display unaffected.
Performance
Non-clinical tests and accuracy and safety validation tests were conducted following established protocols, showing mis-identification rates under 5%, accuracy over 80%, and successful software tests without anomalies, confirming safety and effectiveness of the device with the new femoral block addition.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/11/2023
25 days - 2
FDA Approval
10/6/2023
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