EchoGuide (Version 1)
Sonavex, Inc.EchoGuide is a portable 3D ultrasound imaging device designed to assist healthcare providers in identifying the proper vascular access points on the skin for patients with arteriovenous fistulas or grafts. It automates ultrasound imaging acquisition and displays live coronal plane images to guide clinicians during cannulation, improving accuracy and ease of use during the procedure.
Intended Use
EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings.
Technology
EchoGuide uses a 52 mm linear (192 element) motorized ultrasound probe moving along a track to capture 2D coronal plane ultrasound images, which are then reconstructed into live 3D coronal views through image analysis and processing. The probe houses a 2D array and the system is laptop-based with a touch screen user interface.
Performance
Performance testing included internal verification and validation bench testing confirming design output compliance, clinical imaging adequacy in a prospective observational study validating vessel visualization quality, and conformance with applicable safety standards. Testing demonstrated substantial equivalence and no new safety or effectiveness concerns compared to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/8/2024
5 months - 2
FDA Approval
4/23/2025
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