Accuro® 3S Needle Guide Kit
Rivanna Medical, Inc.The Accuro® 3S Needle Guide Kit by Rivanna Medical, Inc. is a sterile, disposable accessory designed for use with the Accuro® 3S ultrasound imaging system. It helps healthcare professionals accurately align needles with the ultrasound imaging plane during procedures, stabilizing the needle guide position and isolating the needle insertion site from contaminants. This aids in precise anatomical targeting and improved procedural safety.
Intended Use
The Accuro® 3S Needle Guide Kit is intended to be used with the Accuro® 3S diagnostic ultrasound imaging system to support alignment of a needle with the ultrasound imaging plane to assist the healthcare professional in placing the tip of a needle relative to a specific anatomical structure.
Technology
The kit includes a single-use sterile needle guide with integrated probe cover, conductive ultrasound gel, a patient drape with elastic bands to stabilize probe position, all sterilized by ethylene oxide. It physically supports needle alignment with the ultrasound imaging plane and isolates the needle insertion site from contamination.
Performance
Non-clinical testing including simulated use, benchtop verification and validation tests were conducted for needle guide dimensions, insertion force, angulation, sterility integrity, image quality, and elastic band durability to ensure safety and effectiveness. No new risks were introduced compared to predicate.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/18/2025
3 months - 2
FDA Approval
6/13/2025
Other devices from Rivanna Medical, Inc.
- Accuro 3S2025 • 510K
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