ND Needle Guidance System
Accurate Access, LLCThe ND Needle Guidance System is a sterile, single-use accessory designed to help clinicians accurately place needles during ultrasound-guided procedures, such as obtaining vascular access. It attaches to ultrasound probes and provides mechanical and directional support, improving the precision and safety of needle placement for both patients and healthcare providers.
Intended Use
The ND Needle Guidance System is indicated for use in ultrasound-guided procedures where precise placement of common interventional devices is required, such as for vascular access.
Technology
A sterile, single-use molded plastic device with two interchangeable needle guides (in-plane and out-of-plane) that securely attaches to a commercially available ultrasound probe. It provides mechanical and directional guidance for accurate, adjustable needle placement. The design allows selection of insertion depth and alignment, and accommodates both in-plane and out-of-plane techniques within a single device.
Performance
Non-clinical testing included design verification (legibility, needle fit, resistance, durability, cycle testing), biocompatibility (ISO 10993), and sterility validation. Usability and phantom testing demonstrated appropriate performance, and an animal study in a porcine model showed successful vascular access at all target sites without adverse outcomes. All acceptance criteria across testing were met, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
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