Accuro® 3S Needle Guide Kit

The Accuro® 3S Needle Guide Kit is a single-use sterile disposable assembly consisting of a needle guide with integrated probe cover, ultrasound gel, and a patient drape with elastic bands. It is used with the Accuro® 3S diagnostic ultrasound system to align a needle with the ultrasound imaging plane, assist healthcare professionals in placing needles relative to anatomical structures, and isolate the needle insertion site from microbial contamination. The elastic bands stabilize the needle guide positioning during ultrasound imaging and needle advancement.

The key difference from the predicate device (Pinpoint™ GT Needle Guide Kits) is the addition of a patient drape with integrated elastic bands that provide pressure against the back of the transducer probe to stabilize its position. The elastic bands do not contact the patient directly. Both devices have similar needle guides, probe covers for microbial isolation, and are indicated for the same diagnostic ultrasound applications.

ISO 10993 series (cytotoxicity, biological evaluation, ethylene oxide residuals, irritation, systemic toxicity, sample preparation), ISO 11135 and ISO 11607 (sterilization and packaging validation), ASTM D4332 and F1980 (packaging conditioning and accelerated aging), ASTM F756 (hemolytic properties), and FDA-2013-D-0305 guidance on ISO 10993-1 risk management.

The device is substantially equivalent because it has identical indications for use to the predicate—both cover ultrasound probes, isolate from microbial contaminants, and guide needle placement to anatomical structures. Both are prescription-use devices for the same clinical environment. The added elastic bands do not introduce new risks; non-clinical testing including simulated use, benchtop verification, risk management per ISO 14971, and safety compliance verification confirmed that the bands maintain performance and usability without compromising safety or effectiveness.