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The NuVue ColorMark™ Needle is intended for use when one desires the visualization of an interventional needle (e.g. biopsy needle) on B-scan ultrasound screens which have color flow Doppler imaging capability. The NuVue ColorMark™Needle is indicated for use in clinical applications and at anatomical sites for which the biopsy needle and the ultrasound system have received marketing clearance by the FDA.

The NuVue ColorMark™Needle combines a hand-piece and echogenic needles like its predicates. The NuVue ColorMark™Needle is intended to allow the visualization by ultrasound of a needle- such as biopsy needle- inserted into the body. The principle is that the needle is made to vibrate at low sonic frequencies (<1 kHz), which makes it visible on a Doppler Color-flow system, since the vibration of the needle appears as motion to the Doppler system. As Stipulated, NuVue's ColorMark™ Needle, a hand-held needle device, consists of the driving handpiece and integrated needle. The system is a self-contained, battery-operated, and single-use device that integrates and vibrates interventional biopsy needle(s). The hand-piece accommodates a range of NuVue Therapeutics compatible biopsy needles that fit within its integrated sleeve. The sleeve is the guide and vibration transmitter for the needle. The NuVue ColorMark™Needle is an electro-mechanical needle device. The mechanical coupling of the needle with the hand-piece exciter is mediated by two electromagnets that make the hand-piece sleeve to vibrate in an orbital-like motion, through a phasing of the coils +- 90 degrees apart. This motion is transferred to the interventional needle that is coaxially catheterizing the hand-piece sleeve. This allows for the representation of color Doppler imaging in 360 degrees of rotation of the needle while it is in NuVue's new hand held interventional driver device and in the on position. The needle motion stimulates the Doppler motion sensing function of the imager to display colors corresponding to turbulent fluid motion pattern in close vicinity with the biopsy needle. NuVue Therapeutics will purchase in bulk needles designated by application (biopsy, aspiration, other), needle type (Chiba, Franseen, spinal, other), needle gauge (19 to 27). The needle device, as stipulated, is a single use, hand-piece that integrates and guides the needle for lengths of tissue insertion from 10 to 20 cm. The needle device will be repackaged as a single use device, sterilized with Ethylene Oxide, and distributed commercially under the NuVue Therapeutics, Inc. Name, with the stipulation on the packaging, do not reuse or re-sterilize.