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The Perineologic Access Needle is intended for use as a guiding needle in obtaining core biopsy samples from soft tissue and tumors of such organs as liver, kidney, spleen, lymph nodes, prostate, lung and various soft tissue lesions.

The Perineologic Access Needle is a sterile, single use, disposable, hollowed/tubular, stainless steel needle that is sharpened at one end and blunt on the opposing end while containing a polymeric hub with a female luer-lock style fitting to accept a male luer lock syringe. The polymeric hub contains a female luer fitting on the proximal end, a protruding, elongated rectangle for gripping, and a distal circumferential tubular lip that protrudes approximately 1 cm along the axis of the stainless steel needle. The protruding rectangle in the middle of the polymeric hub has 2 opposing and equal sides in the shape of a tapered rectangle containing ribs for gripping. The remaining 2 sides of the tapered rectangle are hollowed. The Perineologic Access Needle is provided in various lengths and diameters as required for particular biopsy procedures. The Perineologic Access Needle is provided in lengths ranging from 7cm to 20cm and inner diameters ranging from 14 gauge to 20 gauge.

The intended use of the Perineologic PrecisionPoint™ Biopsy Needle Guide when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system's transducer, is to facilitate proper needle placement to access anatomical structures.

The PrecisionPoint Biopsy Needle Guide is a sterile, single use, disposable, polymeric needle guide containing 2 pieces of molded plastic (carriage and rail/clamp). The PrecisionPoint Biopsy Needle Guide is pressed / placed onto the region overlying the area to be biopsied. The PrecisionPoint Biopsy Needle Guide holds both the ultrasound probe and the needle guide in place relative to each other while the ultrasound-guided biopsy is being preformed. The PrecisionPoint Biopsy Needle Guide is an assembly of 3 unique polymeric components: carriage, rail, and clamp. The carriage component slides onto the rails to create an assembly that can hold and maintain the relative position of an ultrasound probe and a needle guide at the same time. The clamp component is a ring shaped structure with 2 opposing rectangular handles at the bottom of the ring that contain a male flange that is designed to mate with the opposing female cavern. The male flange has ridges on the bottom of the flange while the female cavern has ridges on the top of the cavern, creating an adjustable locking mechanism in which the next row of ridges align and lock as the male flange advances. The advancement of the male flange into the opposing female cavern creates a ring with decreased and smaller circumference that imposes increased pressure on a cylindrical ultrasound probe positioned within the ring of the clamp component. The clamp component is designed to accommodate a cylindrical style transrectal ultrasound transducer (0.7' to .85" diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system cleared under K043524. The carriage component has 5 equal holes to accommodate a 14 gauge needle and may contain holes of equal or various diameters from 14 gauge to 20 gauge. The 5 needle holes are equally spaced approximately 5cm apart and may be spaced closer or farther apart depending on the diameter of the holes. The number of needle holes may vary from as few as 1 to as many as 8. The dimensions of the fully assembled PrecisionPoint Biopsy Needle Guide are approximately 5.5cm long, 7cm tall, and 4.5cm wide.