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To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only. The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.

The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed.