Brevera Breast Biopsy System User Guide
Chapter 1: Introduction
Page 2 MAN-04303-002 Revision 006
1.5 System Capabilities
The Hologic Brevera breast biopsy system with CorLumina imaging technology is a
vacuum-assisted biopsy device which is used to remove breast tissue in a minimally
invasive manner using stereotactic or tomosynthesis imaging. The system is designed for
biopsy and for specimen radiographic image acquisition and display only. The system is
NOT intended to be used outside the standards, specifications, and limitations outlined
in these instructions for use.
The Brevera biopsy needle is single-use and is disposable. The user connects the biopsy
needle to a reusable device driver and connects the biopsy device components to the
console. The biopsy needle primarily consists of a hollow needle with a side aperture and
a sharpened inner cannula that, when connected to the Brevera breast biopsy system,
rotates and extends across the aperture to acquire targeted tissue. The Brevera device
driver contains mechanical and electrical components that drive needle rotation and
advancement. During the biopsy process, vacuum created inside the biopsy device pulls
tissue into the aperture. The cannula translates and rotates to cut the tissue. The tissue
sample is then aspirated through a tubing line to a tissue filter. Saline is supplied through
the biopsy device to lavage the cavity and deliver tissue to the tissue filter.
When the Brevera biopsy needle is connected to the Brevera device driver, the
combination is referred to as the Brevera breast biopsy device.
An introducer system, specifically designed for use with the Brevera breast biopsy
system, is packaged with the biopsy needle. This introducer maintains access to the
targeted area of interest and allows for deployment of a biopsy site marker. The
introducer is used to control the variable aperture function of the device. The introducer
also prohibits the user from administering medication through the Y-site in the tubing
while the device is in the armed (pre-fire) position.
The Brevera breast biopsy system with CorLumina imaging technology acquires and
displays the radiographic images of core specimens contained in the tissue filter. A tissue
filter, specifically designed for use with the Brevera breast biopsy system, is provided
with the biopsy needle. The Brevera breast biopsy system with CorLumina imaging
technology also has the capability to display images as well as to transfer these images to
external devices. The images acquired with this system are intended to confirm removal
of tissue from a suspected lesion or pathology. The system is not intended for diagnostic
purposes.
Radiology technologists, surgical personnel, surgeons, radiologists, and pathologists can
use the specimen radiography equipment in the Brevera breast biopsy system with
CorLumina imaging technology.
Hologic recommends that users receive training in basic ionizing radiation safety before
using the system.
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