Hologic Brevera - 1: Introduction; Preface; Indications for Use; Contraindications

Brevera Breast Biopsy System User Guide
Chapter 1: Introduction
MAN-04303-002 Revision 006 Page 1
1: Introduction
1.1 Preface
Read all this information carefully before installation and operation. Follow all warnings
and precautions as stated in this manual. Keep this manual available during procedures.
Physicians should tell patients about all potential risks and adverse events described in
this manual with respect to the operation of the system.
1.2 Indications for Use
Caution: United States federal law restricts this device to sale by or on the order of a
physician.
The Hologic
®
Brevera
®
breast biopsy system with CorLumina
®
imaging technology is
intended to provide breast tissue samples for diagnostic sampling of breast
abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally
delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy
system is intended to provide breast tissue for histologic examination with partial or
complete removal of the imaged abnormality. In instances when a patient presents with a
palpable abnormality that has been classified as benign through clinical and/or
radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast
biopsy system may also be used to partially remove such palpable lesions. The extent of
histologic abnormality cannot be reliably determined from its mammographic
appearance. Therefore, the extent of removal of the imaged evidence of an abnormality
does not predict the extent of removal of histological abnormality, for example,
malignancy. When the sampled abnormality is not histologically benign, it is essential
that the tissue margins be examined for completeness of removal using standard surgical
procedure.
1.3 Contraindications
• The Brevera breast biopsy system with CorLumina imaging technology is not
intended for therapeutic applications.
• The Brevera breast biopsy system with CorLumina imaging technology is
contraindicated for those patients who, based on the physician’s judgment, may be at
increased risk or develop complications associated with core removal or biopsy.
Patients receiving anticoagulant therapy or who may have bleeding disorders may
be considered at increased risk of procedural complications.
1.4 Essential Performance
The essential performance of the Brevera breast biopsy system is to maintain compliance
with IEC 61010-2-91:2012 to prevent exposure of the patient, operator, or other
individuals to unacceptable levels of X-ray radiation.
Chapter 1