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Brevera
Biopsy Needle
®
Instructions for Use
Introduction
Please read all information carefully. Failure to properly follow the instructions may lead to unintended consequences.
Important: This package insert is designed to provide instructions for clinical use (IFU) for the Brevera breast biopsy device to be used with the Brevera
breast biopsy system. It is not a reference to surgical techniques.
Patient Target Group
The Brevera Breast Biopsy System is intended to be used on patients with suspicious breast tissue abnormalities that need to be histologically sampled
via biopsy for the primary diagnosis of said abnormality.
Indications
The Hologic Brevera breast biopsy system with CorLumina
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.
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.
Intended User
Mammography Technologist
• Meets all requirements that apply to the location in which the Mammography Technologist operates.
• Completed training on the mammography system.
• Has training in mammography positions.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Understands sterile procedures.
Radiologists, Surgeons
• Meets all requirements that apply to the location in which the Physician operates.
• Understands stereotactic breast biopsy procedures.
• Understands how to operate a computer and its peripherals.
• Understands sterile procedures.
• Gives local anesthesia.
• Understands basic surgical procedures for core biopsy.
Medical Physicist
• Meets all requirements that apply to the location in which the Medical Physicist operates.
• Understands mammography.
• Has experience with digital imaging.
• Understands how to operate a computer and its peripherals.
Device Description
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 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.
Biopsy Needle Nomenclature and Product Selection by Catalog Number
Brevera biopsy needle catalog numbers use the following nomenclature:
REF
BREVDISP07
Refer to www.hologic.com for an updated list of biopsy needle product offerings.
imaging technology is intended to provide breast tissue samples for diagnostic sampling
®
Cutting Cannula Needle
Gauge
7 gauge
13 cm long
Needle Length (cm)
20 mm (optionally 12mm based on
orientation of the introducer)
1 1
Aperture Size
Suffix
(mm)
(if any)
None
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