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ATEC Breast Biopsy Device
®
Instructions for Use (IFU)
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 ATEC breast biopsy device to be used with the ATEC® breast biopsy and excision
®
system. It is not a reference to surgical techniques.
Indications
The ATEC Breast Biopsy and Excision System is indicated to provide breast tissue samples
®
for diagnostic sampling of breast abnormalities. The ATEC Breast Biopsy and Excision
System is intended to provide breast tissue for histologic examination with partial or
complete removal of the imaged abnormality. 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 histologic
abnormality, e.g. 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 ATEC breast biopsy device is for diagnostic use only and is NOT indicated for therapeutic
use. The ATEC breast biopsy device is contraindicated for those patients who, based on
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 at increased risk of procedural complications.
Device Description
The ATEC Breast Biopsy and Excision System is comprised of an ATEC breast biopsy
device, appropriate console, and associated accessories. The ATEC breast biopsy device
is a sterile, latex free, single use device intended for use with visual imaging guidance,
such as ultrasound, stereotactic and magnetic resonance imaging (MRI). The ATEC breast
biopsy device is a vacuum-assisted biopsy device which is used to remove breast tissue in
a minimally invasive manner designed for biopsy and diagnosis only. The device is NOT
intended to be used outside the standards, specifications and limitations as outlined in
this IFU and other related materials. The device is single use and the entire handpiece is
fully disposable. The device primarily consists of a hollow needle with a side aperture and
a sharpened inner cannula that rotates at high speeds and extends across the aperture to
acquire targeted tissue. Throughout this process, vacuum is created inside the device to
assist in pulling tissue into the aperture. Saline is supplied through the device to lavage the
cavity and deliver tissue to the tissue filter. A compatible biopsy site marker may be used in
conjunction with the ATEC breast biopsy device following tissue removal or biopsy to mark
the location of the biopsy site for future procedures.
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