Contraindications - Hologic Atec Gebrauchsanweisung

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.
Patient Target Group
The target patient population of ATEC Breast Biopsy and Excision System includes patients
undergoing breast tissue removal for diagnostic sampling of breast abnormalities.
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.
Intended user
The ATEC Breast Biopsy and Excision System should be used only by physicians trained in open
or percutaneous biopsy procedures.
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.
Expected Clinical Benefit
The ATEC Breast Biopsy and Excision System enables physicians to use a minimally invasive
system to extract small biopsy samples of potentially malignant breast tissue.
Instructions for Use
Refer to the "ATEC Breast Biopsy and Excision System Operator's Manual" for console and
handpiece instructions for use, performance characteristic and accessory information.
Warnings and Precautions
• Caution: Federal (USA) law restricts this device to sale by or on the order of a
physician.
• The biopsy procedure should be performed only by persons having adequate training and
familiarity with this procedure. Consult medical literature relative to techniques, complications
and hazards prior to performance of any minimally invasive procedure.
Date Release: 03/26/25
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