1
Instructions for Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
A. Device Description
The F
INESSE
®
U
LTRA
Breast Biopsy System is composed of a driver and a probe and allows for obtaining
and storing multiple samples with a single probe insertion. The components of the system are designed
to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure.
The driver is a self-contained, handheld, reusable electro-mechanical vacuum-assisted biopsy
device (Figure 1) that utilizes a rechargeable lithium-ion battery and comes complete with AC power
accessories (Figure 2) and carrying case. The biopsy probe is composed of a hollow outer cutting
cannula, an inner needle with a notched sample chamber, and an integrated coaxial cannula. The outer
cannula and integrated coaxial cannula have sharpened cutting edges and the inner needle has a
sharpened trocar tip. The driver utilizes DC operated motors to create a vacuum while simultaneously
moving the outer cannula backward to expose the sample chamber to draw tissue in. The outer
cannula is released and moves forward over the sample chamber to cut the tissue. The tissue sample
is transported via the sample chamber to the sample container. The sample chamber is returned to the
original position and is available to acquire another sample. The integrated coaxial cannula may be
detached after the biopsy and remain in the breast to retain a track to the biopsy site when placing a
tissue marker.
Figure 1
®
Figure 2
B. Indications for Use
The F
INESSE
®
U
LTRA
Breast Biopsy System is indicated to obtain tissue samples from the breast
or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument 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 a 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 procedures.
C. Contraindications
1. The
F
INESSE
®
U
LTRA
Breast Biopsy System is for diagnostic use only, NOT for therapeutic use.
2. The
F
INESSE
®
U
LTRA
Breast Biopsy System is contraindicated for those patients where, in the
physician’s judgment, there is an increased risk of complications associated with percutaneous
removal of tissue samples.
D. Warnings
1. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may
be at increased risk of complications.
2. As with any biopsy instrument, there is a potential for infection.
3. The driver should not be used in a MRI suite.
4. The driver charger should not be used in an operating room.
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