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Indications for Use
The Mammotome elite Biopsy System is indicated to obtain tissue samples from the
breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.
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The Mammotome elite Biopsy System is intended to provide breast tissue for
histologic examination with partial or complete removal of the imaged
abnormality.
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The Mammotome elite Biopsy System is intended to provide breast tissue for
histologic examination with partial removal of a palpable abnormality.
The extent of a histologic abnormality cannot always be readily determined from the
palpation or imaged appearance. Therefore, the extent of removal of the palpated or
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.
In instances when a patient presents with a palpable abnormality that has been
classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma,
fibrocystic lesion), the Mammotome elite Biopsy System may also be used to partially
remove such palpable lesions. Whenever breast tissue is removed, histological
evaluation of the tissue is the standard of care. 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.
This instrument is for diagnostic use only and is not indicated for therapeutic use.
Contraindications
None known.
Device Descriptions
Devicor’s Mammotome elite Biopsy System is composed of a Holster and a Probe. The
System may also include the use of the optional accessory (the Introducer Stylet) to
initiate the track within the breast tissue to the biopsy site (refer to Introducer Stylet IFU
for details). The Mammotome elite system may be used with ultrasound imaging
guidance to excise and collect diagnostic samples with a single insertion of the Probe.
The components of the system are designed to operate safely when used together for
diagnostic sampling of tissue during a biopsy procedure.
The Holster, reusable and supplied non-sterile, is a self-contained, handheld, electro-
mechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-
polymer battery and includes a charging base with an AC power cord and adapters
(See Figure 1).
