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The EnCor EnCompass™ Breast Biopsy and Tissue Removal System is indicated to acquire breast tissue for histologic examination with partial or complete removal of the abnormality.

The subject device, the EnCor EnCompass™ Breast Biopsy and Tissue Removal System, is a console-based vacuum-assisted breast biopsy device. It is intended to obtain breast tissue samples for diagnostic or histologic analysis and may be used under Ultrasound, Stereotactic, or MR imaging guidance. The system consists of a console, handheld driver, foot switch, biopsy probes, canister liner bags, MRI extension tubing, a stereotactic adapter, MRI introducer sets, and spare sample containers. Replacement parts and components of the console, driver, and foot switch that are also sold separately include a reusable vacuum canister, exhaust filter, driver extension cable, foot switch cable, and power cable.

The EnCor EnCompass™ Breast Biopsy and Tissue Removal System consists of multiple devices that are intended to be used together to obtain breast tissue samples. This includes the EnCor EnCompass™ Console, EnCor EnCompass™ Driver, and EnCor EnCompass™ Foot Switch. The console, driver, and foot switch are designed to provide a user interface and to accept inputs used for specific procedures. The console contains a vacuum system and touchscreen monitor. The driver contains multiple buttons to control procedure functionality and is compatible for use with Ultrasound, Stereotactic, and Magnetic Resonance Imaging (MRI) procedures. The foot switch also contains buttons and a pedal to control procedure functionality and has both wired and wireless connectivity options. They are intended to be used with EnCor EnCompass™ Probes, Canister Liner Bags, MRI Extension Tubing, VisiLoc™ MRI Introducer Sets, and Stereotactic Adapter, which are sold separately. The Probes are the Applied Part of the EnCor EnCompass™ Breast Biopsy and Tissue Removal System.

The EnCor EnCompass™ Probe contains a tubular cutter for tissue acquisition and either a sharp trocar tip at the distal end for insertion or a blunt tip at the distal end for use in areas with sensitive structures. A detachable tissue collection chamber is located on the proximal end of the device. The tissue collection chamber incorporates both a suction line for acquisition and transport of tissue samples and a saline line for optional lavage functionality. A Y-valve luer lock is provided for introducing anesthetic to the biopsy site. Compatible breast tissue markers which are sold and packaged separately may be inserted through the proximal end of the device.

The integrated tubing cassette provides vacuum to an EnCor EnCompass™ Probe during a biopsy procedure.

The EnCor EnCompass™ Probe sample container collects samples as they are acquired and transported during the biopsy procedure. The basket allows for drainage of fluid that is acquired during sampling, vacuuming, and lavaging of the cavity. The basket allows visualization of the samples during and after the procedure and is detachable for sample retrieval post procedure.

The marker adapter allows for marker placement using a marker deployment device through the back of the probe.

The EnCor EnCompass™ Canister Liner Bag collects fluid waste generated during the procedure.

The EnCor EnCompass™ Stereotactic Adapter provides a mechanical interface between the combined EnCor EnCompass™ Driver and EnCor EnCompass™ Probe and the stereotactic biopsy table. The EnCor EnCompass™ Stereotactic Adapter is reusable and affixes directly to the EnCor EnCompass™ Probe with a T-shape fastener and two pins and the EnCor EnCompass™ Driver with rear sliding latches.

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