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The Concorde Models Concorde ST Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including brostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissologic examination, with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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.

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The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are intended for diagnostic sampling of soft tissue during soft tissue biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses. The SpeedBird Model SB38, Model SBU, and Model SBU99 Soft Tissue Biopsy Devices are indicated to provide soft tissue samples for diagnostic sampling of soft tissue abnormalities, including breast, liver, kidney, prostate, spleen, lymph nodes, and various other soft tissue abnormalities. They are designed to provide soft tissue for histologic examination, with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from imaging appearance (ultrasound, radiographic, e.g., mammographic) of a soft tissue abnormality. 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.

**SpeedBird Model SB38 Soft Tissue Biopsy Device Description:** The SpeedBird Model SB38 Soft Tissue Biopsy Device is a sterile, single-use, percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality. The handle contains controls, a laser pointer, a specimen collection tube, a drive mechanism, a vacuum pump, a DC motor, a power indicator light, and batteries. The working end includes a stainless steel coring cannula with twin opposed cutter blades. **SpeedBird Model SBU Soft Tissue Biopsy Device Description:** The SpeedBird Model SBU Soft Tissue Biopsy Device is a sterile, single-use percutaneous electro-mechanical vacuum-assisted biopsy device used to provide soft tissue samples for histological examination with partial or complete removal of the imaged abnormality. The handle contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input. The working end includes a stainless steel coring cannula with twin opposed cutter blades. **SpeedBird Model SBU99 Soft Tissue Biopsy Device Description:** The SpeedBird Model SBU99 Soft Tissue Biopsy Device is a two-component biopsy device comprising a sterile, single-use percutaneous biopsy needle cassette for use within a reusable biopsy needle handle (driver). The Biopsy Needle Cassette contains a stainless steel coring cannula with twin opposed cutter blades, a detachable coaxial outer tube, and fluid transport tubing. The Biopsy Needle Handle (driver) contains controls, a trigger, a vacuum pump or tubing for external vacuum, a DC motor, a power indicator light, a current rectifier, resistors, an accessory attachment rail, and a receptacle for electrical current input.