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- · The Intact® Gen2 System is indicated to provide tissue sampling of breast abnormalities. - · The Intact® Gen2 System is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. - · The Intact · Gen2 System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. - The Intact Gen2 System is intended to preserve lesion architecture in samples with a diameter of 12–30 mm. .

The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample to preserve the tissue architecture for histologic examination. The device is a highfrequency, vacuum-assisted electrosurgical device used to remove tissue by electrosurgical cutting and simultaneous capture of an incised tissue volume. The device includes the following components: 1. Probe/Wand Intact® Gen2 Probe/wand (Sizes: 12mm, 15mm, 20mm and 30mm) 2. Handle 3. Gen2 Controller with Power Cord and Foot Pedal 4. Table Mount 5. Cart

- The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue sampling of breast abnormalities - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to histologic examination with partial removal of a palpable abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm - The Intact® BLES with Intact® Excision XL wand and handle is indicated to provide tissue samples for diagnostic sampling of breast abnormalities - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality - The Intact® BLES with Intact® Excision XL wand and handle is intended to preserve lesion architecture in samples with a diameter of 12-30mm

The intent of the device is to be a biopsy tool to capture a sample of breast tissue in one intact sample to preserve the tissue architecture for histologic examination. The device is a high frequency, vacuumassisted electrosurgical devices used to remove tissue by electro-surgical cutting and simultaneous capture of an incised tissue volume. The devices include the following components: 1. Probe/Wand (1a) Intact BLES Probe/wand (1b) Intact Advance BLES Probe/wand (1c) Intact Excise XL Probe/wand 2. Handle (2) The Intact BLES Handle (2a) Intact Excise XL Handle 3. Intact Medical ™ Model 3000 Controller 4. Controller Power Cord Footpedal 5. Table Mount (6a) Table Mount, BLES attaches the Intact BLES Handle to a stereotactic table (Fischer and Lorad mounts). (6b) Table Mount, Excise XL attaches the Intact Excise XL Handle to a stereotactic table (Fischer and Lorad mounts). 6. Vacuum Source 7. Cart

The Intact Excision XL is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The Intact® Excision XL is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The Intact Excision XL 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 palpation or imaged appearance. Therefore, the extent of removal of the palpable 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 Intact System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic 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.

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The intact™ BLES is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. The intact™ BLES is intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality. The intact™ BLES 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 palpation or imaged appearance. Therefore, the extent of removal of the palpable 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 intact™ BLES may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histologic 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.

Common or Usual Name: Electrosurgical Generator Trade or Proprietary Name: intact™ Breast Lesion Excision System (BLES) Classification Name: Electrosurgical Cutting & Coagulation Device & Accessories (21 C.F.R. § 878.4400) Biopsy Instrument (21 C.F.R. § 876.1075)