EnCor Enspire™ Breast Biopsy System

INDICATIONS FOR USE

The EnCor Enspire™ Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. • It is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • It 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 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 EnCor Enspire™ Breast 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.

CONTRAINDICATIONS

1. This device is not intended for use except as indicated.
2. The EnCor Enspire™ 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.

WARNINGS

1. The EnCor Enspire™ Breast Biopsy System must be properly grounded to ensure patient safety. The system is supplied with a medical grade Power Cord with AC plug. Do not connect the included Power Cord to extension cords or three-prong to two-prong Adapters. To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth.
2. To minimize interference with other equipment, cables should be positioned in such a manner to prevent contact with other cables.
3. Use of accessories not compatible with the EnCor Enspire™ Breast Biopsy System may create potentially hazardous conditions.
4. Only use EnCor™ and EnCor™ MRI Drivers with script version 1.19 or greater with the EnCor Enspire™ Breast Biopsy System. The system is not compatible with earlier driver scripts. The script version is identified on the touch screen display during system initialization.
5. EnCor Enspire™ Breast Biopsy System console may not be placed in an MRI suite. Place the console outside of the MRI suite and use the appropriate EnCor™ MRI accessories when performing a biopsy under MRI guidance.
6. No modification of this equipment is allowed. Do not remove the EnCor Enspire™ Breast Biopsy System housing. Removal of the housing may cause electrical shock.
7. The EnCor Enspire™ Breast Biopsy System is not classified as an AP or APG classified device. The system is not suitable for use in the presence flammable anesthetic.
8. Do not use in the presence of infection.
9. After use, this product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations.

PRECAUTIONS

1. This device should only be used by physicians trained in percutaneous biopsy procedures.
2. Carefully inspect the device prior to use to verify that the device has not been damaged. Do not use if product damage is evident and/or needle is bent.
3. Locate the EnCor Enspire™ Breast Biopsy System as far as possible from other electronic equipment to minimize interference or degradation of performance of the EnCor Enspire™ Breast Biopsy System.
4. Inspect accessories and cords for breaks, cracks, nicks, or other damage before every use. If damaged, do not use. Failure to observe this precaution may result in injury or electrical shock to the patient or to the operator.
5. Inspect tubing connection to the Vacuum Canister and the Vacuum Tubing Cassette to ensure proper vacuum levels are achieved and maintained during use.
6. Inspect the Vacuum Canister to ensure the lid is secure and that no damage has occurred during shipping or installation. A heavily scratched canister can break during use.
7. Do not leave the EnCor Enspire™ Breast Biopsy System powered on overnight. Damage may occur to the Vacuum or the Vacuum and Rinse Tubing Cassette.
8. Connect the Power Cord to a hospital grade wall outlet having the correct voltage or product damage may result.
9. Patients who may have a bleeding disorder or who are receiving anticoagulant therapy may be at increased risk of complications.
10.  As with any biopsy instrument, there is a potential for infection.
11. All breast biopsies should be performed under imaging guidance to confirm that Probe position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy.
12. When performing a biopsy with the EnCor™ and EnCor™ MRI Probes, the orientation of the sample notch is dictated by the image guidance selected. Prior to initiating the procedure, confirm that the sample notch orientation is correct for the image guidance being used.
13. Ensure that the EnCor Enspire™ Breast Biopsy System is positioned in such a way that the Power Cord and retainer are accessible. In the event that the system Power Switch is inoperable, release retainer and remove cord to shut off system power.

POTENTIAL COMPLICATIONS

Potential complications may include, but are limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the Biopsy Probe during removal from the breast (as per routine biopsy procedures, it may be necessary to cut tissue adhering to the stylet or coaxial while removing it from the breast).

Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

BD-74915