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. The 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 of 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 connections 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 the 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 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 not 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).

EnCor® MRI Directional Vacuum-Assisted Biopsy Device and Driver

INDICATIONS FOR USE

The EnCor® MRI Breast Biopsy Probe and EnCor® MRI Breast Biopsy Driver are indicated to acquire tissue for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its imaged appearance. 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.

CONTRAINDICATIONS

This device is not intended for use except as indicated. In addition, it is not intended for use under conditions where breast tissue excision is contraindicated.

WARNINGS

• Care must be taken when positioning the device trocar tip near the chest wall or skin margin.

• EnCor® MRI Breast Biopsy Probe has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contaminationof the device with pyrogens or microorganisms which may lead to infectious complications.

• Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

• Di(2-ethylhexyl)phthalate (DEHP) is a plasticizer used in some polyvinyl chloride medical devices. DEHP has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy. Although the toxic and carcinogenic effects of DEHP have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial. There is no evidence that neonates, infants, pregnant and breast feeding women exposed to DEHP experience any related adverse effects. However, a lack of evidence of causation between DEHP-PVC and any disease or adverse effect does not mean that there are no risks.

• This device is not recommended for use in patients with breast implants.

• Do not use in the presence of infection.

• 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

• This device should only be used by physicians trained in percutaneous biopsy procedures.

• Do not use the EnCor® MRI Breast Biopsy Probe if the product sterile barrier system or its packaging is compromised.

• Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident and/or needle is bent.

• A scalpel should be used to incise the skin prior to inserting the trocar tip.

• Do not autoclave or immerse the EnCor® MRI Breast Biopsy Driver in liquid.

• Keep EnCor® MRI Breast Biopsy Driver a minimum of 24 inches from the magnet bore while keeping the system hardware and cart outside of the room housing the magnet. Due to variations in magnet strength and shielding, the Operator should check the magnetic pull on the Driver, at the planned biopsy area, and adjust coil location and/or table position to allow the biopsy to be completed at a place acceptable to the physician.

• These devices may be used under the following conditions:

• Static magnetic field of 3 or 1.5 Tesla

• Spatial gradient magnetic field of 200-Gauss/cm or less

The EnCor®/EnCor Enspire® Breast Biopsy System (CM3000&VS3000/E4115, E4230) must be kept outside of the room housing the magnet.

POTENTIAL COMPLICATIONS

Potential complications may include, but are not 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).

EnCor® VisiLoc™ MRI Introducer Set

INSTRUCTIONS FOR USE

The EnCor® Introducer Set is indicated for use to penetrate the breast under image guidance and provide a passageway through which a diagnostic biopsy of the breast may be performed.

CONTRAINDICATIONS

This device is not intended for use except as indicated.

Warnings

• This device is not recommended for use in patients with breast implants.

• Do not use in the presence of infection.

• This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.

• Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and /or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

• 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

 •  This device should only be used by physicians trained in percutaneous biopsy procedures.

 • Do not use if the product sterile barrier system or its packaging is compromised.

 • Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident and /or needle is bent.

 • Exercise caution in proximity to the magnet by maintaining control of the Trocar and EnCor® MRI Breast Biopsy Probe, which may accelerate in a strong magnetic field.

 • Verify that the Cannula does not move when inserting or removing the Trocar / VisiLoc™ Obturator.

POTENTIAL COMPLICATIONS

Potential complications may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the EnCor® MRI Breast 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).

EnCor™ Breast Biopsy System Fire Forward Accessory

INDICATIONS FOR USE

The EnCor™ Fire Forward Accessory is intended to attach the EnCor™ Breast Biopsy Driver to a Fischer™/Mammotest™ or Lorad™/Hologic™ prone biopsy table.

CONTRAINDICATIONS

This device is not intended for use except as indicated.

WARNINGS

• Do not use in the presence of infection.

• 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.

• Care must be taken to set up the EnCor™ Fire Forward Accessory per the applicable biopsy table Instructions for Use to avoid chest wall injury.

• Exercise care when handling the EnCor™ Fire Forward Accessory while armed.

• Verify secure attachment of the EnCor™ Breast Biopsy Driver to the EnCor™ Fire Forward Accessory mounting pins and screw to avoid misalignment of the EnCor™ Breast Biopsy Probe tip or detachment of the EnCor™ Breast Biopsy Driver.

• The EnCor™ Fire Forward Accessory should only be used in conjunction with the appropriate EnCor™ Needle Guide.

PRECAUTIONS

• This device should only be used by physicians trained in percutaneous biopsy procedures.

• Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident.

• Sterilization of the device is not necessary under normal use conditions.

POTENTIAL COMPLICATIONS

Potential complications may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, pneumothorax, and tissue adherence to the EnCor™ Breast 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).

Note: Users and/or patients within the European Union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established (https://ec.europa.eu/growth/sectors/medical-devices/contacts). Users outside of the European Union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.

EnCor™ Breast Biopsy System GE™ Vertical Adapter

INDICATIONS FOR USE

The EnCor™ GE™ Vertical Adapter is intended to attach the EnCor™ Breast Biopsy Driver and EnCor™ Fire Forward Accessory to a GE™ Senographe DS.

CONTRAINDICATIONS

This device is not intended for use except as indicated.

WARNINGS

• Do not use in the presence of infection.

• 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

• The device should only be used by physicians trained in percutaneous biopsy procedures.

• Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident.

• Do not use if the product packaging is compromised.

• Sterilization of the device is not necessary under normal use conditions.

POTENTIAL COMPLICATIONS

Potential complications may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the EnCor™ Breast 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).

Note: Users and/or patients within the European Union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established (https://ec.europa.eu/growth/sectors/medical-devices/contacts). Users outside of the European Union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.

EnCor™ Breast Biopsy System Needle Guide (Fischer™)

INDICATIONS FOR USE

The EnCor™ Needle Guide is intended to support the EnCor™ Breast Biopsy Probe in a Fischer™/Mammotest™ prone biopsy table.

CONTRAINDICATIONS

This device is not intended for use except as indicated.

WARNINGS

• Do not use in the presence of infection.

• The EnCor™ Needle Guide Insert has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.

• Do not resterilize the EnCor™ Needle Guide Insert. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

• After use, the EnCor™ Needle Guide Insert 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

• This device should only be used by physicians trained in percutaneous biopsy procedures.

• Carefully inspect the device prior to use to verify that device has not been damaged. Do not use if product damage is evident.

• Sterilization of the EnCor™ Needle Guide is not necessary under normal use conditions.

POTENTIAL COMPLICATIONS

Potential complications may include, but are not limited to hematoma, hemorrhage, infection, adjacent tissue injury, pain, allergic reaction, and tissue adherence to the EnCor™ Breast 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).

Note: Users and/or patients within the European Union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the Member State in which the user and/or patient is established (https://ec.europa.eu/growth/sectors/medical-devices/contacts).Users outside of the European Union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.

BD and the BD logo, EnCor, EnCor Enspire and VisiLoc are trademarks of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of their respective owners. ©2025 BD. All rights reserved.

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