BD EleVation™ Breast Biopsy System (For information on Marquee™ Disposable Core Biopsy Instrument and UltraCor™ Twirl™ Breast Tissue Marker, please continue scrolling.)

Indications for Use:

The BD EleVation™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The BD EleVation™ Breast Biopsy System 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 mammographic 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:

1. The BD EleVation™ Breast Biopsy System is for diagnostic use only, NOT for therapeutic use.
2. The BD EleVation™ 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. Patients who may have a bleeding disorder, or who are receiving anticoagulant therapy, may be at increased risk of complications.
2. As with any biopsy instrument, there is a potential risk for infection.
3. The BD EleVation™ Breast Biopsy System should not be used in a Magnetic Resonance Imaging (MRI) Suite.
4. The BD EleVation™ Breast Biopsy System has not been tested using stereotactic guidance or for use with an MRI.
5. The BD EleVation™ Breast Biopsy System should not be used in an operating room.
6. The BD EleVation™ Breast Biopsy System is not classified as an AP or APG device.
7. The BD EleVation™ Breast Biopsy System is not suitable for use in the presence of flammable anesthetic.
8. The BD EleVation™ Breast Biopsy System is not suitable for use in an oxygen rich environment.
9. The BD EleVation™ Driver must only be used with BD EleVation™ Probes and BD EleVation™ Accessories.
10. All breast biopsies should be performed under ultrasound guidance to confirm the BD EleVation™ Probe’s position relative to the target region to be sampled and to help mitigate the occurrence of a false negative biopsy. The BD EleVation™ Breast Biopsy System is intended for use with ultrasound imaging only.
11. The battery may only be replaced or disposed of by an authorized Service and Repair facility.
12. Use only with supplied AC power BD EleVation™ Accessories. Removing the AC adapter plug from wall power shall serve as isolation means. Do not position the AC adapter plug and wireless charging stand such that it is difficult to remove the AC adapter plug from the wall outlet if needed to remove mains power.
13. Do not reuse BD EleVation™ Probe. Reusing the BD EleVation™ Probe bears the risk of cross-patient contamination as biopsy probes, 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 BD EleVation™ Probe for an indeterminable period of time. The residue of biological material can promote the contamination of the BD EleVation™ Probe with pyrogens or microorganisms which may lead to infectious complications.
14. Do not resterilize BD EleVation™ Probe. After resterilization, the sterility of the BD EleVation™ Probe is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilizing the BD EleVation™ Probe increases the probability that it will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.

Precautions:

1. The BD EleVation™ Breast Biopsy System should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.
2. Do not attempt to remove the cover or modify the device in any way.

Potential Complications:

1. Potential complications are those associated with any percutaneous removal/biopsy technique for tissue collection. Potential complications are limited to the region surrounding the biopsy site and include hematoma, lymphedema, hemorrhage, infection, non-healing wound, pain, nerve injury, and tissue adherence to the BD EleVation™ Probe while removing it from the breast.
2. As per routine biopsy procedures, it may be necessary to cut tissue adhering to the BD EleVation™ Probe while removing it from the breast.

Please consult package insert for more detailed safety information and instructions for use.

BD and the BD logo and EleVation are trademarks of Becton, Dickinson and Company or its affiliates. ©2025 BD. All rights reserved.

Marquee™ Disposable Core Biopsy Instrument

Indications for Use

The Marquee™ Disposable Core Biopsy Instrument and Kit are intended for use in obtaining biopsies from soft tissues such as breast, liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Contraindications

None known.

• Warnings

1.Good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have a bleeding problem.

2. Post-biopsy patient care may vary with the biopsy technique utilized and the individual patient’s physiological condition. Observation of vital signs and other precautions should be taken to avoid and/or treat potential complications that may be associated with biopsy procedures.
3. When used for breast biopsy, the product is for diagnosis only.
4. The collection of multiple core biopsy samples may help to ensure the detection of any cancer tissue. A “negative” biopsy in the presence of suspicious radiographic findings does not preclude the presence of carcinoma.
5. The Instrument and Kit have 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. Additionally, re-use and/or repackaging may compromise the structural integrity and/or material and design characteristics of the device, which may lead to device failure, and/or lead to patient injury.
6. Do not resterilize the Instrument or Kit. 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.

Note: Inspect Instrument and Kit needle components for damaged point, bent shaft or other imperfections prior to use and after each sample is collected. DO NOT USE the device if any imperfection is noted.

Note: After use, the Instrument and Kit may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations. Dispose of sharps in designated sharps disposal containers; the Instrument and Kit are for single-use only and should be disposed of appropriately, not recapped or resterilized.

Precautions

1. The Instrument and Kit should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific tissue being biopsied.
2. The introduction of the needle into the body should be carried out under imaging guidance (ultrasound, X-Ray, CT, etc.).

Note: This product has not been tested for MR Imaging compatibility.

3.Never test the Instrument by firing into the air. Damage may occur to the Instrument needle tip and could result in patient and/or user injury.

4.Unusual force applied to the stylet or unusual resistance against the stylet while extended out of the cutting cannula may cause the stylet to bend at the sample notch. A bent sample notch may interfere with needle function.

Potential Complications

Potential complications associated with core biopsy procedures are site specific and may include:

Air embolism

Non-target tissue, organ or vessel perforation or injury

Allergic reaction

Pain

Bleeding

Pneumothorax

Hematoma

Tract seeding

Hemothorax

Vasovagal reaction

Infection

Air embolism is a rare but serious potential complication of lung biopsy procedures. Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism. Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air embolism.

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. 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.

Please consult package insert for more detailed safety information and instructions for use.

BD and the BD logo and Marquee are trademarks of Becton, Dickinson and Company or its affiliates. ©2025 BD. All rights reserved.

UltraCor™ Twirl™ Breast Tissue Marker

Indications for Use: The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft

breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy

procedure.

Contraindications: Patients with a known hypersensitivity to the materials listed in the device

description may suffer an allergic reaction to this implant. The implant is made from a nickel-titanium alloy; if there is a known allergy to nickel, use of the UltraCor™ Twirl™ Breast Tissue Marker is not advised. This device is not intended for use except as indicated above.

Warnings:

• As with any foreign object implanted into the body, potential adverse reactions are possible. It is

the responsibility of the physician to evaluate the risk/benefit prior to the use of this device.

• Use caution when inserting near a breast implant to avoid puncture of the implant capsule.
• The UltraCor™ Twirl™ Breast Tissue Marker is not recommended for use in patients with breast implants.
• 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. Additionally, re-use and/or repackaging may compromise the structural

integrity and/or material and design characteristics of the device, which may lead to device

failure, and/or lead to patient injury.

• 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

accepted medical practice and local, state and federal laws and regulations. Dispose of sharps in

designated sharps disposal containers. This product should be disposed of appropriately, not

recapped or resterilized.

• Keep dry. Keep away from sunlight.
• Examine the product to ensure it has not been damaged during shipment and that its size,

shape, and condition are suitable for the procedure for which it is to be used. Do not use if

product damage or contamination is evident.

Precautions:

• Do not use if needle is bent and/or tip is damaged.
• Use caution when handling the device to prevent premature deployment of the breast tissue

marker.

• This product should only be used by a physician who is completely familiar with the indications, contraindications, limitations and typical findings and possible side effects of breast tissue marker placement.

Potential Complications: Complications may occur at any time during or after the procedure. Potential complications of breast tissue marker placement may include, but are not limited to: hematoma/bleeding, hemorrhage, infection, lymphedema, unspecified tissue injury, pain, nerve injury, marker migration, allergic reaction and inaccurate marker placement, which may affect the accuracy of future tissue diagnoses.

Note: Users 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.

Note: Breast tissue markers have the potential to migrate after placement. Based on a systematic literature search on commercially available breast tissue markers, the reported mean marker migration distances ranged from 3.4 mm - 28.1 mm and marker migration rates ranged from 0 - 54% in breast tissue and 0 - 10% in axillary lymph nodes.

Please consult packaging inserts for more detailed safety information and instructions for use.

BD and the BD logo, Twirl and UltraCor are trademarks of Becton, Dickinson and Company or its affiliates. ©2025 BD. All rights reserved.