Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)
FDA Clearance Information
FDA-Cleared Indications
- The system is indicated for acquiring and handling breast tissue samples during percutaneous biopsy.
- It is intended for use with stereotactic and tomosynthesis-guided breast biopsy procedures.
- The system provides imaging of excised tissue specimens to help assess specimen adequacy during the biopsy procedure.
Clinical Applications
- Stereotactic-guided breast biopsy
- Digital breast tomosynthesis-guided breast biopsy
- Percutaneous sampling of suspicious breast lesions or calcifications
- Collection, handling and imaging of breast biopsy specimens during the procedure
Practical Considerations
- The system is designed for breast biopsy and should be used with compatible biopsy needles, vacuum assistance components and imaging equipment specified in the labeling.
- It is used with mammographic imaging guidance, including stereotactic or tomosynthesis guidance; it is not a general-purpose ultrasound or CT biopsy system.
- The device is not an MRI-guided biopsy system. MRI compatibility should not be assumed for the console, needle, handpiece or accessories.
- Patient selection, needle size, local anesthesia, specimen handling and the number of samples depend on the lesion, imaging findings and the treating clinician's judgment.
- Contraindications, warnings, device compatibility and cleaning or disposal requirements should be reviewed in the current manufacturer's instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the Brevera Biopsy System used for?
It is used to obtain breast tissue samples during stereotactic or tomosynthesis-guided percutaneous biopsy. The system also images collected specimens during the procedure.
Is the Brevera Biopsy System MRI safe?
It is not an MRI-guided biopsy system, and MRI safety should not be assumed. Patients and clinicians should follow the current labeling for each system component and accessory.
What needle sizes are available for the Brevera Biopsy System?
Needle and accessory sizes depend on the specific compatible biopsy kit and configuration. The current manufacturer labeling should be checked for available sizes and compatibility.
How long does the Brevera Biopsy System last?
The console and reusable components have service and maintenance requirements, while biopsy needles and other sterile components may be single-use. The expected service life and reuse instructions are specified by the manufacturer.
How much does the Brevera Biopsy System cost?
Pricing varies by facility, configuration, service contract and disposable biopsy components. Patients should ask the breast imaging center or insurer about procedure and out-of-pocket costs.