Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
Devicor Medical Products, Inc.
Product: Mammotome Prima — all models and sizes · Where to buy
FDA Clearance Information
FDA-Cleared Indications
- The system is indicated for percutaneous breast tissue sampling using MRI guidance.
- It is intended to obtain breast biopsy specimens for diagnostic evaluation of suspicious breast lesions or abnormalities.
- The disposable probe is intended for vacuum-assisted removal of multiple tissue samples during a single needle insertion.
Clinical Applications
- MRI-guided vacuum-assisted biopsy of suspicious breast lesions
- Sampling nonpalpable breast abnormalities identified on breast MRI
- Obtaining multiple breast tissue specimens for histopathologic examination
- Sampling lesions when MRI guidance is clinically indicated and appropriate
Reported off-label uses
- Partial or complete vacuum-assisted removal of selected benign breast lesions after appropriate clinical evaluation
- Vacuum-assisted excision of breast lesions that are not being sampled solely for diagnosis
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The system includes an 8-gauge disposable probe and an 8-gauge disposable targeting set; the specified size should be confirmed before the procedure.
- Use requires an MR environment and compatibility with the MRI system, procedure table, accessories, and local safety protocols.
- The disposable probe and targeting set are single-use components; the tray and other designated components require handling according to the manufacturer's instructions.
- Patients with contraindications to MRI, including certain unsafe implants or retained metallic foreign bodies, may not be candidates for MRI-guided use.
- MRI-guided biopsy requires breast-imaging expertise, sterile technique, local anesthesia, and management of bleeding, infection, and other biopsy-related risks.
Procedures that use this device
Frequently Asked Questions
What is the Mammotome Prima MR system used for?
It is used to collect multiple tissue samples from suspicious breast lesions during MRI-guided vacuum-assisted breast biopsy.
Is the Mammotome Prima MR system MRI safe?
The system is designed for use with MRI guidance, but the complete setup must be used according to its labeling and the MRI facility's safety requirements. Compatibility with the specific MRI environment should be confirmed before use.
What size probe does the Mammotome Prima MR system use?
This FDA record identifies an 8-gauge disposable biopsy probe and an 8-gauge disposable targeting set.
How long does the Mammotome Prima MR system last?
The disposable probe and targeting set are used for one procedure and then discarded. Reusable components, including the tray, require inspection, cleaning, maintenance, and replacement according to the manufacturer's instructions.
How much does the Mammotome Prima MR system cost?
The cost varies by facility, contract, procedure, and whether disposable or reusable components are being purchased. Patients should ask the imaging center and insurance plan about procedure and device-related charges.