Devicor Medical Products, Inc. · Class II · Cleared Mar 4, 2026
| K-number | K260365 |
| Device name | 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 |
| Applicant | Devicor Medical Products, Inc. |
| Product code | KNW |
| Device class | Class II |
| Decision date | Mar 4, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 876.1075 |
The Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System is a battery-operated, MRI-guided minimally invasive device designed to acquire breast tissue samples from imaged abnormalities for histologic examination. It uses vacuum and radial cutting functions to collect diagnostic tissue specimens, with both reusable components (control module, batteries, foot switch) and sterile disposable components (probe, targeting set, vacuum canister).
Both the subject device and predicate (Mammotome MR Biopsy System K042753) use stainless steel cutting elements, facilitate tissue removal through vacuum and radial cutting, and employ similar probe and targeting set designs. Key differences include automatic specimen retrieval in a basket (subject) versus manual removal with forceps (predicate), use of PEEK material in subject versus Liquid Crystal Polymer in predicate, and operation inside the MR procedure room (subject) versus outside (predicate).
ASTM F2213-17 (magnetically-induced torque), ASTM F2182-19e2 (RF-induced heating), ASTM F2503-23e1 (MR safety), IEC 60601-1, IEC 60601-2-2, IEC 60601-1-6, IEC 60601-1-2 (electrical safety and EMC), ISO 10993 series (biocompatibility including cytotoxicity, sensitization, pyrogenicity, and irritation).
The subject device has the same general intended use, similar indications for use, and identical core technological principles (MR-guided vacuum-assisted breast biopsy with stainless steel cutting elements) as the predicate. Performance testing demonstrates equivalent sample acquisition, sample quality rated as excellent diagnostic quality, and successful meeting of all bench and animal testing criteria, supporting that design differences do not raise new safety or effectiveness questions.
View the full FDA submission: accessdata.fda.gov