Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 12, 2026 Hologic, Inc. Christine Stahley Principal Regulatory Affairs Specialist 250 Campus Dr. Malborough, Massachusetts 01752 Re: K262792 Trade/Device Name: Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: August 6, 2026 Received: August 6, 2026 Dear Christine Stahley: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1} K262792 - Christine Stahley Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K262792 - Christine Stahley Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, JESSICA CARR -S Jessica Carr, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K262792 Device Name Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09) Indications for Use (Describe) The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. 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 histological abnormality, for example, 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 procedure. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) **CONTINUE ON A SEPARATE PAGE IF NEEDED.** This section applies only to requirements of the Paperwork Reduction Act of 1995. **\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} Hologic, Inc. Brevera Biopsy System with CorLumina Imaging Technology Special 510(k) K262792 ### 510(k) Summary Date Prepared: August 7, 2026 ### 510(k) Submitter Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Contact: Christine Stahley Phone:+774-293-3872 Email: Christine.Stahley@hologic.com Trade Name: Brevera Biopsy System with CorLumina Imaging Technology Common Name: Biopsy Instrument Regulation name: Gastroenterology-urology biopsy instrument Regulation number: 21 CFR 876.1075 Product Code: KNW Classification: Class II Panel: General & Plastic Surgery ### Predicate Device Trade Name: Brevera Biopsy System with CorLumina Imaging Technology Submitter / 510(k) Holder: Hologic, Inc. 510(k) number: K163052 ### Device Description The Brevera breast biopsy system with CorLumina imaging technology enables a physician to utilize vacuum-assisted breast tissue biopsy technology and cabinet x-ray technology to remove suspicious lesions and confirm the suspect lesion has been collected at the point of care. The vacuum assisted breast biopsy subsystem collects breast tissue and transports it through tubing into a collection tray located in the console. Within the console, the in-line cabinet x-ray subsystem then allows the user to visually confirm calcifications that may be present in the collected breast tissue. The overall system is intended to be used with a stereotactic biopsy guidance system. Page 1 of 4 {5} Hologic, Inc. Brevera Biopsy System with CorLumina Imaging Technology Special 510(k) The subject device differs from the predicate device only with respect to design refinements to the 9-gauge biopsy needle assembly. These refinements improve control of critical geometric characteristics that influence device performance. No changes were made to the fundamental scientific technology, system architecture, or imaging capabilities of the device. ## Indications for Use The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic sampling of breast abnormalities. The Brevera breast biopsy system excises targeted tissue and optionally delivers in-line radiographic images of the excised tissue. The Brevera breast biopsy system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (for example, fibroadenoma, fibrocystic lesion), the Brevera breast biopsy system may also be used to partially remove such palpable lesions. 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 histological abnormality, for example, 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 procedure. ## Comparison of Characteristics The Brevera breast biopsy system has the same intended use and indications for use, physical and technical characteristics, and principles of operation as the previously cleared predicate device, Brevera breast biopsy system device (K163052). A table comparing the key features of the subject and predicate device is provided below. | Characteristic | Brevera Breast Biopsy System (K163052) | Brevera Breast Biopsy System (Subject Device) | Comparison to Predicate | | --- | --- | --- | --- | | Major Components | Minimally invasive biopsy handpiece, console, and specimen imaging system. | Minimally invasive biopsy handpiece, console, and specimen imaging system. | Identical to predicate | | Technology: Biopsy | Vacuum-assisted biopsy (VAB) device | Vacuum-assisted biopsy (VAB) device | Identical to predicate | | Technology: Imaging | Radiographic | Radiographic | Identical to predicate | Page 2 of 4 {6} Hologic, Inc. Brevera Biopsy System with CorLumina Imaging Technology Special 510(k) The subject device incorporates design modifications are limited to the 9-gauge biopsy needle assembly. These modifications include: - Tightening of cannula pairing distance tolerance specification - Establishment and control of outer cannula straightness tolerance - Labeling updates These modifications were implemented under the manufacturer's design control system as part of the total product life cycle (TPLC). The modifications do not alter the device's intended use, operating principles, or fundamental technological characteristics. Other than the needle modifications, the subject device remains technologically identical to the predicate device. The biopsy technology, imaging technology, method of use, method of action, major system components, and operational characteristics are unchanged. ### Performance Testing Performance verification testing was conducted to evaluate the impact of design modifications to the 9-gauge biopsy needle assembly. Testing focused on characteristics associated with tissue acquisition and handling, including core quality. Verification testing was performed to evaluate: - Inner cannula advancement velocity - Specimen acquisition performance - Specimen distribution within the specimen collection system Verification activities demonstrated that the modified needle assembly meets all established design inputs and performance requirements. All acceptance criteria were met. The modifications were implemented and evaluated in accordance with 21 CFR 820.30 design control requirements. The results support that the design modifications effectively mitigate the identified risks and that the clinical benefits of the device outweigh the risks. ### Labeling Proposed labeling has been updated to provide additional clarity and to reinforce existing use-related considerations, including updated warnings. These updates are consistent with the established risk profile of the device and do not affect intended use. The subject and predicate devices retain the same indications for use and contraindications. Page 3 of 4 {7} Hologic, Inc. Brevera Biopsy System with CorLumina Imaging Technology Special 510(k) ## Conclusion Based on the intended use, descriptive information and performance provided in this submission, the Brevera Biopsy System with CorLumina Imaging Technology has been shown to be substantially equivalent to the predicate. Page 4 of 4