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 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, 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.

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

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Brevera Biopsy System with Corlumina Imaging Technology, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on a full-scale clinical trial to prove a device meets specific efficacy acceptance criteria against a clinical endpoint. Therefore, much of the information typically found in such a study (like detailed sample sizes for test sets, expert qualifications for ground truth, MRMC studies, or training set details) is not present in this document. The "studies" described are primarily performance testing to ensure the device functions as intended and is safe.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Method)	Reported Device Performance (Results)
Specimen Acquisition & Core Handling:	All Acceptance Criteria Met
Confirm the device fires and arms when instructed.	Demonstrated that the device has an inner cannula that rotates and advances to cut tissue.
Confirm that a core is sucked into the aperture and the inner cannula cuts the tissue.	Demonstrated that the average cycle time for the acquisition of each core is less than or equal to 8 seconds for all cycles except for the first and last cycle.
To confirm that the core travels the correct pathway to the tissue filter and travels in a consistent time.	Demonstrated that the average cycle time for the acquisition of each core is less than or equal to 8 seconds for all cycles except for the first and last cycle.
To confirm that the core is the intended weight.	Core weight is equivalent or larger than the predicate device (ATEC) with the same size needle and aperture.
Integrated Specimen Collection:	All Acceptance Criteria Met
Confirm the device pulls saline consistently into the cannulas and to the body cavity.	Demonstrated that the system delivered 0.9% buffered saline into the aperture as well as not leak fluid when exposed to twice the volume of a saline bag (500 mL).
To confirm that the console supplies suction to pull the core and any excess liquid to the canister.	Demonstrated that core specimens are transported into a tissue filter via vacuum and that waste fluids are collected in a disposable vacuum canister.
Confirm the console responds to all commands (Setup and Test Mode).	The Brevera System software performs as intended.
Integrated Specimen Imaging:	All Acceptance Criteria Met
Confirm that the x-ray takes an image of the core at the correct time and populates the image to the screen.	Demonstrated that it allows collection and imaging of up to two cores in each filter chamber. A user can visually recognize calcifications without obstruction by the tissue.
Visually recognize calcifications as small as 240um from the radiographic images.	Demonstrated the system enables a user to visually recognize calcifications as small as 240um from the radiographic images based on predicate (Trident) imaging capability.
Disposable/Sterile Biopsy Handpiece Component:	All Acceptance Criteria Met
Testing per ISO 11737-1 & 11737-2 and ASTM F1980-07 (Sterility).	Disposable components maintained sterile barrier integrity after simulated aging conditions.
Testing per ISO-10993-1 and G95-1 (Biocompatibility).	Disposable components met required biocompatibility requirements.
System Performance (Software for both biopsy and imaging):	All Acceptance Criteria Met
Integration testing of electro-mechanical system.	Provides correct power to the Corlumina Imaging Technology and Vacuum Assisted Biopsy subsystems to allow for successful integration of core collection and imaging of core specimens.
Monitoring and controlling of performance requirements.	The Brevera System software performs as intended.
Animal Testing (Live Model - System's ability to successfully biopsy and transport tissue): (Implicit acceptance: successful operation)	Successfully biopsied and transported tissue to the tissue filter. (This is derived from the summary statement, specific metrics are not provided in the table).
Bench Testing (Functional, packaging, usability): (Implicit acceptance: successful operation)	Equivalence in performance to predicate devices (ATEC and Trident), and demonstrated to be as safe and effective, meeting all acceptance criteria. (This is a summary conclusion, specific metrics for these tests are not individually detailed).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient cases or a large dataset for imaging analysis. The testing described is primarily engineering and functional performance testing.
- For the "core weight" test, it compares the Brevera System cores to the ATEC Biopsy System, implying multiple cores were tested.
- For imaging, it states the system enables a user to visually recognize calcifications, suggesting evaluation by human observation, but specific numbers of images or observers are not given.
- Animal testing was performed in a "live model," but the number of animals or biopsies is not specified.
Data Provenance: Not explicitly stated for specific data sets. The testing itself is presented as internal performance testing conducted by Hologic, Inc.
- The animal model testing would be prospective for that specific test.
- Bench testing would be specific to manufactured components.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- The visual recognition of calcifications would necessarily involve trained personnel (e.g., radiologists or technologists), but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of the performance tests (e.g., measuring cycle time, core weight, fluid flow, software function), "adjudication" in the sense of resolving conflicting expert opinions is likely not applicable. The tests likely had predefined objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No, an MRMC comparative effectiveness study is not described in this document. The studies are focused on direct device performance and comparison to predicate device capabilities rather than a comparative effectiveness study involving human readers' diagnostic accuracy with vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. The Brevera Biopsy System is a hardware device with integrated imaging and software, designed to be used by a clinician. The imaging component ("Corlumina Imaging Technology") is for visual confirmation by a user, not for an AI algorithm to provide diagnostic output in a standalone manner. The device does not appear to employ an AI algorithm for diagnostic interpretation that would have standalone performance metrics.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the various performance tests is specific to the test itself:
- Functional tests: The expected operational behavior of the device components (e.g., firing, suction, software commands).
- Measurement tests: Quantitative measurements (e.g., core weight, cycle time, fluid volume) compared against design specifications or predicate device performance.
- Imaging capability: The ability to physically display calcifications of a certain size, validated by visual inspection and comparison to predicate device capabilities (Trident System). This would likely involve phantoms with known calcification sizes or actual calcified specimens.
- Sterility/Biocompatibility: Standards (ISO, ASTM) are the ground truth references.
- Animal Model: Direct observation of successful biopsy and transport of tissue.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The Brevera Biopsy System, as described, is a mechanical and imaging device. It does not appear to utilize machine learning or AI that would require a "training set" for an algorithm. The software mentioned is for system control and image display, not for learning-based diagnostic interpretation.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for an AI algorithm.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 29, 2017

Hologic, Inc. Ms. Sarah Fairfield Manager, Regulatory Affairs 250 Campus Drive Marlborough, Massachusetts 01752

Re: K163052

Trade/Device Name: Brevera Biopsy System with Corlumina Imaging Technology Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 24, 2017 Received: February 27, 2017

Dear Ms. Fairfield:

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 (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. 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.

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163052

Device Name

Brevera Breast Biopsy System with Corlumina Imaging Technology

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Date: March 27 2017

2. Submitter:

Hologic, Inc. 250 Campus Dr. Marlborough, MA 01752

Sarah Fairfield, Manager, Regulatory Affairs, RAC Contact: B.S. Biomedical Engineering Email: sarah.fairfield@hologic.com Telephone: 508.263.8857

3. Device:

Trade Name: Brevera Biopsy System with Corlumina Imaging Technology Common Name: Biopsy instrument Classification Name: Gastroenterology-urology biopsy instrument Classification Regulation: 21 CFR 876.1075 Class: II

4. Predicate Device:

Tradename: ATEC handpiece and ATEC Sapphire console Submitter / 510(k) Holder: Hologic, Inc. 510(k) #'s: K042290

Tradename: Trident Specimen Radiography System Submitter / 510(k) Holder: Hologic, Inc. 510(k) #'s: K111508

ട്. Device Description:

6. Intended Use:

The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic

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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.

7. Comparison of Characteristics:

The method of use, mechanism of action, mode of operation and functional performance of the Brevera Biopsy System with CorLumina Imaging Technology is similar to the ATEC breast biopsy system, as it relates to vacuum-assisted biopsy, and is similar to the Trident specimen radiography system as it relates to in line specimen imaging of the acquired breast biopsy sample. The overall workflow for the Brevera Biopsy System with CorLumina Imaging Technology is similar to the ATEC breast biopsy system, for the biopsy portion of the workflow, and is similar to the Trident specimen radiography system for the specimen imaging portion of the workflow. The following table contains a comparison summary of the subject device to the predicate devices.

Characteristic	ATEC BreastBiopsy System(K042290,PREDICATEDEVICE))	TridentSpecimenRadiographySystem(K111508,PREDICATEDEVICE)	Brevera BiopsySystem(SUBJECTDEVICE)	Comparison toPredicates
MajorComponents	Minimallyinvasivebiopsyhandpiece andconsole.	Imaging system.	Minimally invasivebiopsy handpiece,console, andspecimen imagingsystem.	SubstantiallyEquivalent topredicates
Technology:Biopsy	Vacuum-assisted biopsy(VAB) device	N/A	Vacuum-assistedbiopsy (VAB)device	SubstantiallyEquivalent topredicates

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Characteristic	ATEC BreastBiopsy System(K042290,PREDICATEDEVICE))	TridentSpecimenRadiographySystem(K111508,PREDICATEDEVICE)	Brevera BiopsySystem(SUBJECTDEVICE)	Comparison toPredicates
Technology:Imaging	N/A	Radiographic	Radiographic	SubstantiallyEquivalent topredicates

8. Performance Testing:

Performance testing applicable to the Brevera Biopsy system with Corlumina Imaging Technology was determined based on an analysis of risks and hazards posed by the intended use of the device and the proposed modifications that the subject device has over the predicate devices. The scope of the analysis included the principal components that the system are made up of that relate to a vacuum assisted biopsy and x-ray cabinet specimen radiography. Specifically included features are:

·Biopsy specimen acquisition and core handling
·X-ray generation for imaging
•System's performance when used in live tissue with an Animal Model
•User control of system operation

Performance Testing Overview
Modifications	Test Method	Results
Specimenacquisition; twocomponenthandpiece	Confirm the device firesand arms wheninstructed.	The Gen 2 Biopsy System was tested, and it wasdemonstrated that the device has an inner cannula thatrotates and advances to cut tissue.All Acceptance Criteria Met
	Confirm that a core issucked in to the apertureand the inner cannulacuts the tissue.	The Brevera System was tested and it wasdemonstrated that the average cycle time for theacquisition of each core is less than or equal to 8seconds for all cycles except for the first and last cycle.All Acceptance Criteria Met
	To confirm that the coretravels the correctpathway to the tissuefilter and travels in aconsistent time.	The Brevera System was tested and it wasdemonstrated that the average cycle time for theacquisition of each core is less than or equal to 8seconds for all cycles except for the first and last cycle.All Acceptance Criteria Met
Performance Testing Overview
Modifications	Test Method	Results
	To confirm that the coreis the intended weight.	The Brevera System was tested against the ATECBiopsy System and was found that core weight isequivalent or larger than the predicate device (ATEC)with the same size needle and aperture.All Acceptance Criteria Met
IntegratedSpecimencollection	Confirm that the devicepulls saline consistentlyinto the cannulas and tothe body cavity.	The Brevera Disposable was flow tested and all partsdemonstrated that the system delivered 0.9% bufferedsaline into the aperture as well as not leak fluid whenexposed to twice the volume of a saline bag (500 mL).All Acceptance Criteria Met
	To confirm that theconsole supplies suctionto pull the core and anyexcess liquid to thecanister.	The Brevera biopsy System was tested, and it wasdemonstrated that core specimens are transported intoa tissue filter via vacuum and that waste fluids arecollected in a disposable vacuum canister
	Confirm the console	All Acceptance Criteria Met
	responds to allcommands (Setup andTest Mode)	The Brevera System software performs as intended.All Acceptance Criteria Met
IntegratedSpecimenimaging	Confirm that the x-raytakes an image of thecore at the correct timeand populates the imageto the screen	The Brevera System was tested and it wasdemonstrated that it allows collection and imaging ofup to two cores in each filter chamber.The Brevera System was tested and it wasdemonstrated that a user can visually recognizecalcifications without obstruction by the tissue.All Acceptance Criteria Met
	Visually recognizecalcifications as small as240um from theradiographic images	The Brevera System was tested and demonstrated thesystem enables a user to visually recognizecalcifications as small as 240um from the radiographicimages based on predicate (Trident) imagingcapability.All Acceptance Criteria Met
Disposable/sterilebiopsy handpiececomponent	Testing per ISO 11737-1 &11737-2 and ASTM F1980-07	Disposable components maintained sterile barrierintegrity after simulated aging conditions.All Acceptance Criteria Met
	Testing per ISO-10993-1and G95-1.	Disposable components met required biocompatibilityrequirements.All Acceptance Criteria Met
Performance Testing Overview
Modifications	Test Method	Results
System performance:Software for bothbiopsy and imaging	Integration testing ofelectro-mechanicalsystem	The Brevera System provides correct power to theCorlumina Imaging Technology and Vacuum AssistedBiopsy subsystems to allow for successful integrationof core collection and imaging of core specimens.All Acceptance Criteria Met
	Monitoring andcontrolling ofperformancerequirements	The Brevera System software performs as intended.All Acceptance Criteria Met

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The Brevera Biopsy System with Corlumina Imaging Technology successfully performed system design control verification and validation tests, which are summarized in accordance with FDA's Guidance for the Content of premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005) based on a moderate level of concern. Animal testing in a live model was also completed to demonstrate the system's ability to successfully biopsy and transport tissue to the tissue filter. Additional bench testing including functional testing, biocompatibility, sterilization, package testing, and usability testing was also performed on the Brevera system. The comparative and other performance testing showed that the overall system demonstrated equivalent performance, and showed to be as safe and effective as the predicate devices, and met all acceptance criteria.

9. Conclusion:

Based on the intended use, descriptive information and performance testing provided in this submission, the Brevera Biopsy System with Corlumina Imaging Technology has been shown to be equivalent in technology, method of operation, functional performance and intended use to the predicate ATEC Breast Biopsy System(K042290) and Trident Specimen Radiography System(K111508).

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.