(148 days)
Not Found
No
The summary describes a vacuum-assisted biopsy system with integrated cabinet x-ray for imaging excised tissue. There is no mention of AI, ML, or any advanced image processing beyond visual confirmation of calcifications by the user. The performance studies focus on mechanical and functional aspects of the biopsy and imaging components, not on algorithmic performance.
No
The device is intended for diagnostic sampling of breast abnormalities to provide tissue for histologic examination and is explicitly stated to not predict the extent of removal of histological abnormality. While it may partially remove benign palpable lesions, its primary purpose is diagnosis rather than therapy.
Yes
The device, the Hologic Brevera breast biopsy system, is explicitly stated as intended to "provide breast tissue samples for diagnostic sampling of breast abnormalities." It excises tissue for "histologic examination," which is a diagnostic process.
No
The device description explicitly states it is a "system" that includes vacuum-assisted breast tissue biopsy technology and cabinet x-ray technology, which are hardware components. The performance studies also detail testing related to hardware aspects like biopsy specimen acquisition, x-ray generation, and system performance in live tissue.
Based on the provided information, the Hologic Brevera breast biopsy system with CorLumina imaging technology is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to "provide breast tissue samples for diagnostic sampling of breast abnormalities" and "provide breast tissue for histologic examination". Histologic examination is a laboratory process performed in vitro (outside the body) to diagnose diseases by examining tissue samples under a microscope.
- Device Description: The system collects breast tissue and allows for in-line radiographic imaging of the excised tissue (tissue that has been removed from the body). This imaging is used to confirm the presence of calcifications in the collected tissue. This process of examining tissue samples outside the body for diagnostic purposes aligns with the definition of an IVD.
While the system is used in vivo to collect the tissue, the subsequent handling, imaging, and the ultimate purpose of providing tissue for histologic examination (an in vitro process) classify it as an IVD. The imaging component is specifically for examining the collected tissue, not for guiding the biopsy procedure itself (although it is intended to be used with a stereotactic guidance system).
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted based on an analysis of risks and hazards. This included:
- Biopsy specimen acquisition and core handling: Confirmed device fires and arms when instructed; demonstrated inner cannula rotates and advances to cut tissue; demonstrated average cycle time for acquisition of each core is
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
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.
1
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)
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.
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:
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
6. Intended Use:
The Hologic Brevera breast biopsy system with CorLumina imaging technology is intended to provide breast tissue samples for diagnostic
4
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 Breast
Biopsy System
(K042290,
PREDICATE
DEVICE)) | Trident
Specimen
Radiography
System
(K111508,
PREDICATE
DEVICE) | Brevera Biopsy
System
(SUBJECT
DEVICE) | Comparison to
Predicates |
|-----------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------|
| Major
Components | Minimally
invasive
biopsy
handpiece and
console. | Imaging system. | Minimally invasive
biopsy handpiece,
console, and
specimen imaging
system. | Substantially
Equivalent to
predicates |
| Technology:
Biopsy | Vacuum-
assisted biopsy
(VAB) device | N/A | Vacuum-assisted
biopsy (VAB)
device | Substantially
Equivalent to
predicates |
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| Characteristic | ATEC Breast
Biopsy System
(K042290,
PREDICATE
DEVICE)) | Trident
Specimen
Radiography
System
(K111508,
PREDICATE
DEVICE) | Brevera Biopsy
System
(SUBJECT
DEVICE) | Comparison to
Predicates |
|------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------|
| Technology:
Imaging | N/A | Radiographic | Radiographic | Substantially
Equivalent to
predicates |
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 |
| Specimen | ||
| acquisition; two | ||
| component | ||
| handpiece | Confirm the device fires | |
| and arms when | ||
| instructed. | The Gen 2 Biopsy System was tested, and it was | |
| demonstrated that the device has an inner cannula that | ||
| rotates and advances to cut tissue. | ||
| All Acceptance Criteria Met | ||
| Confirm that a core is | ||
| sucked in to the aperture | ||
| and the inner cannula | ||
| cuts the tissue. | The Brevera System was tested and it was | |
| 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. | ||
| All Acceptance Criteria Met | ||
| To confirm that the core | ||
| travels the correct | ||
| pathway to the tissue | ||
| filter and travels in a | ||
| consistent time. | The Brevera System was tested and it was | |
| 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. | ||
| All Acceptance Criteria Met | ||
| Performance Testing Overview | ||
| Modifications | Test Method | Results |
| To confirm that the core | ||
| is the intended weight. | The Brevera System was tested against the ATEC | |
| Biopsy System and was found that core weight is | ||
| equivalent or larger than the predicate device (ATEC) | ||
| with the same size needle and aperture. | ||
| All Acceptance Criteria Met | ||
| Integrated | ||
| Specimen | ||
| collection | Confirm that the device | |
| pulls saline consistently | ||
| into the cannulas and to | ||
| the body cavity. | The Brevera Disposable was flow tested and all parts | |
| 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). | ||
| All Acceptance Criteria Met | ||
| To confirm that the | ||
| console supplies suction | ||
| to pull the core and any | ||
| excess liquid to the | ||
| canister. | The Brevera biopsy System was tested, and it was | |
| 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 | All Acceptance Criteria Met | |
| responds to all | ||
| commands (Setup and | ||
| Test Mode) | The Brevera System software performs as intended. | |
| All Acceptance Criteria Met | ||
| Integrated | ||
| Specimen | ||
| imaging | Confirm that the x-ray | |
| takes an image of the | ||
| core at the correct time | ||
| and populates the image | ||
| to the screen | The Brevera System was tested and it was | |
| demonstrated that it allows collection and imaging of | ||
| up to two cores in each filter chamber. | ||
| The Brevera System was tested and it was | ||
| demonstrated that a user can visually recognize | ||
| calcifications without obstruction by the tissue. | ||
| All Acceptance Criteria Met | ||
| Visually recognize | ||
| calcifications as small as | ||
| 240um from the | ||
| radiographic images | The Brevera System was tested and demonstrated the | |
| system enables a user to visually recognize | ||
| calcifications as small as 240um from the radiographic | ||
| images based on predicate (Trident) imaging | ||
| capability. | ||
| All Acceptance Criteria Met | ||
| Disposable/sterile | ||
| biopsy handpiece | ||
| component | Testing per ISO 11737-1 & | |
| 11737-2 and ASTM F1980-07 | Disposable components maintained sterile barrier | |
| integrity after simulated aging conditions. | ||
| All Acceptance Criteria Met | ||
| Testing per ISO-10993-1 | ||
| and G95-1. | Disposable components met required biocompatibility | |
| requirements. | ||
| All Acceptance Criteria Met | ||
| Performance Testing Overview | ||
| Modifications | Test Method | Results |
| System performance: | ||
| Software for both | ||
| biopsy and imaging | Integration testing of | |
| electro-mechanical | ||
| system | The Brevera 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. | ||
| All Acceptance Criteria Met | ||
| Monitoring and | ||
| controlling of | ||
| performance | ||
| requirements | 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).