The Eviva Stereotactic Guided Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. 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 histologic abnormality, e.g., 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 Eviva Stereotactic Guided Breast Biopsy System is a hand-held biopsy device that is marketed for guidance with stereotactic imaging. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. 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 histologic abnormality, e.g., 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.

AI/ML Overview

The provided text is a 510(k) summary for the Eviva Stereotactic Guided Breast Biopsy System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain specific acceptance criteria, detailed results of performance testing, or information about the studies asked for in your request.

Here's a breakdown of what is and isn't available based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the typical sense (e.g., sensitivity, specificity, accuracy, or quantitative metrics for biopsy success).
It generically states: "Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria."
And in the conclusion: "The Eviva Stereotactic Guided Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."
These are assertions that acceptance criteria were met, but the criteria themselves and the specific "reported performance" against those criteria are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the document. The document refers to "bench testing" but does not specify sample sizes or data provenance for any clinical or performance studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the document. The filing does not describe a study involving expert-established ground truth. The device is a biopsy system, and the ground truth for diagnosis typically comes from pathology of the acquired tissue, not from expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the document, as no such study is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not present in the document. The device is a biopsy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to AI assistance would not be applicable or expected for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not present in the document. The device is hardware (a biopsy system), not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the intended use of a breast biopsy system, the ultimate ground truth for a diagnosis from the tissue collected would be pathology. While the document doesn't explicitly state "pathology was used as ground truth," this is the standard for such devices. The "extent of histologic abnormality" is mentioned multiple times, strongly implying pathology as the diagnostic gold standard for the tissue obtained.

8. The sample size for the training set

This information is not present in the document. The device is a mechanical biopsy system, not an AI model that requires a training set in that context.

9. How the ground truth for the training set was established

This information is not present in the document, as it's not applicable to the type of device.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through functional, biocompatibility, sterilization, and package bench testing. It does not include detailed clinical study data, performance metrics against specific acceptance criteria, or information about AI algorithm performance studies which are typically associated with the questions asked. The "acceptance criteria" referred to are related to the engineering and safety performance of the device rather than diagnostic accuracy as would be assessed in clinical reader studies for imaging software.

Summary

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April 10, 2018

Hologic. Inc Ms. Brenda Geary Regulatory Affairs Specialist 250 Campus Drive Marlborough, Massachusetts 01752

Re: K180233

Trade/Device Name: Eviva Stereotactic Guided Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 8, 2018 Received: February 9, 2018

Dear Ms. Geary:

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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -S3 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) K180233

Device Name

Eviva Stereotactic Guided Breast Biopsy System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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6.0 510(k) Summary

January 11, 2018

6.1 510(k) Submitter

Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 Attn: Brenda Geary P: 508.263.8819 F: 844.223.4956

6.2 Establishment Registration Number: 1222780

6.3 Trade Name: Eviva Stereotactic Guided Breast Biopsy System
6.4 Common/Usual Name: Biopsy Instrument, 21CFR.876.1075

6.5 Product Code: KNW

6.6 Classification: Class II
6.7 Panel: Gastroenterology/Urology

6.8 Predicate Device

Tradename:	ATEC Breast Biopsy System
Submitter / 510(k) Holder:	Hologic, Inc.
510(k) #:	K042290
Classification code:	KNW
Regulation:	21.CFR.876.1075

6.9 Device Description

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HOLOGIC, Inc.

Premarket Notification Eviva Stereotactic Guided Breast Biopsy System

6.10 Intended Use:

Attribute	Predicate DeviceATEC Breast Biopsy System(K042290)	Subject DeviceEviva Stereotactic Breast BiopsySystem	Status
Intended Use	The ATEC Breast Biopsy System isintended to provide breast tissue forhistologic examination with partial orcomplete removal of the imagedabnormality. The extent of thehistologic abnormality cannot bereliably determined from itsmammographic appearance.Therefore, the extent of the removal ofthe imaged evidence of an abnormalitydoes not predict the extent of removalof histologic abnormality, e.g.,malignancy. When the sampledabnormality is not histologicallybenign, it is essential that the tissuemargins be examined for completenessof removal using standard surgicalprocedure.	The Eviva Stereotactic GuidedBreast Biopsy System is indicatedto provide breast tissue samples fordiagnostic sampling of breastabnormalities under stereotacticbreast biopsy guidance. The Evivadevice is intended to provide breasttissue for histologic examinationwith partial or complete removal ofthe imaged abnormality. The extentof histologic abnormality cannot bereliably determined from itsmammographic appearance.Therefore, the extent of removal ofthe imaged evidence of anabnormality does not predict theextent of removal of histologicabnormality, e.g., malignancy.When the sampled abnormality isnot histologically benign, it isessential that the tissue margins beexamined for completeness ofremoval using standard surgicalprocedure.	Subject device issubstantiallyequivalent topredicate device
Method of Use	Vacuum-assisted device to removebreast tissue in a minimally invasivemanner.For use with Ultrasound, Stereotacticor MRI.Requires additional Introduceraccessory for marker.	Vacuum-assisted device to removebreast tissue in a minimallyinvasive manner.For use only in Stereotactic.Integrated Introducer for marker.	Subject device issubstantiallyequivalent topredicate device
Mechanism forAction	Manually fired.Rotate all device to acquire tissue360°.	Pneumatic firing mechanism.Rotate using thumbwheel and using"clock position" window.	Subject device issubstantiallyequivalent topredicate device
	Tissue retrieval part of device.	Remote tissue retrieval.

6.11 Comparison to Predicate Device:

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HOLOGIC, Inc. Premarket Notification Eviva Stereotactic Guided Breast Biopsy System

Attribute	Predicate DeviceATEC Breast Biopsy System(K042290)	Subject DeviceEviva Stereotactic Breast Biopsy System	Status
Mode ofOperation	Tissue acquisition, press downfootswitch and hold.Pressure and Vacuum from Consoleactivate internal mechanism to cutand acquire tissue.	Tissue acquisition, press downfootswitch and hold.Pressure and Vacuum from Consoleactivate internal mechanism to cutand acquire tissue.	Subject device issubstantiallyequivalent topredicate device

6.12 Performance Testing:

Bench testing of the Eviva Stereotactic Guided Breast Biopsy System including functional testing, biocompatibility, sterilization and package testing demonstrated equivalent performance, and showed to be as safe and effective as the predicate device, and met all acceptance criteria.

6.13 Conclusion:

The Eviva Stereotactic Guided Breast Biopsy System met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The Eviva Stereotactic Guided Breast Biopsy System is substantially equivalent to the legally marketed predicate device (Hologic's ATEC Breast Biopsy System K042290).

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.