Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.

Device Description

The proposed Affirm® Contrast Biopsy is a licensable software for the Selenia Dimensions and 3Dimensions system platforms (P010025 and P08003, respectively). The proposed software option will be used with the Affirm® Breast Biopsy Guidance System (K103512). The proposed software is a stereotactic lesion localization system option for the Dimensions systems. It allows clinicians to perform biopsy targeting on captured contrast enhanced images. Affirm® Contrast Biopsy uses the same workflow as stereotactic biopsy, substituting standard scout and stereo pair views with contrast enhanced views captured at the associated angles. The proposed device is compatible with the standard vertical biopsy approach as well as the right or left lateral approach.

Affirm® Contrast Biopsy introduces new software and labeling. There are no changes to the Dimensions platform and Affirm® Breast Biopsy Guidance System hardware, platform software architecture, or stereotactic function as a result of the proposed software.

AI/ML Overview

The provided text is a 510(k) Summary for the Hologic Affirm® Contrast Biopsy system. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for AI/ML device performance.

Therefore, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML system's performance. The device described appears to be a hardware/software system for guiding biopsies using contrast-enhanced imaging, not an AI/ML algorithm that requires performance metrics like sensitivity, specificity, or reader studies.

Specifically, the document states: "Non-clinical bench testing demonstrates the Affirm® Contrast Biopsy is substantially equivalent to the predicate and reference device with regards to the indication for use, software, technology, and performance. Design verification testing demonstrates the proposed device complies with design specifications. The software, and performance showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate..." This indicates that bench testing and design verification were conducted to show equivalence, typical for traditional medical devices, not a study focused on AI/ML performance.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document discusses "design specifications" and "equivalent performance" but no specific quantitative acceptance criteria or results are listed.
Sample size used for the test set and the data provenance: Not mentioned. There is no description of a clinical test set or data origins.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided text, as no clinical test set for performance evaluation (e.g., sensitivity/specificity) is described using expert ground truth.
Adjudication method: Not applicable.
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: Not applicable. This is not an AI-assisted interpretation device in the traditional sense, but rather a biopsy guidance system. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is described as a system for guidance, not a standalone diagnostic algorithm.
The type of ground truth used: Not applicable. No ground truth for performance evaluation (e.g., pathology, expert consensus) is described.
The sample size for the training set: Not applicable. This document does not describe an AI/ML model that would have a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary are for a biopsy guidance system that uses contrast-enhanced images, which is cleared based on substantial equivalence to existing predicate devices through bench testing and design verification, rather than a clinical performance study with specific AI/ML acceptance criteria and human-in-the-loop evaluations.

Summary

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October 5, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Hologic, Inc % Ms. Kate Brown Sr. Specialist, Regulatory Affairs 36 Apple Ridge Road DANBURY CT 06810

Re: K202294

Trade/Device Name: Affirm® Contrast Biopsy Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: Class II Product Code: IZH Dated: September 21, 2020 Received: September 22, 2020

Dear Ms. Brown:

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. 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 located 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.

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202294

Device Name Affirm® Contrast Biopsy

Indications for Use (Describe)

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)

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Section 006 – 510(k) Summary K202294

Please see the next page for the 510(k) Summary.

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Special 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807.92

Date Prepared:	October 1, 2020
Manufacturer:	Hologic, Inc.36 Apple Ridge RoadDanbury, CT 06810 USA
Establishment Registration #:	1220984
Contact Person:	Kate BrownSr. Regulatory Affairs SpecialistP: 203.702.7819
Identification of the Device:
Proprietary/Trade Name:	Affirm® Contrast Biopsy
Classification Name:	Mammographic X-ray System
Regulatory Number:	21 CFR 892.1710
Product Code:	IZH
Device Class:	Class II
Review Panel:	Radiology
Identification of the Legally Marketed Predicate Device:
Trade Name:	Affirm® Breast Biopsy Guidance System
Classification Name:	Mammographic X-ray System
Regulatory Number:	21 CFR 892.1710
Product Code:	IZH
Device Class:	Class II
Review Panel:	Radiology
Submitter/510(k) Holder:	Hologic, Inc.
Clearance:	K103512 (cleared January 07, 2011)
Identification of the Legally Marketed Reference Device:
Trade Name:	Contrast Enhanced Digital Mammograp
Classification Name:	Full Field Digital, System, X-Ray, Mamm

Regulatory Number: Product Code: Device Class: Review Panel: Submitter/510(k) Holder: Clearance:

graphy ammographic 21 CFR 892.1715 MUE Class II Radiology Hologic, Inc. K123873 (cleared January 29, 2013)

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Device Description

Indications for Use

The Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.

Technological Characteristics

The Affirm® Contrast Biopsy uses the same technological principles as that of the cleared Affirm® Breast Biopsy Guidance System; however, Contrast Enhanced Digital Mammography (K123873) images are utilized instead of standard scout and standard stereo pair images. In the proposed device the lesion will be localized by 2D stereotactic image acquisition of the lesion enhancement after an IV injection of an iodinated contrast agent. Stereo pair images are captured at plus and minus 15-degree angles using Dual Energy Contrast Enhanced Digital Mammography (CEDM). Low energy, and subtracted images can be displayed on the Acquisition Workstation monitor and are used for targeting purposes. The user then positions on-screen cursors to identify the position of the target lesion in the projected image pairs. Utilizing the target lesion information from these acquired images, the software uses trigonometric calculations to determine the Cartesian coordinates (X, Y, and Z) of the targeted lesion within the breast. The calculated coordinates of the targeted lesion are sent to the Affirm biopsy control module mounted on the Selenia Dimensions Gantry C-Arm, which positions the biopsy device under user guidance in preparation of the biopsy procedure.

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Comparison with Predicate Devices

The Affirm® Contrast Biopsy and its predicate device, Affirm® Breast Biopsy Guidance System (K103512) and reference device, Contrast Enhanced Digital Mammography (K123873), have the same or similar intended use, technological characteristics, and operational use.

Summary of Substantial Equivalence

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	Affirm® BreastBiopsy GuidanceSystem	I-View™/ ContrastEnhanced DigitalMammography(CEDM)	Affirm® ContrastBiopsy	Comparison
Features andCharacteristics	Primary Predicate(K103512)	Reference Device(K123873)	Proposed
Indications forUse	The Affirm®Breast BiopsyGuidance Systemis an optionalaccessory for theSeleniaDimensions 2DFull Field DigitalMammographySystem. It isdesigned to allowthe accuratelocation of lesionsin the breast inthree dimensions,using informationextracted fromstereotactic pairsof two-dimensionalimages. It isintended toprovide guidancefor interventionalpurposes (such asbiopsy, pre-surgicallocalization ortreatmentdevices).	Contrast EnhancedDigitalMammography(CEDM) is anextension of theexisting indicationfor diagnosticmammographywith the SeleniaDimensionssystem. The CEDMapplication shallenable contrastenhanced breastimaging using adual energytechnique. Thisimaging techniquecan be used as anadjunct followingmammographyand/or ultrasoundexams to localize aknown orsuspected lesion.	Affirm® ContrastBiopsy is indicatedas an optionalaccessory for theSelenia Dimensions2D Full Field DigitalMammographySystem and3Dimensionssystem. It isdesigned to allowthe accuratelocation of lesionsin the breast inthree dimensions,using informationextracted fromstereotactic pairsof two-dimensionalimages. It isintended toprovide guidancefor interventionalpurposes (such asbiopsy, pre-surgicallocalization ortreatment devices).Contrast EnhancedDigitalMammography(CEDM) is anextension of theexisting indicationfor diagnosticmammographywith the SeleniaDimensions systemand 3Dimensionssystem. Biopsytargeting can bedone on captured	Similar. Theproposed device'sindications for usewill be acombination of theprimary predicateand referencedevice's indicationsfor use statement.The addition of"3Dimensionssystem" was addedto the proposedindications for usestatement. The3Dimensionssystem does notdiffertechnologicallyfrom that of theSelenia Dimensionssystem.
			contrast enhancedimages (scout andstereo pair). TheCEDM applicationshall enablecontrast enhancedbreast imagingusing a dual energytechnique. Thisimaging techniquecan be used as anadjunct followingmammographyand/or ultrasoundexams to localize aknown orsuspected lesion.Affirm® ContrastBiopsy is intendedfor patientsrecommended forbiopsy who havehad a suspiciousfinding on previouscontrast enhancedimaging or havelesions that may beoccult under other
X-Ray ImageDevice	SeleniaDimensions 2DFFDM	Selenia Dimensions2D FFDM	modalities.Selenia Dimensionsand 3Dimensions	Similar. SeleniaDimensions and3Dimensions areboth capable of 2DFFDM which isutilized for theproposed device'slesion localization.
CoordinateDetermination	CartesianCoordinatesdetermined fromDimensionsStereotacticsoftware	Not applicable toCEDM	CartesianCoordinatesdetermined fromDimensionsStereotacticsoftware	Same as primarypredicate, Affirm®Breast BiopsyGuidance System
MovementMethod	X: MotorizedY: MotorizedZ: Manual	Not applicable toCEDM	X: MotorizedY: MotorizedZ: Manual	Same as primarypredicate, Affirm®Breast BiopsyGuidance System

StereotacticAngle	+/- 15°	Not applicable toCEDM	+/- 15°	Same as primarypredicate, Affirm®Breast BiopsyGuidance System
Method ofUse	Lesion localizationis obtained from2D stereotacticimage acquisition.	Lesion localizationis obtained fromcontrast enhanced2D breast imagingusing a dual energytechnique.	Lesion localizationis obtained from2D contrastenhanced imageacquisition fromlow energy andsubtracted imagepairs.	Similar. Lesionlocalization isobtained utilizingthe primarypredicate andreference device'smethod of use.
Mechanism ofAction	Guidance forbreast biopsy:-Standard(vertical)approach	Not applicable toCEDM	Guidance forbreast biopsy:-Standard (vertical)approach-Right or left lateralapproach	Similar. Theaddition of thelateral approachwas cleared viaK161575 and iscompatible withthe proposeddevice.
Workflow	Stereotacticbiopsy workflow	Dual energyimaging techniqueworkflow	Stereotactic biopsyworkflow	Similar. Theproposed device'sworkflow is similarto the primarypredicate device'sworkflow. The onlydifference are theadditional steps onthe AWS GUI whichallow the user tochoose ContrastEnhanced DigitalMammographyimages instead of2D images beforeperforming thestereotactic biopsy.The proposeddevice Affirm®Contrast Biopsyworkflow differsfrom the referencedevice CEDMworkflow as it isspecific to biopsy.

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Summary of Testing

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Non-clinical bench testing demonstrates the Affirm® Contrast Biopsy is substantially equivalent to the predicate and reference device with regards to the indication for use, software, technology, and performance. Design verification testing demonstrates the proposed device complies with design specifications. The proposed device was developed under Hologic's Quality Management System which adheres to 21 CFR Part 820 and ISO 13485:2016. Risk management activities, in accordance with ISO 14971:2019, demonstrate that the risks associated with the use of the Affirm® Contrast Biopsy software are mitigated as far as possible. Analyses of these activities indicate the benefits associated with the use of the Affirm® Contrast Biopsy outweigh the residual risks.

The software, and performance showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate Affirm® Breast Biopsy Guidance System (K103512) and reference Contrast Enhanced Digital Mammography (K123873).

Benefit-Risk Analysis

The benefit of the device is to allow visualization and biopsy of suspicious lesions that may otherwise be occult or difficult to confidently target using other modalities. The main risks are the additional radiation dose and exposure to contrast agents.

The radiation dose is approximately 25% greater than performing FFDM stereotactic biopsy, and per exposure would be about the same as the reference device operating in 2D contrast enhanced imaging mode.

The exposure of the patient to the iodinated contrast agent presents another risk. Although the probability of occurrence is remote, the most significant additional risk to a patient during a contrast enhanced biopsy procedure relative to a stereotactic biopsy is an allergic reaction to the injected contrast agent which could potentially result in a life threatening aphylactic reaction. Recent estimates suggest that the rate of acute adverse events for low-osmolar contrast agents is approximately 0.2%-0.7%, with a severe acute reactions being approximately 0.04%. This risk is mitigated via procedural guidelines set up in hospitals which cover training, pre-screening of patients' kidney function (i.e.; glomerular filtration rate or GFR), and appropriate acute care readiness (e.g., "crash carts"), as may be expected to be in place for the reference device as well. Furthermore, if the patient has had previous exposure to iodinated contrast agents safely with no adverse reaction, such as a contrast-enhanced digital mammography exam, then this risk will be additionally reduced. These additional radiation and contrast agent risks are therefore likely outweighed by the benefits of the device for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.

Conclusion

The Affirm® Contrast Biopsy is substantially equivalent to the legally marketed predicate device, Affirm Breast Biopsy Guidance System cleared on January 08, 2011 via K103512, and the legally marketed reference device, Contrast Enhanced Digital Mammography, cleared on January 29, 2013 via K123873. The indications for use and fundamental scientific technology of the proposed device are the same or similar to that of the Affirm® Breast Biopsy Guidance System and Contrast Enhanced Digital Mammography.

Regulation Number and Section

§ 892.1710 Mammographic x-ray system.

(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.