Hologic, Inc October 5, 2020

℅ 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 (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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.18
Silver Spring, MD 20993
www.fda.gov
K202294 – Ms. Kate Brown Page 2

https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-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-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-
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,

Laurel M. Digitally signed by

Laurel M. Burk -S

Burk -S Date: 2020.10.05

16:13:06 -04'00' 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
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: 0MB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2023
Indications for Use See PRA Statement below.

51 0(k) Number (if known)

K202294

Device Name
Affirm® Contrast Biopsy

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

IZ! Prescription Use (Part 21 CFR 801 Subpart D) 0 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 CO MPLETED 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:
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Food and Drug Administration
Office of Chief Information Officer
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"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 0MB number."

FORM FDA 3881 (6120) Page 1 of 1 PSC Publishing Scl"\iccs 00 I) 44:i-,6740 EF

Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

Section 006 – 510(k) Summary

K202294
Please see the next page for the 510(k) Summary.
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

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 Road
Danbury, CT 06810 USA

Establishment Registration #: 1220984

Contact Person: Kate Brown

Sr. Regulatory Affairs Specialist
P: 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 Mammography
Classification Name: Full Field Digital, System, X-Ray, Mammographic
Regulatory Number: 21 CFR 892.1715
Product Code: MUE
Device Class: Class II
Review Panel: Radiology
Submitter/510(k) Holder: Hologic, Inc.
Clearance: K123873 (cleared January 29, 2013)
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

Device Description
The proposed Affirm® Contrast Biopsy is a licensable software feature for the Selenia Dimensions and
3Dimensions system platforms (P010025 and P080003, 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 and 3Dimensions 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.

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 based on visualization 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 location 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 or 3Dimensions Gantry C-Arm, which
positions the biopsy device under user guidance in preparation of the biopsy procedure.
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

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

Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

Affirm® Breast I-View™/ Contrast

Affirm® Contrast
Biopsy Guidance Enhanced Digital
Biopsy
System Mammography
Features and
(CEDM) Comparison
Characteristics
Primary Predicate Reference Device
Proposed
(K103512) (K123873)
The Affirm® Contrast Enhanced Affirm® Contrast Similar. The
Breast Biopsy Digital Biopsy is indicated proposed device’s
Guidance System Mammography as an optional indications for use
is an optional (CEDM) is an accessory for the will be a
accessory for the extension of the Selenia Dimensions combination of the
Selenia existing indication 2D Full Field Digital primary predicate
Dimensions 2D for diagnostic Mammography and reference
Full Field Digital mammography System and device’s indications
Mammography with the Selenia 3Dimensions for use statement.
System. It is Dimensions system. It is The addition of
designed to allow system. The CEDM designed to allow “3Dimensions
the accurate application shall the accurate system” was added
location of lesions enable contrast location of lesions to the proposed
in the breast in enhanced breast in the breast in indications for use
three dimensions, imaging using a three dimensions, statement. The
using information dual energy using information 3Dimensions
extracted from technique. This extracted from system does not
stereotactic pairs imaging technique stereotactic pairs differ
of two- can be used as an of two-dimensional technologically
dimensional adjunct following images. It is from that of the
Indications for
images. It is mammography intended to Selenia Dimensions
Use
intended to and/or ultrasound provide guidance system.
provide guidance exams to localize a for interventional
for interventional known or purposes (such as
purposes (such as suspected lesion. biopsy, pre-surgical
biopsy, pre- localization or
surgical treatment devices).
localization or Contrast Enhanced
treatment Digital
devices). 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
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

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.

Similar. Selenia
Dimensions and
3Dimensions are
Selenia
X-Ray Image Selenia Dimensions Selenia Dimensions both capable of 2D
Dimensions 2D
Device 2D FFDM and 3Dimensions FFDM which is
FFDM
utilized for the
proposed device’s
lesion localization.
Cartesian Cartesian
Coordinates Coordinates Same as primary
Coordinate determined from Not applicable to determined from predicate, Affirm®
Determination Dimensions CEDM Dimensions Breast Biopsy
Stereotactic Stereotactic Guidance System
software software
Same as primary
X: Motorized X: Motorized
Movement Not applicable to predicate, Affirm®
Y: Motorized Y: Motorized
Method CEDM Breast Biopsy
Z: Manual Z: Manual
Guidance System
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

Not applicable to Same as primary

Stereotactic CEDM predicate, Affirm®
+/- 15° +/- 15°
Angle Breast Biopsy
Guidance System
Lesion localization
Similar. Lesion
Lesion localization is obtained from
localization is
Lesion localization is obtained from 2D contrast
obtained utilizing
Method of is obtained from contrast enhanced enhanced image
the primary
Use 2D stereotactic 2D breast imaging acquisition from
predicate and
image acquisition. using a dual energy low energy and
reference device’s
technique. subtracted image
method of use.
pairs.
Similar. The
Guidance for addition of the
Guidance for
breast biopsy: lateral approach
breast biopsy:
Mechanism of Not applicable to -Standard (vertical) was cleared via
-Standard
Action CEDM approach K161575 and is
(vertical)
-Right or left lateral compatible with
approach
approach the proposed
device.
Similar. The
proposed device’s
workflow is similar
to the primary
predicate device’s
workflow. The only
difference are the
additional steps on
the AWS GUI which
allow the user to
choose Contrast
Dual energy Enhanced Digital
Stereotactic Stereotactic biopsy
Workflow imaging technique Mammography
biopsy workflow workflow
workflow images instead of
2D images before
performing the
stereotactic biopsy.
The proposed
device Affirm®
Contrast Biopsy
workflow differs
from the reference
device CEDM
workflow as it is
specific to biopsy.

Summary of Testing
Affirm® Contrast Biopsy Special 510(k)
Hologic, Inc.

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.