The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Device Description

This submission introduces the optional Affirm Lateral Arm Upright Biopsy Accessory which attaches to the Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D/3D Mammography System, software version 1.8.4 and higher.

The optional Affirm Lateral Arm Upright Biopsy Accessory attaches to the Affirm Biopsy Guidance Module (BGM) to enable lateral needle approach procedures. The Lateral Arm can only be used when the Selenia Dimensions C-arm is positioned at 0 degrees. When using the Lateral Arm, the X- Y- and Z-axis movement is the same as for the Affirm standard (upright) needle approach. For the lateral approach, the biopsy needle is manually advanced into the breast along its own X-axis, referred to as "Lat X".

When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).

New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.

AI/ML Overview

The document provided describes the Affirm Lateral Arm Upright Biopsy Accessory, an optional accessory for the Selenia Dimensions Mammography System. This device is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices) with a lateral needle approach.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion for this device appears to be its targeting accuracy, which is compared to existing predicate devices.

Acceptance Criterion	Reported Device Performance (Affirm Lateral Arm Upright Biopsy Accessory)	Predicate Device (Affirm Breast Biopsy Guidance System - K122836)	Reference Device (GE Senographe Stereo - K040125)
Stated Accuracy	+/- 1 mm in X, Y and Z Axis (overall targeting accuracy not more than 2 mm from either side)	Same	+/- 1 mm in X, Y and Z Axis
Guidance for Breast Biopsy	Standard (vertical) approach, and Right or left lateral approach	Standard (vertical) approach	Standard (vertical), and right or left lateral approach
Stereotactic/Tomographic Angle (Stereo)	+/- 15 °	Same	+/- 15 °
Stereotactic/Tomographic Angle (Tomo)	15 degrees total (+/- 7.5 degrees)	Same	N/A (Only stereo mentioned)

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

Sample Size: Not explicitly stated as a number of patient cases or images. The testing focused on functional and performance characteristics using test reports.
Data Provenance: Not applicable, as no clinical studies were performed. The testing was non-clinical.

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

Number of Experts: Not applicable. Ground truth was established through physical measurements and engineering tests.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The testing described is primarily engineering and performance verification, not an interpretation of medical findings requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done? No. The document explicitly states: "No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing." Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Standalone Study Done? Yes, in essence, the "Lateral Arm Targeting Accuracy Test" and "Default Needle Parameter Validation Test Report" represent standalone performance tests of the device's mechanical and software accuracy without direct human intervention in the targeting process during the test. The device provides guidance, but the testing assesses the accuracy of that guidance mechanism itself.

7. Type of Ground Truth Used:

Type of Ground Truth: Physical measurement and engineering specifications. For target accuracy, this would involve precise measurements of the actual needle tip position relative to the intended target point within a phantom or test setup.

8. Sample Size for the Training Set:

Sample Size: Not applicable. The device is a mechanical accessory with integrated software for guidance. It does not appear to use machine learning or AI models that require a "training set" in the conventional sense. Its function is based on pre-programmed algorithms and physical calibration.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The system's accuracy and functionality were verified through engineering tests and validation against established standards.

Summary of Testing:

The document highlights that the device underwent system design control verification and validation tests, conforming to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (moderate level of concern).

Specific tests included:

Lateral Arm Targeting Accuracy Test: This directly addresses the core function of the device to accurately guide interventions.
Default Needle Parameter Validation Test Report: Ensures correct operation with needle parameters.
Updated Affirm CB test report (including Lateral Arm Accessory): Likely refers to a comprehensive test suite for the combined system.
Third-party testing on:
- Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
- Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
- Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices (IEC 60601-2-45, Subclause 201.9.2.1013 a,b,c)

The conclusion states that substantial equivalence was demonstrated by nonclinical testing, and no clinical studies were performed. The device's design, operation, construction, and materials were deemed substantially equivalent to the predicate and reference devices.

Summary

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

August 10, 2016

Hologic, Inc. % Ms. Debbie Peacock Senior Manager, Regulatory Affairs 36 Apple Ridge Road DANBURY CT 06810

Re: K161575

Trade/Device Name: Affirm Lateral Arm Upright Biopsy Accessory Regulation Number: 21 CFR 892.1710 Regulation Name: Mammography x-ray system Regulatory Class: II Product Code: IZH Dated: June 8, 2016 Received: June 9, 2016

Dear Ms. Peacock:

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 (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); 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/Resourcesfor You/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.

Michael D. O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161575

Device Name Affirm Lateral Arm Upright Biopsy Accessory

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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Traditional 510(k) Summary

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

Date Prepared:	June 6, 2016
Manufacturer:	Hologic, Inc.36 Apple Ridge RoadDanbury, CT 06810 USA
Est. Registration #:	1220984
Manufacturer:	Hologic, Inc.37 Apple Ridge RoadDanbury, CT 06810 USA
Est. Registration #:	1225717
Contact Person:	Debbie PeacockSr. Manager, Regulatory AffairsPhone: (203) 702-7794
Identification of the Device:

Identification of the Device:

Proprietary/Trade Name	Affirm™ Lateral Arm Upright Biopsy Accessory
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 General name: Mammographic X-ray system Submitter / 510(k) Holder: HOLOGIC, Inc. 510(k) #'s: K122836, cleared on 01/11/13 Product Code: IZH Regulation Number: 892.1710

Identification of the Legally Marketed Reference Device:

Trade name: GE Senographe General name: Mammographic X-ray system Submitter / 510(k) Holder: General Electric, Inc. 510(k) #'s: K040125, cleared on 04/19/04 Product Code: IZH Regulation Number: 892.1710

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Device Description:

When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).

New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.

The Indications for Use is unchanged from the predicate Affirm Breast Biopsy Guidance System as shown below.

Indications for Use:

The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Substantial Equivalence:

The (optional) Affirm Lateral Arm Upright Biopsy Accessory is substantially equivalent to the predicate Affirm Breast Biopsy Guidance System (K122836) and to the lateral arm attachment used as a reference device, cleared in GE's Senographe Stereo System, (K040125). Substantial equivalence is based on design, technology, Indications for Use, labeling, operation, basic constructions and materials used. The addition of the optional Lateral Arm Accessory to the cleared Affirm Biopsy Guidance System poses no additional hazards and is substantially equivalent to our predicate and reference devices listed below.

	Affirm Lateral ArmUpright BiopsyAccessory(Proposed)	Predicate DeviceAffirm Breast BiopsyGuidance System(K122836)	Reference DeviceGE SenographeStereo (K040125);(lateral arm)
Indicationsfor Use	The Affirm Breast BiopsyGuidance System is anoptional accessory for theSelenia DimensionsMammography System. It	The Affirm Breast BiopsyGuidance System is anoptional accessory for theSelenia DimensionsMammography System. It is	Senographe Stereo isan optional accessoryfor the Senographe DSfull field digital system.It is designed to allow

X-ray ImageDevice	is designed to allow theaccurate localization oflesions in the breast intwo/and or threedimensions. It is intendedto provide guidance forinterventional purposes(such as biopsy, pre-surgical localization ortreatment devices).Hologic SeleniaDimensions 2D/3DMammography System	designed to allow theaccurate localization oflesions in the breast in threedimensions. It is intendedto provide guidance forinterventional purposes(such as biopsy, pre-surgicallocalization or treatmentdevices).Same	the accurate location oflesions in the breast inthree dimensions, usinginformation extractedfrom stereotactic pairsof two-dimensionalimages. It is intendedto provide guidance forinterventional purposes(such as biopsy, pre-surgical localization, ortreatment devices).GE Senographe DS 2D
Software	Selenia Dimensions V1.8.4and higher)	Selenia Dimension V1.8.3(current version)	Same description;version unknown.
Method of Use	Breast lesion localizationand biopsycore biopsy vacuum assistedbiopsy fine needleaspiration hook wirelocalizationexams.	Breast lesion localizationand biopsycore biopsy vacuum assistedbiopsy fine needleaspiration hook wirelocalization exams.	Breast lesionlocalization and biopsy,such as:core biopsy vacuumassisted biopsy fine needleaspiration hook wirelocalizationexams.
DedicatedBreast BiopsyPositioner	Yes	Yes	Yes
Mechanism ofAction	Guidance for breast biopsy-Standard (vertical)approach, and-Right or left lateralapproach.	Guidance for breast biopsy-Standard (vertical) approach	Guidance for breastbiopsy-Standard (vertical),and right or left lateralapproach.
Technology
CoordinateDetermination	Yes	Yes	Yes
NeedlePositioning	Biopsy PositioningModule gets X, Y, Zcoordinates of target areafrom AWS	Biopsy Positioning Modulegets X, Y, Z coordinates oftarget area from AWS	Biopsy PositioningModule gets X, Y, Zcoordinates of targetarea from AWS

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Stereotactic/TomographicAngle	Stereo:+/- 15 °Tomo:15 degrees total (+/- 7.5degrees)	Stereo:SameTomo:Same	Stereo:+/- 15 °Tomo:N/A
StatedAccuracy	+/- 1 mm in X, Y and ZAxis[overall targetingaccuracy is equal tocombined targetingaccuracy of the Biopsyarm controller and thebiopsy device (maximumdeviation from targetcoordinate will not bemore than 2 mm fromeither side)].	Same	+/- 1 mm in X, Y and ZAxis
CompressionMethod	Manual, automaticcompression release isdisabled automaticallywhen the BGM isinstalled.	Same	Manual, compressionrange is 10-100 mm,with compressioncontrolled manually.
CompressionPaddle	Vertical approachw/window,Lateral approach, nowindow	Vertical approach w/window	Vertical approachw/window,Lateral approach, nowindow:
SafetyFeatures	SamePlus:When the system is inlateral approach biopsymode, the system shallonly allow exposures at C-arm position of 0 degrees.	Automatic detection ofmounting, latching andconnection of biopsy moduleC-arm motion disabled ifbiopsy module is not lockedin place.Automatic compressionrelease disabled when biopsymodule installedC-Arm Motion disabledwhen breast is undercompressionMotorized movement ofbiopsy device only underuser control.Audible alert when biopsydevice motion may result in	Unknown
		mechanical interference.
Materials (Short-term Skin Contracting)
BreastPlatformMaterial	Carbon Fiber	Same	Same
Biopsy PaddleMaterial	Polycarbonate plastics	Same	Same

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Summary of Testing:

The (optional) Affirm Lateral Arm Upright Biopsy Accessfully 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.

In addition, the following test reports are included:

Lateral Arm Targeting Accuracy Test ●
Default Needle Parameter Validation Test Report .

The Affirm CB test report was updated to include the optional Lateral Arm Accessory and the new lateral biopsy paddle. Third party testing was conducted on the tests listed below which were considered necessary to evaluate the noted changes:

Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices *IEC ● 60601-2-45, Subclause 201.9.2.1013 a,b,c)

No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing.

Conclusion:

The Affirm Lateral Arm Upright Biopsy Accessory is a modification to the predicate Affirm Breast Biopsy Guidance System (K122836) and is also substantially equivalent to the lateral arm component used in the reference GE Senographe Stereo System. (K040125). The design, operation, basic construction and materials used are substantially equivalent to the above predicate devices. Selenia Dimensions software V1.8.4 and higher enables use of either 2D or tomosynthesis-guided biopsy in a standard (vertical) or lateral approach. The addition of the (optional) Affirm Lateral Arm Upright Biopsy Accessory to the cleared Affirm Biopsy Guidance System is substantially equivalent to our predicate and reference devices listed above.

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.