The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

Device Description

The Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Digital Mammography system. It is designed for positioning the needle when performing Stereotactic and/or Tomosynthesis Biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a Stereo pair of images and/or Tomosynthesis images. The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the images, as indicated by the operator, and the known geometry of the system.

FDR-2000BPY is mainly composed of the following elements:

The Positioner that supports and positions the needle .
The Positioner Control Cabinet which supplies power to the positioned .
The Operation panel which displays the distance between the compression plate and . target pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.

The subject of this Special 510(k) premarket notification is addinq use of Digital Breast Tomosynthesis (DBT) images for extracting information to determine three dimensional lesion locations in the breast.

AI/ML Overview

This document describes the Biopsy Positioner (FDR-2000BPY) for determining 3D lesion locations in the breast for interventional purposes using stereotactic and/or Digital Breast Tomosynthesis (DBT) images.

There is no information in the provided text regarding a study on "AI" performance or human reader improvement with AI assistance. The device described is a biopsy positioner and not an AI algorithm for image interpretation.

Here's the information that can be extracted based on the provided text, focusing on the device itself and its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Metric	Acceptance Criteria (Implicit from testing standards or predicate)	Reported Device Performance
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014	Met all acceptance criteria.
Radiation Safety	Compliance with IEC 60601-1-3:2013 and IEC 60601-2-45:2015	Met all acceptance criteria.
Software Validation	Compliance with ANSI/AAMI/IEC 62304:2006 and FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"	Met all acceptance criteria (implied by statement).
Needle Positioning Accuracy (Stereotactic & Tomosynthesis Biopsy)	± 1mm (Derived from predicate device K122836)	Bench testing performed, implying it met the required accuracy. The document states "evaluated...to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy," and the conclusion states the device is "as safe and effective as the predicate device," which had a ±1mm accuracy.
Biopsy Type Supported	Stereo Biopsy, Tomosynthesis Biopsy (Reference Predicate)	Stereo Biopsy, Tomosynthesis Biopsy
Exposure Position	± 15° (Stereo Exposure), ± 7.5° (Tomosynthesis Exposure)	± 15° (Stereo Exposure), ± 7.5° (Tomosynthesis Exposure)
Compression Plate Construction Material/Type	Plastic (Predicate K113284)	Plastic (Same as K113284)
Lockout Movement under Compression	Movements inhibited if compression force > 30N or needle attached (Predicate K113284)	Same as K113284
Automatic Detection of Biopsy Unit	Yes (alarm/warning for improper connection) (Predicate K113284)	Same as K113284
Needle Guide Positioning	Yes (Predicate K113284)	Same as K113284
Positioning Software	Fujifilm (Predicate K113284)	Same as K113284
Calibration Frequency	User executes accuracy testing at every use; annual maintenance check (Predicate K113284)	Same as K113284
Mammotome-compatible Devicor Medical Products	Yes (Predicate K113284)	Same as K113284
Mammotome Revolve Compatibility	No (Predicate K113284)	Yes (This is an added feature / difference)
Hologic ATEC/Eviva Compatibility	No (Predicate K113284)	Yes (This is an added feature / difference)
BARD Compatible	Yes (Predicate K113284)	Same as K113284

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

The document states "Bench testing was performed... to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy." It does not specify a numerical sample size for this bench testing.

Data Provenance: Bench testing, so it is synthetic/physical testing, not patient data. No country of origin is specified for the bench testing.

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

This device is a biopsy positioner, not an image interpretation or diagnostic AI device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance is not directly applicable.
The accuracy of the device (e.g., needle positioning) would be verified against physical measurements or established calibration standards during bench testing. No human experts are mentioned for establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable as the testing involves physical performance metrics (e.g., positioning accuracy) rather than subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a biopsy positioner accessory, not an image reader or an AI diagnostic tool. There is no mention of human readers or AI assistance in the document.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is built on the premise that the device is an "algorithm." The FDR-2000BPY is a physical "Biopsy Positioner," an accessory to a mammography system. While it has software and computes 3D coordinates, it is not described as a standalone diagnostic algorithm. Its performance is integrated with the mammography system and involves human operation for marking targets.
The "performance data" section focuses on hardware-related compliance (EMC, radiation safety) and "needle positioning accuracy" via bench testing, not autonomous algorithmic performance.

7. The Type of Ground Truth Used

For the needle positioning accuracy, the ground truth would likely be physical measurements against known target coordinates or established calibration standards in a bench test environment. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy, not the accuracy of a physical positioning system itself.

8. The Sample Size for the Training Set

Not applicable. This device is a physical accessory with integrated software for coordinate calculation, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration, not data-driven model training.

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

Not applicable, as there is no "training set" for an AI model. For the device's development and calibration, ground truth would be established through engineering specifications, precise physical measurements, and system calibration procedures.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 3, 2019

FUJIFILM Corporation % Mr. Jeffrey Wan Specialist, Regulatory Affairs FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421

Re: K191495

Trade/Device Name: Biopsy Positioner (FDR -2000BPY) Regulation Number: 21 CFR 892.1710 Regulation Name: Mammographic x-ray system Regulatory Class: Class II Product Code: IZH Dated: May 31, 2019 Received: June 5, 2019

Dear Mr. Wan:

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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.

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K191495

Device Name

BIOPSY POSITIONER(FDR-2000BPY)

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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED 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:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov
"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 OMB number."

==============================================================================================================================================================================

{3}------------------------------------------------

510(k) Summary K191495

Date Prepared: July 3, 2019

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928

Contact Person:

Jeffrey Wan Specialist, Regulatory Affairs Telephone: (201) 675-8947 Email: jeffrey.wan@fujifilm.com

Device Name and Classification:

Product Name:	Biopsy Positioner
Model Number:	FDR-2000BPY
Classification Name:	Mammographic X-ray system
Classification Panel:	Radiology
CFR Section:	21 CFR 892.1710
Device Class:	Class II
Product Code:	IZH

Predicate Devices:

	Primary Predicate	Reference Predicate
Product Name	FUJIFILM Biopsy Positioner (FDR-1000BPY)	Affirm Breast Biopsy GuidanceSystem
510(k) Number	K113284	K122836
ClassificationName	Mammographic X-ray system	Mammographic X-ray system
ClassificationPanel	Radiology	Radiology
CFR Section	21 CFR 892.1710	21 CFR 892.1710
Device Class	Class II	Class II
Product Code	IZH	IZH

{4}------------------------------------------------

Indications for Use:

The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide quidance for interventional purposes (such as biopsy, pre-surqical localization or treatment devices).

Description of the Device:

FDR-2000BPY is mainly composed of the following elements:

The Positioner that supports and positions the needle .
The Positioner Control Cabinet which supplies power to the positioned .
The Operation panel which displays the distance between the compression plate and . target pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.

Comparison of Technological Characteristics:

The Biopsy Positioner (FDR-2000BPY) differs from the predicate device in the following modifications:

Addition of tomosynthesis biopsy feature
Compatibility with additional needle guides ●

A comparison of the technological characteristics between the proposed device and predicate devices is provided below:

{5}------------------------------------------------

	Biopsy Positioner (FDR-2000BPY)	Biopsy Positioner (FDR-1000BPY)	Affirm Breast Biopsy Guidance System
K number	K191495	K113284	K122836
IFU	The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).	The FUJIFILM Biopsy Positioner (FDR-1000BPY) is an optional accessory for the Aspire HD (FDR MS-1000) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast 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).	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)
Biopsysystem	Type of biopsy	Same as K122836	Stereo Biopsy	Stereo BiopsyTomosynthesis Biopsy
	Exposureposition	Same as K122836	$\pm$ 15°(Stereo Exposure)	$\pm$ 15°(Stereo Exposure)$\pm$ 7.5°(Tomosynthesis Exposure)
	Positioningaccuracy	Same as K113284	$\pm$ 1mm	$\pm$ 1mm
	Weight	Same as K113284	Biopsy Unit 5.5kg	7.0kg
	Positioningmethod	Same as K113284	Electrically & Manually	Electrically & Manually
	Method of beamlimitation	Same as K113284	Automatic collimation	Automatic collimation
	Size of biopsyField of View	Same as K113284	6.0cm x 7.0cm	5.4cm x 5.2cm7.4cm x 6.2cm
	Lateral Approach	Same as K113284	Yes	Yes

{6}------------------------------------------------

		Biopsy Positioner (FDR-2000BPY)	Biopsy Positioner (FDR-1000BPY)
Compressionsystem	Constructionmaterial / typeof biopsycompressionpaddle	Same as K113284	Plastic
	Lockoutmovementwhen undercompression	Same as K113284	All movements shall be inhibited when:• The compression force is detected tobe more than 30N• The needle is attached to the needleholder
	Automaticdetection ofbiopsy unit	Same as K113284	Yes (alarm sounds and warning displayed orindication panel if not connected properly)
NeedleGuide	Needle guidepositioning	Same as K113284	Yes
	Positioningsoftware	Same as K113284	Fujifilm
	Calibrationfrequency	Same as K113284	User executes the accuracy testing at everyuse and an annual maintenance check isperformed
	Mammotome-compatibleDevicor MedicalProducts	Same as K113284	Yes
	MammotomeRevolve	Yes	No
	HologicATEC/Eviva	Yes	No
	BARDCompatible	Same as K113284	Yes

Performance Data:

Biopsy Positioner (FDR-2000BPY) was evaluated for electromagnetic compatibility and radiation safety when used with the Aspire Cristalle (FDR MS-3500) digital mammography system in accordance with IEC 60601-1-2:2014, IEC 60601-1-3:2013, and IEC 60601-2-45:2015. The proposed device met all acceptance criteria described in these standards.

Software validation was evaluated in accordance with ANSI/AAMI/IEC 62304:2006 and the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Bench testing was performed on the Biopsy Positioner (FDR-2000BPY) to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy when used with the Aspire Cristalle (FDR MS-3500) digital mammography system.

{7}------------------------------------------------

Substantial Equivalence

The modified FUJIFILM Biopsy Positioner (FDR-2000BPY) is adding the intended use with Digital Breast Tomosynthesis (DBT) images for extracting information to determine three dimensional lesion locations in the breast. Both the modified and primary predicate devices have the same fundamental scientific technology, principles of operation, performance, and design and materials. The addition of the tomosynthesis biopsy feature is supported by the reference predicate device. Therefore, FDR-2000BPY can be considered to be substantially equivalent to FDR-1000BPY.

Conclusion:

This Special 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate device.

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.