The Pristina Serena 3D option provides the three-dimensional location of target lesions, using information obtained from Digital Breast Tomosynthesis (DBT) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.q. hookwire), and fine needle aspirations (FNA).

Device Description

Pristina Serena 3D is DBT Biopsy System for Senographe Pristina. It is an additional option that builds upon the Pristina Serena device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina platform). Pristina Serena was cleared on May 14, 2018 (K173576).

Pristina Serena 3D enables biopsy medical application to be done using Digital Breast Tomosynthesis (DBT) images.

The Pristina Serena 3D add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena 3D option. Labeling for the Biopsy DBT (3D) Medical application. Pristina Serena 3D option is compatible with previously installed Senographe Pristina systems. Pristina Serena 3D does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena 3D (K173576) was also not modified.

AI/ML Overview

The Pristina Serena 3D device is designed to provide three-dimensional localization of target lesions using Digital Breast Tomosynthesis (DBT) images to guide minimally invasive breast procedures.

Here's an analysis of the acceptance criteria and the studies that prove the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state a table of quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for lesion detection or biopsy targeting. Instead, the "Determination of Substantial Equivalence" section emphasizes the device's conformance to standards, successful verification/validation testing, and demonstrated performance according to specifications.

However, based on the technology description and comparison with reference devices, the key performance criteria for a biopsy guidance system generally revolve around accuracy of lesion localization and image quality.

Acceptance Criteria (Inferred from device description and comparison)	Reported Device Performance (as stated in the document)
Accuracy of 3D lesion localization (X, Y, and Z coordinates)	-"The target lesion 3D coordinates information, together with the complete geometry of the device, are used to compute the required position of a biopsy device holder that will allow intervention in the breast at the exact target position." - "Both 3D localization features calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices." (referring to the predicate and reference devices, implying similar performance) - "same stated accuracy" (when comparing with Hologic's Affirm)
Image Quality for Biopsy Procedures	-"Since Pristina Serena 3D option uses the Image chain of the Senographe Pristina platform, the image quality of images during the biopsy procedure is equivalent to that of standard screening/diagnostic images of Senographe Pristina 3D." - "Non-Clinical Data - Image Quality and Dose test that demonstrates that images acquired with Pristina Serena 3D are of same quality as images acquired with Senographe Pristina at similar dose levels."
Dose Management	-"a single DBT acquisition allows for both confirming appropriate breast positioning and for lesion targeting (as opposed to a Stereotaxy procedure that requires three X-ray acquisitions: one scout image plus a stereotaxic pair). This translates into dose reduction to patient." - "uses a single AOP mode available when acquiring biopsy images. This AOP mode provides the same parameters as the Senographe Pristina 3D AOP mode called "STD+" (P130020/S003 3D STD+ on Senographe Pristina 3D submission)."
Mechanical Accuracy/Precision of Biopsy Device Holder	-"motorized and takes into account the geometry of the biopsy needles, so when the biopsy device holder is in place, the user introduces the needle in the breast until reaching the mechanical stop of the biopsy device holder..."
Usability/Functionality	-"Pristina Serena 3D Design and Usability Validation Report which contains evidence of validation of claims and performance bench testing" - "allows two different needle approaches for Biopsy: vertical and horizontal"
Safety and Compliance	-"successfully completed required design control testing per GE Healthcare's quality management system." -"designed and will be manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485."

2. Sample Size for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of clinical images or patient data with a defined sample size for evaluating the device's diagnostic or interventional accuracy. The evaluation appears to be based on non-clinical data, engineering bench performance testing, and design/usability validation.

"Non-Clinical Data - Image Quality and Dose test": No sample size or data provenance (e.g., country of origin, retrospective/prospective) is provided for this test. It focuses on demonstrating equivalent image quality and dose to the predicate.
"Pristina Serena 3D Design and Usability Validation Report": No sample size for user studies or specific details on data provenance are provided. This likely involved internal validation testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since specific clinical test sets are not detailed in the summary, information regarding the number of experts, their qualifications, or how they established ground truth for these tests is not provided. The assessment appears to rely on simulated use testing and technical performance specifications rather than clinical reads.

4. Adjudication Method for the Test Set

As there is no described clinical "test set" involving expert interpretation, an adjudication method (such as 2+1 or 3+1) is not applicable or described in this document.

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

A MRMC comparative effectiveness study that demonstrates how much human readers improve with AI vs. without AI assistance was not mentioned in the provided 510(k) summary. This device is an accessory for biopsy guidance and not an independent AI-powered diagnostic tool for image interpretation.

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

The device acts as a guidance system. Its primary function is to accurately calculate 3D coordinates for a biopsy. The technology description focuses on the system's ability to determine 3D location and guide the biopsy needle, not an algorithm that performs standalone interpretation. Therefore, a standalone performance evaluation in the typical sense of an AI diagnostic algorithm is not discussed. The device's "performance" is inherently linked to its interaction with the imaging platform and the biopsy accessories.

7. Type of Ground Truth Used

Based on the documentation, the "ground truth" for evaluating the targeting accuracy in the non-clinical and bench testing would likely be phantom measurements or simulated lesion placements with known coordinates. For image quality, the ground truth would be established through technical image quality metrics and comparison to established standards for the predicate device. For usability, the ground truth would come from user feedback and task completion analysis. Clinical outcomes data are not mentioned as being used for these specific tests.

8. Sample Size for the Training Set

The document does not describe the specific underlying algorithms or models that would require a "training set" in the context of machine learning. The device is described as using principles of DBT image analysis to determine 3D locations. If any internal algorithms that contribute to coordinate calculations or image processing were developed using data, the sample size of such a training set is not disclosed.

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

As no "training set" for a machine learning model is explicitly mentioned or described, the method for establishing its ground truth is not provided. The device functionality appears to be based on established physics and geometric principles of imaging and targeting rather than a data-driven learning approach from a large labeled dataset.

Summary

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January 18, 2019

GE Healthcare Nicole Landreville Regulatory Affairs Manager 283 rue de la Miniere BUC, 78530 FRANCE

Re: K182951

Trade/Device Name: Pristina Serena 3D Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: October 22, 2018 Received: October 23, 2018

Dear Nicole Landreville:

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 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); medical

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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 https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see 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,

Michael D. O'Hara

For

Robert A. 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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Indications for Use

510(k) Number (if known)

K182951

Device Name Pristina Serena 3D

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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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	January 18, 2018
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC – FRANCE
Primary Contact Person:	Nicole Landreville, Eng, RAC, FRAPSRegulatory Affairs Manager380 Hampton Heath roadBurlington, ON, CanadaL7L 4R2Phone : 289-208-2365Email : nicole.landreville@ge.com
Secondary Contact Person:	Gregory Pessato,Regulatory Affairs Program Manager,GE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC – FRANCEPhone : + 33 1 30 70 93 16Email : gregorypessato@ge.com
Device Trade Name:	Pristina Serena 3D
Common/Usual Name:	Stereotaxy biopsy guidance application for a Digital Breast Tomosynthesis (DBT) Mammography System Biopsy System for Senographe Pristina
Classification Names:	21 CFR 892.1715, Class II
Product Code:	MUE
Predicate Device:	Pristina Serena (K173576)
Reference devices:	Senographe Pristina 3D (P130020/S002 and S003) Hologic's Affirm Breast Biopsy Guidance System (K122836) and Affirm Lateral Arm Upright Biopsy Accessory (K161575)
Device Description:	Pristina Serena 3D is DBT Biopsy System for Senographe Pristina. It is an additional option that builds upon the Pristina Serena device (GE Healthcare Stereotaxy biopsy option for Senographe Pristina platform). Pristina Serena was cleared on May 14, 2018 (K173576).Pristina Serena 3D enables biopsy medical application to be done using Digital Breast Tomosynthesis (DBT) images.The Pristina Serena 3D add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena 3D option. Labeling for the Biopsy DBT (3D) Medical application. Pristina Serena 3D option is compatible with previously installed Senographe Pristina systems. Pristina Serena 3D does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena 3D (K173576) was also not modified.
Intended Use:	Pristina Serena 3D is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions.
Indications for Use	The Pristina Serena 3D option provides the three-dimensional location of target lesions, using information obtained from Digital Breast Tomosynthesis (DBT) images. This information provides guidance for a variety of minimally invasive or interventional procedures in the breast such as: vacuum assisted biopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fine needle aspirations (ENA)
Technology:	Pristina Serena 3D uses the DBT images to determine the three-dimensional (3D) location (X, Y and Z coordinates) of an object of interest in the breast (such as a suspicious lesion). The X and Y coordinates are determined directly from the displayed plane as it is parallel to the detector while the Z coordinate is determined with the height of this same plane in the whole reconstructed volume.The target lesion 3D coordinates information, together with the complete geometry of the device, are used to compute the required position of a biopsy device holder that will allow intervention in the breast at the exact target position (biopsy of sample tissue or placement of a hook wire for guidance of surgical interventions). With Pristina Serena 3D, the positioning of the biopsy device holder is motorized and takes into account the geometry of the biopsy needles, so when the biopsy device holder is in place, the user introduces the needle in the breast until reaching the mechanical stop of the biopsy device holder. As the biopsy needle is fixed on and guided by the biopsy device holder (not handed), the needle tip (or notch) will then be at the target lesion 3D coordinates.As it was for Pristina Serena option, the Pristina Serena 3D allows two different needle approaches for Biopsy: vertical and horizontal (left or right). In vertical approach, the needle is introduced from the “top” of the compressed breast. In horizontal approach, the needle is introduced from the side of the compressed breast. Depending on patient morphology and location of the lesion to be biopsied in the breast, a radiologist might choose an approach or the other. Usually an effort is made to use an approach that would limit the distance crossed by the needle in the breast to reach the target location.Since Pristina Serena 3D option uses the Image chain of the Senographe Pristina platform, the image quality of images during the biopsy procedure is equivalent to that of standard screening/diagnostic images of Senographe Pristina 3D.Regarding dose management, with Pristina Serena 3D, a single DBT acquisition allows for both confirming appropriate breast positioning and for lesion targeting (as opposed to a Stereotaxy procedure that requires three X-ray acquisitions: one scout image
	plus a stereotaxic pair). This translates into dose reduction topatient.
Comparison withReference Devices	In regards with Image Quality / Image processing, the Proposeddevice and the reference device Senographe Pristina 3D(P130020/S002 and S003) both use the same DBT image chainand DBT reconstruction.Regarding dose management, the Proposed Pristina Serena 3Duses a single AOP mode available when acquiring biopsyimages. This AOP mode provides the same parameters as theSenographe Pristina 3D AOP mode called "STD+"(P130020/S003 3D STD+ on Senographe Pristina 3Dsubmission).
	The Proposed Pristina Serena 3D and the reference deviceHologic's Affirm Breast Biopsy Guidance System (K122836)and Affirm Lateral Arm Upright Biopsy Accessory (K161575),both DBT features use tomosynthesis images to provide accuratelocation of lesions in the breast in three dimensions.Both 3D localization features calculate a three dimensionallocation for percutaneous placement for biopsy, pre-surgicallocalization or treatment devices.
	It is important to note also that the Senographe Pristina withPristina Serena and Pristina Serena 3D offer both the 2Dstereotactic or 3D tomosynthesis image acquisition.Both DBT features use the same method of use, they both use aDedicated Breast Biopsy Positioner, same mechanism of actionand same stated accuracy. They have the same StereotacticAngle (±15°) but they differ slightly in DBT Tomographic angle15° total (± 7.5 degrees) for Hologics reference device versus25° total (± 12.5°) (which has no impact on the target coordinatecomputation for biopsy applications).
Determination ofSubstantial Equivalence:	The device has successfully completed required design controltesting per GE Healthcare's quality management system. Nounexpected test results were obtained. The Pristina Serena 3Doption was designed and will be manufactured under the QualitySystem Regulations of 21CFR 820 and ISO 13485. Thefollowing quality assurance measures were applied to thedevelopment of the system:
	Risk Analysis•Design Reviews•
•	Software Development Lifecycle
•	Testing on unit level (Module verification)
•	Integration testing (System verification)
•	Performance testing (Verification)
•	Safety testing (Verification)
•	Simulated use testing (Validation)
The safety and performance of the Pristina Serena 3D optionwas demonstrated through full verification testing and additionalengineering bench performance testing such as:- Non-Clinical Data - Image Quality and Dose test thatdemonstrates that images acquired with PristinaSerena 3D are of same quality as images acquiredwith Senographe Pristina at similar dose levels.- Pristina Serena 3D Design and Usability ValidationReport which contains evidence of validation ofclaims and performance bench testing
These tests were performed to provide the requisite data tosubstantiate performance, claims, and ultimately substantialequivalence. The testing demonstrated that Pristina Serena 3Dperforms according to specifications and functions as intended.
Conclusion:	Based on: conformance to standards; development under GEHealthcare's quality management system and design controls;successful verification/validation testing; utilization of the verywell established stereotactic imaging principles and additionalbench performance testing, GE Healthcare believes that theoptional Pristina Serena 3D option is substantially equivalent toits predicate device Pristina Serena (K173576) and referencedevices: Senographe Pristina 3D (P130020/S002 and S003) andHologic's Affirm Breast Biopsy Guidance System (K122836)and Affirm Lateral Arm Upright Biopsy Accessory (K161575).Therefore, GE Healthcare concludes that Pristina Serena 3D isas safe and as effective as the Predicate device for its intendeduse.

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Regulation Number and Section

§ 892.1715 Full-field digital mammography system.

(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.