The Pristina Serena Bright option provides the three-dimensional location of target lesions, using information obtained from stereotactic pairs of two-dimensional X-ray images acquired with Contrast Enhanced Spectral Mammography (CESM) under the same breast compression. 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 (FNA).
CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.

Device Description

Pristina Serena Bright is a Biopsy System for Senographe Pristina. It is an additional software 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 Bright enables biopsy medical application to be done using Contrast Enhanced Spectral Mammography images.
The Pristina Serena Bright add-on includes the following items: Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application.
Pristina Serena Bright option is compatible with previously installed Senographe Pristina systems. Pristina Serena Bright does not require any hardware modification on the Senographe Pristina platform. The hardware that was cleared on Pristina Serena (K173576) was also not modified.

AI/ML Overview

The provided text describes the regulatory submission for GE Healthcare's "Pristina Serena Bright" and mentions substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes for test sets, ground truth establishment, or MRMC study results as requested.

The document states that "Pristina Serena Bright has successfully completed required design control testing per GE Healthcare's quality management system." It also mentions "Non-Clinical Data – Biopsy accuracy testing: verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." However, it does not provide the specific acceptance criteria for this accuracy (e.g., within X mm), nor the quantitative results of this testing.

Therefore, I cannot provide the complete answer to your request. I can only extract what is present in the document.

Based on the provided text, here's what can be gathered, and what is missing:

Missing Information:

A table of specific acceptance criteria (e.g., accuracy must be X mm) and reported device performance against those criteria.
Sample sizes used for the test set.
Data provenance (country of origin, retrospective/prospective) for the test set.
Number of experts used to establish ground truth for the test set.
Qualifications of those experts.
Adjudication method for the test set.
Whether an MRMC comparative effectiveness study was done, and if so, the effect size.
Specific quantitative results from the standalone performance (e.g., numerical accuracy metrics).
The type of ground truth used (beyond "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)").
Sample size for the training set.
How the ground truth for the training set was established.

Information Extracted (albeit limited):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms within the provided text. The document refers to "Biopsy accuracy testing" for "verification of the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)."
- Reported Device Performance: "The testing demonstrated that Pristina Serena Bright performs according to specifications and functions as intended." No specific performance metrics (e.g., mean accuracy, standard deviation) are provided.
Sample sized used for the test set and the data provenance: Not specified in the provided text. The testing is referred to as "Non-Clinical Data – Biopsy accuracy testing."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The ground truth appears to be based on the physical position of a needle or target in a phantom/bench test, rather than human expert interpretation of images for ground truth.
Adjudication method for the test set: Not applicable based on the "Non-Clinical Data – Biopsy accuracy testing" described, which suggests a physical measurement validation rather than a reader study on images.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not indicated. The focus of the provided text is on demonstrating "substantial equivalence" of the device through technical and performance testing against a predicate, particularly in terms of image quality and biopsy accuracy, rather than clinical efficacy studies involving human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The "Biopsy accuracy testing" appears to be a standalone performance test of the system's ability to accurately guide a needle to a target, based on the stereotactic principles. However, specific metrics are not provided. The device provides "guidance for a variety of minimally invasive or interventional procedures," implying human involvement in the procedure, but the accuracy testing itself seems to be of the system's geometric capability.
The type of ground truth used:
- For the "Biopsy accuracy testing": Ground truth was established by verifying "the geometrical accuracy between the target lesion identified on the X-ray Stereo pair images and the actual position of the biopsy needle tip (or needle notch)." This implies a physical, measurable ground truth (e.g., using a phantom or controlled setup).
- For image quality and dose tests: Comparison to "SenoBright HD" images at similar dose levels.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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May 15, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

GE Healthcare % Barthelemy Arman Regulatory Affairs Leader 283 rue de la Miniere 78530 Buc FRANCE

Re: K193334

Trade/Device Name: Pristina Serena Bright Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: April 10, 2020 Received: April 17, 2020

Dear Barthelemy Arman:

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

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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-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) K193334

Device Name Pristina Serena Bright

Indications for Use (Describe)

CESM-Biopsy application is indicated for patients with suspicious lesions only seen with certainty when imaged with a contrast agent or that do not have a definite correlate on mammography or ultrasound.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Premarket Notification Submission

Image /page/3/Picture/2 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by three curved lines on the top and bottom, resembling water droplets or stylized waves. The logo is simple, recognizable, and represents the brand identity of General Electric.

Section 5: 510(k) Summary

PRISTINA SERENA BRIGHT

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GE Healthcare

510(k) Premarket Notification Submission

Image /page/4/Picture/2 description: The image shows the GE logo, which is a blue circle with the letters "GE" in white inside. The letters are stylized and connected with swirling lines. Below the logo is the text "K193334" in black.

510(k) Summary

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

Date:	May 13th, 2020
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE
Primary Contact Person:	Barthélémy ArmanRegulatory Affairs Leader283 rue de la Minière78530 Buc - FRANCEPhone : +33 1 30 70 40 40Email : Barthelemy.ARMAN1@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 Bright
Common/Usual Name:	Stereotaxy biopsy guidance application using contrast imaging
Classification Names:Product Code:	21 CFR 892.1715, Class IIMUE
Predicate / ReferenceDevice(s):	Pristina Serena (K173576) - predicate / SenoBright HD (K172404) -reference
Device Description:	Pristina Serena Bright is a Biopsy System for Senographe Pristina. It isan additional software option that builds upon the Pristina Serenadevice (GE Healthcare Stereotaxy biopsy option for Senographe Pristinaplatform). Pristina Serena was cleared on May 14, 2018 (K173576).

	Pristina Serena Bright enables biopsy medical application to be doneusing Contrast Enhanced Spectral Mammography images.The Pristina Serena Bright add-on includes the following items:Software: A new software version for the Senographe Pristina platform which includes software to manage the Pristina Serena Bright option. Labeling for the CESM Biopsy Medical application.
	Pristina Serena Bright option is compatible with previously installedSenographe Pristina systems. Pristina Serena Bright does not requireany hardware modification on the Senographe Pristina platform. Thehardware that was cleared on Pristina Serena (K173576) was also notmodified.
Intended Use:	Pristina Serena Bright is an optional accessory of Senographe Pristinaintended to provide accurate location of lesions in the breast in threedimensions.
Indications for Use	The Pristina Serena Bright option provides the three-dimensionallocation of target lesions, using information obtained from stereotacticpairs of two-dimensional X-ray images acquired with Contrast EnhancedSpectral Mammography (CESM) under the same breast compression.This information provides guidance for a variety of minimally invasive orinterventional procedures in the breast such as: vacuum assistedbiopsy, core biopsy, pre-surgical localization (e.g. hookwire), and fineneedle aspirations (FNA).CESM-Biopsy application is indicated for patients with suspicious lesionsonly seen with certainty when imaged with a contrast agent or that donot have a definite correlate on mammography or ultrasound.
Technology:	Pristina Serena Bright reuses the Stereotaxy principle of the cleareddevice Pristina Serena with Contrast Enhanced Spectral Mammography(CESM) images instead of 2D images to determine the three-dimensional (3D) location (X, Y and Z coordinates) of an object ofinterest in the breast (such as a suspicious lesion).With Pristina Serena Bright, the stereotaxy biopsy process uses a stereo

	breast at the exact target position (biopsy of sample tissue orplacement of a hook wire for guidance of surgical interventions). WithPristina Serena Bright reuses the positioning of the biopsy deviceholder from Pristina Serena which is motorized and takes into accountthe geometry of the biopsy needles, so when the biopsy device holder isin place, the user introduces the needle in the breast until reaching themechanical stop of the biopsy device holder. As the biopsy needle isfixed on and guided by the biopsy device holder (not handed), theneedle tip (or notch) will then be at the target lesion 3D coordinates.
	As it was for Pristina Serena option, the Pristina Serena Bright allowstwo different needle approaches for Biopsy: vertical and horizontal (leftor 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 bebiopsied in the breast, a radiologist might choose an approach or theother. Usually an effort is made to use an approach that would limit thedistance crossed by the needle in the breast to reach the targetlocation.
	Pristina Serena Bright option uses the Image chain of the SenographePristina platform with SenoBright HD (CESM application) thus the imagequality of images during the biopsy procedure is equivalent to that ofSenoBright HD .
Substantial Equivalence /Predicate and ReferenceDevices	The Pristina Serena Bright has identical intended use and substantiallyequivalent indications for use to its legally marketed predicate device,the Pristina Serena .The functionalities, specifications and technological characteristics ofPristina Serena Bright option are identical or equivalent to PristinaSerena .The principles of operation, image quality and dose characteristics andperformances of the Pristina Serena Bright are equivalent to those ofthe reference device SenoBright HD .The Pristina Serena Bright was designed to provide an image qualityperformance equivalent to SenoBright HD and the same accuracy asPristina Serena as demonstrated in Image Quality and AccuracyPerformance Testing.
Benefit-Risk Analysis:	The proposed Pristina Serena Bright device offers the same benefitsand risk as the predicate device Pristina Serena except for the following:Improved benefit by allowing to perform breast biopsy forpatients with suspicious findings only clearly seen when imagedwith a contrast agent or that do not have a definite correlate onmammography or ultrasound, meaning potential earlierdetection of breast cancer and earlier initiation of treatment. Increased risk due to the use of contrast agent injection. Thesame contrast injection protocols are used in CESM and CESM-guided Biopsy, so this risk is identical to the Reference deviceSenoBright HD for CESM diagnostic imaging. As compared to the alternative standard of care MRI-guided Biopsy,Pristina Serena Bright might offer the following benefits:From a workflow and access perspective: potential benefit withregards to reduced cost and faster access. From a patient perspective: potentially improved patientcomfort for patients with claustrophobia and allows to handlepatients that cannot be imaged with MRI due to the presenceof metallic objects in their body and is a shorter procedure. Regarding the other alternative to CESM-guided Biopsy, i.e. surgicalbiopsy, it presents a higher risk profile as it is a more invasiveprocedure, it has a longer recovery time and it has a higher risk ofinfection and bruising. Besides it might remain difficult for the surgeonto localize the appropriate area to be biopsied as no biopsy hook/wirewould have been able to be placed in the breast prior to surgery.
	Overall GE Healthcare believes that as the increased risk is accompaniedby an increase in benefit, the proposed device has a comparablebenefit-risk profile to the predicate device.
Determination of SubstantialEquivalence:	Pristina Serena Bright has successfully completed required designcontrol testing per GE Healthcare's quality management system. Nounexpected test results were obtained. This new device was designedand will be manufactured under the Quality System Regulations of21CFR 820 and ISO 13485. The following quality assurance measureswere applied to the development 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 Bright option wasdemonstrated through full verification testing and additionalengineering bench performance testing such as:- Non-Clinical Data – Image Quality and Dose test thatdemonstrates that images acquired with Pristina Serena Bright are of same quality as images acquired withSenographe Pristina with SenoBright HD at similar doselevels.- Non-Clinical Data – Biopsy accuracy testing: verification ofthe geometrical accuracy between the target lesionidentified on the X-ray Stereo pair images and the actualposition of the biopsy needle tip (or needle notch).- Non-clinical Data – Study that demonstrates thecompatibility of the biopsy application on the PristinaSerena platform with the timeframe of the contrast agentvisibility in the breast.These tests were performed to provide the requisite data tosubstantiate performance and substantial equivalence. The testingdemonstrated that Pristina Serena Bright performs according tospecifications and functions as intended.
Conclusion:	Based on: conformance to standards; development under GEHealthcare's quality management system and design controls; benefit-risk analysis, successful verification/validation testing and additionalbench performance testing and clinical testing, GE Healthcare believesthat the Pristina Serena Bright option is substantially equivalent to itspredicate device Pristina Serena (K173576) and reference deviceSenoBright HD (K162268). Therefore, GE concludes that Pristina Serena Bright is as safe and effective for its intended use as its predicatedevice.

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GE Healthcare

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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are water droplet-like shapes around the edge of the circle. The logo is simple and recognizable.

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Image /page/7/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves. The logo is presented in a solid blue color, providing a clean and recognizable brand representation.

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GE Healthcare

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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.