Sample Imaging for Senographe Pristina by GE Healthcare

Sample Imaging for Senographe Pristina™ with Pristina Serena™ biopsy option is intended to provide digital X-ray images of the biopsy excised breast tissues while the patient is still under compression, to allow rapid verification that the correct tissue has been excised during the biopsy procedure.

Device Description

Sample Imaging for Senographe Pristina is an additional option that builds upon the Pristina Serena Stereotaxy biopsy device cleared on May 14, 2018 (K173576). The Sample Imaging option enables the imaging of breast tissue samples collected during biopsy medical application. In other words, the Sample Imaging option provides the capability to image, within the same examination, and while the patient is still under compression, the breast tissue samples collected during biopsy procedures performed with any biopsy medical application available on the system. The acquisition of such images is done with dose to the patient limited to scatter radiation from the samples.

AI/ML Overview

The provided text describes a 510(k) submission for "Sample Imaging for Senographe Pristina" by GE Healthcare. The purpose of this device is to provide X-ray images of excised breast tissues during biopsy procedures for rapid verification.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the safety and performance claims made and the comparative testing against a predicate device and a reference device. The primary performance claim is regarding image quality and dose.

Acceptance Criteria / Claim	Reported Device Performance (as tested)
Image quality equivalent to or better than Pristina Serena (reference device).	Image Quality test: Images acquired with Sample Imaging are of the same quality as images acquired with Pristina Serena or Pristina Serena 3D. The image quality assessment conducted shows that Sample Imaging views have better performance than 2D scout biopsy and DBT biopsy views. This assessment was performed with the ACR mini stereotactic breast biopsy accreditation phantom. The test results demonstrate that image quality of Sample Imaging mode is sufficient to verify the presence of targeted tissues in the samples and to achieve its indications for use.
Image quality sufficient to verify the presence of targeted tissues in samples.	As above: The test results demonstrate that image quality of Sample Imaging mode is sufficient to verify the presence of targeted tissues in the samples and to achieve its indications for use.
Continuous zoom feature allows the user to reach a zoom identical or better than a magnification glass.	The device, similar to the predicate, "Both features provide the capability of continuous zoom which allows the user to reach a zoom identical or better that what the magnification glass offers." (This is a statement of shared functionality with the predicate, implying this is met).
MTF (Modulation Transfer Function) performance.	MTF measurement: MTF was measured using the same acquisition techniques and compared between biopsy area and sample imaging area. Images were processed with "FineView" adapted to biopsy and simple imaging parameters respectively. With "FineView" applied, the MTF of the Sample images is higher than the MTF for the Biopsy 2D images at any frequency.
Patient Radiation Dose.	Patient Radiation Dose Testing: Since the breast of the patient is not in the primary X-ray beam, no direct radiation dose is delivered to the patient. However, scatter radiation from the samples and detector were measured. The Air Kerma at the point of skin entry in the patient's breast closest to the biopsy samples being imaged was measured at 1.99% of the Entrance Skin Air Kerma (ESAK) from a biopsy AOP scout view for an average breast.
Conformance to specifications and intended function.	The testing demonstrated that Sample Imaging for Senographe Pristina performs according to specifications and functions as intended.

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

The document does not specify the sample size for the test set used in the performance evaluation.
The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective patient data. The tests appear to be pre-clinical bench testing ("Image Quality test," "Patient Radiation Dose Testing," "MTF was measured") rather than studies on a patient cohort. The "ACR mini stereotactic breast biopsy accreditation phantom" was used, indicating phantom-based testing.

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

The document does not mention any human experts being used to establish a ground truth for the test set. The evaluation relies on objective technical measurements (image quality, MTF, dose) using a phantom, rather than human expert interpretation of images.

4. Adjudication Method for the Test Set

Since no human experts were involved in evaluating images for ground truth, there was no adjudication method described. The tests were objective, technical measurements.

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

No MRMC comparative effectiveness study was done as described in the provided text. The evaluation focuses on technical performance metrics (image quality, MTF, dose) of the device itself, rather than assessing human reader performance with or without the device.

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

The device itself is an "imaging option" that provides digital X-ray images. The "performance" described is about the quality of these images and the dose produced. This is inherently a "standalone" or "algorithm only" performance since it refers to the image acquisition and processing capabilities of the system (e.g., "FineView" processing, MTF measurements, image quality on a phantom). It's not an AI algorithm but a hardware/software imaging feature.

7. The Type of Ground Truth Used

The ground truth for the performance testing was established by technical metrics and a standardized phantom.

ACR mini stereotactic breast biopsy accreditation phantom: Used for Image Quality assessment.
MTF measurements: Optical/technical property of image sharpness.
Air Kerma measurements: Objective radiation dose measurement.
This is not expert consensus, pathology, or outcomes data, but rather a phantom-based, objective technical evaluation.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. This device is an imaging system component, not an AI algorithm that requires a training set of data. The development process mentions "development under GE Healthcare's quality management system and design controls" and "full verification testing and additional engineering bench performance testing."

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

As there is no mention of a "training set" for an AI/ML component, this question is not applicable based on the provided information. The device functions as an imaging system, and its performance verification appears to be based on engineering and quality control procedures, rather than a data-driven training/validation paradigm.

Summary

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July 29, 2019

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 & Human Services logo. To the right of that 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 GE Medical Systems SCS % Nicole Landreville, P.Eng., RAC, FRAPS Regulatory Affairs Manager 283 rue de la Miniere 78530. Buc FRANCE

Re: K190809

Trade/Device Name: Sample Imaging for Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: June 28, 2019 Received: July 1, 2019

Dear Ms. 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 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

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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-reportingcombination-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 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,

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)

K190809

Device Name Sample Imaging for Senographe Pristina

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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Revised Section 5: 510(k) Summary

Sample Imaging for Senographe Pristina

K190809

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510(k) Summary

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

Date:	July 26, 2019
510(k) Number:	K190809
Submitter:	GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE
Primary Contact Person:	Nicole Landreville, P.Eng, RAC, FRAPSRegulatory Affairs Manager380 Hampton Heath roadBurlington, ON, CanadaL7L 4R2Phone : 289-208-2365Email : nicole.landreville@ge.com
Secondary ContactPerson:	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:	Sample Imaging for Senographe Pristina
Common/Usual Name:	Sample Imaging option for the Biopsy applications (Pristina Serena andPristina Serena 3D) for the Senographe Pristina mammography platform.
Classification Names:	21 CFR 892.1715, Class II
Product Code:	MUE
Predicate Device:	MAMMOMAT Revelation with InSpect feature (K173408)
Reference devices:	Pristina Serena (K173576)
Device Description:	Sample Imaging for Senographe Pristina is an additional option thatbuilds upon the Pristina Serena Stereotaxy biopsy device cleared on May14, 2018 (K173576).
	The Sample Imaging option enables the imaging of breast tissue samplescollected during biopsy medical application. In other words, the SampleImaging option provides the capability to image, within the sameexamination, and while the patient is still under compression, the breasttissue samples collected during biopsy procedures performed with anybiopsy medical application available on the system. The acquisition ofsuch images is done with dose to the patient limited to scatter radiationfrom the samples.
Intended Use:	The Sample Imaging option is intended to provide digital X-ray imagesof biopsy excised breast tissues.
Indications for Use	The Sample Imaging option for Senographe Pristina™ with PristinaSerena™ biopsy option is intended to provide digital X-ray images of thebiopsy excised breast tissues while the patient is still under compression,to allow rapid verification that the correct tissue has been excised duringthe biopsy procedure.
Technology:	The Sample Imaging option uses an angulated 2D view acquired either at+15° or -15° gantry angulation to image breast tissue samples collectedduring biopsy procedures performed during biopsy procedures with anybiopsy medical application available on the system. The angulated imageis acquired without moving the patient from the position in which thesample collection was performed, nor modifying the compression appliedto the breast. Therefore, sample imaging does not affect the biopsy setup.The Sample Imaging option can be used to image breast tissues extracted
	during micro or macro biopsy with a vacuum assisted device or corebiopsy device for histopathology analysis.
Substantial Equivalence/ Predicate andReference Devices	The proposed device Sample Imaging for Senographe Pristina™ and thepredicate device InSpect feature on the Mammomat Revelation(K173408) share an equivalent intended use and indications for use andare used for the purpose of providing digital X-Ray images of biopsyexcised breast tissues.
	Both features provide the capability of continuous zoom which allows theuser to reach a zoom identical or better that what the magnification glassoffers.
	The fundamental principles of operation, functionalities, specificationsand technological characteristics of Sample Imaging option areequivalent to InSpect feature on the MAMMOMAT Revelation.
	The proposed device Sample Imaging for Senographe Pristina™ and thereference device Pristina Serena™ offer the same image chain butdifferent image processing are applied.
	The Sample Imaging function was designed to provide an image qualityperformance equivalent or better than Pristina SerenaTM as demonstratedin Image Quality Performance Bench Testing results.The image quality and dose characteristics and performances of theSample Imaging are equivalent to those of the reference device PristinaSerenaTM.
Determination ofSubstantial Equivalence:	The device has successfully completed required design control testing perGE Healthcare's quality management system. No unexpected test resultswere obtained. The Sample Imaging for Senographe Pristina option wasdesigned and will be manufactured under the Quality System Regulationsof 21CFR 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 Sample Imaging option wasdemonstrated through full verification testing and additional engineeringbench performance testing such as:
	Non-Clinical Data:Image Quality test that demonstrates that imagesacquired with Sample Imaging are of same quality asimages acquired with Pristina Serena or PristinaSerena 3D. The image quality assessment conductedshows that Sample Imaging views have betterperformance than 2D scout biopsy and DBT biopsyviews. The image quality assessment was performedwith the ACR mini stereotactic breast biopsyaccreditation phantom. The test results demonstratethat image quality of Sample Imaging mode issufficient to verify the presence of targeted tissues inthe samples and to achieve its indications for use.

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MTF was measured using the same acquisition O techniques and compared between biopsy area and sample imaging area. Images were processed with "FineView" adapted to biopsy and simple imaging parameters respectively. With "FineView" applied, the MTF of the Sample images is higher than the MTF for the Biopsy 2D images at any frequency. Patient Radiation Dose Testing: Since the breast of the O patient is not in the primary X-ray beam, no direct radiation dose is delivered to the patient. However, since the primary X-Ray beam can be in close proximity to the breast, scatter radiation from the samples and detector were measured. The Air Kerma at the point of skin entry in the patient's breast closest to the biopsy samples being imaged was measured at 1.99% of the Entrance Skin Air Kerma (ESAK) from a biopsy AOP scout view for an average breast. Sample Imaging Design and Usability Validation Report contains evidence of validation of claims and performance bench testing. These tests were performed to provide the requisite data to substantiate performance, claims, and ultimately substantial equivalence. The testing demonstrated that Sample Imaging for Senographe Pristina performs according to specifications and functions as intended. Conclusion: Based on: conformance to standards; development under GE Healthcare's quality management system and design controls; successful verification/validation testing; utilization of the very well established stereotactic imaging principles and additional bench performance testing, GE Healthcare believes that the optional Sample Imaging for Senographe Pristina is substantially equivalent to its predicate device MAMMOMAT Revelation with InSpect feature (K173408) and reference device Pristina Serena (K173576). Therefore, GE Healthcare concludes that Sample Imaging for Senographe Pristina is as safe and as effective as the Predicate device for its intended use.

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.