(63 days)
No
The description focuses on a deterministic image post-processing algorithm (eContrast) and its modification, without mentioning any learning or adaptive capabilities characteristic of AI/ML.
No
The device is described as an image post-processing algorithm for mammographic images used for screening and diagnosis of breast cancer, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the system "generates digital mammographic images which can be used for screening and diagnosis of breast cancer."
No
The device is described as a software modification to an existing hardware platform (Senographe Pristina), and its function is image post-processing for digital mammographic images generated by that hardware. While the submission is for a software and labeling change, the device's operation is intrinsically tied to the hardware that acquires the images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Senographe Pristina system and its eContrast algorithm are used to generate and process digital mammographic images. This is an imaging modality, not a test performed on a biological sample.
- Intended Use: The intended use is for screening and diagnosis of breast cancer through the analysis of these images. This is a diagnostic process based on visual interpretation of images, not on the analysis of in vitro samples.
The device is clearly described as a mammography system with image processing software, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/ screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
Product codes
MUE
Device Description
eContrast is an image post-processing algorithm applied to the DICOM "for processing" images in order to generate “for presentation" images. It consists in optimizing the local contrasts while reducing the overall dynamic range. This submission is proposing a software modification consisting of a new version of eContrast algorithm for Senographe Pristina platform to allow more flexibility for proposing different levels. preserving/enhancing the visibility of the different structures present in the breast image. The first version of the eContrast image processing was previously cleared for Senographe Essential platform in the 510(k)# K131885. Then it was cleared with Senographe Pristina platform in the 510(k) # K162268. This design change is a software and labeling only option, compatible with Senographe Pristina installed base and does not require any hardware modification on the Senographe Pristina platform.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and performance of Senographe Pristina with the new version of eContrast was demonstrated through full verification testing and additional engineering bench performance testing such as:
- Non-Clinical Data – Image Quality and Dose test that demonstrates that images acquired with Senographe Pristina with the new version of eContrast are of same quality as images acquired with Senographe Pristina with eContrast as cleared in K162268 at similar dose levels.
- Clinical Data – Clinical image review by radiologists, with objective criteria defined that demonstrates the clinical image acceptability of images generated with Senographe Pristina with the new version of eContrast.
These tests demonstrated the substantial equivalence with the predicate device and concluded that Senographe Pristina with the new version of eContrast do not raise any questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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August 6, 2021
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
GE Healthcare % Barthélémy Arman Regulatory Affairs Leader 283 rue de la Minière BUC, 78530 FRANCE
Re: K211725
Trade/Device Name: Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: June 4, 2021 Received: June 4, 2021
Dear Barthélémy 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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) K211725
Device Name Senographe Pristina
Indications for Use (Describe)
The Senographe Pristina system is intended to be used in the same clinical applications as traditional mammographic film/ screen systems. It generates digital mammographic images which can be used for screening and diagnosis of breast cancer.
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 — K211725
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 6th, 2021 |
|---|---|
| Submitter: | GE Healthcare |
| GE Medical Systems SCS | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| Primary Contact Person: | Barthélémy Arman |
| Regulatory Affairs Leader | |
| 283 rue de la Minière | |
| 78530 Buc - FRANCE | |
| Phone : +33 1 30 70 40 40 | |
| Email : Barthelemy.ARMAN1@ge.com | |
| Secondary Contact Person: | Gregory Pessato, |
| Regulatory Affairs Senior Manager, | |
| GE Medical Systems SCS | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| Phone : + 33 1 30 70 93 16 | |
| Email : gregorypessato@ge.com | |
| Device Trade Name: | Senographe Pristina [Design change: New version of eContrast] |
| Common/Usual Name: | Full Field Digital,System,X-Ray,Mammographic |
| Classification Names: | 21 CFR 892.1715, Class II |
| Product Code: | MUE |
| Predicate / Reference Device(s): | Senographe Pristina (K162268) – predicate |
| Device Description: | eContrast is an image post-processing algorithm applied to the DICOM |
| "for processing" images in order to generate “for presentation" images. | |
| It consists in optimizing the local contrasts while reducing the overall | |
| dynamic range. | |
| This submission is proposing a software modification consisting of a | |
| new version of eContrast algorithm for Senographe Pristina platform | |
| to allow more flexibility for proposing different levels. | |
| preserving/enhancing the visibility of the different structures present in | |
| the breast image. | |
| The first version of the eContrast image processing was previously | |
| cleared for Senographe Essential platform in the 510(k)# K131885. Then | |
| it was cleared with Senographe Pristina platform in the 510(k) # | |
| K162268. | |
| This design change is a software and labeling only option, compatible | |
| with Senographe Pristina installed base and does not require any | |
| hardware modification on the Senographe Pristina platform. | |
| Intended Use: | The Senographe Pristina system is intended for screening and |
| diagnostic mammography. | |
| Note: The intended use of Senographe Pristina cleared in K162268 is not | |
| changed. | |
| Indications for Use | The Senographe Pristina system is intended to be used in the same |
| clinical applications as traditional mammographic film/screen systems. | |
| It generates digital mammographic images which can be used for | |
| screening and diagnosis of breast cancer. | |
| Note: The Indications for use of Senographe Pristina cleared in K162268 | |
| are not changed. | |
| Technology: | The modification of the eContrast post-processing algorithm is |
| completely independent from all other parts of the digital | |
| mammographic equipment Senographe Pristina. Only the software is | |
| affected by this change. | |
| This new version of eContrast offers as before, 6 settings (eContrast 1 | |
| to eContrast 6) to accommodate different user preferences. eContrast 1 | |
| and 6 remain unchanged, with a 2-band decomposition. However, for | |
| settings 2, 3, 4 and 5, the new version of eContrast is an extension of | |
| the current algorithm with a third band decomposition to allow more | |
| flexibility for proposing different levels preserving/enhancing the | |
| visibility of the different structures present in the breast image. | |
| Substantial Equivalence / | |
| Predicate and Reference | |
| Devices | The new version of eContrast algorithm for Senographe Pristina does |
| not change the intended use and indications for use to its legally | |
| marketed predicate device, the Senographe Pristina with eContrast | |
| (K162268). | |
| The fundamental principles of operation, functionalities, specifications | |
| and technological characteristics of Senographe Pristina remain | |
| unchanged. | |
| The eContrast post-processing algorithm is modified to allow more | |
| flexibility for proposing different levels preserving/enhancing the | |
| visibility of the different structures present in the breast image. | |
| It was demonstrated in Image Quality Performance Testing that the | |
| image quality of Senographe Pristina with this new version of | |
| eContrast performs similarly as its legally marketed predicate device, | |
| the Senographe Pristina with eContrast (K162268). | |
| Determination of Substantial | |
| Equivalence: | Senographe Pristina with the new version of eContrast has successfully |
| completed required design control testing per GE Healthcare's quality | |
| management system. No unexpected test results were obtained. The | |
| design change was designed and will be manufactured under the | |
| Quality System Regulations of 21CFR 820 and ISO 13485. The following | |
| quality assurance measures were 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 Senographe Pristina with the new
version of eContrast was demonstrated through full verification testing
and additional engineering bench performance testing such as: - Non-Clinical Data – Image Quality and Dose test that
demonstrates that images acquired with Senographe
Pristina with the new version of eContrast are of same
quality as images acquired with Senographe Pristina with
eContrast as cleared in K162268 at similar dose levels. - Clinical Data – Clinical image review by radiologists, with
objective criteria defined that demonstrates the clinical
image acceptability of images generated with Senographe
Pristina with the new version of eContrast.
These tests demonstrated the substantial equivalence with the
predicate device and concluded that Senographe Pristina with the new
version of eContrast do not raise any questions of safety and
effectiveness. |
| Conclusion: | Based on: conformance to standards; development under GE
Healthcare's quality management system and design controls;
successful verification/validation testing and additional bench
performance testing and clinical testing, GE Healthcare believes that
Senographe Pristina with the new version of eContrast is substantially
equivalent to its predicate device Senographe Pristina with eContrast as
cleared in K162268. Therefore, GE concludes that Senographe Pristina
remains as safe and effective for its intended use as its predicate
device. |
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GE Healthcare
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510(k) Premarket Notification Submission
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