(60 days)
No
The description focuses on an improved "recombination" algorithm that uses local breast thickness estimation and motion compensation, which are traditional image processing techniques, not explicitly AI/ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No
The device is used for diagnostic imaging to help localize lesions, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" states that SenoBright HD "can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion." Localizing a lesion is a diagnostic step, indicating the device's role in diagnosing or aiding in the diagnosis of conditions.
No
The device is described as a software update to the SenoBright HD application, which is part of the Senographe Pristina FFDM system. While the submission focuses on a software change, the device itself is the SenoBright HD application running on the Senographe Pristina hardware, which is a physical mammography system. The software is an integral part of a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that SenoBright HD is an imaging technique (Contrast Enhanced Spectral Mammography - CESM) used as an adjunct following mammography and ultrasound exams to help localize lesions in the breast. It involves acquiring images of the breast after injecting an iodinated contrast media.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It processes and recombines images generated by an X-ray system.
Therefore, SenoBright HD falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright HD application shall enable contrast enhanced breast imaging a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion.
Product codes
MUE
Device Description
This submission is proposing a software update to SenoBright HD consisting of an improvement of the existing "recombination" algorithm with the New Image Recombination Algorithm (NIRA) by adding a local estimation of breast thickness in the images recombination to account for the non-uniformity of the breast thickness, and by compensating for potential patient movement between the 2 CESM acquisitions (Low Energy and High Energy).
SenoBright HD (K172404) is the name of Senographe Pristina FFDM system allowing to perform Contrast Enhanced Spectral Mammography (CESM) application.
The CESM acquisition technique consists in acquiring two images (one High Energy and one Low Energy) in sequence and under the same breast compression after patient injection with an iodinated contrast media. The two images are then recombined through a post-processing algorithm.
This design change is a software and labeling only option, compatible with SenoBright HD installed base and does not require any hardware modification on the Senographe Pristina platform.
Mentions image processing
The image processing of SenoBright HD is improved with the New Image Recombination Algorithm by adding a local estimation of breast thickness in the images recombination to account for the non-uniformity of the breast thickness, and by compensating for potential patient movement between the 2 CESM acquisitions (LE and HE).
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Dual energy X-ray mammography
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
A clinical image evaluation comparing SenoBright HD with NIRA to the predicate device SenoBright HD, performed by 3 independent MQSA-qualified radiologists on 50 clinical images.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- A Non-clinical Performance Testing on phantoms, including Image quality testing to demonstrate that SenoBright HD with NIRA performs at least as well as the cleared device SenoBright HD (K172404) and brings Image Quality improvements. The performance testing also demonstrates reduction of artifacts in case of either patient motion or breast thickness non-uniformity to increased lesion visibility.
- A clinical image evaluation performed by 3 independent MQSA-qualified radiologists on 10 images with objective criteria defined. It illustrated the clinical image acceptability of images generated by SenoBright HD with NIRA.
- A clinical image evaluation comparing SenoBright HD with NIRA to the predicate device SenoBright HD, performed by 3 independent MQSA-qualified radiologists on 50 clinical images, showing results including: The contrast uptake visibility assessed equivalent or better in 97% of the cases. The visibility of artifacts assessed equivalent or lower in 99% of the cases. The overall clinical image quality assessed superior in more than 98% of the cases. The results of verification and performance testing demonstrate the safe and effective use of SenoBright HD with NIRA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The contrast uptake visibility assessed equivalent or better in 97% of the cases. The visibility of artifacts assessed equivalent or lower in 99% of the cases. The overall clinical image quality assessed superior in more than 98% of the cases.
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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June 22, 2021
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GE Healthcare % Florian Akpakpa Regulatory Affairs Program Manager 283 Rue de la Minière Buc, 78530 FRANCE
Re: K211215
Trade/Device Name: SenoBright HD Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: Class II Product Code: MUE Dated: April 22, 2021 Received: April 23, 2021
Dear Florian Akpakpa:
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) K211215
Device Name
SenoBright HD
Indications for Use (Describe)
SenoBright HD is an extension of the existing indication for diagnostic mammography with Senographe Pristina. The SenoBright HD application shall enable contrast enhanced breast imaging a dual energy technique. This imaging technique can be used as an adjunct following mammography and ultrasound exams to help localize a known or suspected lesion.
| 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.
3
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4
510(k) Premarket Notification Submission
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Section 5: 510(k) Summary
NIRA for SENOBRIGHT HD
510(k) Number: K211215
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | June 17, 2021 |
|---|---|
| Submitter: | GE Healthcare |
| GE Medical Systems SCS | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| Primary Contact Person: | Florian Akpakpa |
| Regulatory Affairs Program Manager | |
| 283 rue de la Minière | |
| 78530 Buc - FRANCE | |
| Phone : +33 1 30 70 40 40 | |
| Email : florian.akpakpa@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 40 40 | |
| Email : gregorypessato@ge.com | |
| Device Trade Name: | SenoBright HD |
| Common/Usual Name: | Contrast Enhanced Spectral Mammography |
| Classification Names: | |
| Product Code: | 21 CFR 892.1715, Class II |
| MUE | |
| Predicate Device: | Predicate device: SenoBright HD (K172404) |
| Device Description: | This submission is proposing a software update to SenoBright HD |
| consisting of an improvement of the existing "recombination" algorithm | |
| with the New Image Recombination Algorithm (NIRA) by adding a local | |
| estimation of breast thickness in the images recombination to account | |
| for the non-uniformity of the breast thickness, and by compensating for | |
| potential patient movement between the 2 CESM acquisitions (Low | |
| Energy and High Energy). | |
| SenoBright HD (K172404) is the name of Senographe Pristina FFDM | |
| system allowing to perform Contrast Enhanced Spectral Mammography | |
| (CESM) application. | |
| The CESM acquisition technique consists in acquiring two images (one | |
| High Energy and one Low Energy) in sequence and under the same | |
| breast compression after patient injection with an iodinated contrast | |
| media. The two images are then recombined through a post-processing | |
| algorithm. | |
| This design change is a software and labeling only option, compatible | |
| with SenoBright HD installed base and does not require any hardware | |
| modification on the Senographe Pristina platform. | |
| Intended Use: | SenoBright HD is an extension of the existing indication for diagnostic |
| mammography with Senographe Pristina. The SenoBright HD | |
| application shall enable contrast enhanced breast imaging using a dual | |
| energy technique. This imaging technique can be used as an adjunct | |
| following mammography and ultrasound exams to help localize a | |
| known or suspected lesion. | |
| Note: The intended use of SenoBright HD cleared in K172404 is not | |
| changed. | |
| Indications for Use | Refer to Intended use. |
| Technology: | The update of the existing recombination algorithm to New Image |
| Recombination Algorithm (NIRA) for SenoBright HD is completely | |
| independent from all other parts of the digital mammographic | |
| equipment Senographe Pristina. It therefore does not affect the dual- | |
| energy image acquisition. | |
| The changes introduced with NIRA are specific to the recombination | |
| algorithm and can affect exclusively the recombined image. Thus, it also | |
| does not affect the acquisition, processing and display of the low- | |
| energy image when used as a regular FFDM image. | |
| NIRA is an evolution of the SenoBright HD Recombination algorithm | |
| bringing the following improvements: |
- Use of a local estimation of breast thickness in the image
recombination to account for the non-uniformity of the breast
thickness. - Compensation for potential patient movement between the 2
CESM acquisitions (Low Energy and High Energy). |
| Substantial Equivalence /
Predicate Device | The update of the existing recombination algorithm to the New Image
Recombination Algorithm (NIRA) for SenoBright HD does not impact
the intended use/indications for use of the legally marketed device
SenoBright HD |
| | |
| | The fundamental principles of operation, functionalities, specifications
and technological characteristics of SenoBright HD with NIRA are |
| | identical to those of the Predicate device SenoBright HD. |
| | The image processing of SenoBright HD is improved with the New |
| | Image Recombination Algorithm by adding a local estimation of breast |
| | thickness in the images recombination to account for the non- |
| | uniformity of the breast thickness, and by compensating for potential |
| | patient movement between the 2 CESM acquisitions (LE and HE). |
| | Image Quality Performance Testing results demonstrated that the |
| | image quality of SenoBright HD with NIRA performs similarly as its |
| | legally marketed predicate device, SenoBright HD (K172404). |
| Determination of Substantial
Equivalence: | NIRA for SenoBright HD successfully completed required design control
testing per GE Healthcare's quality management system. No |
| | unexpected test results were obtained. The device is designed and will |
| | be manufactured in compliance with 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 NIRA for SenoBright HD was |
| | demonstrated through full verification testing and additional |
| | performance testing such as: |
| | 1. A Non-clinical Performance Testing on phantoms, including |
| | Image quality testing to demonstrate that SenoBright HD |
| | with NIRA performs at least as well as the cleared device |
| | SenoBright HD (K172404) and brings Image Quality |
| | improvements. The performance testing also demonstrates |
| | reduction of artifacts in case of either patient motion or |
| | breast thickness non-uniformity to increased lesion visibility. |
| | 2. A clinical image evaluation performed by 3 independent |
| | MQSA-qualified radiologists on 10 images with objective |
| | criteria defined. It illustrated the clinical image acceptability |
| | of images generated by SenoBright HD with NIRA. |
| | 3. A clinical image evaluation comparing SenoBright HD with NIRA to the predicate device SenoBright HD, performed by 3 independent MQSA-qualified radiologists on 50 clinical images, showing results including:
The contrast uptake visibility assessed equivalent or better in 97% of the cases. The visibility of artifacts assessed equivalent or lower in 99% of the cases. The overall clinical image quality assessed superior in more than 98% of the cases. The results of verification and performance testing demonstrate the safe and effective use of SenoBright HD with NIRA .
SenoBright HD with NIRA is substantially equivalent to the predicate device SenoBright HD (K172404) and there is no new question of safety and effectiveness that was raised. |
| Conclusion: | The fundamental principles of operation, functionalities, specifications and technological characteristics of SenoBright HD with NIRA are identical to those of the Predicate device SenoBright HD.
Furthermore, results of successful verification activities and additional bench performance testing and clinical image evaluations do not raise any new issue regarding the safety and effectiveness of the device.
Based on this information, GE Healthcare believe that SenoBright HD with NIRA is substantially equivalent to its predicate device SenoBright HD (K172404). |
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GE Healthcare
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510(k) Premarket Notification Submission
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GE Healthcare
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510(k) Premarket Notification Submission
8
Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are in a light blue color. There are also some white curved lines around the letters.