(82 days)
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.
The subject of this submission is a modification of Senographe Pristina FFDM system (cleared in K162268) that will introduce a new imaging option called SenoBright HD. This imaging option has been previously cleared for Senographe Essential FFDM system in K103485,marketed as SenoBright Contrast Enhanced Spectral Mammography (CESM). The dual energy exposures will be done following an iodine based contrast injection of the patient and with a single breast compression. The new mode of operation for Senographe Pristina system is referred to as SenoBright HD Contrast Enhanced Spectral Mammography (CESM) due to the nature of taking an exposure with the x-ray spectrum optimized for general mammographic imaging and a second exposure with the x-ray spectrum optimized for the iodine based contrast image. The main modification of the Senographe Pristina system is the addition of software feature to control the low and high energy images and post processing and recombination of those images to create FFDM like image and recombined image. These two images allow the visualization of the breast tissue in a way that is typical and familiar for mammographic imaging and the x-ray contrast enhancement in the breast at the same time.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific reported device performance metrics against such criteria. Instead, it makes a general statement about "appropriate performance" and "good" image quality.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions a "Clinical image evaluation was performed" without specifying the number of images or cases in the test set.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: "expert radiologists" (plural) were used, but the exact number is not specified.
- Qualifications of Experts: Only "expert radiologists" is stated, without details on their specific experience (e.g., years of experience, board certifications).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify an adjudication method for the test set. It only mentions that an evaluation was performed by "expert radiologists."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. The device description explicitly states: "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." This implies it is a diagnostic imaging tool, not an AI-assisted reader tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an imaging system (Full-field digital mammography system with contrast enhancement), not an algorithm. Therefore, a "standalone algorithm only" performance study is not directly applicable in the way it would be for an AI-CAD device. The "Clinical image evaluation" mentioned was likely to assess the quality and utility of the images produced by the device, which would then be interpreted by human readers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states "A Clinical image evaluation was performed showing that image quality of SenoBright HD in a clinical setting is good as assessed by expert radiologists." This implies that the ground truth for the image quality assessment was expert radiologist assessment/consensus. It does not mention pathology or outcomes data as ground truth for this specific evaluation, as the evaluation focused on image quality rather than diagnostic accuracy against a definitive truth for lesions.
8. The sample size for the training set
The document does not provide any information about a specific "training set" or its size. The device is a modification of an existing FFDM system, introducing new software features for image acquisition and processing. This suggests that the development likely involved engineering and image processing adjustments rather than deep learning model training in the conventional sense that would require a distinct "training set."
9. How the ground truth for the training set was established
As no training set is mentioned for an AI model, this question is not applicable based on the provided text. The "ground truth" for the development of the image processing might have involved phantom studies and clinical images used for optimization, but these are not described as a formal "training set" with established ground truth in the context of machine learning.
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October 30, 2017
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GE Healthcare GE Medical Systems SCS % Mounir Zaouali Regulatory Affairs Leader 283 rue de la Miniere Buc, 78530 FRANCE
Re: K172404
Trade/Device Name: SenoBright HD Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 4, 2017 Received: August 9, 2017
Dear Mounir Zaouali:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara For
Robert 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)
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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Section 5: 510(k) Summary
SenoBright HD
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 4, 2017 |
|---|---|
| Submitter: | GE HealthcareGE Medical Systems SCS283 RUE DE LA MINIERE78530 BUC - FRANCE |
| Primary Contact Person: | Mounir Zaouali,Regulatory Affairs Leader,GE Medical Systems SCS,283 RUE DE LA MINIERE78530 BUC - FRANCE Phone : + 33 1 30 70 45 39Phone : + 33 1 30 70 45 39Fax : + 33 1 30 70 41 40Email : Mounir.Zaouali@ge.com |
| Secondary Contact Person: | Diane UriellSr. Director of Regulatory Affairs, XR and Women's Health,GE Healthcare,Atlanta, Georgia - USAPhone +1 262 290 8212Email: Diane.Uriell@ge.com |
| Device Trade Name: | SenoBright HD |
| Common/Usual Name: | Full Field Digital Mammography System |
| Classification Names: | 21 CFR 892.1715, Class II |
| Product Code: | MUE |
| Predicate Device(s): | K103485Contrast Enhanced Spectral Mammography (CESM) |
| Device Description: | The subject of this submission is a modification of SenographePristina FFDM system (cleared in K162268) that will introduce a new |
| imaging option called SenoBright HD. This imaging option has beenpreviously cleared for Senographe Essential FFDM system inK103485,marketed as SenoBright Contrast Enhanced SpectralMammography (CESM).The dual energy exposures will be done following an iodine basedcontrast injection of the patient and with a single breast compression. | |
| The new mode of operation for Senographe Pristina system isreferred to as SenoBright HD Contrast Enhanced SpectralMammography (CESM) due to the nature of taking an exposure withthe x-ray spectrum optimized for general mammographic imaging anda second exposure with the x-ray spectrum optimized for the iodinebased contrast image. | |
| The main modification of the Senographe Pristina system is theaddition of software feature to control the low and high energyimages and post processing and recombination of those images tocreate FFDM like image and recombined image. These two imagesallow the visualization of the breast tissue in a way that is typical andfamiliar for mammographic imaging and the x-ray contrastenhancement in the breast at the same time. | |
| Intended Use: | SenoBright HD is an extension of the existing indication for diagnosticmammography with Senographe Pristina. The SenoBright applicationshall enable contrast enhanced breast imaging using a dual energytechnique. This imaging technique can be used as an adjunctfollowing mammography and ultrasound exams to help localize aknown or suspected lesion. |
| Technology: | SenoBright HD and predicate device, SenoBright Contrast EnhancedSpectral Mammography (CESM), have the same intended use, samefundamental scientific technology, principle of operation and similaroperating parameters. |
| Comparison of TechnologicalCharacteristics with ThePredicate Device: | SenoBright HD |
| The main changes between SenoBright HD and the predicate deviceSenoBright Contrast Enhanced Spectral Mammography (CESM)include: | |
| 1) Different hosting mammography system (SenographeEssential vs Senographe Pristina. | |
| 2) Improvements to the acquisition technique, the high energyAOP takes into account both the breast thickness and the breastdensity to determine the optimal X-rays techniques. This is based onthe predicate and Senographe Pristina low energy AOP that takes intoaccount both breast thickness and density. | |
| 3) Additional artefacts management is incorporated to minimize the artefacts that may appear at the breast skin line and nipple. | |
| Determination of SubstantialEquivalence: | SenoBright HD has the same indications for use as its predicate device. It uses the same fundamental technology as Contrast Spectral Mammography (CESM). Differences between SenoBright HD do not raise new questions of safety and effectiveness. The impact of differences between the predicate and new device has been assessed using applicable FDA Guidance and Standards. In particular, the following testing was performed: • Complete Image Quality Bench Performance testing was completed showing appropriate performance. • A Clinical image evaluation was performed showing that image quality of SenoBright HD in a clinical setting is good as assessed by expert radiologists. • Successful System and Software verification and validation. |
| Conclusion: | GE Healthcare considers the SenoBright HD to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |
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GE Healthcare 510(k) Premarket Notification Submission
§ 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.