(83 days)
P990066/S021
Not Found
No
The summary describes a standard digital mammography system with image processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The performance studies focus on image quality and clinical evaluation by radiologists, not on the performance of an AI/ML algorithm.
No
The device is described as generating digital mammographic images for screening and diagnosis of breast cancer, which are diagnostic purposes, not therapeutic.
Yes
The device is explicitly stated to be used "in the diagnosis of breast cancer," which clearly indicates a diagnostic function.
No
The device description explicitly states it includes hardware components such as an X-ray image acquisition system, digital detector, x-ray tube, high voltage generator, and compression paddles.
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 Senographe Pristina is an X-ray imaging system used to generate digital mammographic images. It works by using X-rays to create images of the breast.
- No Sample Analysis: The device does not analyze biological samples taken from the patient. It directly images the anatomical site (breast) using an external energy source (X-rays).
Therefore, Senographe Pristina falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screen-film systems.
Product codes
MUE
Device Description
Senographe Pristina is a new Full Field Digital Mammography (FFDM) system. The system consists of an X-ray image acquisition system dedicated to breast imaging and of a control station for image acquisition, processing and display. The image acquisition system includes a Cesium Iodine digital detector, x-ray tube, integrated high voltage generator, compression paddles. The control station provides a touch-screen user interface to control image acquisition, image processing, and image transfer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
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
Complete Image Quality Bench Performance testing was completed showing appropriate performance. A Clinical image evaluation was performed showing that image quality of Senographe Pristina in a clinical setting is good as assessed by expert radiologists. Compliance was demonstrated against applicable safety and performance standards. Successful System and Software verification and validation.
Key Metrics
Not Found
Predicate Device(s)
Senographe Essential (P990066/S021)
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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 3, 2016
GE Healthcare % Mr. Gregory Pessato Regulatory Affairs Program Manager 283 rue de la Miniere Buc, 78530 FRANCE
Re: K162268
Trade/Device Name: Senographe Pristina Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: August 16, 2016 Received: August 17, 2016
Dear Mr. Pessato:
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 (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.
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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 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. 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 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 yours,
Michael D.'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)
K162268
Device Name Senographe Pristina
Indications for Use (Describe)
Senographe Pristina generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. Senographe Pristina is intended to be used in the same clinical applications as traditional mammographic screenfilm systems.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 5, 2016 |
|---|---|
| Submitter: | GE Medical Systems SCS |
| Primary Contact Person: | Gregory Pessato |
| Regulatory Affairs Program Manager | |
| GE Healthcare | |
| 283 RUE DE LA MINIERE | |
| 78530 BUC - FRANCE | |
| Phone : + 33 1 30 70 93 16 | |
| Email : GregoryPessato@ge.com | |
| Secondary Contact | |
| Person: | Diane Uriell |
| Director of Regulatory Affairs, XR and Women's Health | |
| GE Healthcare | |
| Atlanta GA | |
| Phone +1 262 290 8212 | |
| Email:Diane.Uriell@ge.com . | |
| Device Trade Name: | Senographe Pristina |
| Common/Usual Name: | Full-field digital mammography system |
| Classification Names: | Full-field digital mammography system |
| Class II CFR 892.1715 | |
| Product Code: | MUE |
| Predicate Device(s): | Senographe Essential (P990066/S021) |
| Device Description: | Senographe Pristina is a new Full Field Digital Mammography (FFDM) |
| system. The system consists of an X-ray image acquisition system | |
| dedicated to breast imaging and of a control station for image acquisition, | |
| processing and display. The image acquisition system includes a Cesium | |
| lodine digital detector, x-ray tube, integrated high voltage generator, | |
| compression paddles. The control station provides a touch-screen user | |
| interface to control image acquisition, image processing, and image | |
| transfer. | |
| Indications for Use: | Senographe Pristina generates digital mammographic images that can be |
| used for screening and in the diagnosis of breast cancer. Senographe | |
| Pristina is intended to be used in the same clinical applications as | |
| traditional film-based mammographic systems. | |
| Comparison Of | |
| Technological | |
| Characteristics With The | |
| Predicate Device: | Senographe Pristina uses the same fundamental technology as |
| Senographe Essential in terms of image acquisition (X-ray tube, detector, | |
| image processing). Senographe Pristina includes a dual track anode with | |
| silver filter, a Cesium lodine detector | |
| Senographe Pristina was redesigned using actualized components and | |
| improved ergonomics. In particular Senographe Pristina was designed | |
| with: | |
| Improved patient ergonomics (rounded shapes, soft armrests, thin | |
| breast support) for improved patient comfort; | |
| Improved technologist ergonomics (large workspace, sliding implant / | |
| small breast paddle) for better access to patient and eased patient | |
| positioning; | |
| A new gantry motorization with independent compression and X-ray | |
| tube head angulation for upgradability to 3D; | |
| Integrated X-ray generator for reduced footprint. | |
| Determination of | |
| Substantial Equivalence: | Senographe Pristina has the same indications for use as its predicate |
| device. It uses the same fundamental technology as Senographe Essential. | |
| Differences between Senographe Pristina 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 Senographe Pristina in a clinical setting is good as assessed by expert | |
| radiologists. | |
| Compliance was demonstrated against applicable safety and | |
| performance standards. Successful System and Software verification and validation. | |
| Conclusion: | Senographe Pristina is substantially equivalent to its predicate device |
| Senographe Essential. |
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