(283 days)
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.
Patient-assisted compression (Self-Compression) is an option of the Senographe Pristina Full Field Digital Mammography system. It consists of a handheld wireless remote control to allow patient to adjust the compression force during breast positioning. The remote transmits the compression command to the Senographe Pristina. Senographe Pristina executes the command by raising or lowering the compression paddle, if conditions for motion are met.
Patient-assisted compression is designed to minimize patients perceived pain and discomfort by giving them an active role in the application of compression. The technologist positions the patient and initiates compression. The technologist then guides the patient while she operates the remote to gradually increase compression until she reaches adequate compression.
The provided text describes the Senographe Pristina Full-Field Digital Mammography System and an optional patient-assisted compression feature. However, the text does not contain acceptance criteria or a detailed study that proves the device meets specific performance criteria related to the image quality or diagnostic accuracy of the mammography system itself.
The "Performance Testing" section primarily focuses on the patient-assisted compression option and its impact on image quality compared to technologist-applied compression. It states that patient-assisted compression produced images of similar quality.
Here's an attempt to answer your questions based only on the provided text, acknowledging that many questions cannot be fully answered due to limited information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for the mammography device's diagnostic performance (e.g., sensitivity, specificity for cancer detection). The performance testing described is for the patient-assisted compression feature, not the core mammography system's diagnostic ability.
| Acceptance Criteria (for Patient-Assisted Compression) | Reported Device Performance (for Patient-Assisted Compression) |
|---|---|
| Image quality comparable to technologist-applied compression | Patient-assisted compression produced images of similar quality (assessed by MQSA qualified radiologists). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: 30 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be prospective as it's a "clinical evaluation."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The text states "MQSA qualified radiologists" assessed image quality. It does not specify the number of radiologists or their years of experience.
- Ground Truth for Image Quality: Radiologist assessment of image quality based on criteria set in the "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System." This is an expert opinion/consensus on image quality, not disease presence.
4. Adjudication method for the test set
Not specified. The text only mentions "Image quality was assessed by MQSA qualified radiologists." It does not indicate if multiple radiologists assessed each image and how disagreements were resolved.
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
No. This document does not mention an MRMC study or any AI assistance. The "performance testing" was a clinical evaluation of the patient-assisted compression feature, comparing image quality between two compression methods.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical imaging device, not an algorithm being tested in standalone mode.
7. The type of ground truth used
For the patient-assisted compression clinical evaluation, the "ground truth" was expert assessment/opinion of image quality by MQSA qualified radiologists. It was not pathology, outcomes data, or expert consensus on disease diagnosis.
8. The sample size for the training set
Not applicable/mentioned. The document describes a medical device, not a machine learning algorithm that requires a training set in the typical sense. If the "design and test" phase involved iterative development, the "training" would be part of the engineering and testing process rather than a distinct dataset for an algorithm.
9. How the ground truth for the training set was established
Not applicable/mentioned. See answer to question 8.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2017
Ge Healthcare Camille Vidal Director of RA Strategy 283 Rue De La Miniere Buc. 78530 FRANCE
Re: K163302
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: August 16, 2017 Received: August 18, 2017
Dear Camille Vidal:
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. Iisting 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
Robert Oals
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) K163302
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 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 29, 2017 |
|---|---|
| Submitter: | GE Healthcare Medical Systems SCS |
| Primary Contact Person: | Camille VidalDirector of RA StrategyGE Healthcare283 RUE DE LA MINIERE78530 BUC - FrancePhone: +1 (240) 280-5356Email: Camille.Vidal@ge.com |
| Secondary Contact Person: | Diane UriellDirector of Regulatory Affairs, XR and Women's HealthGE HealthcareAtlanta, GAPhone: +1 (262) 290-8212Email: Diane.Uriell@ge.com |
| Device Trade Name: | Senographe Pristina |
| Common/Usual Name: | Full-Field Digital Mammography System |
| Classification Names: | 21 CFR 892.1715 – Full Field Digital Mammography System |
| Product Code: | MUE |
| Predicate Device(s): | Senographe Pristina (K162268) |
| Device Description: | Patient-assisted compression (Self-Compression) is an option of theSenographe Pristina Full Field Digital Mammography system. Itconsists of a handheld wireless remote control to allow patient toadjust the compression force during breast positioning. The remotetransmits the compression command to the Senographe Pristina.Senographe Pristina executes the command by raising or loweringthe compression paddle, if conditions for motion are met. |
| Patient-assisted compression is designed to minimize patients perceived pain and discomfort by giving them an active role in the application of compression. The technologist positions the patient and initiates compression. The technologist then guides the patient while she operates the remote to gradually increase compression until she reaches adequate compression. | |
| 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. |
| Device Comparison | The difference between Senographe Pristina (K162268) and Senographe Pristina with Patient-assisted compression (Self-Compression) is:- the addition of a wireless remote control to adjust compression during breast positioning,- the installation of a paired wireless receiver on Senographe Pristina to receive and relay the patient-assisted compression commands to the FFDM unit,Senographe Pristina includes two wired compression footswitches. |
| Performance Testing | The patient-assisted compression option was designed and tested in accordance with GEHC Design Controls Procedures. Verification and validation testing was performed and passed for this modification.A clinical evaluation was conducted on 30 patients undergoing standard FFDM views (CC and MLO). Image quality was assessed by MQSA qualified radiologists using the criteria set in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System. Compared to images where compression was applied solely by the Technologist, patient-assisted compression produced images of similar quality. |
| Substantial Equivalence Determination | Senographe Pristina indications for use remain unchanged. New technological characteristics include a new wireless interface. Performance testing and clinical evaluation demonstrate that Senographe Pristina with patient-assisted compression (Self-Compression) is substantially equivalent to its predicate device. |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the design is simple and recognizable.
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.