Senographe Pristina

K163302 · GE Healthcare · MUE · Sep 1, 2017 · Radiology

Device Facts

• Record ID: K163302
• Device Name: Senographe Pristina
• Applicant: GE Healthcare
• Product Code: MUE · Radiology
• Decision Date: Sep 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1715
• Device Class: Class 2

Intended 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 Story

Senographe Pristina is a Full-Field Digital Mammography (FFDM) system. This modification introduces a patient-assisted compression (Self-Compression) option. The system includes a handheld wireless remote control allowing patients to adjust breast compression force during positioning. The remote transmits commands to a wireless receiver on the FFDM unit, which then raises or lowers the compression paddle if safety conditions are met. The technologist initiates the process and guides the patient to reach adequate compression. The device is used in clinical settings by technologists and patients. The output is digital mammographic images used by radiologists for breast cancer screening and diagnosis. The primary benefit is reduced patient pain and discomfort by providing the patient an active role in compression.

Clinical Evidence

Clinical evaluation conducted on 30 patients undergoing standard CC and MLO FFDM views. Image quality assessed by MQSA-qualified radiologists using FDA Class II Special Controls guidance criteria. Results showed patient-assisted compression produced images of similar quality to technologist-applied compression.

Technological Characteristics

Full-Field Digital Mammography system. New technological characteristic: wireless remote control and paired wireless receiver for compression adjustment. System includes wired compression footswitches. Operates as an FFDM unit.

Indications for Use

Indicated for screening and diagnosis of breast cancer in patients requiring mammographic imaging.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Senographe Pristina (K162268)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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) | |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;"><b> Prescription Use (Part 21 CER 801 Subpart D) </b></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 Vidal<br>Director of RA Strategy<br>GE Healthcare<br>283 RUE DE LA MINIERE<br>78530 BUC - France<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact Person: | Diane Uriell<br>Director of Regulatory Affairs, XR and Women's Health<br>GE Healthcare<br>Atlanta, GA<br>Phone: [phone]<br>Email: [e-mail] |
| 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 the<br>Senographe Pristina Full Field Digital Mammography system. It<br>consists of a handheld wireless remote control to allow patient to<br>adjust the compression force during breast positioning. The remote<br>transmits the compression command to the Senographe Pristina.<br>Senographe Pristina executes the command by raising or lowering<br>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. |
| 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:<br>- the addition of a wireless remote control to adjust compression during breast positioning,<br>- the installation of a paired wireless receiver on Senographe Pristina to receive and relay the patient-assisted compression commands to the FFDM unit,<br>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.<br>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. |

{4}------------------------------------------------

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