SIGNA PET/MR

K142098 · Ge Medical Systems, LLC · OUO · Nov 24, 2014 · Radiology

Device Facts

• Record ID: K142098
• Device Name: SIGNA PET/MR
• Applicant: Ge Medical Systems, LLC
• Product Code: OUO · Radiology
• Decision Date: Nov 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images and/ or spectra, and displays the internal struction of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Story

SIGNA PET/MR combines 3.0T MR and PET scanners for simultaneous, isocentric, whole-body imaging; used for oncology, neurology, and cardiology. MR component provides anatomical/spectroscopic data; PET component measures radiopharmaceutical distribution. System uses MR data for PET attenuation correction, replacing CT-based attenuation. Operated by trained healthcare professionals in clinical settings. Output includes fused high-resolution metabolic and anatomic images; aids physicians in disease diagnosis and metabolic/physiologic evaluation. Supports interventional procedures with MR-compatible devices. Benefits include simultaneous acquisition, precise anatomical reference, and reduced radiation exposure by eliminating CT-based attenuation correction.

Clinical Evidence

No clinical trials; bench testing only. Evidence consists of sample images collected from multiple sites to confirm simultaneous diagnostic image quality and verification/validation testing including design reviews, module verification, integration testing, and simulated use testing.

Technological Characteristics

3.0T superconducting magnet; gradient coil; body coil; local surface RF coils. PET detectors modified for MR bore integration. Connectivity: DICOM. Standards: IEC 60601-1, 60601-1-2, 60601-2-33; NEMA MS1-MS5, MS8, MS9, NU2, PS3.1-3.18. Software-based image reconstruction and processing.

Indications for Use

Indicated for use by trained healthcare professionals to aid in detection, localization, and diagnosis of diseases and disorders, including cardiovascular disease, neurological disorders, and cancer, in patients requiring MR and/or PET imaging.

Regulatory Classification

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Predicate Devices

• Siemens Biograph mMR (K133226)

Reference Devices

• Discovery XR (Discovery PET/CT 690) (K081496)
• Discovery MR750w 3.0T (K132376)

Submission Summary (Full Text)

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November 24, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

GE Medical Systems, LLC % Ms. Robin Martin Regulatory Affairs Manager 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K142098 Trade/Device Name: SIGNA PET/MR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO Dated: November 14, 2014 Received: November 17, 2014

Dear Ms. Martin:

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 yours,

Robert A Ochs

for

Janine M. Morris 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)

### k142098

Device Name SIGNA PET/MR

#### Indications for Use (Describe)

The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images and/ or spectra, and displays the internal struction of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles. PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | July 31, 2014 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter (Manufacturer): | GE Medical Systems, LLC.<br>3200 N. Grandview Blvd.<br>Waukesha, WI 53188 |
| Manufacturing Site: | GE Medical Systems, LLC.<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53188 |
| Primary Contact Person: | Robin Martin<br>Regulatory Affairs Manager<br>GE Medical Systems, LLC<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact Person: | Glen Sabin<br>Regulatory Affairs Director<br>GE Medical Systems, LLC<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | SIGNA PET/MR |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device /<br>Positron Emission Tomography (PET) System |
| Classification Names:<br>Product Code: | Emission Computed Tomography System per 21 CFR 892.1200<br>OUO |
| Predicate Device(s): | K133226 Siemens Biograph mMR<br>Reference Devices:<br>K081496 Discovery XR (Currently marketed as Discovery PET/CT 690)<br>K132376 Discovery MR750w 3.0T |
| Device Description: | The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic<br>Device (MRDD) and Positron Emission Tomography (PET) scanner. The system<br>is designed for whole body oncology, neurology and cardiology examinations.<br>The SIGNA PET/MR system provides simultaneous acquisition of high-<br>resolution metabolic and anatomic information from the two major components<br>of each system (MR and PET). Additional components of the system include: a<br>patient table and both the acquisition and processing workstations with associated<br>software.<br><br>The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil,<br>body coil and local surface RF coils based on those of the reference device<br>Discovery MR750w 3.0T. The system includes dual drive capabilities. The<br>SIGNA PET detectors have been modified from those of the reference device, the<br>Discovery PET/CT 690, to allow them to be integrated into the bore of the MR.<br>This allows for simultaneous, precisely aligned whole body MR and PET<br>acquisition. Similar to Discovery PET/CT D690, PET supports Time of Flight |

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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. There are decorative swirls around the outside of the circle, giving it a classic and recognizable appearance.

| | (ToF). SIGNA PET/MR software is based on a combination of Discovery<br>MR750w with Discovery PET/CT 690 software. It is used for patient<br>management, data management, scan control, image reconstruction and image<br>archival and evaluation. All images conform to DICOM imaging format<br>requirements.<br>The SIGNA PET/MR system and surface coil suite, the subject of this<br>application, is substantially equivalent to the commercially available devices<br>above with modifications made to integrate the two modalities together into a<br>whole-body system. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | whole-body system. |
| Intended Use: | The SIGNA PET/MR system combines magnetic resonance diagnostic devices<br>(MRDD) and Positron Emission Tomography (PET) scanners that provide<br>registration and fusion of high resolution physiologic and anatomic information,<br>acquired simultaneously and isocentrically. The combined system maintains<br>independent functionality of the MR and PET devices, allowing for single<br>modality MR and / or PET imaging. |
| | These systems are intended to be utilized by appropriately trained health care<br>professionals to aid in the detection, localization, and diagnosis of diseases and<br>disorders. The MR is intended to produce transverse, sagittal, coronal and<br>oblique cross-sectional MR images, spectroscopic images and/or spectra, and<br>displays the internal structure and/or function of the human body. Other physical<br>parameters derived from the images and/or spectra may also be produced.<br>Depending on the region of interest, approved contrast agents may be used, as<br>described in their labeling. This system may also be used for imaging during<br>interventional procedures when performed with MR compatible devices, such as<br>MR safe biopsy needles. |
| | The PET images and measures the distribution of PET radiopharmaceuticals in<br>humans to aid the physician in determining various metabolic (molecular) and<br>physiologic functions within the human body for evaluation of diseases and<br>disorders such as, but not limited to, cardiovascular disease, neurological<br>disorders and cancer. |
| | The combined system utilizes the MR for radiation-free attenuation correction<br>maps for PET studies. The system provides inherent anatomical reference for the<br>fused PET and MR images due to precisely aligned MR and PET image<br>coordinate systems. |
| Technology: | The proposed SIGNA PET/MR employs much of the same fundamental<br>scientific technology as its respective reference devices for MR and PET<br>technology and has the same intended use as the claimed predicate device. The<br>proposed device combines PET and MR technologies for simultaneous imaging.<br>Subsequently, the PET subsystem requires different technology from the<br>Discovery PET/CT 690 for compatibility with the MR subsystem (detectors,<br>chiller system, etc.). Additionally, MR images are used to correct for PET<br>attenuation compared to the reference PET/CT, which uses CT technology for<br>PET attenuation. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The SIGNA PET/MR and Coil Suite comply with the following voluntary |

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Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and the circle is surrounded by a thin blue line. The logo is simple and recognizable, and it is often used to represent the company.

| | standards (3rd Edition):<br>IEC 60601-1 (system and coil suite) IEC 60601-1-2 (system and coil suite) IEC 60601-2-33 (system and coil suite) In addition, this SIGNA PET/MR scanner and surface coils are in compliance<br>with the applicable NEMA standards, including NEMA MS1, MS2, MS3, MS4,<br>MS5, MS8, MS9, NEMA NU2 and NEMA PS3.1-3.18.<br><br>The following quality assurance measures were applied to the development of the<br>system:<br>Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation) Summary of Clinical Tests:<br>Sample images from the SIGNA PET/MR were collected from multiple sites to<br>confirm simultaneous diagnostic image quality. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | GE Medical Systems, LLC. considers the SIGNA PET/MR to be as safe, as<br>effective, and performance is substantially equivalent to the predicate device and<br>reference devices. |