SIGNA PET/MR

K163619 · Ge Medical Systems, LLC · OUO · Feb 14, 2017 · Radiology

Device Facts

• Record ID: K163619
• Device Name: SIGNA PET/MR
• Applicant: Ge Medical Systems, LLC
• Product Code: OUO · Radiology
• Decision Date: Feb 14, 2017
• 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, localization, and diagnosis of diseases and disorders. MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/ or spectra, and displays the internal structure and/or function 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-free attenuation 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 scanner and PET detector system integrated into MR bore; enables simultaneous, isocentric acquisition of high-resolution metabolic and anatomic data. System includes patient table, acquisition/processing workstations, and software for patient management, scan control, image reconstruction, and archival. PET subsystem supports Time of Flight (ToF). Used in clinical settings by trained professionals (physicians, technologists) for oncology, neurology, and cardiology. MR data provides radiation-free attenuation correction maps for PET; precisely aligned coordinate systems allow inherent anatomical reference for fused images. Output consists of cross-sectional MR images, spectroscopic images/spectra, and PET metabolic maps. Clinicians use fused images to aid diagnosis and interventional procedure guidance. Benefits include simultaneous multi-modality imaging, reduced scan time, and improved anatomical localization of metabolic activity.

Clinical Evidence

Bench testing only. Clinical evidence consists of sample clinical images and qualitative/quantitative comparisons of the modified MR Attenuation Correction technology against the predicate device to demonstrate equivalent performance.

Technological Characteristics

3.0T superconducting magnet; gradient and body coils; integrated PET detectors in MR bore. Supports Time of Flight (ToF) PET. DICOM-compliant software for image reconstruction and processing. Standards: AAMI/ANSI 62304, AAMI/ANSI ES60601-1, IEC 60601-2-33. Software-based MR attenuation correction.

Indications for Use

Indicated for use by trained healthcare professionals for detection, localization, and diagnosis of disorders in oncology, neurology, and cardiology. Applicable to patients requiring MR and/or PET imaging for metabolic and physiologic evaluation. Contraindications include non-MR compatible implants or devices.

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

• SIGNA PET/MR (K142098)

Submission Summary (Full Text)

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

February 14, 2017

GE Medical Systems, LLC % Ms. Janice Sich Regulatory Affairs Manager 3200 N. Grandview Blvd. Waukesha WI 53188

Re: K163619

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: December 21, 2016 Received: December 22, 2016

Dear Ms. Sich:

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

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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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

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 ofthe 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. localization, and diagnosis of disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function 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.

The 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) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |

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k163619

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is blue and has a vintage look.

# GE Healthcare 510(k) Premarket Notification Submission

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | December 21, 2016 |
| Primary Contact Person: | Janice M Sich<br>Regulatory Affairs Manager, MR<br>GE Healthcare, (GE Medical Systems, LLC)<br>Phone: [phone]<br>Fax: [phone] |
| Secondary Contact<br>Person: | Glen Sabin<br>Regulatory Affairs Director, MR<br>GE Healthcare, (GE Medical Systems, LLC)<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | SIGNA PET/MR |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device / Positron Emission<br>Tomography (PET) System |
| Classification Names: | Emission Computed Tomography System per 21 CFR 892.1200 |
| Product Code: | OUO |
| Predicate Device: | SIGNA PET/MR (K142098) |
| Device Description: | The GE SIGNA PET/MR system is a combined Magnetic<br>Resonance Diagnostic Device (MRDD) and Positron Emission<br>Tomography (PET) scanner. The system is designed for whole body<br>oncology, neurology and cardiology examinations. The SIGNA<br>PET/MR system provides simultaneous acquisition of high-<br>resolution metabolic and anatomic information from the two major<br>components of each system (MR and PET). Additional components<br>of the system include: a patient table and both the acquisition and<br>processing workstations with associated software.<br><br>The SIGNA PET/MR includes a 3.0T superconducting magnet,<br>gradient coil and body coil. The system includes dual drive<br>capabilities. The SIGNA PET detectors are integrated into the MR<br>bore. This allows for simultaneous, precisely aligned whole body<br>MR and PET acquisition. The PET subsystem supports Time of<br>Flight (ToF). The SIGNA PET/MR software is used for patient<br>management, data management, scan control, image reconstruction<br>and image archival and evaluation. All images conform to DICOM<br>imaging format requirements. |
| Indications for Use: | The SIGNA PET/MR system combines magnetic resonance<br>diagnostic devices (MRDD) and Positron Emission Tomography<br>(PET) scanners that provide registration and fusion of high<br>resolution physiologic and anatomic information, acquired<br>simultaneously and isocentrically. The combined system maintains<br>independent functionality of the MR and PET devices, allowing for<br>single modality MR and / or PET imaging. These systems are<br>intended to be utilized by appropriately trained health care<br>professionals to aid in the detection, localization, and diagnosis of<br>diseases and disorders. MR is intended to produce transverse,<br>sagittal, coronal and oblique cross-sectional MR images,<br>spectroscopic images and/ or spectra, and displays the internal<br>structure and/or function of the human body. Other physical<br>parameters derived from the images and/or spectra may also be<br>produced. Depending on the region of interest, approved contrast<br>agents may be used, as described in their labeling. This system may<br>also be used for imaging during interventional procedures when<br>performed with MR compatible devices, such as MR safe biopsy<br>needles. PET images and measures the distribution of PET<br>radiopharmaceuticals in humans to aid the physician in determining<br>various metabolic (molecular) and physiologic functions within the<br>human body for evaluation of diseases and disorders such as, but not<br>limited to, cardiovascular disease, neurological disorders and cancer.<br>The combined system utilizes the MR for radiation-free attenuation<br>correction maps for PET studies. The system provides inherent<br>anatomical reference for the fused PET and MR images due to<br>precisely aligned MR and PET image coordinate systems. |
| Comparison of Intended<br>Use | The proposed modifications do not impact the indications for use of<br>the device, therefore the intended use has not changed compared to<br>the predicate.<br>The modifications outlined within this submission have the same<br>intended use as the predicate device in accordance with the FDA's<br>guidance document "The 510(k) Program: Evaluating Substantial<br>Equivalence in Premarket Notifications [510(k)]", dated 28 July<br>2014. |
| Technology: | The SIGNA PET/MR with the proposed software modifications<br>employs the same fundamental scientific technology as the predicate<br>device. This subject of this premarket notification includes<br>modifications to MR Attenuation Correction compared to the<br>predicate device. |
| Determination of<br>Substantial Equivalence: | Summary of Non-Clinical Tests:<br>The features that are the subject of this premarket notification are<br>software only features that comply with the following voluntary |
| standards:<br>AAMI/ANSI 62304 AAMI/ANSI ES60601-1 IEC 60601-2-33 The following quality assurance measures were applied to the development of subject features: Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Safety testing (Verification) Simulated use testing (Validation) Non-clinical tests have been summarized in the verification and validation testing. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate because the software features were developed under quality assurance Design Controls.<br>Summary of Clinical Tests:<br>Sample clinical images, qualitative and quantitative comparisons compared to the predicate MR Attenuation Correction technology are included in this submission to support substantial equivalence of the modified features. | |
| Conclusion:<br>GE Healthcare considers the SIGNA PET/MR with the modified software to be as safe, as effective, and performance is substantially equivalent to the 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 blue circle. The letters are also blue, matching the color of the circle. The logo is simple and recognizable, representing the multinational conglomerate corporation.

## GE Healthcare 510(k) Premarket Notification Submission

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo is a circular emblem with the letters 'GE' intertwined in the center. The letters are stylized and have a flowing, cursive appearance. The logo is blue and has a white background.

# GE Healthcare

510(k) Premarket Notification Submission