SIGNA PET/MR

{0}------------------------------------------------ January 20, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. GE Medical Systems, LLC % Mr. Brian Zielski Regulatory Affairs Leader 3200 N. Grandview Blvd. WAUKESHA WI 53188 Re: K213709 Trade/Device Name: SIGNA PET/MR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: OUO Dated: November 22, 2021 Received: November 24, 2021 Dear Mr. Zielski: 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. 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Sincerely, For Julie Sullivan Associate Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) ### K213709 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, 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 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) | 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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Form Approved: OMB No. 0910-0120 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three water droplet-like shapes around the circle. The logo is simple and recognizable. # 510(k) Summary K213709 In accordance with 21 CFR 807.92 the following summary of information is provided: | Date: | November 22, 2021 | |----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | GE Medical Systems, LLC<br>3200 N. Grandview Blvd.<br>Waukesha, WI 53188 | | Primary Contact: | Brian R. Zielski<br>Regulatory Affairs Leader<br>Phone: 262-227-3596<br>Email: brian.zielski@ge.com | | Secondary Contact: | Andrew Menden<br>Senior Regulatory Affairs Manager<br>Phone: 262-308-5719<br>Email: andrew.menden@ge.com | | Device Trade Name: | SIGNA PET/MR | | Common / Usual Name: | Magnetic Resonance Diagnostic Device / Positron<br>Emission Tomography (PET) System | | Classification Name: | Emission Computed Tomography System 21 CFR<br>892.1200 | | Product Code: | OUO | | Predicate Device(s): | SIGNA PET/MR (K163619) | | Device Description: | The GE SIGNA PET/MR system is a combined Magnetic<br>Resonance Diagnostic Device (MRDD) and Positron<br>Emission Tomography (PET) scanner. The system is<br>designed for whole body oncology, neurology and<br>cardiology examinations. The SIGNA PET/MR system<br>provides simultaneous acquisition of high resolution<br>metabolic and anatomic information from the two major<br>components of each system (MR and PET). Additional<br>components of the system include: a detachable patient<br>table and both the acquisition and processing<br>workstations with associated software.<br><br>The SIGNA PET/MR includes a 3.0T superconducting<br>magnet, gradient coil and a transmit/receive whole body<br>radiofrequency coil. The system includes patient<br>adaptable RF shimming capabilities. The SIGNA PET | | | detectors are integrated into the MR bore. This allows for<br>simultaneous, precisely aligned whole body MR and PET<br>acquisitions. The PET subsystem supports Time of Flight<br>(ToF) coincidence detection. The SIGNA PET/MR<br>software is used for patient management, data<br>management, scan control, image reconstruction and<br>image archival and evaluation. All images conform to<br>DICOM imaging format requirements. | | | The modifications to this system include the MotionFree<br>Brain software feature, which allows users the flexibility to<br>correct patient head motion using the acquired PET data<br>from the exam, without the need of external tracking<br>devices, additional MR data, or other motion tracking data<br>schemes. | | Indications for Use: | The SIGNA PET/MR system combines magnetic<br>resonance diagnostic devices (MRDD) and Positron<br>Emission Tomography (PET) scanners that provide<br>registration and fusion of high resolution physiologic and<br>anatomic information, acquired simultaneously and<br>isocentrically. The combined system maintains<br>independent functionality of the MR and PET devices,<br>allowing for single modality MR and / or PET imaging. | | | These systems are intended to be utilized by<br>appropriately trained health care professionals to aid in<br>the detection, localization, and diagnosis of diseases and<br>disorders. MR is intended to produce transverse, sagittal,<br>coronal and oblique cross-sectional MR images,<br>spectroscopic images and/or spectra, and displays the<br>internal structure and/or function of the human body.<br>Other physical parameters derived from the images<br>and/or spectra may also be produced. Depending on the<br>region of interest, approved contrast agents may be used,<br>as described in their labeling. This system may also be<br>used for imaging during interventional procedures when<br>performed with MR compatible devices, such as MR safe<br>biopsy needles. | | | PET images and measures the distribution of PET<br>radiopharmaceuticals in humans to aid the physician in<br>determining various metabolic (molecular) and<br>physiologic functions within the human body for<br>evaluation of diseases and disorders such as, but not<br>limited to, cardiovascular disease, neurological disorders<br>and cancer. | | | The combined system utilizes the MR for radiation-free<br>attenuation correction maps for PET studies. The system | | | provides inherent anatomical reference for the fused PET<br>and MR images due to precisely aligned MR and PET<br>image coordinate systems. | | Comparison of<br>Technological<br>Characteristics: | The SIGNA PET/MR with the proposed software feature<br>employs the same fundamental technology as the<br>predicate device. | | | The SIGNA PET/MR has been modified to include the<br>MotionFree Brain feature. The user interface provides<br>operators of the system with an option for enabling this<br>feature. MotionFree Brain derives head motion<br>information from the PET data; there is no need for<br>external tracking devices, additional MR data, or<br>additional PET data collection. The feature measures<br>and incorporates the rigid-body motion information into<br>the PET reconstruction, correcting the position of each<br>coincidence event to account for patient head motion. | | | These technological differences do not raise any different<br>questions regarding safety and effectiveness. Both<br>devices must allow for an effective method to setup an<br>appropriate scan prescription. The performance data<br>described in this submission include results of both bench<br>testing and clinical testing that show the performance of<br>the SIGNA PET/MR compared to the predicate device. | | Summary of Nonclinical<br>Testing: | The following quality assurance measures were applied<br>to the development of the device:<br>• Risk Analysis<br>• Requirements Reviews<br>• Design Reviews<br>• Verification (functional testing for subsystem and<br>system integration)<br>• Validation (simulated use testing) | | | Non-clinical tests have been summarized in the<br>verification and validation testing. The testing was<br>completed with passing results per the pass/fail criteria<br>defined in the test cases. This supports<br>substantial equivalence to its predicate because the<br>software feature was developed under quality assurance<br>Design Controls. Performance testing on phantoms as<br>part of non-clinical testing demonstrated MotionFree<br>Brain achieved performance claims for Quantitation,<br>Temporal Resolution, and Spatial Accuracy. | | | | | Summary of Clinical<br>Testing: | An external reader evaluation study was performed for<br>MotionFree Brain. The retrospective blind study involved<br>board-certified readers who were asked to evaluate<br>randomly labeled cases that were reconstructed with and<br>without MotionFree Brain. Verification documents, validation documents, and test<br>reports have been provided for more details. Testing<br>demonstrated that the device is as safe, as effective, and<br>performs as well as or better than the predicate device.<br>No new questions of safety and effectiveness were raised<br>during nonclinical testing. | | | The readers were blinded to feature use (e.g. whether<br>feature was enabled or disabled), report case history, as<br>well as to the assessments made by the other readers.<br>The readers were asked to complete an assessment,<br>including additional commentary, and report their<br>preference on the pair of image series presented. | | | Clinical testing confirms that MotionFree Brain can be<br>used safely and effectively in a clinical setting. | | Conclusion Drawn from<br>Performance Testing: | The SIGNA PET/MR with the modified software feature<br>has the same intended use as the predicate. This 510(k)<br>submission includes information on the technological<br>characteristics of the proposed software feature, as well<br>as performance data demonstrating that the feature is as<br>safe and effective as the predicate, and does not raise<br>different questions of safety and effectiveness. | | | In conclusion, GE Healthcare considers the SIGNA<br>PET/MR to be at least as safe and effective, and its<br>performance is substantially equivalent to the predicate<br>device. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Three water droplets or wave-like shapes surround the circle, adding a dynamic element to the design. The logo is simple, recognizable, and associated with the multinational conglomerate. {5}------------------------------------------------ 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 a stylized font in the center. There are three white water droplet shapes surrounding the circle. The logo is simple and recognizable, and it is often used to represent the company's brand. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. There are three water droplet-like shapes surrounding the circle, one at the top and one on each side. The logo is simple and recognizable, representing the company's brand identity.