(115 days)
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.
The GE SIGNA PET/MR system is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner. The system is designed for whole body oncology, neurology and cardiology examinations. The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient table and both the acquisition and processing workstations with associated software.
The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil, body coil and local surface RF coils based on those of the reference device Discovery MR750w 3.0T. The system includes dual drive capabilities. The SIGNA PET detectors have been modified from those of the reference device, the Discovery PET/CT 690, to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. Similar to Discovery PET/CT D690, PET supports Time of Flight (ToF). SIGNA PET/MR software is based on a combination of Discovery MR750w with Discovery PET/CT 690 software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
The SIGNA PET/MR system and surface coil suite, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SIGNA PET/MR device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance data from a clinical trial. Therefore, specific numerical acceptance criteria and corresponding device performance metrics are not explicitly stated in this document.
However, based on the non-clinical and clinical tests mentioned, we can infer the intent of the acceptance criteria. The performance is reported in a qualitative manner, affirming compliance and confirming image quality.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Compliance with Safety and Performance Standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, NEMA standards NU2, MS1-MS5, MS8, MS9, PS3.1-3.18) | The SIGNA PET/MR and Coil Suite comply with the listed voluntary standards. Quality assurance measures applied include design reviews, unit-level testing, integration testing, performance testing, safety testing, and simulated use testing. |
| Independent Functionality of MR and PET devices | The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. |
| Simultaneous Acquisition of High-Resolution Metabolic and Anatomic Information | The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information. |
| Production of Transverse, Sagittal, Coronal, Oblique Cross-Sectional MR Images and Spectra | The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra. (Implied that the device performs this as intended, aligning with the predicate's capabilities). |
| Measurement of PET Radiopharmaceutical Distribution for Evaluation of Diseases | 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. (Implied that the device performs this as intended, aligning with the predicate's capabilities). |
| Utilization of MR for Radiation-Free Attenuation Correction Maps for PET Studies | The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. |
| Inherent Anatomical Reference for Fused PET and MR images due to Precisely Aligned Coordinate Systems | The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems. |
| Diagnostic Image Quality (Clinical Evaluation) | Sample images from the SIGNA PET/MR were collected from multiple sites to confirm simultaneous diagnostic image quality. |
| Substantial Equivalence to Predicate Device | GE Medical Systems, LLC. considers the SIGNA PET/MR to be as safe, as effective, and performance is substantially equivalent to the predicate device and reference devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document only states "Sample images from the SIGNA PET/MR were collected from multiple sites." It does not specify a numerical sample size for the test set used in clinical evaluation.
- Data Provenance: The data was collected "from multiple sites". The country of origin is not specified. Given it's a submission to the US FDA by a company based in the US (Waukesha, WI), it is highly probable that at least some, if not all, of the sites were in the USA, but this is not explicitly stated. The study was likely retrospective for the collected "sample images" to confirm image quality, though this is also not directly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document. It only mentions that the system is intended to be used by "appropriately trained health care professionals."
4. Adjudication Method for the Test Set:
- The document does not specify any adjudication method. It notes that "sample images... were collected... to confirm simultaneous diagnostic image quality," implying some form of expert review, but details on how disagreements or consensus were reached are absent.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study is not mentioned. The document describes clinical evaluation to "confirm simultaneous diagnostic image quality," which is a verification of functionality, not a comparative study of human reader performance with or without AI assistance. The device itself is a diagnostic imaging system, not an AI-assisted diagnostic tool that augments human interpretation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Yes, in spirit, the clinical evaluation focused on the standalone performance of the device (SIGNA PET/MR system) in producing diagnostic image quality. The "algorithm" here refers to the entire imaging system's capability to generate images, not a separate AI algorithm that interprets those images. The statement "Sample images... were collected... to confirm simultaneous diagnostic image quality" implies an evaluation of the system's output directly.
7. The Type of Ground Truth Used:
- The document states "to confirm simultaneous diagnostic image quality." This suggests the ground truth was likely expert consensus or qualitative assessment by healthcare professionals evaluating the diagnostic utility and clarity of the acquired images. It is not pathology, outcomes data, or a quantifiable "true" diagnostic outcome in the strict sense for individual cases.
8. The Sample Size for the Training Set:
- This information is not applicable and not provided. The SIGNA PET/MR system is a medical imaging hardware device combined with imaging software, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense of machine learning for classification or prediction. Its software functions (patient management, data management, scan control, image reconstruction, archival, and evaluation) are based on established engineering principles and prior device software, not iterative learning from a large training dataset.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable and not provided for the reasons stated in point 8.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.3200 N. Grandview Blvd.Waukesha, WI 53188 |
| Manufacturing Site: | GE Medical Systems, LLC.3000 N. Grandview Blvd.Waukesha, WI 53188 |
| Primary Contact Person: | Robin MartinRegulatory Affairs ManagerGE Medical Systems, LLCPhone: (414) 336-9228Fax: (262) 894-4968 |
| Secondary Contact Person: | Glen SabinRegulatory Affairs DirectorGE Medical Systems, LLCPhone: (262) 521-6848Fax: (262) 894-4968 |
| Device Trade Name: | SIGNA PET/MR |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device /Positron Emission Tomography (PET) System |
| Classification Names:Product Code: | Emission Computed Tomography System per 21 CFR 892.1200OUO |
| Predicate Device(s): | K133226 Siemens Biograph mMRReference Devices:K081496 Discovery XR (Currently marketed as Discovery PET/CT 690)K132376 Discovery MR750w 3.0T |
| Device Description: | The GE SIGNA PET/MR system is a combined Magnetic Resonance DiagnosticDevice (MRDD) and Positron Emission Tomography (PET) scanner. The systemis designed for whole body oncology, neurology and cardiology examinations.The SIGNA PET/MR system provides simultaneous acquisition of high-resolution metabolic and anatomic information from the two major componentsof each system (MR and PET). Additional components of the system include: apatient table and both the acquisition and processing workstations with associatedsoftware.The SIGNA PET/MR includes a 3.0T superconducting magnet, gradient coil,body coil and local surface RF coils based on those of the reference deviceDiscovery MR750w 3.0T. The system includes dual drive capabilities. TheSIGNA PET detectors have been modified from those of the reference device, theDiscovery PET/CT 690, to allow them to be integrated into the bore of the MR.This allows for simultaneous, precisely aligned whole body MR and PETacquisition. 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 DiscoveryMR750w with Discovery PET/CT 690 software. It is used for patientmanagement, data management, scan control, image reconstruction and imagearchival and evaluation. All images conform to DICOM imaging formatrequirements.The SIGNA PET/MR system and surface coil suite, the subject of thisapplication, is substantially equivalent to the commercially available devicesabove with modifications made to integrate the two modalities together into awhole-body system. | |
|---|---|
| whole-body system. | |
| Intended Use: | The SIGNA PET/MR system combines magnetic resonance diagnostic devices(MRDD) and Positron Emission Tomography (PET) scanners that provideregistration and fusion of high resolution physiologic and anatomic information,acquired simultaneously and isocentrically. The combined system maintainsindependent functionality of the MR and PET devices, allowing for singlemodality MR and / or PET imaging. |
| These systems are intended to be utilized by appropriately trained health careprofessionals to aid in the detection, localization, and diagnosis of diseases anddisorders. The MR is intended to produce transverse, sagittal, coronal andoblique cross-sectional MR images, spectroscopic images and/or spectra, anddisplays the internal structure and/or function of the human body. Other physicalparameters derived from the images and/or spectra may also be produced.Depending on the region of interest, approved contrast agents may be used, asdescribed in their labeling. This system may also be used for imaging duringinterventional procedures when performed with MR compatible devices, such asMR safe biopsy needles. | |
| The PET images and measures the distribution of PET radiopharmaceuticals inhumans to aid the physician in determining various metabolic (molecular) andphysiologic functions within the human body for evaluation of diseases anddisorders such as, but not limited to, cardiovascular disease, neurologicaldisorders and cancer. | |
| The combined system utilizes the MR for radiation-free attenuation correctionmaps for PET studies. The system provides inherent anatomical reference for thefused PET and MR images due to precisely aligned MR and PET imagecoordinate systems. | |
| Technology: | The proposed SIGNA PET/MR employs much of the same fundamentalscientific technology as its respective reference devices for MR and PETtechnology and has the same intended use as the claimed predicate device. Theproposed device combines PET and MR technologies for simultaneous imaging.Subsequently, the PET subsystem requires different technology from theDiscovery PET/CT 690 for compatibility with the MR subsystem (detectors,chiller system, etc.). Additionally, MR images are used to correct for PETattenuation compared to the reference PET/CT, which uses CT technology forPET attenuation. |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests: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):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 compliancewith the applicable NEMA standards, including NEMA MS1, MS2, MS3, MS4,MS5, MS8, MS9, NEMA NU2 and NEMA PS3.1-3.18.The following quality assurance measures were applied to the development of thesystem: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:Sample images from the SIGNA PET/MR were collected from multiple sites toconfirm simultaneous diagnostic image quality. | |
|---|---|
| Conclusion: | GE Medical Systems, LLC. considers the SIGNA PET/MR to be as safe, aseffective, and performance is substantially equivalent to the predicate device andreference devices. |
§ 892.1200 Emission computed tomography system.
(a)
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.(b)
Classification. Class II.