(54 days)
Not Found
No
The document describes a combined PET/MR system and its software for image processing and management, but there is no mention of AI or ML technologies being used.
No.
The device is intended for detection, localization, and diagnosis of diseases and disorders, which are diagnostic purposes rather than therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is intended "to aid in the detection, localization, and diagnosis of diseases and disorders." It also describes the MR and PET components as providing information "for evaluation of diseases and disorders."
No
The device description explicitly states it is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner, including hardware components like a superconducting magnet, gradient coil, body coil, and PET detectors. While it includes software, it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or conditions.
- Device Function: The SIGNA PET/MR system is an imaging device that uses magnetic resonance and positron emission tomography to visualize the internal structure and function of the human body. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the system as aiding in the detection, localization, and diagnosis of diseases and disorders through imaging. This is consistent with an in vivo diagnostic imaging device, not an in vitro diagnostic.
The device is clearly described as an imaging system that works by scanning the patient directly, not by analyzing biological samples in a lab setting.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OUO
Device Description
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 and body coil. The system includes dual drive capabilities. The SIGNA PET detectors are integrated into the MR bore. This allows for simultaneous, precisely aligned whole body MR and PET acquisition. The PET subsystem supports Time of Flight (ToF). The SIGNA PET/MR software is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR), Positron Emission Tomography (PET)
Anatomical Site
human body (whole body)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The features that are the subject of this premarket notification are software only features that comply with the following voluntary standards: 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.
Summary of Clinical Tests:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SIGNA PET/MR (K142098)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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.
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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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 |
| Regulatory Affairs Manager, MR | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6312 | |
| Fax: 414-908-9585 | |
| Secondary Contact | |
| Person: | Glen Sabin |
| Regulatory Affairs Director, MR | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-521-6848 | |
| Fax: 414-908-9585 | |
| Device Trade Name: | SIGNA PET/MR |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device / Positron Emission |
| 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 |
| 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 and body coil. The system includes dual drive
capabilities. The SIGNA PET detectors are integrated into the MR
bore. This allows for simultaneous, precisely aligned whole body
MR and PET acquisition. The PET subsystem supports Time of
Flight (ToF). The SIGNA PET/MR software is used for patient
management, data management, scan control, image reconstruction
and image archival and evaluation. All images conform to DICOM
imaging format requirements. |
| Indications for 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. |
| Comparison of Intended
Use | The proposed modifications do not impact the indications for use of
the device, therefore the intended use has not changed compared to
the predicate.
The modifications outlined within this submission have the same
intended use as the predicate device in accordance with the FDA's
guidance document "The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]", dated 28 July
2014. |
| Technology: | The SIGNA PET/MR with the proposed software modifications
employs the same fundamental scientific technology as the predicate
device. This subject of this premarket notification includes
modifications to MR Attenuation Correction compared to the
predicate device. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The features that are the subject of this premarket notification are
software only features that comply with the following voluntary |
| standards:
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.
Summary of Clinical Tests:
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:
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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GE Healthcare 510(k) Premarket Notification Submission
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GE Healthcare
510(k) Premarket Notification Submission