(115 days)
K133226 Siemens Biograph mMR
No
The summary describes a combined PET/MR system and its software for image acquisition, reconstruction, and evaluation, but it does not mention the use of AI or ML technologies.
No
The device is used for imaging and diagnosis, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "intended to be utilized by appropriately trained health care professionals to aid in the detection, and diagnosis of diseases and disorders."
No
The device description clearly states it is a combined Magnetic Resonance Diagnostic Device (MRDD) and Positron Emission Tomography (PET) scanner, including hardware components like a magnet, gradient coil, and PET detectors. While it includes software, it is not solely software.
Based on the provided information, the SIGNA PET/MR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- SIGNA PET/MR Function: The SIGNA PET/MR system is an imaging device that uses magnetic resonance and positron emission tomography to create images of the inside of the human body. It directly interacts with the patient to acquire data.
- Intended Use: The intended use clearly states that the system is used to "aid in the detection, and diagnosis of diseases and disorders" by producing images and measuring the distribution of radiopharmaceuticals within the human body. This is an in vivo (within the living organism) process.
Therefore, the SIGNA PET/MR system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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, 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.
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, 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.
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
Sample images from the SIGNA PET/MR were collected from multiple sites to confirm simultaneous diagnostic image quality.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The SIGNA PET/MR and Coil Suite comply with the following voluntary 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 compliance with 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 the system:
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 to confirm simultaneous diagnostic image quality.
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.
K133226 Siemens Biograph mMR
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.
K081496 Discovery XR (Currently marketed as Discovery PET/CT 690), K132376 Discovery MR750w 3.0T
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
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.
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,
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
2
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)
3
Image /page/3/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 decorative swirls or flourishes around the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the well-known multinational corporation.
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 Martin |
| Regulatory Affairs Manager | |
| GE Medical Systems, LLC | |
| Phone: (414) 336-9228 | |
| Fax: (262) 894-4968 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Medical Systems, LLC | |
| Phone: (262) 521-6848 | |
| Fax: (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 892.1200 |
| OUO | |
| Predicate Device(s): | K133226 Siemens Biograph mMR |
| Reference 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 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 |
4
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
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. |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | whole-body system. |
| 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. 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-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. |
| Technology: | The proposed SIGNA PET/MR employs much of the same fundamental
scientific technology as its respective reference devices for MR and PET
technology and has the same intended use as the claimed predicate device. The
proposed device combines PET and MR technologies for simultaneous imaging.
Subsequently, the PET subsystem requires different technology from the
Discovery PET/CT 690 for compatibility with the MR subsystem (detectors,
chiller system, etc.). Additionally, MR images are used to correct for PET
attenuation compared to the reference PET/CT, which uses CT technology for
PET attenuation. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The SIGNA PET/MR and Coil Suite comply with the following voluntary |
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 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 compliance
with 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 the
system:
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 to
confirm simultaneous diagnostic image quality. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | 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. |