(88 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the descriptions of the device and testing do not mention any AI/ML components or methodologies.
No
The device is described as a "diagnostic imaging device" intended to "assist in diagnosis" by producing images, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device".
No
The device description clearly states it is a "whole body magnetic resonance scanner," which is a hardware device. The summary also details testing against hardware-related standards like AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SIGNA(TM) Premier system is a "diagnostic imaging device" that produces images and spectra to assist in diagnosis when interpreted by a trained physician. This describes an imaging modality, not a test performed on biological samples in vitro.
- Device Description: The device is described as a "whole body magnetic resonance scanner," which is a type of medical imaging equipment.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (like blood, urine, tissue) outside of the body. IVDs are designed to perform tests on these types of samples to provide diagnostic information.
Therefore, the SIGNA(TM) Premier system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SIGNA(TM) Premier system is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA(TM) Premier system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Product codes
LNH, LNI, MOS
Device Description
SIGNAT™ Premier is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times, and is designed for improved patient comfort and workflow. The system features a 3.0T superconducting magnet with a 70cm bore size and can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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 SIGNA™ Premier and the predicate device were subject to similar risk management testing to demonstrate substantial equivalence of safety and performance. Testing to the following voluntary standards included: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, AAMI/ANSI 62304, ISO 10993-1. In addition, the SIGNA™ Premier complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device. Both the SIGNATM Premier and the predicate device have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices. The following quality assurance measures were applied to the development of the subject device, as they were for the predicate device: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance testing (Verification), Simulated use testing (Validation).
Summary of Clinical Tests:
The subject of this premarket submission, the SIGNATM Premier, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission. The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNATM Premier in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on November 18, 2016. The image quality of the SIGNATM Premier is substantially equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIGNATM Architect (K163331)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2017
GE Medical Systems, LLC (GE Healthcare) % Mary A. Mayka, Ph.D. Regulatory Affairs Manager 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K171128
Trade/Device Name: SIGNA" Premier Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: April 14, 2017 Received: April 17, 2017
Dear Dr. Mayka:
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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ResourcesforYou/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,
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
Indications for Use
510(k) Number (if known)
Device Name SIGNA(TM) Premier
Indications for Use (Describe)
The SIGNA(TM) Premier system is a whole body magnetic resonance scanner designed to support high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used.
The images produced by the SIGNA(TM) Premier system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle has a white outline and is surrounded by three curved lines on each side, resembling stylized water droplets or waves.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 14, 2017 |
|---|---|
| Submitter: | GE Medical Systems, LLC (GE Healthcare) |
| 3200 N. Grandview Blvd., | |
| Waukesha, WI 53188 | |
| USA | |
| Primary Contact Person: | Mary A. Mayka, Ph.D. |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| Phone: 262-527-3148 | |
| Fax: 262-364-2785 | |
| Secondary Contact Person: | James McMahon |
| Senior Director, Regulatory Affairs | |
| GE Healthcare | |
| Phone: 508-382-2858 | |
| Fax: 262-364-2785 | |
| Device Trade Name: | SIGNA™ Premier |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | Magnetic Resonance Diagnostic Device per 21 CFR |
| 892.1000 | |
| Product Code: | LNH, LNI, MOS |
| Predicate Device(s): | SIGNATM Architect (K163331) |
| Device Description: | SIGNAT™ Premier is a whole body magnetic resonance |
| scanner designed to support high resolution, high signal- | |
| to-noise ratio, and short scan times, and is designed for | |
| improved patient comfort and workflow. The system | |
| features a 3.0T superconducting magnet with a 70cm bore | |
| size and can image in the sagittal, coronal, axial, oblique, | |
| and double oblique planes, using various pulse sequences, | |
| imaging techniques and reconstruction algorithms. The | |
| system is designed to conform to NEMA DICOM | |
| standards (Digital Imaging and Communications in | |
| Medicine). | |
| Indications for Use | The SIGNA™ Premier system is a whole body magnetic |
| resonance scanner designed to support high resolution, | |
| high signal-to-noise ratio, and short scan times. It is | |
| indicated for use as a diagnostic imaging device to | |
| produce axial, sagittal, coronal, and oblique images, | |
| spectroscopic images, parametric maps, and/or spectra, | |
| dynamic images of the structures and/or functions of the |
|
| Technology: | The SIGNA™ Premier employs the same fundamental
scientific technology as its predicate devices.
SIGNATM Premier builds on the 3.0T wide bore magnet,
TDI RF architecture and SIGNA™Works software
platform and application suite.
The following is a summary of the different technology
characteristics from the predicate devices:
Newly designed gradient system Expanded RF receive chain capabilities Redesigned body coil Updated patient table |
| Comparison of Indications
for Use | The changes in technology do not impact the indications
for use. The indications for use have not changed, other
than to reflect the SIGNATM Premier product name.
Therefore, the intended use is the same 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. |
| Comparison of
Technological
Characteristics | Overall, the SIGNATM Premier employs the same
fundamental scientific technology as the predicate device.
System Design: There are two notable technological
differences between the SIGNATM Premier and the
predicate device: a newly designed gradient system and
an expanded channel count for the RF receive chain.
The differences are summarized below:
Gradient system: The SIGNA Premier can deliver a
maximum gradient amplitude of 80 mT/m and
maximum gradient slew rate of 200 T/m/s compared
to the predicate's maximum gradient amplitude of 44
mT/m and maximum gradient slew rate of 200
T/m/s. RF receive chain: The SIGNATM Premier is
equipped with 146 receive channels as compared to
the predicate's 128 channels. Operating Principles: The SIGNATM Premier functions
using the same operating principles as the predicate
device.
Materials: The SIGNATM Premier and the predicate
device both use flame retardant materials.
Safety and Performance Testing: Both the SIGNATM
Premier and the predicate device comply with the same
safety and performance testing (see Determination of
Substantial Equivalence, below). |
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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' written in a stylized script, enclosed within a blue circle. The circle is surrounded by a pattern of swirling lines, also in blue, which gives the impression of movement or energy.
5
Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around its perimeter, giving it a distinctive and recognizable appearance.
6
Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue, and the background is white.
These technological differences do not raise any different questions regarding safety and effectiveness. Both devices must address questions of whether they provide an adequate level of image quality appropriate for diagnostic use. The performance data described in this submission include results of both bench testing and clinical testing that show the image quality performance of SIGNA™ Premier compared to the predicate device. Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The SIGNA™ Premier and the predicate device were subject to similar risk management testing to demonstrate substantial equivalence of safety and performance. Testing to the following voluntary standards included: AAMI/ANSI ES60601-1 ● IEC 60601-1-2 ● ● IEC 60601-2-33 AAMI/ANSI 62304 ● ● ISO 10993-1 In addition, the SIGNA™ Premier complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device. Both the SIGNATM Premier and the predicate device have a successful biocompatibility track record, as demonstrated by ISO 10993 testing and by their history of use in previously cleared devices. The following quality assurance measures were applied to the development of the subject device, as they were for the predicate device: Risk Analysis ● Requirements Reviews ● ● Design Reviews . Testing on unit level (Module verification) ● Integration testing (System verification) ● Performance testing (Verification) Simulated use testing (Validation) ●
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The logo is colored in a light blue hue, which gives it a clean and modern appearance.
| Summary of Clinical Tests: | |
|---|---|
| The subject of this premarket submission, the SIGNATM | |
| Premier, did not require clinical studies to support | |
| substantial equivalence. Sample clinical images have been | |
| included in this submission. | |
| The sample clinical images demonstrate acceptable | |
| diagnostic image performance of the SIGNATM Premier in | |
| accordance with the FDA Guidance "Submission of | |
| Premarket Notifications for Magnetic Resonance | |
| Diagnostic Devices" issued on November 18, 2016. | |
| The image quality of the SIGNATM Premier is | |
| substantially equivalent to that of the predicate device. | |
| Substantial Equivalence Conclusion: | |
| The indications for use of the proposed device are | |
| comparable to the claimed predicate device. The | |
| SIGNA™ Premier employs equivalent technology to the | |
| claimed predicate device. Additionally, the results from | |
| the above non-clinical tests demonstrate that the device | |
| performs as intended. Therefore, the SIGNA™ Premier is | |
| substantially equivalent to the predicate device to which it | |
| has been compared. | |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNATM |
| Premier to be as safe, as effective, with performance that | |
| is substantially equivalent to the predicate device. |