(59 days)
SIGNA™ Voyager (K192426)
No
The document describes a standard MRI scanner and its features, focusing on hardware, basic software functionalities (pulse sequences, reconstruction algorithms, image processing), and regulatory compliance. There is no mention of AI, ML, deep learning, or any related terms or concepts in the intended use, device description, or performance summaries. The testing and validation described are standard for medical devices and do not indicate AI/ML specific methodologies.
No.
The device is indicated for use as a "diagnostic imaging device" to produce images and/or spectra that "when interpreted by a trained physician yield information that may assist in diagnosis." It does not provide any therapeutic function.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device "is indicated for use as a diagnostic imaging device".
No
The device description explicitly states it is a "whole body magnetic resonance scanner" and details hardware components like a "1.5T superconducting magnet with 70cm bore size" and "time-varying magnet fields (Gradients) and RF transmissions". While it includes software features, it is fundamentally a hardware device with integrated software.
Based on the provided information, the SIGNA™ Champion 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 for diagnosis, monitoring, or screening.
- SIGNA™ Champion Function: The SIGNA™ Champion is a magnetic resonance scanner. It produces images of the internal structures and functions of the body in vivo (within the living body) using magnetic fields and radiofrequency pulses. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is a "diagnostic imaging device" to produce images and spectra of the entire body. This is consistent with in vivo imaging, not in vitro analysis.
Therefore, the SIGNA™ Champion falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SIGNA™ Champion 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 entire body, including, but not limited to, head, neck, TMI, 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 SIGNA™ Champion reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI
Device Description
SIGNA™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
A high-level summary of significant hardware and software modifications is provided below:
Hardware changes (compared with Predicate Device SIGNA™ Voyager):
- Magnet Enclosure -
- -Patient Table and related support components
- Host Computer -
- RF Transmit Chain -
- Wireless Gating -
Software Changes (compared with Reference Device 2 SIGNA™ Hero)
- Sonic DL -
- AIR Recon DL -
Mentions image processing
Yes, "image processing applications" is mentioned.
Mentions AI, DNN, or ML
Yes, "AIR Recon DL" is mentioned. DL stands for Deep Learning.
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
Whole body, including, but not limited to, head, neck, TMI, 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™ Champion 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:
- ANSI AAMI ES60601-1
- IEC 60601-1-2
- IEC 60601-2-33
- IEC 62304
- IEC 60601-1-6
- IEC 62366-1
- ISO 10993-1
In addition, the SIGNA™ Champion complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA™ Champion 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 SIGNA™ Champion, 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 SIGNA™ Champion in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on October 10, 2023. The image quality of the SIGNA™ Champion is substantially equivalent to that of the predicate device.
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™ Voyager (K192426)
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.
(1) SIGNA™ Victor (K223439), (2) SIGNA™ Hero (K213668)
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.
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Image /page/0/Picture/0 description: The image shows 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.
January 19, 2024
GE Healthcare (Tianjin) Company Limited % Glen Sabin Director - Regulatory Affairs, MR Strategy GE Medical Systems, LLC 3200 N Grandview Blvd. Waukesha, Wisconsin 53188
Re: K233728
Trade/Device Name: SIGNA™ Champion Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 21, 2023 Received: November 21, 2023
Dear Glen Sabin:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SIGNA™ Champion
Indications for Use (Describe)
The SIGNA™ Champion 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 entire body, including, but not limited to, head, neck, TMI, 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 SIGNA™ Champion reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
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.
3
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Image /page/4/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circle with a white GE monogram inside, followed by the words "GE HealthCare" in purple. The font is sans-serif and the overall design is clean and modern.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date | January 19, 2024 | ||
|---|---|---|---|
| Submitter | GE Healthcare (Tianjin) Company Limited | ||
| No. 266 Jingsan Road, Tianjin Airport Economic Area | |||
| Tianjin, P.R. China 300308 | |||
| Primary | |||
| Contact Person | Xinyu Song | ||
| Lead Specialist, Regulatory Affairs, MR | |||
| GE HealthCare | |||
| Phone: +86 186 1188 4503 | |||
| E-mail: Xinyu.Song@ge.com | |||
| Secondary | |||
| Contact Person | Glen Sabin | ||
| Director - Regulatory Affairs, MR Strategy | |||
| GE HealthCare | |||
| Phone: 262 894-4968 | |||
| E-mail: glen.sabin@ge.com | |||
| Device Trade | |||
| Name | SIGNA™ Champion | ||
| Common/Usual | |||
| Name | Magnetic Resonance Diagnostic Device | ||
| Classification | |||
| Names | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 | ||
| Product Code | LNH, LNI | ||
| Predicate | |||
| Device | SIGNA™ Voyager (K192426) | ||
| Reference | |||
| Device | (1) SIGNA™ Victor (K223439) | ||
| (2) SIGNA™ Hero (K213668) |
Reason for Submission:
This 510(k) is being submitted due to the introduction of SIGNA™ Champion, a new 1.5T MR system from GE HealthCare.
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Image /page/5/Picture/1 description: The image shows the GE HealthCare logo. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem features a stylized "GE" monogram inside a circle with decorative flourishes. The text "GE HealthCare" is written in a clean, sans-serif font and is colored in the same purple as the emblem.
Device Description:
SIGNA™ Champion is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time. The system uses a combination of time-varying magnet fields (Gradients) and RF transmissions to obtain information regarding the density and position of elements exhibiting magnetic resonance. The system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 1.5T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
A high-level summary of significant hardware and software modifications is provided below:
Hardware changes (compared with Predicate Device SIGNA™ Voyager):
- Magnet Enclosure -
- -Patient Table and related support components
- Host Computer -
- RF Transmit Chain -
- Wireless Gating -
Software Changes (compared with Reference Device 2 SIGNA™ Hero)
- Sonic DL -
- AIR Recon DL -
Indications for Use
The SIGNA™ Champion 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 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 SIGNA™ Champion reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance.
These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
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Image /page/6/Picture/1 description: The image shows the GE HealthCare logo. On the left is the GE monogram in purple, which is a stylized version of the letters G and E intertwined. To the right of the monogram is the text "GE HealthCare" in purple. The text is in a simple, sans-serif font.
Technology
The SIGNA™ Champion employs the same fundamental scientific technology as its predicate device.
SIGNA™ Champion is built with superconducting magnet, RF transmit architecture, RF receive chain and software application suite.
Comparison of Indications for Use
The changes in technology do not impact the indications for use.
The indications for use have not been changed, other than to reflect the SIGNA™ Champion 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 SIGNA™ Champion employs the same fundamental scientific technology and operating principles as the predicate device.
There are some differences in characteristics between the proposed device and the predicate device, as summarized below:
| Subsystem or
Component | Predicate Device
SIGNA™ Voyager
(K192426) | Proposed Device
SIGNA™ Champion
(K233728) | Comments |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Magnet | 1.5T Superconducting Magnet with active
shielding | 1.5T Superconducting Magnet with active
shielding | SIGNA™ Champion uses the
same magnet as the
predicate SIGNA™ Voyager,
with a modified enclosure
design. |
| Gradient
Subsystem | Water cooled gradient coil with active
shielding. | Water cooled gradient coil with active
shielding. | SIGNA™ Champion uses the
same gradient subsystem as
the predicate SIGNA™
Voyager. |
| Subsystem or
Component | Predicate Device
SIGNA™ Voyager
(K192426) | Proposed Device
SIGNA™ Champion
(K233728) | Comments |
| RF Transmit
Subsystem | Transmit with integrated body coil and local
T/R coil. | Transmit with integrated body coil and local
T/R coil. | SIGNA™ Champion uses the
same integrated body coil as
the predicate SIGNA™
Voyager, but other
components in the transmit
chain are different. The
SIGNA™ Champion uses the
In Scan Room transmit
architecture found in
Reference Device 1 (SIGNA™
Victor). |
| RF Receive
Subsystem | Digitize-Per-Pin (DPP) receive chain
architecture. | Digitize-Per-Pin (DPP) receive chain
architecture. | SIGNA™ Champion uses the
same DPP architecture as
the predicate SIGNA™
Voyager. |
| RF Coils | Comprehensive suite of detachable coils for
imaging all anatomies | Comprehensive suite of detachable coils for
imaging all anatomies | Coils used by SIGNA™
Champion are also used by
the predicate SIGNA™
Voyager and/or Reference
Device 1 (SIGNA™ Victor). |
| Software
Features | Comprehensive suite of software features,
pulse sequences, and image processing
applications to support MR imaging of all
anatomies. | Comprehensive suite of software features,
pulse sequences, and image processing
applications to support MR imaging of all
anatomies. | Both SIGNA™ Champion and
the predicate SIGNA™
Voyager are fully capable MR
systems with a wide range of
software features. SIGNA™
Champion includes some
new and enhanced features
such as AIR Recon DL and
Sonic DL that were not
included in the predicate
K192426 submission. The
SIGNA™ Champion software
features are similar to those
found on Reference Device 2
(SIGNA™ Hero). |
| Gating
Accessories | Respiratory,
peripheral, and
cardiac gating. | Respiratory
peripheral and
cardiac gating with
wireless connection
option. | In addition to SIGNA™
Voyager's gating solution,
SIGNA™ Champion offers an
additional option to use
wireless connection. |
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SIGNA Champion
510(k) Premarket Notification
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These 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™ Champion compared to the predicate device.
Determination of Substantial Equivalence
Summary of Non-Clinical Tests:
The SIGNA™ Champion 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:
- ANSI AAMI ES60601-1 ●
- IEC 60601-1-2
- IEC 60601-2-33
- IEC 62304
- IEC 60601-1-6 ●
- IEC 62366-1
- . ISO 10993-1
In addition, the SIGNA™ Champion complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA™ Champion 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 SIGNA™ Champion, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission.
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Image /page/9/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circle with a white GE monogram inside. To the right of the circle is the text "GE HealthCare" in purple.
SIGNA Champion
510(k) Premarket Notification
The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Champion in accordance with the FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued on October 10, 2023. The image quality of the SIGNA™ Champion 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™ Champion 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™ Champion is substantially equivalent to the predicate device to which it has been compared.
Conclusion
In conclusion, GE HealthCare considers the SIGNA™ Champion to be as safe, as effective, with performance that is substantially equivalent to the predicate device.