(34 days)
The SIGNA Prime Elite 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, 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 Prime Elite 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.
SIGNA Prime Elite 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 60 cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The document does not provide a table of acceptance criteria and reported device performance. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative performance metrics against pre-defined acceptance criteria.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The document does not contain a specific table outlining quantitative acceptance criteria and corresponding reported device performance metrics. It indicates that the SIGNA Prime Elite's image quality performance was compared to the predicate device through bench and clinical testing and found to be "substantially equivalent."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The subject of this premarket submission, the SIGNA Prime Elite, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission."
Therefore, there is no formal test set sample size mentioned for a specific clinical performance study. The "sample clinical images" are used to demonstrate acceptable diagnostic image performance, but details about their sample size, provenance (country of origin), or whether they are retrospective or prospective are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no formal clinical study with a defined test set and ground truth establishment is described, this information is not provided. The document mentions that images "when interpreted by a trained physician yield information that may assist in diagnosis," but it doesn't specify expert review for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no formal test set described for a clinical performance study, an adjudication method is not applicable and not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document states that the SIGNA Prime Elite is a "whole body magnetic resonance scanner." There is no mention of AI assistance or a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The submission is for an imaging device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a magnetic resonance scanner, not an algorithm that operates standalone without human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given that clinical studies were not required and only "sample clinical images" were included to demonstrate acceptable diagnostic image performance, there is no mention of a formally established ground truth type (e.g., expert consensus, pathology, outcomes data) for a test set. The images are expected to be interpreted by a "trained physician."
8. The sample size for the training set
The document describes the SIGNA Prime Elite as a new 1.5T MR system. It is a hardware device with associated software, not a machine learning model. Therefore, the concept of a "training set" in the context of machine learning is not applicable and not mentioned.
9. How the ground truth for the training set was established
As the device is an MR scanner and not an AI/ML model requiring a training set, this information is not applicable and not provided.
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March 17th, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.
GE Medical Systems, LLC Glen Sabin Director - Regulatory Affairs, MR Strategy 3200 N Grandview Blvd. Waukesha, Wisconsin 53188
Re: K250379
Trade/Device Name: SIGNA Prime Elite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH. LNI Dated: February 7, 2025 Received: February 11, 2025
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"
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(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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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.
Ningzhi - S
for
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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
Enclosure
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Indications for Use
510(k) Number (if known) K250379
Device Name SIGNA Prime Elite
Indications for Use (Describe)
The SIGNA Prime Elite is a whole body magnetic resonance scanner designed to support high signal-tonoise 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, 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 Prime Elite 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 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 is purple and features a stylized, swirling design. The text is also purple and is written in a clean, sans-serif font.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | 24 February 2025 |
|---|---|
| Submitter: | GE Medical Systems, LLC3200 N Grandview Blvd. Waukesha, WI USA 53188 |
| Distributor: | GE Medical Systems, LLC3200 N Grandview BLVD. Waukesha, WI USA 53188 |
| Primary ContactPerson: | Glen SabinDirector, Regulatory AffairsGE HealthCarePhone: 262- 5216848E-mail: glen.sabin@gehealthcare.com |
| SecondaryContact Person: | Huande LiManager, Regulatory Affairs, MRPhone: 86-18101131237E-mail: huande.li@gehealthcare.com |
| Device TradeName: | SIGNA Prime Elite |
| Common/UsualName: | Magnetic Resonance Diagnostic Device |
| ClassificationNames: | Magnetic Resonance Diagnostic Device per 21 CFR892.1000 |
| Product Code: | LNH, LNI |
| PredicateDevice(s): | SIGNA Victor (K223439) |
| ReferenceDevice(s): | SIGNA Champion (K233728) |
Reason for Submission:
This 510(k) is being submitted due to introduction of SIGNA Prime Elite, a new 1.5T MR system from GE HealthCare.
Device Description:
SIGNA Prime Elite 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
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Image /page/5/Picture/0 description: The image shows the GE HealthCare logo. The logo consists of a purple circular emblem with a stylized "GE" inside, followed by the text "GE HealthCare" in purple. The text is in a simple, sans-serif font.
reqarding 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 60 cm 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 Victor):
- Maqnet
- l Gradient coil
- Integrated RF whole body coil —
Software Changes (compared with reference device SIGNA Champion):
- -There is no Significant change
Indications for Use:
The SIGNA Prime Elite 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 Prime Elite 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.
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 Prime Elite 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 Prime Elite employs the same fundamental scientific technology as the predicate device.
There are some differences in characteristics between the proposed device and the predicate device, as summarize below.
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510(k) Premarket Notification
| Subsystem orcomponent | Predicate DeviceSIGNA Victor | Proposed DeviceSIGNA Prime Elite | Comments |
|---|---|---|---|
| Magnet | 1.5T Superconducting Magnet withactive shielding. | SIGNA Prime Eliteuses a magnetequivalent to that of thepredicate SIGNAVictor. | |
| Gradientsubsystem | Water cooled gradient coil with activeshielding | SIGNA Prime Eliteuses an equivalentgradient subsystem asthe predicate SIGNAVictor. | |
| RF transmitsubsystem | Transmit with integrated body coil andlocal T/R coil. | SIGNA Prime Eliteuses an equivalent RFtransmit subsystem asthe predicate SIGNAVictor. | |
| RF receivesubsystem | Digitize-Per-Pin (DPP) receive chainarchitecture. | SIGNA Prime Eliteuses the identical DPParchitecture asthe predicate SIGNAVictor. | |
| RF coils | Comprehensive suite of detachable coilsfor imaging all anatomies | Coils used by SIGNAPrime Elite areidentical with thoseused by the predicateSIGNA Victor. | |
| Softwarefeatures | Comprehensive suite of softwarefeatures, pulse sequences, and imageprocessing applications to support MRimaging of all anatomies. | SIGNA Prime Eliteuses equivalentsoftware with SIGNAChampion. |
Operating Principles: The SIGNA Prime Elite functions using the same operating principles as the predicate device.
Materials: The SIGNA Prime Elite and the predicate device both use flame retardant materials.
Safety and Performance Testing: Both the SIGNA Prime Elite and the predicate device comply with the same safety and performance testing (see Determination of Substantial Equivalence, below).
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 Prime Elite compared to the predicate device.
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Image /page/7/Picture/1 description: The image shows the logo for GE HealthCare. The logo consists of a circular emblem on the left and the text "GE HealthCare" on the right. The emblem is purple and features a stylized "GE" monogram. The text "GE HealthCare" is also purple.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The SIGNA Prime Elite 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 Prime Elite complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA Prime Elite 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 Prime Elite, 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 Prime Elite 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 Prime Elite 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 Prime Elite 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 Prime Elite is substantially equivalent to the predicate device
to which it has been compared.
Conclusion:
In conclusion, GE HealthCare considers the SIGNA Prime Elite to be as safe, as effective, with performance that is substantially equivalent to the predicate device.
§ 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.