(59 days)
Not Found
No
The document describes a standard MRI scanner and its technical specifications, focusing on hardware and basic imaging techniques. There is no mention of AI, ML, or any advanced image processing or analysis features that would typically indicate the use of such technologies. The performance studies focus on safety, standards compliance, and image quality comparison to a predicate device, without any mention of AI/ML-specific performance metrics or validation.
No.
The device is indicated for diagnostic imaging purposes, and the images assist a trained physician in diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use as a diagnostic imaging device." It also mentions that the images and/or spectra, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly states it is a "whole body magnetic resonance scanner" and details hardware components like a "3.0T superconducting magnet with 70cm bore size." The performance studies also mention testing to hardware-related standards like ANSI/AAMI ES60601-1 and IEC 60601-2-33.
Based on the provided information, the SIGNA Hero is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- SIGNA Hero Function: The SIGNA Hero is a magnetic resonance scanner. It works by using magnetic fields and radiofrequency pulses to create images of the internal structures and functions of the body without taking samples from the patient.
- Intended Use: The intended use clearly states it is a "diagnostic imaging device" that produces images and/or spectra when interpreted by a trained physician to assist in diagnosis. This is consistent with in vivo imaging, not in vitro testing of samples.
Therefore, the SIGNA Hero falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SIGNA Hero 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 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, 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 Hero 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
Device Description
SIGNA Hero is a whole body magnetic resonance scanner designed to support high resolution, high signal to-noise ratio, and short scan times. The systems use 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 oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 3.0T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Mentions image processing
Not Found
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
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 Hero 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
- ISO 10993-1
- IEC 62464-1
In addition, the SIGNA Hero complies with applicable NEMA MS 3, NEMA MS 4, NEMA MS 8, and the NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA Hero and the predicate device have a successful biocompatibility track record, as demonstrated by ISO 10993-1 testing and by the patient contacting materials' 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 Hero, 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 Hero 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 SIGNA Hero is substantially equivalent to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIGNA™ Pioneer (K160621)
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
January 20, 2022
Image /page/0/Picture/1 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.
GE Healthcare (GE Medical Systems, LLC) % Sandra Westphal Regulatory Affairs Leader 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K213668
Trade/Device Name: SIGNA Hero Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI Dated: November 19, 2021 Received: November 22, 2021
Dear Sandra Westphal:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SIGNA Hero
Indications for Use (Describe)
The SIGNA Hero 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 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, 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 Hero 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are three white teardrop shapes around the circle. The logo is simple and recognizable.
Section 5 510(K) Summary
4
Image /page/4/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 three white, teardrop-shaped elements surrounding the circle, positioned at roughly equal intervals. The logo is simple, clean, and easily recognizable.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Nov 19, 2021 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3200 N Grandview Blvd. | |
| Waukesha, WI USA 53188 | |
| Primary Contact | |
| Person: | Sandra Westphal |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Phone: 262-720-8872 | |
| E-mail: Sandra.westphal@ge.com | |
| Secondary | |
| Contact Person: | Glen Sabin |
| Director, Regulatory Affairs | |
| GE Healthcare | |
| Phone: 262-521-6848 | |
| E-mail: glen.sabin@ge.com | |
| Device Trade | |
| Name: | SIGNA™ Hero |
| Common/Usual | |
| Name: | Magnetic Resonance Diagnostic Device |
| Classification | |
| Names: | Magnetic Resonance Diagnostic Device per 21 CFR 892.1000 |
| Product Code: | LNH, LNI |
| Predicate | |
| Device(s): | SIGNA™ Pioneer (K160621) |
| Device | |
| Description: | SIGNA™ Hero is a whole body magnetic resonance scanner designed to support high resolution, high signal to-noise ratio, and short scan times. The systems use 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 oblique planes, using various pulse sequences, imaging techniques and reconstruction algorithms. The system features a 3.0T superconducting magnet with 70cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine). | |
| Indications for Use | The SIGNA™ Hero 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™ Hero 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. |
| Technology: | The SIGNA™ Hero employs the same fundamental scientific technology as its predicate device. SIGNA™ Hero offers two magnet configurations, building on the 3.0T 3TLC magnet, and introducing the newly designed 3.0T ARES (Platform) magnet. SIGNA™ Hero builds on the existing Gradient Driver design, RF transmit architecture design, RF receive chain design and software platform. SIGNA™ Hero offers a detachable eXpress patient table, similar to detachable tables available on other GEHC 3T MR systems. |
| 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 | |
| SIGNA™ Hero 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™ Hero employs the same fundamental |
| scientific technology as the predicate device. | |
| System Design: There are one notable technological difference | |
| between the SIGNA™ Hero and the predicate device: the 3.0T | |
| ARES (Platform) magnet. | |
| Operating Principles: The SIGNA™ Hero functions using the | |
| same operating principles as the predicate device. | |
| Materials: The SIGNA™ Hero and the predicate device both use | |
| flame retardant materials. | |
| Safety and Performance Testing: Both the SIGNA™ Hero 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™ Hero compared to the predicate device. | |
| Determination of | |
| Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The SIGNA™ Hero 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 | |
| ISO 10993-1 | |
| ● | |
| IEC 62464-1 | |
| In addition, the SIGNA™ Hero complies with applicable NEMA MS | |
| 3, NEMA MS 4, NEMA MS 8, and the NEMA PS3 standard for | |
| DICOM, as does the predicate device. | |
| Both the SIGNA™ Hero and the predicate device have a | |
| successful biocompatibility track record, as demonstrated by ISO | |
| 10993-1 testing and by the patient contacting materials' 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™ Hero, did | |
| not require clinical studies to support substantial equivalence. | |
| Sample clinical images have been included in this submission. | |
| The sample clinical images demonstrate acceptable diaqnostic | |
| image performance of the SIGNA™ Hero 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 SIGNA™ Hero 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™ Hero 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™ Hero is substantially equivalent to the predicate device to | |
| which it has been compared. | |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNA™ |
| Hero to be as safe, as effective, with performance that | |
| is substantially equivalent to the predicate device. |
5
Image /page/5/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 has small, wave-like details around its perimeter, giving it a dynamic appearance.
6
Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a decorative, water-like pattern around the letters, giving it a distinctive and recognizable appearance.
7
Image /page/7/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 circular border. The logo is colored in a bright blue hue, and the background is white. The logo is simple, yet recognizable.
8
Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circle. The circle is surrounded by three curved lines that resemble water droplets or waves. The logo is colored in a bright blue hue.