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.

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).

AI/ML Overview

The provided text describes information about the GE Healthcare SIGNA Hero MRI system (K213668). However, it does not contain details about specific acceptance criteria related to a specific diagnostic task (like detecting a particular disease), nor does it describe a study specifically designed to prove that the device meets such criteria for a diagnostic algorithm.

Instead, the document focuses on demonstrating substantial equivalence of the SIGNA Hero to its predicate device, the SIGNA Pioneer (K160621), as per FDA 510(k) premarket notification requirements.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria for a specific diagnostic task or algorithm performance metrics (e.g., sensitivity, specificity, AUC). Instead, it states that the device was tested against safety and performance standards to demonstrate substantial equivalence to the predicate device.

Acceptance Criteria (General for MRI System Substantial Equivalence):

Compliance with voluntary standards (ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-33, IEC 62304, ISO 10993-1, IEC 62464-1).
Compliance with NEMA standards (MS 3, MS 4, MS 8, PS3 for DICOM).
Successful biocompatibility track record (ISO 10993-1 testing and history of patient contacting materials).
Acceptable diagnostic image performance comparable to the predicate device in accordance with FDA Guidance "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."

Reported Device Performance:

The SIGNA Hero and predicate device were subject to similar risk management testing.
The SIGNA Hero complies with all listed standards.
The SIGNA Hero has a successful biocompatibility track record.
"The image quality of the SIGNA™ Hero is substantially equivalent to that of the predicate device."
"The sample clinical images demonstrate acceptable diagnostic image performance of the SIGNA™ Hero..."
The device performs as intended based on non-clinical tests.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "sample clinical images" were included to demonstrate acceptable diagnostic image performance. However, it does not specify:

The exact sample size of these clinical images.
The provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document states that images are "interpreted by a trained physician" but does not specify:

The number of experts involved in reviewing the "sample clinical images."
The specific qualifications of these experts (e.g., radiologists with certain years of experience).

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth or evaluating the clinical images.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, the document explicitly states: "The subject of this premarket submission, the SIGNA™ Hero, did not require clinical studies to support substantial equivalence." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or detailed in this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This submission is for an MRI scanner, not a specific diagnostic algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm isn't directly applicable in the context of this document. The performance evaluation focuses on the image quality and safety of the MR system itself.

7. The Type of Ground Truth Used

For the "sample clinical images," the ground truth implicitly refers to the interpretation by a trained physician regarding the diagnostic image performance. Beyond this, for the system's overall performance and safety, ground truth is established through compliance with established industry standards and recognized risk management practices.

8. The Sample Size for the Training Set

The document describes the submission of an MR scanner, not an AI/ML algorithm that requires a distinct training set. Hence, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set was Established

As there is no mention of an algorithm or training set, this information is not applicable.

Summary

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January 20, 2022

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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

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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

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Indications for Use

510(k) Number (if known)

Device Name SIGNA Hero

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 510(K) Summary

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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, LLC3200 N Grandview Blvd.Waukesha, WI USA 53188
Primary ContactPerson:	Sandra WestphalRegulatory Affairs LeaderGE HealthcarePhone: 262-720-8872E-mail: Sandra.westphal@ge.com
SecondaryContact Person:	Glen SabinDirector, Regulatory AffairsGE HealthcarePhone: 262-521-6848E-mail: glen.sabin@ge.com
Device TradeName:	SIGNA™ Hero
Common/UsualName:	Magnetic Resonance Diagnostic Device
ClassificationNames:	Magnetic Resonance Diagnostic Device per 21 CFR 892.1000
Product Code:	LNH, LNI
PredicateDevice(s):	SIGNA™ Pioneer (K160621)
DeviceDescription:	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 ofIndicationsfor Use	The changes in technology do not impact the indications for use.The indications for use have not changed, other than to reflect theSIGNA™ Hero product name.Therefore, the intended use is the same as the predicate device inaccordance with the FDA's guidance document “The 510(k)Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)]”, dated 28 July 2014.
Comparison ofTechnologicalCharacteristics	Overall, the SIGNA™ Hero employs the same fundamentalscientific technology as the predicate device.System Design: There are one notable technological differencebetween the SIGNA™ Hero and the predicate device: the 3.0TARES (Platform) magnet.Operating Principles: The SIGNA™ Hero functions using thesame operating principles as the predicate device.Materials: The SIGNA™ Hero and the predicate device both useflame retardant materials.Safety and Performance Testing: Both the SIGNA™ Hero andthe predicate device comply with the same safety and performancetesting (see Determination of Substantial Equivalence, below).These technological differences do not raise any differentquestions regarding safety and effectiveness. Both devices mustaddress questions of whether they provide an adequate level ofimage quality appropriate for diagnostic use. The performancedata described in this submission include results of both benchtesting and clinical testing that show the image qualityperformance of SIGNA™ Hero compared to the predicate device.
Determination ofSubstantialEquivalence:	Summary of Non-Clinical Tests:The SIGNA™ Hero and the predicate device were subject tosimilar risk management testing to demonstrate substantialequivalence of safety and performance.Testing to the following voluntary standards included:• ANSI/AAMI ES60601-1• IEC 60601-1-2

IEC 60601-2-33IEC 62304ISO 10993-1●IEC 62464-1In 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 tothe claimed predicate device. The SIGNA™ Hero employsequivalent technology to the claimed predicate device.Additionally, the results from the above non-clinical testsdemonstrate that the device performs as intended. Therefore, theSIGNA™ Hero is substantially equivalent to the predicate device towhich it has been compared.
Conclusion:	In conclusion, GE Healthcare considers the SIGNA™Hero to be as safe, as effective, with performance thatis substantially equivalent to the predicate device.

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Regulation Number and Section

§ 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.