K Number

Device Name

SIGNA Prime

Manufacturer

GE Healthcare (Tianjin) Company Limited

Date Cleared

2022-01-16

(205 days)

Product Code

LNH

Regulation Number

892.1000

Intended Use

The SIGNA Prime 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, 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 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.

Device Description

SIGNA™ Prime 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 1.5T superconducting magnet with 60cm bore size. The system is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

SIGNA™ Creator (K143251)

Reference Devices

SIGNA™ Premier (K193282)

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms, and the performance studies focus on standard non-clinical and clinical image quality comparisons without describing AI/ML model validation.

Therapeutic

No
The device is described as a "diagnostic imaging device" used to "assist in diagnosis" and produce images that "reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance". There is no mention of it being used for treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device" and that the images and/or spectra produced "when interpreted by a trained physician yield information that may assist in diagnosis."

SaMD (Software as a Medical Device)

The device description explicitly states it is a "whole body magnetic resonance scanner" and details hardware components like a "1.5T superconducting magnet with 60cm bore size" and "time-varying magnet fields (Gradients) and RF transmissions". This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
SIGNA Prime Function: The SIGNA Prime 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 human body while the patient is inside the device. This is an in vivo (within the living body) diagnostic imaging technique.

The description clearly states that the device produces images of the structures and functions of the entire body and that these images are interpreted by a trained physician to assist in diagnosis. This is the core function of an in vivo diagnostic imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime 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

Device Description

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, TMI, spine, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. (From Indications for Use on page 3)
head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. (From Indications for use on page 4)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician (From Indications for Use on page 3)

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™ Prime 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 complies with applicable NEMA MS standards for MRI and NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA™ Prime 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, 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 SIGNAT™ Prime 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™ Prime 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™ Creator (K143251)

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.

SIGNA™ Premier (K193282)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

U.S. FOOD & DRUG
ADMINISTRATION

GE Healthcare (Tianjin) Company Limited % Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188

Re: K211980

Trade/Device Name: SIGNA Prime Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 14, 2021 Received: December 15, 2021

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 (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/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.

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

January 16, 2022

devices or postmarketing safety reporting (21 CFR 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 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 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.

For

CAPT Patrick Hintz, MSIH, CIH, USPHS Associate 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

Indications for Use

510(k) Number (if known)

K211980

Device Name SIGNA Prime

Indications for Use (Describe)

These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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, cursive font, enclosed within a blue circle. There are also small, white, flame-like shapes surrounding the circle, giving the impression of energy or innovation.

510(k) Summary

K211980

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	January 10, 2022
Submitter:	GE Healthcare (Tianjin) Company Limited
No. 266 Jingsan Road, Tianjin Airport Economic Area
Tianjin, P.R. China 300308
Distributor	GE Medical Systems, LLC
3200 N Grandview BLVD. Waukesha, WI USA 53188
Primary Contact Person:	Glen Sabin
Director, Regulatory Affairs
GE Healthcare
Phone: 262- 5216848
E-mail: glen.sabin@ge.com
Secondary Contact Person:	Huande Li
Regulatory Affairs Manager
GE Healthcare
Phone: 86-010-57083027
E-mail: huande.li@ge.com
Device Trade Name:	SIGNA™ Prime
Common/Usual Name:	Magnetic Resonance Diagnostic Device
Classification Names:	Magnetic Resonance Diagnostic Device per 21 CFR
892.1000
Product Code:	LNH
Predicate Device(s):	SIGNA™ Creator (K143251)
Reference Device:	SIGNA™ Premier (K193282)
Device
Description:	SIGNA™ Prime 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 1.5T superconducting magnet
with 60cm bore size. The system is designed to conform to NEMA
DICOM standards (Digital Imaging and Communications in
Medicine).
Indications for
Use	The SIGNA Prime 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
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™ Prime employs the same fundamental scientific
technology as its predicate devices.
SIGNA™ Prime builds on the 1.5T IPM magnet, newly designed
Gradient Driver, new designed RF transmit architecture, new
	designed RF receiving chain and new software platform
	application suite.
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™ Prime 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 employs the same fundamental
scientific technology as the predicate device.
System Design: There are five notable technological differences
between the SIGNA™ Prime and the predicate device: the 1.5T
IPM magnet, newly designed Gradient Driver, new designed RF
transmit architecture, new designed RF receiving chain and
new software platform application suite.
Operating Principles: The SIGNA™ Prime functions using the
same operating principles as the predicate device.
Materials: The SIGNA™ Prime and the predicate device both use
flame retardant materials.
Safety and Performance Testing: Both the SIGNA™ Prime 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 compared to the predicate device.
Determination of
Substantial
Equivalence:	Summary of Non-Clinical Tests:
	The SIGNA™ Prime 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 complies with applicable NEMA
MS standards for MRI and NEMA PS3 standard for DICOM, as
does the predicate device.
	Both the SIGNA™ Prime 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, 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 SIGNAT™ Prime in accordance with the
FDA Guidance "Submission of Premarket Notifications for
Magnetic Resonance Diagnostic Devices" issued on November 18,

The image quality of the SIGNA™ Prime 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 SIGNAT™ Prime 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 is substantially equivalent to the predicate device
to which it has been compared. |
| Conclusion: | In conclusion, GE Healthcare considers the SIGNAT™
Prime to be as safe, as effective, with performance that
is substantially equivalent to the predicate device. |

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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected in a cursive-like font. The blue circle has a white outline, and the overall design is simple and recognizable.

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