(88 days)
SIGNA™ Artist (K202238)
SIGNA Architect (K202966)
No
The document explicitly states "There are no changes to the pulse sequences, imaging protocols and image processing" and there are no mentions of AI, DNN, or ML in the provided text.
No.
The device is indicated for use as a diagnostic imaging device, not for therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "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... These images and/or spectra when interpreted by a trained physician vield 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 "superconducting magnet" and "data acquisition system."
Based on the provided text, the SIGNA™ Artist Evo system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done in vitro (outside the body).
- Description of the SIGNA™ Artist Evo: The description clearly states that the SIGNA™ Artist Evo is a magnetic resonance scanner used to produce images of the entire body. This is an in vivo (within the body) imaging technique.
- Intended Use: The intended use is to produce diagnostic images of structures and functions within the body, interpreted by a trained physician. This is consistent with an imaging device, not an IVD.
Therefore, the SIGNA™ Artist Evo is a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The SIGNA™ Artist Evo system 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, neart, 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™ Artist Evo system reflect the spatial distribution or molecular environment of nuclej exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The SIGNA™ Artist Evo system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The system features a superconducting magnet. The data acquisition system accommodates up to 128 independent receive channels in various increments and multiple independent coil elements per channel during a single acquisition series. The system uses a combination of time varying magnetic 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 and reconstruction algorithms.
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, 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™ Artist Evo and the predicate device were subject to similar risk management activities and performance testing to demonstrate substantial equivalence of safety and performance. Testing included compliance to the following voluntary standards: AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 AAMI/ANSI 62304.
In addition, the SIGNA™ Artist Evo was tested in accordance with applicable NEMA MS standards for MRI, and complies with the NEMA PS3 standard for DICOM, as does the predicate device. Both the SIGNA™ Artist Evo and the predicate device are compliant with ISO 10993.
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 SIGNAT™ Artist Evo, 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™ Artist Evo 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™ Artist Evo is substantially equivalent to that of the predicate device.
Conclusion Drawn from Performance Testing:
The proposed SIGNA™ Artist Evo system has been developed under GE Healthcare's quality system and is at least as safe and effective as the legally marketed predicate. The performance testing did not identify any new hazards, adverse effects, or safety or performance concerns that are significantly different from those associated with MR imaging in general. Therefore, GE Healthcare believes that SIGNAT™ Artist Evo is substantially equivalent to the predicate device, and is safe and effective for its intended use.
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™ Artist (K202238)
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 Architect (K202966)
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
§ 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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February 11, 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 (Tianjin) Company Limited % Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K213603
Trade/Device Name: SIGNATM Artist Evo Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 12, 2021 Received: November 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
1
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
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) K213603
Device Name SIGNA™ Artist Evo
Indications for Use (Describe)
The SIGNA™ Artist Evo system 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, neart, 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™ Artist Evo system reflect the spatial distribution or molecular environment of nuclej exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician vield 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) |
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Image /page/3/Picture/0 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. There are decorative flourishes resembling water droplets or stylized leaves placed around the letters and along the inner edge of the circle. The background of the circle is a solid gray color, while the letters and decorative elements are white.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 12, 2021 |
| Submitter: | GE Healthcare (GE Healthcare (Tianjin) Company Limited) |
| No. 266 Jingsan Road, Tianjin Airport Economic Area | |
| Tianjin, China 300308 | |
| Primary | |
| Contact | |
| Person: | Qiang Ding |
| Regulatory Affairs Program Manager | |
| Phone: +86 13311385163 | |
| Email: Ding.Qiang@ge.com | |
| Secondary | |
| Contact | |
| Person: | Glen Sabin |
| Regulatory Affairs Director | |
| Phone: 262-894-4968 | |
| Email: Glen.Sabin@ge.com | |
| Device Trade | |
| Name: | SIGNA TM Artist Evo |
| Common/Usual | |
| Name: | Magnetic Resonance Diagnostic Device |
| Classification | |
| Names: | Magnetic Resonance Diagnostic Device |
| Regulation | |
| Number: | 21 CFR 892.1000 |
| Primary | |
| Product Code: | LNH |
| Secondary | |
| Product Code: | LNI, MOS |
| Predicate | |
| Device: | SIGNA TM Artist (K202238) |
| Reference | |
| Device | SIGNA Architect (K202966) |
| Device | |
| Description: | The SIGNA TM Artist Evo system is a whole body magnetic resonance |
| scanner designed to support high resolution, high signal-to-noise | |
| ratio, and short scan times. The system features a superconducting | |
| magnet. The data acquisition system accommodates up to 128 | |
| independent receive channels in various increments and multiple | |
| independent coil elements per channel during a single acquisition | |
| series. The system uses a combination of time varying magnetic 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 |
4
|--|
| | oblique planes, using various pulse sequences and reconstruction
algorithms. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use: | The Indications for Use statement for the proposed device is
identical to that of the predicate device:
The SIGNA™ Artist Evo system 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 the SIGNA™ Artist Evo system 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
Characteristics: | Many of the technological characteristics of the proposed SIGNA™
Artist Evo system are unchanged from the predicate device. The
SIGNA™ Artist Evo system reuses GE Healthcare 1.5T LCC
magnets in the installed base, and introduces the new IRMW
gradient coil. There are no changes to the RF transmit and receive
subsystems compared to the predicate K202238. Key performance
specifications (such as magnet stability and spatial homogeneity,
maximum gradient strength, etc.) for the system are also
unchanged.
The SIGNA™ Artist Evo system also uses the same version
software as the predicate device with some minor changes to
accommodate the hardware differences. There are no changes to
the pulse sequences, imaging protocols and image processing. |
| Determination
of
Substantial
Equivalence: | Summary of Non-Clinical Tests:
The SIGNA™ Artist Evo and the predicate device were subject to
similar risk management activities and performance testing to
demonstrate substantial equivalence of safety and performance.
Testing included compliance to the following voluntary standards:
AAMI/ANSI ES60601-1 IEC 60601-1-2 IEC 60601-2-33 AAMI/ANSI 62304 |
| | |
| | In addition, the SIGNA™ Artist Evo was tested in accordance with
applicable NEMA MS standards for MRI, and complies with the
NEMA PS3 standard for DICOM, as does the predicate device.
Both the SIGNA™ Artist Evo and the predicate device are
compliant with ISO 10993.
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 SIGNAT™ Artist Evo,
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™ Artist Evo 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™ Artist Evo 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™ Artist Evo 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™ Artist Evo is
substantially equivalent to the predicate device to which it has been
compared. |
| Conclusion
Drawn from
Performance
Testing: | The proposed SIGNA™ Artist Evo system has been developed
under GE Healthcare's quality system and is at least as safe and
effective as the legally marketed predicate. The performance testing
did not identify any new hazards, adverse effects, or safety or
performance concerns that are significantly different from those
associated with MR imaging in general.
Therefore, GE Healthcare believes that SIGNAT™ Artist Evo is
substantially equivalent to the predicate device, and is safe and
effective for its intended use. |
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Image /page/5/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 circle. There are four decorative flourishes or droplets evenly spaced around the outer edge of the circle. The logo is presented in a grayscale color scheme.