(28 days)
Yes
The document explicitly mentions the "AIR Recon DL software feature" and states that "AIR Recon DL" is a mention of AI, DNN, or ML.
No.
The intended use states it is a diagnostic imaging device to produce images that may assist in diagnosis, not for treatment.
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... that may assist in diagnosis."
No
The device description clearly states it is a "whole body magnetic resonance scanner" and details hardware components like a superconducting magnet and data acquisition system. The software feature (AIR Recon DL) is an addition to this hardware system.
Based on the provided text, the SIGNA Artist system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is 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". This describes an imaging system that visualizes internal structures and functions of the body.
- Device Description: The description details a "whole body magnetic resonance scanner" that uses magnetic fields and RF transmissions to obtain information about the density and position of elements exhibiting magnetic resonance. This is consistent with an imaging device, not a device that analyzes samples outside the body.
- Input Imaging Modality: The input modality is "Magnetic Resonance", which is an imaging technique.
- How IVDs are defined: IVDs are defined as medical devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. The SIGNA Artist system does not analyze such specimens.
The SIGNA Artist system is a medical imaging device used for in vivo (within the living body) diagnosis.
No
The letter explicitly states that "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating no mention of PCCP approval or clearance.
Intended Use / Indications for Use
The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high signalto-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 the SIGNA Artist system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained that may assist in diagnosis.
Product codes
LNH, LNI, MOS
Device Description
The SIGNA Artist 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.
This 510(k) submission is for the SIGNA Artist 1.5T MR system, and has been triggered by the addition of the AIR Recon DL software feature.
The AIR Recon DL feature has been previously cleared for use on the SIGNA Premier 3T system through K193282, which is used as a reference device for this submission.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
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 / Not Found
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 AIR Recon DL feature has undergone the performance testing. These tests were designed to evaluate the AIR Recon DL feature and its impact on image quality, including SNR, sharpness, low contrast detectability, and noise spectral content. Analysis was performed to confirm that the feature does not introduce significant bias that might impact quantitative measurements based on signal intensity. The influence of motion during image acquisition on the performance of AIR Recon DL was also evaluated.
The nonclinical testing demonstrated that AIR Recon DL does improve SNR and image sharpness while maintaining low contrast detectability and having minimal impacts to noise spectral content, average signal intensity, or the appearance of motion artifacts. AIR Recon DL was also able to maintain image SNR and did not sacrifice sharpness for images acquired with a reduced scan time. The nonclinical testing passed the defined acceptance criteria, and did not identify any adverse impacts to image quality or other concerns related to safety and performance.
Summary of Clinical Tests:
Objective measures of in vivo images were analyzed to confirm that AIR Recon DL improves SNR and image sharpness for typical clinical use cases.
Additionally, sample images from clinically indicated scans were evaluated both with and without the AIR Recon DL feature. These samples included images using exogenous contrast and images involving pathology spanning a variety of anatomies and pulse sequences. Radiologists were asked to rate the images, and to comment on any notable aspects related to image quality. This study showed that the AIR Recon DL feature provides images with equivalent or better image quality, lesion conspicuity is maintained, and that the radiologists preferred the AIR Recon DL images for clinical use.
Conclusion Drawn from Performance Testing:
The nonclinical and clinical testing demonstrated that AIR Recon DL satisfies the product claims of improved SNR and image sharpness, and can enable shorter scan times while maintaining SNR and image sharpness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIGNA Artist (K163331)
Reference Device(s)
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.
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September 4, 2020
Image /page/0/Picture/1 description: The image contains 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 % Mr. Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical System, LLC) 3200 N Grandview Blvd. WAUKESHA WI 53188
Re: K202238
Trade/Device Name: SIGNA Artist Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: August 6, 2020 Received: August 7, 2020
Dear Mr. 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 (OS) 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) K202238
Device Name SIGNA Artist
Indications for Use (Describe)
The SIGNA Artist system is a whole body magnetic resonance scanner designed to support high signalto-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 the SIGNA Artist system reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained 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 alphanumeric string "K202238" in a simple, sans-serif font. The characters are uniformly sized and spaced, with a consistent stroke width. The string appears to be a code or identifier, possibly a serial number or product code.
Image /page/3/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. There are three curved lines emanating from the top, left, and right sides of the circle, giving the impression of motion or energy.
510(k) Premarket Notification Submission SIGNA Artist
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | August 06, 2020 |
|---|---|
| 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 Leader | |
| 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 Artist |
| 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 Artist (K163331) |
| Device Description: | The SIGNA Artist 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. | |
| This 510(k) submission is for the SIGNA Artist 1.5T MR system, and has | |
| been triggered by the addition of the AIR Recon DL software feature. | |
| The AIR Recon DL feature has been previously cleared for use on the | |
| SIGNA Premier 3T system through K193282, which is used as a reference | |
| device for this submission. | |
| Indications for Use: | The Indications for Use statement for the proposed device is identical to |
| that of the predicate device: | |
| The SIGNA Artist 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 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. | |
| The addition of the AIR Recon DL feature does not impact the intended | |
| use of the SIGNA Artist system. | |
| Technology | |
| Characteristics: | Many of the technological characteristics of the proposed SIGNA Artist |
| system are unchanged from the predicate device. The SIGNA Artist | |
| system has been introduced an additional configuration with IPM magnet. | |
| There are no changes to gradient, and RF subsystems compared to the | |
| predicate K163331. Key performance specifications (such as magnet | |
| stability, maximum gradient strength and slew rate, etc.) for the system | |
| are also unchanged. | |
| The software used on the proposed SIGNA Artist system has been | |
| modified to include the AIR Recon DL feature. The User interface | |
| provides operators of the system with new options for selecting AIR | |
| Recon DL and adjusting the associated level of image noise reduction. | |
| The resulting images can have higher SNR and improved sharpness | |
| compared to images reconstructed without AIR Recon DL. | |
| AIR Recon DL has been previously cleared for use with GE Healthcare's | |
| 3T SIGNA Premier system through K193282. Due to the technical | |
| similarities, SIGNA Premier (K193282) is used as a reference device for | |
| this submission. | |
| Determination of | Summary of Non-Clinical Tests: |
| Substantial | |
| Equivalence: | The AIR Recon DL feature has undergone the performance testing. |
| These tests were designed to evaluate the AIR Recon DL feature and its | |
| impact on image quality, including SNR, sharpness, low contrast | |
| detectability, and noise spectral content. Analysis was performed to | |
| confirm that the feature does not introduce significant bias that might | |
| impact quantitative measurements based on signal intensity. The | |
| influence of motion during image acquisition on the performance of AIR | |
| Recon DL was also evaluated. | |
| The nonclinical testing demonstrated that AIR Recon DL does improve | |
| SNR and image sharpness while maintaining low contrast detectability | |
| and having minimal impacts to noise spectral content, average signal | |
| intensity, or the appearance of motion artifacts. AIR Recon DL was also | |
| able to maintain image SNR and did not sacrifice sharpness for images | |
| acquired with a reduced scan time. The nonclinical testing passed the | |
| defined acceptance criteria, and did not identify any adverse impacts to | |
| image quality or other concerns related to safety and performance. | |
| Summary of Clinical Tests: | |
| Objective measures of in vivo images were analyzed to confirm that AIR | |
| Recon DL improves SNR and image sharpness for typical clinical use | |
| cases. | |
| Additionally, sample images from clinically indicated scans were | |
| evaluated both with and without the AIR Recon DL feature. These | |
| samples included images using exogenous contrast and images involving | |
| pathology spanning a variety of anatomies and pulse sequences. | |
| Radiologists were asked to rate the images, and to comment on any | |
| notable aspects related to image quality. This study showed that the AIR | |
| Recon DL feature provides images with equivalent or better image | |
| quality, lesion conspicuity is maintained, and that the radiologists | |
| preferred the AIR Recon DL images for clinical use. | |
| Conclusion Drawn from | |
| Performance Testing: | The nonclinical and clinical testing demonstrated that AIR Recon DL |
| satisfies the product claims of improved SNR and image sharpness, and | |
| can enable shorter scan times while maintaining SNR and image | |
| sharpness. | |
| The proposed SIGNA Artist system with AIR Recon DL 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 and | |
| performance. | |
| performance concerns that are significantly different from those. | |
| associated with MR imaging in general. | |
| Therefore, GE Healthcare believes that SIGNA Artist with AIR Recon DL | |
| is substantially equivalent to the predicate device, and is safe and | |
| effective for its intended use. |
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510(k) Premarket Notification Submission SIGNA Artist
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circle. There are three decorative flourishes extending outward from the circle, positioned at the top, left, and right. The logo is black and white.
510(k) Premarket Notification Submission SIGNA Artist
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circle, and there are three droplet-shaped elements evenly spaced around the outside of the circle.
510(k) Premarket Notification Submission SIGNA Artist