(109 days)
Not Found
No
The document describes standard MRI system functionality and software features (MAGIC DWI and CardioMaps) without mentioning AI or ML algorithms for image processing, analysis, or interpretation. The performance studies focus on phantom testing and compliance with standards, not AI/ML model validation.
No
The device is described as a "diagnostic imaging device" used 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...". Its purpose is to assist in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "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."
No
The device description explicitly states that the systems feature a superconducting magnet and other hardware components necessary for magnetic resonance imaging. While the submission mentions software features (MAGIC DWI and CardioMaps), these are modifications to existing hardware systems, not standalone software devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The text clearly describes the device as a "whole body magnetic resonance scanner" that produces images and spectra of the structures and functions of the entire body. It uses magnetic resonance technology to obtain information about the spatial distribution or molecular environment of nuclei.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to generate images and data directly from the patient's body using magnetic fields and radiofrequency transmissions.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners 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, neck, TMI, 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 Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems 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 (comma separated list FDA assigned to the subject device)
LNH
Device Description
The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect and SIGNA Artist systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems each feature 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. Each 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. Each system can image in the sagittal, coronal, axial, oblique, and double oblique planes, using various pulse sequences and reconstruction algorithms. The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Architect. SIGNA Artist systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
The original description hasn't changed from predicate devices (K160618), other than reflecting the additional receive channels available.
The modifications to these systems include the MAGIC DWI and CardioMaps software features, delivered via the DV26 program. The proposed software features will be ported over to other GE Healthcare MR systems based on appropriate design controls and evaluation of the change in accordance with FDA's Guidance—Deciding When to Submit a 510(k) for a Change to an Existing Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
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 changes are software only features and comply with the following voluntary standards:
• AAMI/ANSI 62304
• AAMI/ANSI ES60601-1
• IEC 60601-2-33
The following quality assurance measures were applied to the development of the device:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)
The non-clinical tests have been summarized in this 510(k). Phantom testing for both Synthetic DWI and CardioMaps was completed to demonstrate acceptable performance. Testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicates because it was also developed under quality assurance Design Controls.
Summary of Clinical Tests:
Sample clinical images are included in this submission in accordance with the MR guidance on premarket notification submissions.
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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2017
GE Medical Systems, LLC % Mary A Mayka, Ph.D. Regulatory Affairs Manager 3200 Grandview Blvd. WAUKESHA WI 53188
Re: K163331
Trade/Device Name: SIGNA Architect. SIGNA Artist. Discovery MR750 3.0T. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 17, 2017 Received: February 21, 2017
Dear Dr. Mayka:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163331
.
Device Name
SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T
Indications for Use (Describe)
The SIGNA Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems are whole body magnetic resonance scanners 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, neck, TMI, 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 Architect, SIGNA Artist, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems 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.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 05: 510(k) Summary Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist
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Image /page/4/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. There are also white droplet-like shapes surrounding the circle, giving it a dynamic and fluid appearance. The logo is simple, recognizable, and represents the multinational conglomerate corporation.
| In accordance with 21 CFR 807.92 the following summary of information is provided: | ||
|---|---|---|
| Date: | November 22, 2016 | |
| Primary Contact Person: | Mary A. Mayka, Ph.D. | |
| Regulatory Affairs Manager | ||
| GE Healthcare | ||
| Phone: 262-527-3148 | ||
| Fax: 262-364-2785 | ||
| Secondary Contact Person: | Glen Sabin | |
| Regulatory Affairs Director, MR | ||
| GE Healthcare, (GE Medical Systems, LLC) | ||
| Phone: 262-521-6848 | ||
| Fax: 414-908-9585 | ||
| Device Trade Name: | Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima | |
| MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, | ||
| SIGNA Artist | ||
| Common/Usual Name: | Magnetic Resonance Diagnostic Device | |
| Classification Names: | Magnetic Resonance Diagnostic Device | |
| (21 CFR 892.1000) | ||
| Product Code: | LNH | |
| Predicate Devices: | K160618: Discovery MR750 3.0T, Discovery MR450 1.5T, | |
| Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA | ||
| Architect, SIGNA Artist | ||
| Device Description: | The Discovery MR750 3.0T, Discovery MR450 1.5T, | |
| Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA | ||
| Architect and SIGNA Artist systems are whole body | ||
| magnetic resonance scanners designed to support high | ||
| resolution, high signal-to-noise ratio, and short scan times. | ||
| The systems each feature 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. Each 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. | ||
| Each system can image in the sagittal, coronal, axial, | ||
| oblique, and double oblique planes, using various pulse | ||
| sequences and reconstruction algorithms. | ||
| The Discovery MR750 3.0T, Discovery MR450 1.5T, | ||
| Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA | ||
| Architect. SIGNA Artist systems are designed to conform to |
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Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The space between the letters and the border is filled with a light blue color. The logo is simple and recognizable, representing the company's brand identity.
| | NEMA DICOM standards (Digital Imaging and
Communications in Medicine). |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The original description hasn't changed from predicate
devices (K160618), other than reflecting the additional
receive channels available.
The modifications to these systems include the MAGIC DWI
and CardioMaps software features, delivered via the DV26
program. The proposed software features will be ported
over to other GE Healthcare MR systems based on
appropriate design controls and evaluation of the change in
accordance with FDA's Guidance—Deciding When to
Submit a 510(k) for a Change to an Existing Device. |
| Indications for Use: | The SIGNA Architect, SIGNA Artist, Discovery MR750
3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and
the Optima MR450w 1.5T systems are whole body magnetic
resonance scanners 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 Architect, SIGNA
Artist, Discovery MR750 3.0T, Discovery MR450 1.5T,
Discovery MR750w 3.0T and the Optima MR450w 1.5T
systems 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. |
| Comparison of Intended
Use | The addition of the proposed software features does not
impact the indications for use. The indications for use have
not changed, other than the addition of the SIGNA Architect
and SIGNA Artist systems (K160618/001 and
K160618/002).
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 |
| Comparison of
Technological
Characteristics: | The MR systems with the proposed software features
employ the same fundamental technology as the predicate
devices. |
| Performance Data: | Summary of Non-Clinical Tests:
The changes are software only features and comply with the
following voluntary standards:
• AAMI/ANSI 62304
• AAMI/ANSI ES60601-1
• IEC 60601-2-33 |
| | The following quality assurance measures were applied to
the development of the device:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation) |
| | The non-clinical tests have been summarized in this 510(k).
Phantom testing for both Synthetic DWI and CardioMaps
was completed to demonstrate acceptable performance.
Testing was completed with passing results per the pass/fail
criteria defined in the test cases. This supports substantial
equivalence to its predicates because it was also developed
under quality assurance Design Controls.
Summary of Clinical Tests: |
| | Sample clinical images are included in this submission in
accordance with the MR guidance on premarket notification
submissions. |
| Conclusion: | The GE MR systems with the modified software features
have the same intended use as the predicate. This 510(k)
submission includes information on the technological
characteristics of the proposed software features, as well as
performance data demonstrating that the features are as safe
and effective as the predicate, and does not raise different
questions of safety and effectiveness. |
| | In conclusion, GE Healthcare believes that the MR systems
with the modified software features are substantially
equivalent to the predicate devices. |
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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a series of curved lines that resemble water droplets or splashes. The logo is simple and recognizable, and it is often used to represent the company's brand.