(98 days)
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T [K142085]
Not Found
No
The document describes a standard MRI system and a training PC. There is no mention of AI or ML in the intended use, device description, or performance studies. The "reconstruction algorithms" mentioned are standard image processing techniques for MRI, not necessarily AI/ML.
No
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a diagnostic imaging device," not for therapeutic purposes.
Yes
The text explicitly states in the "Intended Use / Indications for Use" section that the device "is indicated for use as a diagnostic imaging device."
No
The device description clearly states it is a "whole body magnetic resonance scanner" featuring a "superconducting magnet," "data acquisition system," and uses "time-varying magnetic fields (gradients) and RF transmissions," all of which are hardware components. The modification mentioned is a "Training PC," which is also a hardware component.
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 Function: The description clearly states that this device is a magnetic resonance scanner that produces images of the internal structures and functions of the entire body. It works by detecting magnetic resonance signals from nuclei within the body.
- Intended Use: The intended use is to produce diagnostic images and spectra that, when interpreted by a trained physician, may assist in diagnosis. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro.
The device description and intended use are consistent with a medical imaging device used for diagnostic purposes on the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The 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 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 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.
Product codes
LNH
Device Description
The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. The systems feature a superconducting magnet operating at 1.5 Tesla or 3.0 Telsa. The data acquisition system accommodates up to 32 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and the Optima MR450w 1.5T systems are designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Modification for which this Special 510(k) is being filed is a Training PC which was introduced in the DV25.1 program. This modification allows users to train new technologist, optimize protocols, and evaluate pulse sequence development in the off-line environment.
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, 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems with the addition of the new feature training PC complies with the NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance.
The following quality assurance measures were applied to the development of the system with the addition of the new feature training PC:
• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Simulated use testing (Validation)
Summary of Clinical Tests:
The modification that prompted this submission did not require clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T [K142085]
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2016
GE Medical Systems, LLC % Mr. Jason Ma Regulatory Affairs Leader Magnetic Resonance Imaging Modality 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K160618
Trade/Device Name: Discovery MR750 3.0T. Discovery MR450 1.5T. Discovery MR750w 3.0T, Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 11, 2016 Received: May 13, 2016
Dear Mr. Ma:
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,
Robert Ocks
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)
Device Name
Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and Optima MR450w 1.5T
Indications for Use (Describe)
The 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 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 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.
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/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 circular shape. The circle is surrounded by swirling, wave-like elements, giving the logo a dynamic and recognizable appearance. The color of the logo is blue.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | January 18, 2016 |
|---|---|
| Submitter: | GE Healthcare, (GE Medical Systems, LLC) |
| 3200 N Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact Person: | Jason Ma |
| Regulatory Affairs Leader, MR | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Phone: 262-548-2899 | |
| Fax: 414-908-9585 | |
| Secondary Contact Person: | |
| Device Trade Name: | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, |
| and Optima MR450w 1.5T | |
| Common/Usual Name: | Magnetic Resonance Diagnostic Device |
| Classification Names: | 892.1000 |
| Product Code: | LNH |
| Predicate Device(s): | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, |
| and Optima MR450w 1.5T [K142085] | |
| Device Description: | The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w |
| 3.0T and the Optima MR450w 1.5T are whole body magnetic | |
| resonance scanners designed to support high resolution, high signal- | |
| to-noise ratio, and short scan times. The systems feature a | |
| superconducting magnet operating at 1.5 Tesla or 3.0 Telsa. The data | |
| acquisition system accommodates up to 32 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 Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w | |
| 3.0T, and the Optima MR450w 1.5T systems are designed to conform | |
| to NEMA DICOM standards (Digital Imaging and Communications in | |
| Medicine). | |
| Modification for which this Special 510(k) is being filed is a Training PC | |
| which was introduced in the DV25.1 program. This modification allows | |
| users to train new technologist, optimize protocols, and evaluate pulse | |
| sequence development in the off-line environment. | |
| Intended Use: | The 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 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. |
Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved
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Image /page/4/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 inside. There are swirling lines around the letters, giving the impression of movement or energy. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Premarket Notification Submission
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GE Healthcare 510(k) Premarket Notification Submission
Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, cloud-like shapes, also in blue, which give the logo a dynamic and recognizable appearance.
| Technology: | The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T employs the same fundamental scientific technology as its predicate devices. |
|---|---|
| Determination of Substantial | |
| Equivalence: | Summary of Non-Clinical Tests: |
| The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T systems with the addition of the new feature training PC complies with the NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance. | |
| The following quality assurance measures were applied to the development of the system with the addition of the new feature training PC: | |
| • Risk Analysis | |
| • Requirements Reviews | |
| • Design Reviews | |
| • Testing on unit level (Module verification) | |
| • Integration testing (System verification) | |
| • Simulated use testing (Validation) | |
| Summary of Clinical Tests: | |
| The modification that prompted this submission did not require clinical testing. | |
| Conclusion: | GE Healthcare considers the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, and Optima MR450w 1.5T to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |