(57 days)
Not Found
No
The document describes a standard MR imaging system and software updates, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The document explicitly states the device is intended for use as a "diagnostic imaging device".
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is indicated for use as a diagnostic imaging device".
No
The device description explicitly 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," which are all hardware components. While the submission mentions new software features, the device itself is a physical MR scanner.
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. It produces images of the internal structures of the body using magnetic fields and radiofrequency pulses. This is an in vivo imaging technique, meaning it is performed on a living organism.
- Intended Use: The intended use is to produce diagnostic images and spectra of the entire body to assist in diagnosis when interpreted by a trained physician. This aligns with the function of an imaging device, not an IVD.
The device description and intended use are consistent with a medical imaging device used for diagnostic purposes, not a device that analyzes samples outside of the body.
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).
The DV25 release is introducing new software features onto these existing MR Systems.
Mentions image processing
Not Found
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)
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 software features complies with the following voluntary standards:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-33
In addition, these MR scanners are in compliance with the applicable NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance.
The following quality assurance measures were applied to the development of the system:
- 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 the verification testing that was completed for the addition of the new software features to the compatible MR scanners. The 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. In addition, the modified scanners are in compliance to the same Standards.
Clinical Tests:
The subject of this premarket submission, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features. The clinical results demonstrated that the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T maintain the same imaging performance results as its predicate devices (K132376). Sample clinical images are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem consisting of three stylized human profiles facing to the right, stacked one behind the other. The profiles are connected by a flowing line that forms a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2014
GE Medical Systems, LLC % Ms. Jenny Wong Regulatory Affairs Leader, Magnetic Resonance 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K142085
Trade/Device Name: Discovery MR750 3.0T. Discovery MR450 1.5T. Discovery MR750w 3.0T and Optima MR450w 1.5T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 28, 2014 Received: July 31, 2014
Dear Ms. Wong:
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
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Section 4: Indications for Use Statement
Discovery MR750 3.0T, Discovery MR450 1.5T,
Discovery MR750w 3.0T and Optima MR450w 1.5T
3
Indications for Use
510(k) Number (if known)
K142085
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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, and the frame has decorative elements resembling swirls or waves.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: July 28, 2014
| Submitter: | GE Healthcare, (GE Medical Systems, LLC)
3200 N Grandview Blvd.
Waukesha, WI 53188 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Jenny Wong
Regulatory Affairs Leader, MR
GE Healthcare, (GE Medical Systems, LLC)
Phone: 262-548-2899
Fax: 414-908-9585 |
| 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 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 [K132376] |
| 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 |
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is blue and has a vintage or classic design.
GE Healthcare 510(k) Premarket Notification Submission
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).
The DV25 release is introducing new software features onto these existing MR Systems.
- 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.
The Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery Technology: MR750w 3.0T, and Optima MR450w 1.5T employs the same fundamental scientific technology as its predicate devices.
The following is a summary of the differences between the proposed Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T and the predicates (Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and
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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 logo is enclosed within a circular border, and the entire design is in a blue color.
the Optima MR450w 1.5T (K132376)).
- New base software on the MR systems (version DV25) ●
- Addition of new software features onto the MR scanners including DISCO, MDE Plus and Silent Suite updates)
- Hardware modifications to the host computer and reconstruction engine for obsolescence and compatibility with a new operating system
- Revised and updated labeling to include new features
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 software features complies with the following voluntary standards:
- IEC 60601-1
- IEC 60601-1-2 ●
- IEC 60601-2-33 ●
In addition, these MR scanners are in compliance with the applicable NEMA standards, including NEMA PS3.1-3.20 for DICOM conformance.
The following quality assurance measures were applied to the development of the system:
- 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 the verification testing that was completed for the addition of the new software features to the compatible MR scanners. The 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. In addition, the modified scanners are in compliance to the same Standards.
7
Image /page/7/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 blue circle. The circle is surrounded by decorative, swirling lines, also in blue, which give the logo a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
Summary of Clinical Tests:
The subject of this premarket submission, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T, did not require external clinical studies to support substantial equivalence. Internal scans were conducted as part of validation for workflow and image quality for the addition of the new features. The clinical results demonstrated that the Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.5T maintain the same imaging performance results as its predicate devices (K132376). Sample clinical images are included in this submission.
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).