(108 days)
No
The document describes a standard MRI system and its software updates. There is no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No
The "Intended Use / Indications for Use" section clearly states that the device is "intended for use as a diagnostic imaging device". It produces images to assist in diagnosis, not to provide therapy.
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 that the systems feature a superconducting magnet and hardware modifications, indicating it is a hardware-based medical device with software components, not a software-only device.
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 "whole body magnetic resonance scanner" that produces images of the internal structures of the body. It uses magnetic fields and RF transmissions to obtain information directly from the patient's body, not from a sample taken from the body.
- Intended Use: The intended use is to produce diagnostic images and spectra when interpreted by a trained physician to assist in diagnosis. This is consistent with in vivo imaging, not in vitro testing.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
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, 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, TMJ, spine, breast, heart, abdomen, pelvis, 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 MR750w 3.0T and the Optima MR450w I.ST systems reflect the spaial 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 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 32 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 DV24 release is introducing new software features onto these existing MR Systems. There are also hardware modifications to the GEM configurations for Silenz compatibility. The Silenz feature used to reduce the acoustic noise generated during an MR examination is only available on the Optima MR450w GEM and Discovery MR750w GEM configurations.
The 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).
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 / 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)
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 (K123522 and K130115). Sample clinical images are included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Discovery MR750w 3.0T [K130115], Optima MR450w 1.5T [K123522]
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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K132376 Page 1 of 4
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 26, 2013 |
|---|---|
| Submitter: | GE Healthcare. (GE Medical Systems. LLC) |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| Primary Contact Person: | Michelle Huettner |
| Regulatory Affairs Leader | |
| GE Healthcare. (GE Medical Systems, LLC) | |
| Ph: (262) 521-6102 | |
| Fax: (262) 546-0902 | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare, (GE Medical Systems, LLC) | |
| Ph: (262) 521-6848 | |
| Fax: (262) 364-2785 | |
| 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 MR750w 3.0T [K130115] |
| Optima MR450w 1.5T [K123522] |
Device Description: 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. The Systems each feature a superconducting magnet. 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. Each system uses a combination of time-varying magnetic
1
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 DV24 release is introducing new software features onto these existing MR Systems. There are also hardware modifications to the GEM configurations for Silenz compatibility. The Silenz feature used to reduce the acoustic noise generated during an MR examination is only available on the Optima MR450w GEM and Discovery MR750w GEM configurations.
The 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 Discovery MR750 3.0T. Discovery MR450 1.5T. Intended Use: 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 3.07. Discovery MR450 1.5T, Discovery MR750w 3.0T and the Optima MR450w 1.51' 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.
2
Page 3 of 4
Technology: 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 features employs the same fundamental scientific technology as its predicate devices.
Summary of Non-Clinical Tests: Determination of
Substantial Equivalence:
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 60601-1-1 |
- IEC 60601-1-2 .
- . IEC 60601-1-4
- . IEC 60601-1-6
- IEC 60601-2-33
- IEC 62304
- IEC 62366 ●
- . ISO 14971
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)
Verification testing for the new software features has been completed with passing results.
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
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K132376 Page 4 of 4
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 (K123522 and K130115). 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 the Optima MR450w 1.5T with the addition of the new features introduced in the DV24 software release to be as safe, as effective, and performance is substantially equivalent to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is arranged on a single line and is centered horizontally. The words are all capitalized and evenly spaced.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2013
GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) % MICHELLE HUETTNER REGULATORY AFFAIRS LEADER, MAGNETIC RESONANCE 3200 N. GRANDVIEW BLVD WAUKESHA WI 53188
Re: K132376
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: August 20, 2013 Received: August 26, 2013
Dear Ms. Huettner:
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.
5
Page 2-Ms. Huettner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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.
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132376
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, 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, TMJ, spine, breast, heart, abdomen, pelvis, 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 MR750w 3.0T and the Optima MR450w I.ST systems reflect the spaial 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)
X 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)
Sm.h.7)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.