(51 days)
Not Found
No
The document describes a standard MRI system and its technical specifications, with no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: The device is explicitly stated to be a "diagnostic imaging device" whose images "may assist in diagnosis," indicating it is used for diagnosis, not 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 clearly details hardware components such as a superconducting magnet, data acquisition system, gradient coils, and RF transmissions, indicating it is a physical medical device, not software-only.
Based on the provided information, 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 Optima™ MR450w is a magnetic resonance scanner. It produces images of the internal structures of the body using magnetic fields and radiofrequency pulses. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it 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 modality, not an in vitro test.
- Device Description: The description details the physical components and operation of an MRI scanner, not equipment for analyzing biological samples.
Therefore, the Optima™ MR450w falls under the category of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Optima™ MR450w 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 Optima™ MR450w 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 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. 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. The Optima MR450w is proposed to be marketed with an added XP Gradient configuration compatible with systems that have the GEM Coil Suite option. The 1.5T GE Optima MR450w is 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
whole 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
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)
The Optima MR450w and its applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analvsis
- Requirements Reviews .
- Design Reviews
- Performance testing: .
- Signal-to-noise ratio (SNR) -
- Geometric distortion -
- Image uniformity -
- Slice thickness -
- Spatial resolution -
- Component, Subsystem and System Testing (Verification) .
- Simulated use testing (Validation) .
In accordance with voluntary standards identified in Section 9 and FDA's November 14, 1998 guidance entitled 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', the following safety tests were completed:
- Safety Testing .
- Static Field Strength -
- Acoustic noise -
- DB/dt -
- RF heating (SAR) -
- Biocompatibility -
The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Optima MR450w (K091536)
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/0 description: The image shows a date written in a simple, sans-serif font. The date is "JAN 13 2012", indicating January 13th, 2012. The letters and numbers are uniformly sized and spaced, creating a clean and legible appearance. The text is black against a white background.
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KI13490". The characters are written in black ink on a white background.
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
November 22, 2011 Date:
Optima MR450w
892.1000
GE Healthcare (GE Medical Systems, LLC) Submitter: 3200 N. Grandview Blvd. Waukesha, WI 53188
Primary Contact Person:
Robin Martin Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) Ph: (262) 312-1120 Fax: (262) 364-2785
Secondary Contact Person:
Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC) Ph: (262) 521-6848 Fax: (262) 364-2785
Magnetic Resonance Diagnostic Device
Optima MR450w (K091536)
Device: Trade Name: Common/Usual Name:
Classification Names:
LNH Product Code:
Predicate Device(s):
Device Description:
The 1.5T GE Optima MR450w features a superconducting magnet operating at 1.5 Tesla. 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. The Optima MR450w is proposed to be marketed with an added XP Gradient configuration compatible with systems that have the GEM Coil Suite option. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
1
Image /page/1/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 circular border. The border has decorative flourishes at the top and bottom, adding a touch of elegance to the design. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
Intended Use:
The Optima™ MR450w 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 Optima™ MR450w 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 Optima MR450w employs the same fundamental scientific technology as its predicate device, the Optima MR450w. Refer to Section 12 for details of the System, Technical and Application Comparison Charts.
Technology:
2
Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. The letters and the circle are black, while the background is white.
GE Healthcare
510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The Optima MR450w and its applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- . Risk Analvsis
- Requirements Reviews .
- Design Reviews �
- Performance testing: .
- Signal-to-noise ratio (SNR) -
- Geometric distortion -
- Image uniformity -
- Slice thickness -
- Spatial resolution -
- Component, Subsystem and System Testing (Verification) .
- Simulated use testing (Validation) .
In accordance with voluntary standards identified in Section 9 and FDA's November 14, 1998 guidance entitled 'Guidance for the Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices', the following safety tests were completed:
- Safety Testing .
- Static Field Strength -
- Acoustic noise -
- DB/dt -
- RF heating (SAR) -
- Biocompatibility -
Summary of Clinical Tests:
The subject of this premarket submission, Optima MR450w did not require external clinical studies to support substantial equivalence. Internal scans for workflow and image quality data were used for clinical validation.
Conclusion:
GE Healthcare considers the Optima MR450w to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or waves, stacked vertically. The emblem is black, and the text is also in black against a white background.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Robin Martin Regulatory Affairs Leader GE Medical Systems, LLC. 3200 N. Grandview Blvd. WAUKESHA WI 53188
Re: K113490
Trade/Device Name: Optima MR450w Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 22, 2011 Received: November 25, 2011
Dear Ms. Martin:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
JAN 1 3 2012
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
K 113490 510fk) Number (if known):
Device Name: Optima MR450w
Indications for Use:
The Optima™ MR450w 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 Optima™ MR450w reflect the spatial distribution or molecular environment of nucle oxhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Posth
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Saf 510(k)