(118 days)
Optima MR450w (K113490)
Not Found
No
The document describes a standard MR imaging system and its components, focusing on hardware, pulse sequences, and image reconstruction. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies summary.
No
The device is described as a "diagnostic imaging device" that produces images and/or spectra to "assist in diagnosis," not to treat conditions.
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 details hardware components such as a superconducting magnet, data acquisition system, and coils, indicating it is a physical medical device, not software-only.
Based on the provided information, the Optima™ MR450w is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Optima™ MR450w is a magnetic resonance scanner used to produce images of the entire body of a patient. It directly interacts with the patient to acquire data, rather than analyzing samples taken from the patient.
- The device description focuses on the physical components and imaging capabilities. It describes the magnet, data acquisition system, gradients, RF transmissions, and imaging planes, all of which are related to acquiring images in vivo (within the living body).
- The intended use is for diagnostic imaging. The device is used to produce images and spectra that are interpreted by a trained physician to assist in diagnosis. This is a characteristic of an in vivo diagnostic imaging device, not an in vitro diagnostic device.
Therefore, the Optima™ MR450w is an in vivo diagnostic imaging device, not an IVD.
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 (comma separated list FDA assigned to the subject device)
LNH, MOS
Device Description
The 1.5 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 Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM configuration. 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
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
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 Silenz Imaging Application. Sample clinical images are included in this submission.
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.
Optima MR450w (K113490)
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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K123522 | Page 1 of 3
510(k) Summary
MAR 1 3 2013
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: December 10, 2012
GE Healthcare, (GE Medical Systems, LLC) Submitter: 3200 N. Grandview Blvd. Waukesha, W153188
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
Optima MR450w Device: Trade Name:
Common/Usual Name: Magnetic Resonance Diagnostic Device
Classification Names: 892.1000
Product Code: LNH
Optima MR450w (K113490) Predicate Device(s):
The 1.5 GE Optima MR450w features a superconducting Device Description: 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 Silenz Imaging Application using the 3D Radial Pulse sequence reduces the acoustic noise that is generated during an MR examination. This application is compatible on the Optima MR450w system with GEM
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K123522) Page 2 of 3
configuration. The 1.5T GE Optima MR450w is designed to conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
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 vield information that may assist in diagnosis.
- Technology: The modified Optima MR450w employs the same fundamental scientific technology as its predicate device, the Optima MR450w. It is still a whole body magnetic resonance scanner designed to support high resolution. high signal-to-noise ratio, and short scan times. The images produced with the Optima MR450w reflect the spatial distribution or molecular environment of the nuclei which exhibit magnetic resonance. The addition of the Silenz feature does not alter the overall technology of the Optima MR450w System.
Determination of Summary of Non-Clinical Tests:
Substantial Equivalence: The Optima MR450w scanner with the GEM configuration and addition of the Silenz Imaging Application 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 .
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-
KI23522
Page 3 of 3 -
IEC 62304 .
-
ISO 14971 ●
In addition, this MR scanner is in compliance with the applicable NEMA standards. including NEMA PS3.1-3.18 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 Optima MR450w System with the Silenz application. The testing was completed with passing results per the pass/fail criteria defined in the test cases. This supports substantial equivalence to its predicate (Optima MR450w) because it was also developed under quality assurance Design Controls. In addition, it is in compliance to the same Standards.
Summary of Clinical Tests:
The subject of this premarket submission, Optima MR450w, 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 Silenz Imaging Application. Sample clinical images are included in this submission.
GE Healthcare considers the Optima MR450w to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 symbol resembling a caduceus, which is a traditional symbol associated with medicine and healthcare. The symbol features a staff with two snakes coiled around it, topped with a pair of wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Michelle Huettner Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC) 3200 N. Grandview Blvd WAUKESHA. WI 53188
Re: K123522
Trade/Device Name: Optima MR450w Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Dated: February 11, 2013 Received: February 12, 2013
Dear Michelle 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. Drue, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2— Huettner
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Medhat D. DiHasa for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123522
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 nuclei exhibiting 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 (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k) K123522
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