(120 days)
IDEAL Software Option, K072998
Not Found
No
The description focuses on signal processing and iterative decomposition techniques for water and fat separation, which are traditional image processing methods, not AI/ML. There is no mention of learning algorithms, training data, or neural networks.
No
The device is described as an acquisition and reconstruction technique that provides images and maps for diagnosis, not for therapeutic purposes.
Yes
The text states that "When interpreted by a trained physician, these images provide information that can aid in diagnosis." This explicitly indicates its role in aiding diagnosis, a primary characteristic of a diagnostic device.
No
The device is described as a "software option intended for use on GE MR systems" and an "option for GE MR scanners." This indicates it is software that runs on and is integrated with a hardware medical device (the MR scanner), rather than being a standalone software-only medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- IDEAL IQ's function: IDEAL IQ is a software option for GE MR systems. It works by acquiring and processing in vivo (within the living body) magnetic resonance signals to generate images and maps of internal structures and tissue composition. It does not analyze samples taken from the body.
Therefore, IDEAL IQ falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IDEAL IQ is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
Product codes
LNH
Device Description
IDEAL IQ is a software application offered as an option for GE MR scanners. The IDEAL IQ imaging technique (IDEAL: Iterative Decomposition of water and fat with Echo Asymmetr and Least-squares estimation) is a triglyceride fat and water separation technique that acquires multiple images of the anatomy at separate echo times to calculate the phase differences and determine triglyceride fat and water content per pixel. It exploits the resonance frequency differences between triglyceride fat and water, measured as phase differences in multiple echoes, to resolve triglyceride fat and water. It provides reliable and uniform water-fat separation in the presence of B0 field inhomogeneity and improves the accuracy of water-fat separation by estimating and correcting for T2* decay between echoes and by more accurately modeling triglyceride fat's spectral profile as multiple peaks rather than a single peak. It produces images showing the separated water and triglyceride fat signals, and the tissue transverse magnetization relaxation. Finally, IDEAL IO processes decomposed water and triglyceride fat images to generate a relative triglyceride fat-fraction map. Such a representation of a proton density triglyceride fat fraction is intrinsically insensitive to B1 and coil-sensitivity heterogeneity. The IDEAL IO method uses a low flip angle excitation to reduce any TI bias in the relative triglyceride fat fraction map images caused by differences in the TI of triglyceride fat and water. With the confounding effects of T2*, multiple spectral peaks of triglyceride fat, and T1 differences reduced, the images from IDEAL IQ reflect the spatial distribution of relative concentration of triglyceride fat in a voxel.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
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 IDEAL IO software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Design Verification
- . Safety Testing
The following safety parameters were measured: - Acoustic Noise ●
- . dB/dt
- . SAR
The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.
Summary of Clinical Tests:
Clinical image comparisons demonstrate that the IDEAL IQ software option maintains the same imaging performance results as the predicate software option IDEAL. Quantification in the liver is shown through included studies of animal models, and several in vivo human studies showing correlation to MR Spectroscopy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IDEAL Software Option, K072998
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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MAR 2 2 2011
Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are black, while the background is white.
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: | March 21, 2011 |
| Submitter: | GE Healthcare (GE Medical Systems, LLC) |
| 3200 N. Grandview Blvd. | |
| Waukesha, WI 53188 | |
| USA | |
| Primary Contact Person: | Tracey Fox |
| Regulatory Affairs Manager | |
| GE Healthcare (GE Medical Systems, LLC) | |
| (262) 521-6079 | |
| (414) 918-8349 fax | |
| Secondary Contact Person: | Glen Sabin |
| Regulatory Affairs Director | |
| GE Healthcare (GE Medical Systems, LLC) | |
| (262) 521-6848 | |
| (262) 521-6439 fax | |
| Device: | IDEAL IQ Software Option |
| Trade Name: | IDEAL IQ Software Option |
| Common/Usual Name: | Software Option for Magnetic Resonance Imaging System |
| Classification Names: | 21 C.F.R. 892.1000 |
| Magnetic Resonance Diagnostic Device | |
| Product Code: | LNH |
| Predicate Device(s): | IDEAL Software Option, K072998 |
| Device Description: | IDEAL IQ is a software application offered as an option for GE |
| MR scanners. The IDEAL IQ imaging technique (IDEAL: | |
| Iterative Decomposition of water and fat with Echo Asymmetr |
and Least-squares estimation) is a triglyceride fat and water separation technique that acquires multiple images of the anatomy at separate echo times to calculate the phase differences and determine triglyceride fat and water content per pixel. It exploits the resonance frequency differences between triglyceride fat and water, measured as phase differences in multiple echoes, to resolve triglyceride fat and water. It provides reliable and
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GE Healthcare
510(k) Premarket Notification Submission
uniform water-fat separation in the presence of B0 field inhomogeneity and improves the accuracy of water-fat separation by estimating and correcting for T2* decay between echoes and by more accurately modeling triglyceride fat's spectral profile as multiple peaks rather than a single peak. It produces images showing the separated water and triglyceride fat signals, and the tissue transverse magnetization relaxation. Finally, IDEAL IO processes decomposed water and triglyceride fat images to generate a relative triglyceride fat-fraction map. Such a representation of a proton density triglyceride fat fraction is intrinsically insensitive to B1 and coil-sensitivity heterogeneity. The IDEAL IO method uses a low flip angle excitation to reduce any TI bias in the relative triglyceride fat fraction map images caused by differences in the TI of triglyceride fat and water. With the confounding effects of T2*, multiple spectral peaks of triglyceride fat, and T1 differences reduced, the images from IDEAL IQ reflect the spatial distribution of relative concentration of triglyceride fat in a voxel.
IDEAL IQ is a software option intended for use on GE MR Intended Use: systems. IDEAL IO is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast. abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IO is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-byvoxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
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P 3/3
Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters and the frame are solid black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.
GE Healthcare
510(k) Premarket Notification Submission
Technology: The IDEAL IQ acquisition uses a fast 3D SPGR sequence in one or more repetitions. IDEAL IQ exploits the resonant frequency difference between triglyceride fat and water, measured as phase differences in multiple echoes. The IDEAL IQ software option employs the same fundamental scientific technology as its predicate device.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
The IDEAL IO software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Design Verification
- . Safety Testing
The following safety parameters were measured:
- Acoustic Noise ●
- . dB/dt
- . SAR
The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.
Summary of Clinical Tests:
Clinical image comparisons demonstrate that the IDEAL IQ software option maintains the same imaging performance results as the predicate software option IDEAL. Quantification in the liver is shown through included studies of animal models, and several in vivo human studies showing correlation to MR Spectroscopy.
- GE Healthcare considers the IDEAL IQ software option 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Tracey Fox Regulatory Affairs Manager GE Medical Systems 3200 N Grandview Blvd W-827 WAUKESHA, WISCONSIN 53188
MAR 2 2 2011
Re: K103411
Trade/Device Name: IDEAL IQ Software Option Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH Dated: February 23, 2011 Received: February 24, 2011
Dear Ms. Fox,
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
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 5 00%) remarket 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.
Sincerelv Yours.
Mary Pastel
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
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): K103411 Device Name:
IDEAL IQ Software Option
Indications for Use
IDEAL IQ is a software option intended for use on GE MR systems. IDEAL IQ is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, breast, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the abdomen, breast, spine, joints, and extremities.
IDEAL IQ is an acquisition and reconstruction technique that simultaneously obtains independent images of hydrogen nuclei that resonate at different frequencies to provide separation of water and triglyceride fat. IDEAL IQ generates images of separated water and triglyceride fat, relative triglyceride fat fraction map, and tissue transverse magnetization relaxation. In the liver, the relative triglyceride fat fraction map is quantitative; it reflects the proton density (number of protons per unit volume) of triglyceride fat, divided by the sum of the proton density of triglyceride fat and the proton density of water, on a voxel-by-voxel basis.
When interpreted by a trained physician, these images provide information that can aid in diagnosis.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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 Pastel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)
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