(8 days)
IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the human body.
IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective fat saturation techniques and STIR. Specific tissue for separation may include water and fat.
When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities. The independent images produced from IDEAL may be added or subtracted for tissue delineation.
The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The IDEAL Software Option is a software only product for use on GE Signa MR scanners.
To improve the separation between fat and water, the IDEAL technique acquires three measurements of IDEAL echoes to resolve fat, water and the magnetic field variations. The IDEAL processing produces four images from the IDEAL echoes: a water image, a fat image, a combined water plus fat image, and a combined water minus fat image. This process helps achieve uniform fat suppression and reduce chemical shift artifacts.
The provided text makes a general statement about the device's performance relative to predicate devices but does not include specific acceptance criteria or a study detailing numerical performance results.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states that IDEAL provides "higher image quality relative to chemically selective fat saturation techniques and STIR" but does not quantify this improvement with specific metrics or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not available in the provided text. The document states that images should be "interpreted by a trained physician," but this refers to the intended use of the device, not the validation process.
4. Adjudication Method for the Test Set
Not available in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the provided text.
6. Standalone Performance Study
Not mentioned in the provided text. The device is described as "IDEAL is a software option for use on GE Signa MR systems," indicating it functions as an integrated component, not a standalone algorithm in isolation.
7. Type of Ground Truth Used
Not available in the provided text.
8. Sample Size for the Training Set
Not available in the provided text.
9. How the Ground Truth for the Training Set Was Established
Not available in the provided text.
Summary of the Study Discussed in the Document:
The provided document, K072998, is a 510(k) summary of safety and effectiveness for the IDEAL Software Option for GE Signa MR Scanners. It is focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance metrics from a specific clinical study with acceptance criteria.
The conclusion states: "This premarket notification submission demonstrates that the IDEAL software option is substantially equivalent to the analogous feature in the cleared GE 1.5T and 3.0T Signa HDx MR Systems because it has the same intended use and differences in methodology do not raise new questions of safety and efficacy."
This indicates that the "study" proving the device meets its "acceptance criteria" (which in this context is primarily substantial equivalence) is the comparison to the predicate device, K052293. The acceptance criterion appears to be that the IDEAL software option has the same intended use and its methodological differences do not raise new questions of safety and efficacy compared to the predicate. No specific performance numbers or detailed study methodology (like expert reads, sample sizes, or ground truth establishment) are provided in this regulatory summary.
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K072998
Page 1 of 2
NUV - 1 2007
510(k) Summary of Safety and Effectiveness
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).
Submitter:
Name
| Name: | GE Medical Systems, LLC3200 N. Grandview Blvd., W-827Waukesha, WI 53188 |
|---|---|
| Contact: | Mark M. StaufferMR Safety and Regulatory EngineerTel: 262-521-6891Fax: 262-521-6439 |
| Date Prepared: | August 9, 2007 |
| Product Identification: | |
| Proprietary Device Name: | IDEAL Software Option for GE Signa MR Scanners |
| Common Name: | Software Option for Magnetic Resonance ImagingSystem |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging(21 CFR 892.1000, Product Code LNH) |
Predicate Device(s):
GE 1.5T and 3.0T Signa HDx MR Systems
K052293 --
Device Description:
The IDEAL Software Option is a software only product for use on GE Signa MR scanners.
To improve the separation between fat and water, the IDEAL technique acquires three measurements of IDEAL echoes to resolve fat, water and the magnetic field variations. The IDEAL processing produces four images from the IDEAL echoes: a water image, a fat image, a combined water plus fat image, and a combined water minus fat image. This process helps achieve uniform fat suppression and reduce chemical shift artifacts.
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K072998
Page 2 of 2
Intended Use:
IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the human body.
IDEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective fat saturation techniques and STIR. Specific tissue for separation may include water and fat.
When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities. The independent images produced from IDEAL may be added or subtracted for tissue delineation.
The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Comparison with Predicate:
The IDEAL Software Option is substantially equivalent to an analogous feature currently marketed in the GE 1.5T and 3.0T Signa HDx MR Systems (K052293).
Conclusion:
When used in conjunction with a GE Signa MR System, the IDEAL Software Option represents an evolutionary change in fat and water separation methodology. This premarket notification submission demonstrates that the IDEAL software option is substantially equivalent to the analogous feature in the cleared GE 1.5T and 3.0T Signa HDx MR Systems because it has the same intended use and differences in methodology do not raise new questions of safety and efficacy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 2007
GE Medical Systems, LLC % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K072998
Trade/Device Name: IDEAL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 17, 2007 Received: October 24, 2007
Dear Mr. Borsai:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Kc72998
Device Name:
IDEAL
Indications for Use:
IDEAL is a software option intended for use on GE Signa MR systems. It is indicated for magnetic resonance imaging of the musculoskeletal, breast, abdominal, and neurological systems of the body.
1DEAL is an acquisition and reconstruction method that simultaneously obtains independent images of nuclei that resonate at different frequencies. IDEAL provides uniform tissue separation, reduces chemical shift artifacts, and minimizes the effects of magnetic field inhomogeneities. The IDEAL method provides higher image quality relative to chemically selective saturation techniques and STIR . Specific tissue for separation may include water and fat.
When used with a GE Signa MR system, IDEAL is capable of producing transverse, sagittal, coronal, and oblique images of internal structures of the body, including, but not limited to, the musculoskeletal, abdominal, and neurological systems. Specific anatomical regions that may be imaged include the cervical-spine, joints, and extremities.
The images reflect the spatial distribution of nuclei exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, molecular environment, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow.
When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Prescription Use AND/OR (21 CFR 801 Subpart D)
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 Device Evaluation (ODE)
Hoya M. Whing
(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number 2072998
§ 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.