(8 days)
Not Found
No
The description focuses on signal acquisition and reconstruction techniques (IDEAL) based on physical principles of magnetic resonance, not on learning from data or using AI/ML algorithms for image processing or interpretation.
No
The device is described as an acquisition and reconstruction method for magnetic resonance imaging, intended to produce images for diagnostic purposes when interpreted by a trained physician, rather than for treatment of a condition.
Yes
The device is described as producing images that, when interpreted by a trained physician, provide information useful in determining a diagnosis. This aligns with the definition of a diagnostic device.
Yes
The device description explicitly states that the IDEAL Software Option is a "software only product for use on GE Signa MR scanners." While it functions in conjunction with an MR system, the device itself is presented as solely software.
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 IDEAL software option is used on a Magnetic Resonance (MR) system to acquire and process images of internal structures of the human body. It works by manipulating magnetic fields and radio waves to generate images based on the properties of nuclei within the body.
- Input: The input is the human body itself, not a sample taken from the body.
- Output: The output is a set of images, not a diagnostic result derived from analyzing a biological sample.
The device is a medical imaging software option that aids in the diagnosis of conditions by providing enhanced images for interpretation by a trained physician. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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.
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 of the human body. Specific anatomical regions that may be imaged include the cervical-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)
Not Found
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.
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.
0
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, LLC
3200 N. Grandview Blvd., W-827
Waukesha, WI 53188 |
|--------------------------|-------------------------------------------------------------------------------------------------|
| Contact: | Mark M. Stauffer
MR Safety and Regulatory Engineer
Tel: 262-521-6891
Fax: 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 Imaging
System |
| 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.
1
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.
2
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.
3
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
4
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