(189 days)
No
The summary mentions "image processing" but does not explicitly mention AI, ML, or related terms, nor does it describe any AI/ML-specific training or testing data.
No
The device is described as an "imaging device" intended for "diagnosis determination" and provides "physiological and clinical information" non-invasively through "images produced by the MR system." It is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination."
No
The device description explicitly states it is a Magnetic Resonance Imaging System utilizing a 1.5 Tesla superconducting magnet in a gantry design, which are hardware components. The performance studies also include testing related to hardware standards (NEMA, IEC).
Based on the provided information, the ECHELON Oval MRI System 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 ECHELON Oval MRI System is an imaging device that produces images of the internal structure of the head, body, or extremities non-invasively. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device description focuses on the imaging technology (MRI) and its components. It describes a superconducting magnet, gantry design, and the process of producing images based on magnetic resonance properties. This is characteristic of an imaging system, not an IVD.
- The intended use describes providing physiological and clinical information through imaging. This information is obtained directly from the patient's body through the imaging process, not from a specimen taken from the patient.
Therefore, the ECHELON Oval MRI System falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ECHELON Oval MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, 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 diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton Diagnostic uses: T1, T2, proton density weighted imaging Diffusion weighted imaging MR Angiography Image processing Spectroscopy Whole Body
Product codes
LNH, LNI, MOS
Device Description
The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Head, Body, Spine, 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
Non-Clinical Testing:
The ECHELON Oval was subjected to the following laboratory testing as outlined in the FDA MRI 510(k) guidance:
MRI Test Standards:
- NEMA MS 1, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- NEMA MS 2, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- NEMA MS 3, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- NEMA MS 4, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices
- NEMA MS 5, Determination of Slice Thickness in Diagnostic Resonance Imaging
- NEMA MS 7. Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Diagnostic Magnetic Resonance Imaging Devices
- NEMA MS 8. Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
Additional Test Standards: - IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety
- IEC 60601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety -. Collateral Standard: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2, General requirements for safety Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-4, Medical Electrical Equipment Part 1-4: General requirements for safety -. Collateral Standard: Programmable electrical medical systems
- IEC 60601-2-33, Medical Electrical Equipment, Part 2: Particular requirements for the safety of . maqnetic resonance equipment for medical diagnosis
- IEC 62304, Medical device software - Software life cycle processes
Additional Non-clinical Testing: - High Contrast Spatial Resolution
- Estimation of the Ratio of Peak Local (10g average) SAR Values to Whole-Body SAR (numerical simulation)
Clinical Testing:
The Echelon Oval submission includes sample clinical imaging of the head, torso, and extremities using all anatomy coils, as specified in the FDA MRI 510(k) guidance referenced above.
Key Results:
It is the opinion of Hitachi Medical Systems America, Inc. the ECHELON Oval MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON C Magnetic Resonance Imaging System (K083533).
Key Metrics
Not Found
Predicate Device(s)
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.
0
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44087-2371
ph: (330) 425-1313
fax: (330) 963-0749 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | October 21, 2011 |
Device Name
| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|---|---|
| Classification Number: | 90LNH |
| Trade/Proprietary Name: | ECHELON Oval MRI System |
| Predicate Device(s): | ECHELON C Magnetic Resonance Imaging System (K083533) |
Device Intended Use
The ECHELON Oval System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved crosssectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, 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 diagnosis determination.
· Anatomical Region: Head, Body, Spine, Extremities,
Nucleus excited: Proton
Diagnostic uses:
- T1, T2, proton density weighted imaging .
- Diffusion weighted imaging .
- MR Angiography ●
- Image processing .
- Spectroscopy .
1
Device Description
Function
The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.
Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events.
The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
2
Physical and Performance Characteristics
MRI is capable of producing high quality anatomical images without the associated risks of ionizing radiation. The biological properties that contribute to MR image contrast are different from those responsible for x-ray image contrast. In MR imaging, difference in proton density, blood flow, and T1 and T2 relaxation times can all contribute to image contrast. By varying the pulse sequence characteristics, the resulting images can emphasize T1, T2, proton density, or the molecular diffusion of water or other proton containing molecules. And MR system has the function of measuring spectroscopy.
Device Technological Characteristics
The control and image processing hardware and the base elements of the system software are identical to the predicate device.
The ECHELON Oval is equivalent to the Echelon with the following exceptions:
- Gantry bore dimension is changed from circle with diameter 61cm to oval with 74cm x . 65cm
- Maximum RF power is increased from 20 kW to 40 kW .
- Maximum output current of gradient amplifier is increased from 550 A to 700 A .
- AD converter of the MR signal is moved from the equipment room RFIP Cabinet to the . gantry
- Patient table has the function of docking and undocking from the gantry .
- Software operating system is changed to Windows 7 from Windows XP .
- CPU platform is changed to Intel Core i5 3.33GHz from Intel Core2Duo 2.13GHz .
Summary of Clinical/Non-Clinical Testing
Non-Clinical Testing
The ECHELON Oval was subjected to the following laboratory testing as outlined in the FDA MRI 510(k) guidance':
MRI Test Standards
- NEMA MS 1, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic . Resonance Images
- NEMA MS 2, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic . Resonance Images
- NEMA MS 3, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images .
- NEMA MS 4, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance . Imaging Devices
- NEMA MS 5, Determination of Slice Thickness in Diagnostic Resonance Imaging .
1 Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Diagnostic Devices, FDA, November 14, 1998
3
510(k) Summary
- NEMA MS 7. Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Diagnostic . Magnetic Resonance Imaging Devices
- NEMA MS 8. Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging . Systems
Additional Test Standards
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety .
- IEC 60601-1-1, Medical Electrical Equipment Part 1: General Requirements for Safety -. Collateral Standard: Safety Requirements for Medical Electrical Systems
- IEC 60601-1-2, General requirements for safety Collateral standard: Electromagnetic ● compatibility - Requirements and tests
- IEC 60601-1-4, Medical Electrical Equipment Part 1-4: General requirements for safety -. Collateral Standard: Programmable electrical medical systems
- IEC 60601-2-33, Medical Electrical Equipment, Part 2: Particular requirements for the safety of . maqnetic resonance equipment for medical diagnosis
- . IEC 62304, Medical device software - Software life cycle processes
Additional Non-clinical Testing
Additional laboratory testing included:
- High Contrast Spatial Resolution .
- Estimation of the Ratio of Peak Local (10g average) SAR Values to Whole-Body SAR . (numerical simulation)
Clinical Testing
The Echelon Oval submission includes sample clinical imaging of the head, torso, and extremities using all anatomy coils, as specified in the FDA MRI 510(k) guidance referenced above.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. the ECHELON Oval MRI System is substantially equivalent with respect to hardware, base elements of the software, safety, effectiveness, and functionality to the ECHELON C Magnetic Resonance Imaging System (K083533).
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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The text is in uppercase letters and is evenly spaced around the circle.
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
APR 3 0 2012
Mr. Doug Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K113145
Trade/Device Name: ECHELON Oval MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, and MOS Dated: March 15, 2012 Received: March 16, 2012
Dear Mr. Thistlethwaite:
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
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Page 2
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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K113145
Device Name: ECHELON Oval MRI System
Indications for Use:
The ECHELON Oval MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, 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 diagnosis determination.
Anatomical Region: Head, Body, Spine, Extremities Nucleus excited: Proton Diagnostic uses: T1, T2, proton density weighted imaging Diffusion weighted imaging
MR Angiography Image processing Spectroscopy Whole Body
Prescription Use X (Part 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)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K113145
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