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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ECHELON Oval MRI System:

Summary of Acceptance Criteria and Reported Device Performance

The ECHELON Oval MRI System is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet. The submission focuses on demonstrating substantial equivalence to its predicate device, the ECHELON C Magnetic Resonance Imaging System (K083533), rather than setting specific independent performance acceptance criteria. The "acceptance criteria" are implicitly met by demonstrating that the new device performs at least as well as, and adheres to the same standards as, the predicate and relevant industry standards.

Therefore, the table below reflects the relevant standards and the nature of the "reported device performance" as demonstrating compliance.

Acceptance Criteria (Standards/Tests)	Reported Device Performance (Compliance/Result)
Non-Clinical Testing:	Compliance Demonstrated:
NEMA MS 1, Determination of Signal-to-noise Ratio (SNR) in Diagnostic Magnetic Resonance Images	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 2, Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 3, Determination of Image Uniformity in Diagnostic Magnetic Resonance Images	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 4, Acoustic Noise Measurement Procedure for Diagnostic Magnetic Resonance Imaging Devices	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 5, Determination of Slice Thickness in Diagnostic Resonance Imaging	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 7, Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Diagnostic Magnetic Resonance Imaging Devices	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
NEMA MS 8, Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 60601-1-1, Collateral Standard: Safety Requirements for Medical Electrical Systems	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 60601-1-2, Collateral standard: Electromagnetic compatibility - Requirements and tests	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 60601-1-4, Collateral Standard: Programmable electrical medical systems	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 60601-2-33, Particular requirements for the safety of magnetic resonance equipment for medical diagnosis	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence.
IEC 62304, Medical device software - Software life cycle processes	ECHELON Oval was subjected to this test; reported findings allow for a conclusion of substantial equivalence. The software operating system was changed from Windows XP to Windows 7.
High Contrast Spatial Resolution	Additional laboratory testing performed; reported findings allow for a conclusion of substantial equivalence.
Estimation of the Ratio of Peak Local (10g average) SAR Values to Whole-Body SAR (numerical simulation)	Additional laboratory testing performed (numerical simulation); reported findings allow for a conclusion of substantial equivalence. The maximum RF power was increased from 20 kW to 40 kW, and the maximum output current of the gradient amplifier from 550 A to 700 A, necessitating this evaluation.
Clinical Testing:	Compliance Demonstrated:
Sample clinical imaging of the head, torso, and extremities using all anatomy coils (as specified in FDA MRI 510(k) guidance, 1998 November 14)	"The Echelon Oval submission includes sample clinical imaging of the head, torso, and extremities using all anatomy coils". This demonstrates the device's ability to produce diagnostically useful images across its intended anatomical regions, maintaining substantial equivalence to the predicate.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a specific numerical count of patients or images for the clinical testing. The document states "sample clinical imaging of the head, torso, and extremities using all anatomy coils."
- Data Provenance: Not specified (e.g., country of origin). The testing seems to be conducted by Hitachi Medical Systems America, Inc., implying internal or contracted testing associated with USA operations. The clinical imaging is presented as "sample clinical imaging," which could be prospective or retrospective, but the document does not clarify. It does not appear to be a large-scale clinical trial in the traditional sense, but rather a demonstration of imaging capabilities.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. For an MRI system, the "ground truth" to determine image quality and diagnostic utility would typically involve expert interpretation (e.g., radiologists) comparing images to clinical findings or other diagnostic modalities, but details are absent. The document only states that images "provide information that can be useful in diagnosis determination" when "interpreted by a trained physician."
Adjudication method for the test set:
- This information is not provided. Given the nature of the submission (demonstrating substantial equivalence through compliance with technical standards and providing "sample clinical imaging"), a formal adjudication method for a test set of diagnosable cases is not described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission is for an MRI system, not an AI-powered diagnostic tool. The purpose is to demonstrate the system's ability to produce high-quality diagnostic images, substantially equivalent to a predicate MRI system. There is no mention of AI assistance or human reader performance improvement.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is an MRI system, not an algorithm, and is intended to be interpreted by a human physician ("When interpreted by a trained physician").
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical (phantom) tests, the "ground truth" is derived from the established physical properties and measurements required by the NEMA and IEC standards (e.g., actual SNR values, known dimensions for geometric distortion, etc.).
- For the "sample clinical imaging," the specific "ground truth" method for evaluating diagnostic utility is not explicitly stated. It can be inferred that expert interpretation of images relative to established medical knowledge or other clinical data served as an implicit "ground truth," but the document does not detail this process.
The sample size for the training set:
- This information is not applicable/not provided. The device is an MRI hardware system, not a machine learning algorithm that requires a "training set" in the traditional sense. The software operating system was updated, but the core image reconstruction and processing capabilities are stated to be "identical to the predicate device" in terms of "base elements of the system software."
How the ground truth for the training set was established:
- This information is not applicable/not provided as there is no mention of a training set for an AI algorithm.

Summary

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Submitter Information

Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371ph: (330) 425-1313fax: (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 .

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Device Description

Function

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.

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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

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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

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Indications for Use

510(k) Number (if known): K113145

Device Name: ECHELON Oval MRI System

Indications for Use:

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

Page 1 of

Regulation Number and Section

§ 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.