The ECHELON Rapid Cardiac Coil is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.

Device Description

The ECHELON Rapid Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.
The ECHELON Rapid Cardiac Coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

AI/ML Overview

This document describes a 510(k) premarket notification for the ECHELON Rapid Cardiac Coil, a receive-only, multiple array coil for magnetic resonance imaging. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device requiring extensive performance studies with specific acceptance criteria and detailed clinical trial data.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as it pertains to a de novo approval process or performance claim, is largely not applicable to this 510(k) submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance: This submission does not define specific performance metrics with acceptance criteria, as it's a substantial equivalence claim. The "device performance" is implicitly that it functions similarly to the predicate device for cardiac MRI. The coil's specification document (DCA # 2-001017) is stated to contain requirements for supporting contrast-enhanced MRA for the heart and surrounding vasculature, as well as cardiac perfusion studies, which the coil is designed to acquire.
Sample Size and Data Provenance: Not applicable. No clinical study data from a "test set" is presented in this 510(k) submission to evaluate performance against acceptance criteria. The submission focuses on device characteristics and intended use.
Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth establishment with experts is typically for evaluating diagnostic accuracy or clinical utility in a performance study, which is not the focus of this 510(k).
Adjudication Method: Not applicable for the same reasons as above.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. No comparative effectiveness study, especially one involving human readers with and without AI assistance, is mentioned or conducted as such studies are beyond the scope of a 510(k) for an MRI coil.
Standalone (Algorithm Only) Performance Study: Not applicable. This device is a hardware component (an MRI coil), not an algorithm or AI system.
Type of Ground Truth Used: Not applicable. Since there's no clinical performance study presented that requires ground truth for diagnostic accuracy, no specific type of ground truth is mentioned.
Sample Size for Training Set: Not applicable. This is a hardware device; there is no AI algorithm being "trained" in this context.
How Ground Truth for Training Set Was Established: Not applicable for the same reasons as above.

Summary of available information related to performance and equivalence:

The submission focuses on demonstrating substantial equivalence to the Predicate Device: MR-RCC-150 Cardiac Coil (K063513).

The core argument for equivalence is stated as:

"The technological characteristics of the ECHELON Rapid Cardiac Coil are exactly the same to the predicate device as listed in Section 10 - Substantial Equivalence Discussion." (Section not provided in the input, but this is the claim).
The coil specification document (DCA # 2-001017) outlines requirements for the coil to support contrast-enhanced MRA for the heart and surrounding vasculature, and cardiac perfusion studies. The submission states that "a design requirement of the coil is the ability to acquire these images."

In essence, the "study" proving the device meets its acceptance criteria (which are primarily related to functional equivalence and technical specifications) is the design and engineering process that ensured the coil's technological characteristics and intended uses match those of the predicate device, as documented in internal specifications like DCA # 2-001017. The FDA's 510(k) clearance confirms that, based on the submitted information, the FDA found the device substantially equivalent to its predicate.

Summary

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Submitter Information		FEB 25 2011
Submitter:	Hitachi Medical Systems America, Inc.1959 Summit Commerce ParkTwinsburg, Ohio 44087-2371TEL: (330) 425-1313FAX: (330) 963-0749
Contact:	Douglas J. Thistlethwaite
Date:	January 14, 2011

Device Name

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	ECHELON Rapid Cardiac Coil
Predicate Device:	MR-RCC-150 Cardiac Coil (K063513)

Device Intended Use

Device Description

Function

The ECHELON Rapid Cardiac Coil is a receive only RF phased array coil, used for obtaining diagnostic images of the cardiac region, in an open Magnetic Resonance Imaging (MRI) system.

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

The ECHELON Rapid Cardiac Coil is a receive-only coil designed to contour to the outline of the shoulder. The coil consists of 12 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

Device Technological Characteristics

The technological characteristics of the ECHELON Rapid Cardiac Coil are exactly the same to the predicate device as listed in Section 10 - Substantial Equivalence Discussion.

Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. that the ECHELON Rapid Cardiac Coil is substantially equivalent to the listed predicate device.

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Contrast Agent Use

K110120- ECHELON Rapid Cardiac Coil
Hitachi Medical Systems America, Inc
Contact: Doug Thistlethwaite

Feature	Predicate
The Coil Specification Document (DCA # 2-001017)contains requirements that the coil support acquisition ofcontrast-enhanced MRA for the heart and surroundingvasculature as well as cardiac perfusion studies. The coildoes not include these protocols; a design requirement ofthe coil is the ability to acquire these images.	K063513 - EchelonTM MR-RCC-150 Cardiac Coil

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Mr. Doug Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087

FEB 2 5 2011

Re: K110120

Trade/Device Name: ECHELON Rapid Cardiac Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: January 14, 2011 Received: January 18, 2011

Dear Mr. Thistlewaite:

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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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 vou 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,

Mary S Postel

Mary Pastel, ScD. 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):

Device Name: ECHELON Rapid Cardiac Coil

Indications For Use:

The ECHELON Rapid Cardiac Coll is a receive-only, multiple array coil used for magnetic resonance imaging of the musculoskeletal structures, soft tissue and vascular structures of various anatomic regions. It is designed to be used the Hitachi ECHELON 1.5T MRI system.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Ove r-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OIVD Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Shibb

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K 110120

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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.