The MR-NVC-150N, RAPID Neurovascular (NV) Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso. It is designed to be used the Hitachi Echelon 1.5T MRI system.

The MR-RWC-150N, RAPID Small Extremity Coil is a receive-only multiple array device used for MRI imaging of the extremities. It is designed to be used the Hitachi Echelon 1.5T MRI system.

Device Description

The MR-NVC-150N, ECHELON RAPID Neurovascular Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso.

The MR-RWC-150N. ECHELON RAPID Small Extremity Coil is a receive-only multiple arrav device used for MRI imaging of the extremities.

AI/ML Overview

The provided text describes a 510(k) summary for MRI coils. Based on the document, here's an analysis of the acceptance criteria and the "study" that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or report specific device performance metrics in comparison to such criteria. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the new coils function similarly to the predicate devices and produce images that provide information useful for diagnosis when interpreted by a trained physician.

Acceptance Criteria (Quantitative)	Reported Device Performance (Quantitative)
Not specified in the document	Not specified in the document
Function for MRI imaging	"receive-only multiple array device used for MRI imaging of the upper spine and torso" (MR-NVC-150N)
Function for MRI imaging	"receive-only multiple array device used for MRI imaging of the extremities" (MR-RWC-150N)
Compatibility	"designed to be used [with] the Hitachi Echelon 1.5T MRI system"
Signal processing	"The signal output of each element is independently processed by the MRI system to enhance performance."
Safety	Implied by substantial equivalence to legally marketed predicate devices and compliance with general controls provisions of the Act.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific clinical test set or study with a defined sample size for the new devices (MR-NVC-150N and MR-RWC-150N).

The primary method of demonstrating acceptance is through substantial equivalence to predicate devices (ECHELON RAPID Foot Coil and possibly ECHELON RAPID Small Extremity Coil, though the latter is also a new device in the same submission). This means the manufacturer is asserting that the new devices share fundamental scientific technology and intended use with already-cleared devices, implying that their performance and safety would be comparable. No information is provided regarding data provenance (country of origin, retrospective/prospective) for any specific testing of these devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Since there is no description of a dedicated clinical test set with ground truth established, this information is not applicable or provided in the document. The claim of "useful in diagnosis determination" relies on the general understanding of MRI technology and the assumption that qualified physicians would interpret images produced by these coils, similar to predicate devices.

4. Adjudication Method for the Test Set:

As no specific test set requiring ground truth adjudication is described, this information is not applicable or provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention or describe an MRMC comparative effectiveness study, nor does it discuss any effect size of AI assistance (as AI is not explicitly part of the device's main function here). This submission is for MRI coils, which are hardware components, not software algorithms for image interpretation or enhancement in the AI sense.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The concept of a "standalone" algorithm performance study is not applicable here. The devices are MRI coils, which are physical components of an MRI system and do not operate as standalone algorithms. Their performance is inherently tied to the MR system and subsequent human interpretation.

7. Type of Ground Truth Used:

No specific ground truth (like pathology, expert consensus, or outcomes data) is mentioned as being used to evaluate the new coils directly. The basis for acceptance is substantial equivalence to predicate devices that are already cleared for providing diagnostically useful images.

8. Sample Size for the Training Set:

The document does not describe a training set for the new devices. This is consistent with the nature of the device (MRI coils) and the regulatory pathway (510(k) based on substantial equivalence), which typically doesn't involve training data in the algorithmic sense.

9. How the Ground Truth for the Training Set Was Established:

As no training set is described, this information is not applicable or provided.

Summary

{0}------------------------------------------------

K 102889

510(k) Summary

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:	December 15, 2010 &text-align: left;"> DEC 2 0 2010
Device Name
Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	MR-NVC-150N, ECHELON RAPID NeurovascularAttachment Coil
Predicate Device(s):	ECHELON RAPID Foot Coil
Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	MR-RWC-150N, ECHELON RAPID Small Extremity Coil
Predicate Device(s):	ECHELON RAPID Foot Coil

Device Intended Use

The MR 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 ECHELON Specialty Coils are receive-only devices that defect the MR signal used to produce transverse, coronal, sagittal, oblique, and/or curved cross-sectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The indications for use for the ECHELON Specialty Coils are as follows:

The MR-NVC-150N, RAPID Neurovascular (NV) Attachment Coil is a receive-only . multiple array device used for MRI imaging of the upper spine and torso. It is designed to be used the Hitachi Echelon 1.5T MRI system.
The MR-RWC-150N, RAPID Small Extremity Coil is a receive-only multiple array device . used for MRI imaging of the extremities. It is designed to be used the Hitachi Echelon 1.5T MRI system.

{1}------------------------------------------------

Device Description

Function

The MR-NVC-150N, ECHELON RAPID Neurovascular Attachment Coil is a receive-only multiple array device used for MRI imaging of the upper spine and torso.

The MR-RWC-150N. ECHELON RAPID Small Extremity Coil is a receive-only multiple arrav device used for MRI imaging of the extremities.

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.

Physical and Performance Characteristics

he MR-NVC-150N. ECHELON RAPID Neurovascular Attachment Coil is a receive-only device suitable for imaging of the upper spine and torso. The coil consists of 4 or 7 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-RWC-150N. ECHELON RAPID Small Extremity Coil is a receive-only device suitable for imaging extremities. The coil consists of 5 channels. The signal output of each element is independently processed by the MRI system to enhance performance.

{2}------------------------------------------------

Device Technological Characteristics

The technological characteristics of the ECHELON Neurovascular (NV) Attachment Coil and ECHELON RAPID Small Extremity Coil are similar to the predicate devices as listed in Section 10 - Substantial Equivalence Discussion.

Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. that the ECHELON Neurovascular (NV) Attachment Coil and ECHELON RAPID Small Extremity Coil are substantially equivalent to the listed predicate devices.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Douglas J. Thistlethwaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087

DEC 2 0 2010

Re: K102889

Trade Name: MR-NVC-150N, ECHELSON RAPID Neurovascular Attachment Coil Regulation Number: 21 CFR § 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 19, 2010 Received: November 22, 2010

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, Jrug, 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

{4}------------------------------------------------

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 etter 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 (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premy are 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 tollofre ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

DEC 2 0 2010

510(k) Number K102889 (if known): Device Name: ECHELON RAPID NV Attachment & Small Extremity Coils

Indications for Use:

The MR-RWC-150N, RAPID Small Extremity Coil is a receive-only multiple array device used for MRI imaging of the extremities. It is designed to be used the Hitachi Echelon 1.5T MRI system.

Prescription Use	×	AND/OR	Over-the-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

ه 0 06 100 00

510K-

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.