Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.

Device Description

The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF coil for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.

The General-purpose coil consists of two independent parts A and B. The two parts can be used individually or together. The main body of each coil is housed in a flexible structure to conform to the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.

AI/ML Overview

This document (K061950) is a 510(k) premarket notification for the HHF1™ Echelon™ Multi-purpose Coil, a component of an MRI system, not a standalone AI device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methods for an AI or imaging diagnostic algorithm.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (T/R Body coil cleared in HHF1 Echelon MRI System, Cf. K052172).

Here's why the requested information is absent:

No AI/Algorithm: The device is a "receive-only" radiofrequency (RF) coil for an MRI system. It detects MR signals. It is not an imaging algorithm or an AI-powered diagnostic device.
Substantial Equivalence: The 510(k) submission seeks to demonstrate that the new coil is "substantially equivalent" to an already legally marketed predicate device. This typically involves showing similar technological characteristics and intended use, rather than conducting new performance studies that would generate the kind of data you're asking for.
Performance Data Type: While the document describes the scientific concepts of MRI, it does not present performance metrics (like sensitivity, specificity, AUC) that would be relevant for an AI diagnostic tool. It describes the physical and functional characteristics of the coil.

Therefore, it is not possible to fill in the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, or ground truth based on the provided text. The document does not describe a study proving the device meets acceptance criteria in the context of an AI-driven diagnostic.

Summary

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

Ko6 1950

AUG 1 8 2006

Section 2 510(k) Summary of Safety and Effectiveness

: 11:

11 24522 1 82

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

K06 150

Submitter Information

Submitter:

Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park Twinsburg, Ohio 44080-2371 ph: (330) 425-1313 fax: (330) 425-1410

Contact:

July 5, 2006

Douglas J. Thistlethwaite

Date:

Device Name

Classification Name:	Coil, magnetic resonance, specialty
Classification Number:	90MOS
Trade/Proprietary Name:	HHF1™ Echelon™ Multi-purpose Coil
Predicate Device(s):	T/R Body coil cleared in HHF1 Echelon MRISystem (Cf. K052172)

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 general-purpose coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and 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 are as follows:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.

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

Device Description

Function

The HHF Echelon Multi-purpose Coil (hereby referred to as GP coil) is a receive only RF The THT Dencion Mana Frontaining diagnostic images of the abdominal 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 Magnetic resolutios maging (incre) them to act as small spinning bar magnets. The most electionagietic properties that caseen, which makes it the primary nuclei currently used in ubiquitous of these nations in a static magnetic field, these nuclei assume a magnetic robenance mith the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength vector. The magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, Cause a to origination or their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This revaries with the onaracter vacterized by two exponential relaxation times, called T1 and T2.

A RF emission or echo that can be measured accompanies these relaxation events. The receive coil detects these emissions which are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the rechoes 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 y, and 2 directions, and vistibution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.

Physical and Performance Characteristics

The General-purpose coil consists of two independent parts A and B. The two parts can be r no Gellerar parpose overher. The main body of each coil is housed in a flexible structure to used individually of the body. The coil consists of a single element. The signal output of each part is independently processed by the system to enhance performance.

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

Device Technological Characteristics

The technological characteristics of this device are similar to the predicate device.

Conclusions

It is the opinion of Hitachi Medical Systems America that the HHF1™ Echelon™ Multipurpose Coil is substantially equivalent to the T/R Body coil cleared in HHF1 Echelon MRI System (Cf. K052172). The technological characteristics and intended use are identical to the Predicate Device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 8 2006

Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America 1959 Summit Commerce Park TWINSBURG OH 44087-2371

Re: K061950

Trade/Device Name: HHF1 Echelon Multi-purpose Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: July 5, 2006 Received: July 10, 2006

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 either class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/4/Picture/10 description: The image is a black and white circular logo or seal. The text "1906 - 2006" is at the top of the circle. The letters "PA" are in the center of the circle in a stylized font. The word "Centennial" is below the letters "PA". Three stars are at the bottom of the circle.

Protecting and Promoting Public Health

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

Page 2 -

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 (QS) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

1166 1950 510(k) Number (if known): Device Name: HHF1 Echelon Multi-purpose Coil

Indications for Use:

Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures in various anatomic regions.

Prescription Use	X	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)

(Division Sign-Off)	Nancy Brogdon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K061950

Page 1 of 1

Section 3
Page 2 of 2

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.