ECHELON SPECTROSCOPY PACKAGE

K071506 · Hitachi Medical Systems America, Inc. · LNI · Jun 28, 2007 · Radiology

Device Facts

• Record ID: K071506
• Device Name: ECHELON SPECTROSCOPY PACKAGE
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: LNI · Radiology
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

Device Story

The Echelon MR Spectroscopy Package is an add-on feature for existing Hitachi Echelon MRI systems. It utilizes standard MR hardware—main magnetic field, gradient coils, RF transmitter, and RF receiver coils—to acquire spectroscopic data via modified spin echo sequences. The system collects NMR data from specific tissue voxels, reflecting proton density, T1/T2 relaxation times, and chemical shift. Data is processed through spectroscopy algorithms to generate spectra, graphs, or spectral images. Operated by trained medical practitioners in clinical settings, the output provides metabolic information to complement conventional MR imaging. This aids clinicians in diagnostic decision-making by offering non-invasive insights into tissue metabolite concentrations.

Clinical Evidence

No clinical data provided; bench testing only. The device relies on the established safety and effectiveness of the underlying Echelon MRI system and the equivalence of the spectroscopy analysis methodology to the predicate device.

Technological Characteristics

Software-based spectroscopy package for MRI systems. Utilizes existing MR hardware (magnets, gradient coils, RF coils). Employs modified spin echo pulse sequences for data acquisition. Data processing involves spectral analysis algorithms to compute metabolite concentrations from NMR properties (proton density, T1, T2, chemical shift).

Indications for Use

Indicated for use in the head and whole body for 1H nuclei excitation to provide metabolite concentration information for diagnostic support.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Picker MR Spectroscopy Package (K991568)

Reference Devices

• Echelon MRI system (K052172)

Submission Summary (Full Text)

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

510(k) Summary:

K071506

## Submitter Information

JUN 2 8 2007

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: [phone]<br>fax: [phone] |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | 5/28/2007 |

## Device Name

| Classification Name: | System, Nuclear Magnetic Resonance Imaging |
|-------------------------|--------------------------------------------|
| Classification Number: | 90LNI |
| Trade/Proprietary Name: | ECHELON MR Spectroscopy Package |
| Predicate Device(s): | Picker MR Spectroscopy Package (K991568) |

## Device Intended Use

The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

This package is indicated for use as follows:

Anatomical Region: Head, whole body 1H Nuclei Excited:

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

# Device Description

MR Spectroscopy is an imaging and analysis feature that can provide unique information about tissue within a human body. Spectroscopy can be used to complement or augment information and images obtained through other MR imaging and analysis techniques.

The acquisition of spectroscopic information is fundamentally the same as for other MR imaging techniques. For example, a modified spin echo sequence is used to collect data for one or more voxels of tissue. This data collection utilizes existing MR hardware and software, for example, the main magnetic field, gradient coils, RF transmitter, RF receiver coils, and memory or "K-Space".

The analysis of the collected data is what differentiates MR Spectroscopy from other more conventional MR imaging and analysis techniques. The data that is collected from the MR pulse sequence as described above is processed through MR spectroscopy algorithms. After computation and analysis on this data, information is displayed for the operator/reviewer. Spectroscopy data may be displayed in multiple ways, for example as data, graphs or images.

## Safety and Effectiveness

The safety and effectiveness of this MR Spectroscopy Package is similar to the predicate device. The addition of this package does not impact the safety and effectiveness of the Echelon MRI system (Cf. K052172).

## Conclusions

It is the opinion of Hitachi Medical Systems America, Inc. that Echelon Spectroscopy Package is substantially equivalent to the listed predicate device. The intended use is identical to the listed predicate device.

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is black and the background is white.

JUN 28 2007

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

Re: K071506

Trade/Device Name: Echelon MR Spectroscopy Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNI Dated: May 28, 2007 Received: June 1, 2007

#### 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 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/2/Picture/9 description: The image is a circular seal with the text "1906-2006" at the top. The letters "PA" are in the center of the seal in a bold, block-like font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the seal.

olosing and Premoting Public Hoalth

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

Page 2 -

Enclosure

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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely vours,

Nancy C. Hogdon

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

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

510(k) Number (if known): Echelon MR Spectroscopy Package Device Name:

#### Indications for Use:

The Hitachi Echelon MR Spectroscopy Package is intended for use as a non-invasive diagnostic device that provides information based on relative concentrations of metabolites in body tissues. This NMR data in the form of spectra or spectral images reflect the NMR properties of proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and chemical shift. When interpreted by a trained medical practitioner, these spectral data provide information that can be useful in making a diagnosis.

Head, Whole Body Anatomical Region: ેન Nucleus excited:

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

Hubert Reisner

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 510(k) Number