ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL

K081745 · Hitachi Medical Systems America, Inc. · MOS · Aug 12, 2008 · Radiology

Device Facts

• Record ID: K081745
• Device Name: ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL
• Applicant: Hitachi Medical Systems America, Inc.
• Product Code: MOS · Radiology
• Decision Date: Aug 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

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 detect 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-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device . used for MRI imaging of the lower body region. - The MR-RFC-150, ECHELON RAPID Foot Coil is a receive-only multiple array device . used for MRI imaging of the feet. - The MR-RKC-150N, ECHELON RAPID Knee Coil is a receive-only multiple array device used for MRI imaging of the knee.

Device Story

ECHELON RAPID Specialty Coils (PV, Foot, Knee) are receive-only multiple array MRI coils. Devices detect MR signals from hydrogen nuclei in static magnetic fields; signals are spatially encoded via magnetic field gradients. Output consists of raw MR signal data processed by the host MRI system to reconstruct cross-sectional images. Used in clinical settings by trained physicians to provide diagnostic information. Benefits include non-invasive visualization of internal body structures without ionizing radiation. PV Coil features 16 elements; Foot Coil features 8 channels; Knee Coil features 12 channels. Signals from each element are independently processed by the MRI system to enhance image performance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only multiple array MRI coils. PV Coil: 16 elements. Foot Coil: 8 channels. Knee Coil: 12 channels. Independent signal processing per element. Compatible with existing MRI system reconstruction techniques.

Indications for Use

Indicated for MRI imaging of the lower body region (PV Coil), feet (Foot Coil), and knee (Knee Coil) in patients requiring non-invasive diagnostic imaging.

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

• MR-RBC-150N
• ECHELON RAPID Torso Coil

Submission Summary (Full Text)

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

K081745

### Submitter Information

| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44087-2371<br>ph: [phone]<br>fax: [phone] | | AUG 12 2008 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| Contact: | Douglas J. Thistlethwaite | | |
| Date: | June 12, 2008 | | |
| Device Name | | | |
| Classification Name: | Coil, magnetic resonance, specialty | | |
| Classification Number: | 90MOS | | |
| Trade/Proprietary Name: | ECHELON RAPID PV Coil | | |
| Predicate Device(s): | MR-RBC-150N, ECHELON RAPID Torso Coil | | |
| Classification Name: | Coil, magnetic resonance, specialty | | |
| Classification Number: | 90MOS | | |
| Trade/Proprietary Name: | ECHELON RAPID Foot Coil | | |
| Predicate Device(s): | MR-RBC-150N, ECHELON RAPID Torso Coil | | |
| Classification Name: | Coil, magnetic resonance, specialty | | |
| Classification Number: | 90MOS | | |
| Trade/Proprietary Name: | ECHELON RAPID Foot Coil | | |
| Predicate Device(s): | MR-RBC-150N, ECHELON RAPID Torso 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 detect 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-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device . used for MRI imaging of the lower body region.
- The MR-RFC-150, ECHELON RAPID Foot Coil is a receive-only multiple array device . used for MRI imaging of the feet.
- The MR-RKC-150N, ECHELON RAPID Knee Coil is a receive-only multiple array � device used for MRI imaging of the knee.

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

## Device Description

#### Function

The MR-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device used for MRI imaging of the lower body region.

The MR-RFC-150. ECHELON RAPID Foot Coil is a receive-only multiple array device used for MRI imaging of the feet.

The MR-RKC-150N. ECHELON RAPID Knee Coil is a receive-only multiple array device used for MRI imaging of the knee.

#### 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

The MR-RHC-150N, ECHELON RAPID PV Coil is a receive-only device suitable for imaging the lower body region. The coil consists of 16 elements. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-RBC-150N. ECHELON RAPID Foot Coil is a receive-only device suitable for imaging feet. The coil consists of 8 channels. The signal output of each element is independently processed by the MRI system to enhance performance.

The MR-RBC-150N, ECHELON RAPID Knee Coil is a receive-only device suitable for imaging the knee. The coil consists of 12 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 RAPID PV Coil, ECHELON RAPID Foot Coil, and ECHELON RAPID Knee 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 RAPID PV Coil, ECHELON RAPID Foot Coil, and ECHELON RAPID Knee Coil are substantially equivalent to the listed predicate devices.

. .

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 2 2008

Mr. Doug Thistlewaite Manager, Regulatory Affairs Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087-1313

Re: K081745

Trade/Device Name: ECHELON PV Coil, Foot Coil, and Knee Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 13, 2008 Received: June 19, 2008

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. Iisting 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 (PMA), 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.

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

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 not 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 liasing (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 I ogally marketed predicate device results in a classification for your device and thus, verse to volu 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDRH s Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Division of One Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.btml

Sincerely yours,

Nancy Brogdon

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

Enclosure

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

510(k) Number (if known): ECHELON RAPID PV Coil Device Name:

#### Indications for Use:

The MR-PVC-150, ECHELON RAPID PV Coil is a receive-only multiple array device used for MRI imaging of the lower body region.

Prescription Use × AND/OR

Over-the-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lunen

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices ് ' ()(k) Number __

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

510(k) Number (if known): ECHELON RAPID Foot Coil Device Name:

#### Indications for Use:

The MR-RFC-150, ECHELON RAPID Foot Coil is a receive-only multiple array device used for MRI imaging of the feet.

Prescription Use × AND/OR

Over-the-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Huko Leun

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

{7}------------------------------------------------

510(k) Number (if known): Device Name: ECHELON RAPID Knee Coil

#### Indications for Use:

The MR-RKC-150N, ECHELON RAPID Knee Coil is a receive-only multiple array device used for MRI imaging of the knee.

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)

Helwteens

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