ESTEEM 1.5T MRI SYSTEM

K962677 · Elscint Mr, Inc. · LNH · Sep 20, 1996 · Radiology

Device Facts

• Record ID: K962677
• Device Name: ESTEEM 1.5T MRI SYSTEM
• Applicant: Elscint Mr, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body MRI system for producing cross-sectional images of the internal structures of the head, body or extremities in transverse, sagittal, coronal or oblique planes. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) and image appearance is determined by proton density, NMR relaxation time (T1 and T2) and flow. When interpreted by a trained physician, these images yield information that can be useful in determination of a diagnosis, surgery planning or therapy planning.

Device Story

The Esteem 1.5T MRI system is a whole-body magnetic resonance imaging device. It utilizes static magnetic fields, RF pulses, and gradient fields to excite protons in the body, measuring NMR relaxation times (T1, T2) and proton density to generate cross-sectional images. The system includes updated hardware, specifically 4-element receive-only phased array coils for pelvic and body imaging, and various specialized surface coils (spine, shoulder, TMJ). System electronics were modified to support four RF channels for phased array operation. Operated by trained technicians/physicians in clinical settings, the system provides images for interpretation by physicians to assist in diagnosis and treatment planning. The device benefits patients by providing non-invasive internal structural visualization.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

1.5T static magnetic field strength; 4-channel RF system; phased array and surface coils (receive-only); MR operating system Rev 4.0. Safety specs: dB/dt <20T/s; SAR <2 W/kg (whole body), <3.2 W/kg (head); acoustic noise <105dBA.

Indications for Use

Indicated for patients requiring cross-sectional imaging of the head, body, or extremities for diagnostic, surgical, or therapy planning purposes.

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

• Esteem 1.5T MRI System (K942953)

Submission Summary (Full Text)

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SENT BY:FT COLLINS, CO 9-16-96 ; 2:46PM ; ELSCINT MR INC 301 480 4224;# 2/ 3
SEP 20 1996
K962677

Summary of Safety and Effectiveness

The following information is made available pursuant to the requirements of the Safe
Medical devices Act of 1990.

1. Submitter: Elscint MR, Inc.
2555 Midpoint Drive
Fort Collins, CO 80521
Tel: [phone]
Fax: [phone]

Contact: Elizabeth F. Lowder, Director of Quality and Programs

Date: July 3, 1996

2. Trade/Proprietary Name: Esteem 1.5T MRI System

Common Name: Magnetic Resonance Imaging System

Classification Name: Magnetic Resonance Diagnostic Device

3. Predicate device: Esteem 1.5T MRI System (described in
K942953)

4. Device Description:

The Elscint Esteem 1.5T MRI system is designed as a general purpose whole-body
MRI system for producing cross-sectional images of the internal structures of the
head, body or extremities in transverse, sagittal, coronal or oblique planes. The
images produced by the MR system reflect the spatial distribution of protons
(hydrogen nuclei) and image appearance is determined by proton density, NMR
relaxation time (T1 and T2) and flow. When interpreted by a trained physician,
these images yield information that can be useful in determination of a diagnosis,
surgery planning or therapy planning.

The major components changed or updated over that described in he predicate
device submission are:

- A semi-flexible 4-element receive-only phased array pelvic coil for improved pelvic
imaging.

- A semi-flexible 4-element receive-only phased array body coil for improved imaging
of the liver, kidneys and hips.

- Additional receive-only surface coils for imaging the spine, shoulder, pelvis, and
temperomandibular joint:

{1}

SENT BY:FT COLLINS. CO
9-16-96

- A circular polarized spine coil to increase image performance in the thoracic and lumbar spine when compared to the lumbar spine coil.
- A single loop shoulder coil pair for improved patient comfort and general utility. Large and small coils for patients of different sizes are provided.
- A circular polarized pelvic coil to improve performance in imaging pelvic anatomy compared to the body coil alone.
- A bilateral TMJ coil for specialized imaging of the temperomandibular joint.

In addition, the existing system electronics which contained two RF channels per system has been modified to operate with four RF channels including switching and selection mechanisms for Phased Array operation.

## 5. Safety and Performance Parameters

Safety parameters unchanged from the predicate device described in K942953 are as follows:

Static magnetic field strength: 1.5T
Rate of change or magnetic field (dB/dt): &lt;20T/s
RF Power absorption (SAR): &lt;2 W/kg, whole body average
&lt;3.2 W/kg, head average
Acoustic noise: &lt;105dBA, L_sq 1 hour average

Performance parameters are substantially equivalent to the predicate device with the following changes and enhancements shown in the table below:

| Parameter | Predicate Device | Updated Value |
| --- | --- | --- |
| Lumbar spine coil | R-only surface | R-only surface, circularly polarized |
| Neck coil | TR Helmholtz | R-only Helmholtz |
| Shoulder Coil | R-only surface saddle shape | R-only surface circular shape, 2 sizes |
| Pelvic Coil | none | R-only Helmholtz |
| TMJ Coil | none | R-only surface pair |
| 4-Element Pelvic Array | none | 4-element receive-only phased array coil |
| 4-Element Body Array | none | 4-element receive-only phased array coil |
| MR operating system | Rev. 3.0 | Rev. 4.0 |