FLEXART TMJ COIL

K961624 · Toshiba America Mri, Inc. · LNH · Oct 18, 1996 · Radiology

Device Facts

• Record ID: K961624
• Device Name: FLEXART TMJ COIL
• Applicant: Toshiba America Mri, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Device Story

Flexart™ Bilateral TMJ Coil; accessory for magnetic resonance imaging (MRI) systems. Device captures radiofrequency signals from TMJ region; transforms signals into anatomical images via MRI system processing. Used in clinical radiology settings; operated by MRI technicians/radiologists. Output viewed on MRI console; assists clinicians in diagnosing TMJ pathology. Benefits include high-resolution imaging of TMJ structures for improved diagnostic accuracy.

Clinical Evidence

Bench testing only. Performance parameters provided include signal-to-noise ratios (Transaxial: 167, Coronal: 154, Sagittal: 224) and safety metrics (static field strength 0.5T, RF power deposition 0.256 W/kg). Uniformity, geometric distortion, and slice profiles remain unchanged from predicate systems.

Technological Characteristics

Bilateral TMJ surface coil for MRI. Materials consistent with previously cleared Toshiba coils. Operates at 0.5 Tesla static field strength. RF power deposition 0.256 W/kg. Acoustic noise 89.5-94.5 dB. Connectivity via standard MRI coil interface. No changes to tuning/detuning schemes.

Indications for Use

Indicated for patients with general disease of the temporomandibular joints (TMJs).

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

• 100mm surface coil (K933018)
• MRT-150A Bilateral TMJ Coil (K943021)

Reference Devices

• MRT-50GP (K933018)

Submission Summary (Full Text)

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Appendix A

# 510(k) Summary

K961624

OCT 18 1996

Date: 23 April 1996

Submitter: Toshiba America MRI, Inc.
280 Utah Avenue
South San Francisco, CA 94080

Contact: Steven M. Kay
[phone]

Classification Name: Magnetic Resonance Device Accessory - Bilateral TMJ Coil

Classification: Class II-90LNH, per 21 CFR 892.1000

Device Tier: 2, according to the December 15, 1993 DRAERD Triage Pilot Program

Common Name: Bilateral TMJ Coil

Proprietary Name: Flexart™ Bilateral TMJ Coil

Model Name: Flexart™

Establishment Registration Number: 2936923

## Applicable Performance Standards:

None, although this device follows the requirements of the current Guidance for the Content and Review of a Magnetic Resonance Diagnostic Device 510(k) Application.

## Substantial Equivalence Summary:

The new Flexart™ Bilateral TMJ Coil is compared to the 100mm surface coil cleared with the Flexart™ 510(k) K933018 and the MRT-150A Bilateral TMJ Coil cleared in K943021. The coils share similar Signal-to-Noise ratios, attachment schemes, tuning and detuning schemes and safety parameters. The Flexart™ Bilateral TMJ Coil does not change the previously cleared safety parameters of the Flexart™ system. Manufacturing methodology and software verification and validation procedures for the Flexart™ remain unchanged. Patient contact materials are the same as those previously cleared for other Toshiba coils.

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# Safety Parameters

Maximum Static Field Strength: 0.5Tesla
Rate of Change of Magnet Field: 6.97 T/s axial, 10.64 T/s transverse, with T>700 microseconds
Radiofrequency Power Deposition: 0.256 W/kg
Acoustic Noise Levels: 89.5 - 94.5 Typical

Note: Safety parameters of the Flexart are not changed from those cleared in the MRT-50GP 510(k) K933018.

# Imaging Performance Parameters

1. Specification volume: 10 cm dsv head, 20 cm dsv body
2. Signal to Noise Ratio (typical):
- Transaxial: 167
- Coronal: 154
- Sagittal: 224
3. Uniformity: Unchanged
4. Geometric Distortion: Unchanged
5. Slice profile in the orthogonal planes: Unchanged
6. Slice thickness: Unchanged
7. Interslice spacing: Unchanged

# Indications for Use

General disease of the TMJs