MATRIX 3000 FLEXIBLE SPINE COIL

K964753 · Us Asia Instruments, Inc. · LNH · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K964753
• Device Name: MATRIX 3000 FLEXIBLE SPINE COIL
• Applicant: Us Asia Instruments, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.

Device Story

Matrix 3000 Flexible Spine Coil; receive-only phased array RF coil for MRI systems. Input: RF signals from thoracic/lumbar spine anatomy. Operation: two-channel quadrature design; wraps around patient; fixed circumference; switching diode decoupling isolates elements during RF transmission. Output: diagnostic MR images. Used in clinical MRI settings; operated by MRI technicians/radiologists. Benefit: enables high-quality spine imaging; non-conductive housing and decoupling prevent RF burns; SAR algorithm limits power deposition.

Clinical Evidence

Bench testing only. No clinical data provided. Safety established via comparison of design, materials, and decoupling mechanisms to predicate devices.

Technological Characteristics

Receive-only phased array RF coil; two-channel quadrature design; vinyl fabric enclosure; switching diode decoupling; non-conductive housing. Designed for 0.23T Outlook MRI system. No internal software/firmware; relies on host system SAR algorithm for power deposition management.

Indications for Use

Indicated for diagnostic imaging of the thoracic and lumbar spine in patients undergoing standard Magnetic Resonance Imaging (MRI).

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

• Flexible Phased Array Spine Coil Picker International (K960497)
• Profile 7000 C-Spine Coils US ASIA Instruments, Inc. (K943440)

Reference Devices

• Outlook Coils Picker International (K945827)

Submission Summary (Full Text)

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FEB 11 1997
K964753

# SECTION 1

## SUMMARY OF SAFETY AND EFFECTIVENESS

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# SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device Name: Magnetic Resonance Imaging Accessory
2. Proprietary Name: Matrix 3000 Flexible Spine Coil
3. Classification: Class II
4. Establishment Registration #: 1529041
5. Manufacture Facility Location: USA Instruments, Inc., 675-B Alpha Drive, Highland Heights, Ohio 44143, USA
Telephone: [phone]; Fax: [phone].
6. Performance Standard: No applicable performance standards have been issued under Section 514 of the Food, Drug and Cosmetic Act.
7. Intended Use: The Flexible Spine Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the thoracic and lumbar spine in Magnetic Resonance Imaging systems. The indications for use are the same as for standard MR Imaging. The Matrix 3000 Flexible Spine Coil is designed for use with the Outlook (0.23Tesla) MRI scanner manufactured by Picker International Inc.
8. Device Description: The Flexible Spine Coil consists of two volume RF coil elements in a quadrature design. The elements and associated circuitry are enclosed in a flexible vinyl enclosure housing. The coil is wrapped around the patient and the ends are connected and locked. The coil has a fixed circumference.

Please Turn Over

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9. Safety and Effectiveness

| Parameter | Matrix 3000 Flexible Spine Coil | Predicate |
| --- | --- | --- |
| Intended Use | Thoracic and Lumbar Spine Imaging Applications | Flexible Phased Array Spine Coil Picker International (K960497) |
| Indications for Use | Identical to routine MRI imaging | Flexible Phased Array Spine Coil Picker International (K960497)
Profile 7000 C-Spine Coils US ASIA Instruments, Inc. (K943440) |
| Coil Enclosure Material | Vinyl Fabric | Flexible Phased Array Spine Coil Picker International (K960497) |
| Coil Design | Two channel receive-only phased array coil | Flexible Phased Array Spine Coil Picker International (K960497) |
| Decoupling | Switching Diode decoupling | Flexible Phased Array Spine Coil Picker International (K960497)
Profile 7000 C-Spine Coils (K943440), US ASIA Instruments, Inc. |
| Prevention of RF Burns | Does not transmit RF Power
Decoupling isolates the coil elements from RF fields during RF transmission
Coil elements and circuitry are enclosed in a non-conductive housing. | Profile 7000 C-Spine Coils (K943440), US ASIA Instruments, Inc.
Flexible Phased Array Spine Coil Picker International (K960497)
Same as other Outlook Coils Picker International (K945827) |
| Radio Frequency Absorption | Coil is a receive only coil and does not transmit RF power.
Power deposition during imaging is limited by SAR algorithm | Profile 7000 C-Spine Coils (K943440), US ASIA Instruments, Inc.
Algorithm used on Outlook system (K945827) |
| Formation of Resonant Loop | Decoupling isolates the coil elements from RF fields during RF transmission
Length of cable and stiffness does not permit looping | Profile 7000 C-Spine Coils (K943440), US ASIA Instruments, Inc.
Flexible Phased Array Spine Coil Picker International (K960497) |

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