FLEXIBLE PHASED ARRAY SPINE COIL

K960497 · Philips Medical Systems (Cleveland), Inc. · LNH · Jul 5, 1996 · Radiology

Device Facts

• Record ID: K960497
• Device Name: FLEXIBLE PHASED ARRAY SPINE COIL
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.

Device Story

Flexible Phased Array Spine Coil; receive-only phased array coil for MRI systems. Input: MR signals from thoracic/lumbar spine. Operation: solenoid and saddle coil elements encased in flexible vinyl; active PIN diode decoupling isolates elements from transmitted RF. Output: MR image data for clinical interpretation. Used in clinical MRI suites; operated by MRI technologists/radiologists. Benefits: flexible design allows wrapping around patient for improved positioning and image coverage. Safety: non-conductive enclosure; does not transmit RF power; SAR algorithm limits power deposition.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness established through comparison of design, materials, and operational parameters (decoupling, SAR management) to predicate devices.

Technological Characteristics

Two-channel receive-only phased array coil; solenoid and saddle elements; flexible vinyl enclosure. Active PIN diode decoupling. Energy source: MRI system RF. Connectivity: proprietary interface to MRI system. Sterilization: N/A.

Indications for Use

Indicated for patients requiring MR imaging of the thoracic and lumbar spinal regions.

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 Extended Coverage Head Coil (K893619)
• Outlook Body Coil (K945827)

Submission Summary (Full Text)

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JUL - 5 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
K960497

1. General Information

Classification: Class II
Magnetic Resonance (MR) Imaging System

Common/Usual Name: MRI Receive-Only Coil

Proprietary Name: Flexible Phased Array Spine Coil

Establishment Registration:
Manufacturer:
Picker Nordstar, Inc.
P.O. Box 33
FIN-0051 Helsinki, FINLAND
Phone: [phone]
Fax: [phone]
FDA Facility Registration #9680194

United States Representative:
Picker International, Inc.
595 Miner Road
Cleveland, OH 44143
FDA Owner Number: #1580240

Performance Standards
No applicable performance standards have been used under section 514 of the Food, Drug and Cosmetic Act.

2. Intended Uses
The Flexible Phased Array Spine Coil is designed to provide coverage of the thoracic and lumbar spinal regions of the body. The indications for use are the same as for standard MR imaging.

3. Device Description
The Flexible Phased Array Spine Coil is a phased array coil package consisting of a solenoid and a saddle coil element. All elements and associated circuitry are enclosed in a flexible vinyl enclosure.

The patient is wrapped with the coil allowing for ease of patient positioning. The coil has a fixed circumference and attaches by snapping the ends together.

PICKER INTERNATIONAL, INC. (FPASC) (2/1/96) I-1

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# 4. Safety and Effectiveness

SUBSTANTIAL EQUIVALENCE CHART

| PARAMETER | FLEXIBLE SPINE COIL | PREDICATE |
| --- | --- | --- |
| Coil Enclosure Material | Vinyl fabric | Same as material uses in Picker Extended Coverage Head Coil (K893619) |
| Coil Design | Two-channel receive-only phased array coil | Outlook Body Coil is a receive-only phased array coil (K945827) |
| Decoupling | Active PIN diode decoupling | Same as Body Coil for Outlook (K945827) |
| Formation of Resonant Loops | The length of the cable and its stiffness does not permit looping. | N/A |
| Potential for RF burns | Does not transmit RF power.
Coil elements and associated circuitry encased in non-conductive material.
Decoupling isolates the coil elements from transmitted RF. | Same as other Outlook Coils (K945827) |
| Radio Frequency Absorption | Power deposition during imaging is limited by the SAR algorithm. | Algorithm used on Outlook system (K945827) |
| Intended Use | Thoracic and Lumbar spine regions. | Body Coil for Outlook (K945827) |
| Indications for Use | Same as for standard MR imaging. | Body Coil for Outlook (K945827) |

PICKER INTERNATIONAL, INC. (FPASC) (2/1/96)