QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS

K962117 · Philips Medical Systems (Cleveland), Inc. · LNH · Aug 27, 1996 · Radiology

Device Facts

• Record ID: K962117
• Device Name: QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. The Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures Nuclei Excited: Hydrogen

Device Story

Flexible MRI body coils (Quadrature or Phased Array architecture) designed for Picker 1.5T EDGE MRI systems; receive-only antenna. Device wraps around patient anatomy to improve signal-to-noise ratio, image resolution, and acquisition speed compared to standard body coils. Operates by detecting RF energy signals from hydrogen nuclei; signals processed by MRI system to generate soft tissue images. Used in clinical settings by trained physicians to assist in diagnosis. Output interpreted by physicians to visualize abdominopelvic structures.

Clinical Evidence

No clinical data provided. Substantial equivalence established via bench testing and comparison of technical specifications, antenna configuration, and operational parameters against the predicate device.

Technological Characteristics

Receive-only MRI coils; Quadrature (1 channel) or Phased Array (4 channels) architecture. Antenna configuration: co-rotating saddle coil pairs and loops. Fixed tuning and impedance matching. Active PIN diode decoupling. Enclosure: flame-rated foam and fabric. Designed for Picker 1.5T EDGE MRI system.

Indications for Use

Indicated for imaging of liver, kidneys, adrenal glands, spleen, bilateral hips, and abdominopelvic structures using hydrogen nuclei in patients undergoing MRI examinations.

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

• MAI Quadrature and Phased Array Abdominal Flex Coils (K954190)

Submission Summary (Full Text)

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K 962117

# SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

## 1. General Information

AUG 27 1996

Classification: Class II
Magnetic Resonance Imaging (MRI) Accessory

Common/Usual Name: Magnetic Resonance Imaging (MRI) Coil

Proprietary Name: Quadrature and Phased Array Flexible Body Coils

Establishment Registration: Picker International, Inc.
World Headquarters
595 Miner Road
Cleveland, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965

Performance Standards: Not Applicable

## 2. Intended Uses

The Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system.

The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Quadrature and Phased Array Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures

Nuclei Excited: Hydrogen

PICKER INTERNATIONAL, INC. (FBC) 5/29/96 I - 1

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# 3. Device Description

The Picker Flexible Body Coils have either a Quadrature or Phased Array coil architecture enclosed in a flexible package that can be wrapped around the area of interest. The coils are designed to give improved signal-to-noise ratio, image resolution and image acquisition time over that of the standard EDGE body coil.

# 4. Safety and Effectiveness

The Picker Quadrature and Phased Array Flexible Body Coils are substantially equivalent to the MAI Quadrature and Phased Array Abdominal Flex Coils (K954190) in safety and effectiveness. The following chart has been compiled to demonstrate the Flexible Body Coils substantial equivalence to these devices.

| Parameter | Quadrature and Phased Array Flexible Body Coil | MAI Quadrature and Phased Array Abdominal Flex Coil (K954190) |
| --- | --- | --- |
| Compatible MRI Systems | Picker International 1.5T EDGE | GE 1.5T Signa |
| Mode of Operation | Receive-Only | Receive-Only |
| Antenna Configuration | Quadrature: Co-rotating saddle coil pairs
Phased Array: Co-rotating saddle coils and loops | Quadrature: Co-rotating saddle coil pairs
Phased Array: Co-rotating saddle coils and loops |
| Tuning/Impedance Matching | Fixed tuning and matching. Factory set. | Fixed tuning and matching. Factory set. |
| Method of Decoupling | Active PIN diode decoupling | Active PIN diode decoupling |
| Coil Enclosure | Flame rated foam and fabric | Flame rated foam and fabric |
| Number of Receive Channels | Quadrature: 1
Phased Array: 4 | Quadrature: 1
Phased Array: 4 |

PICKER INTERNATIONAL, INC.
(FBC)
5/28/96

{2}

| Intended Use | The MAI Quadrature and Phased Array Abdominal Flex Coils are indicated for use as a receive only antenna of RF energy at a specific frequency. The signal received by the coil is dependent upon the MRI parameters (T1 or spin-lattice relaxation time, T2 or spin-spin relaxation time, density of nuclei, flow velocity and chemical shift). The images produced by the imaging coil correspond to the distribution of nuclei exhibiting nuclear magnetic resonance.

The Abdominal Flex Coils are intended for use in the following anatomic regions: liver, kidneys, adrenal glands, spleen, bilateral hips and knees, and associated abdominopelvic structures.

The Picker Quadrature and Phased Array Flexible Body Coils do not change the intended use of the Picker 1.5T EDGE system. The 1.5T EDGE system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Flexible Body Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: Liver, kidneys, adrenal glands, spleen, bilateral hips and associated abdominopelvic structures

Nuclei Excited: Hydrogen |
| --- | --- |

PICKER INTERNATIONAL, INC.
(FBC)
5/28/96
I - 3