MINI FLEX COIL

K961628 · W. L. Gore & Associates, Inc. · MOS · Sep 5, 1996 · Radiology

Device Facts

• Record ID: K961628
• Device Name: MINI FLEX COIL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: MOS · Radiology
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.

Device Story

Miniflex Coil; receive-only MRI surface coil; compatible with GE 1.5T SIGNA MRI scanner. Antenna structure: two figure-eight shaped coils in flexible, fabric-covered material; conforms to anatomy; secured with flexible straps. Used in clinical imaging settings by radiology staff. Enhances signal reception compared to standard body coils by conforming to specific body parts. Biocompatible patient-contact materials. Decoupling via active or passive diodes; cable length prevents resonant loop formation; no RF transmission capability minimizes RF burn risk.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Receive-only MRI surface coil; two figure-eight antenna loops; flexible GORE-TEX fabric housing; active/passive diode decoupling; cable length optimized to prevent resonant loops; non-transmitting (passive) design; biocompatible materials.

Indications for Use

Indicated for patients requiring MRI imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil is appropriate.

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

• General Purpose Flex Coil (K924349)
• Phased Array Torso Coil (K911806A)

Submission Summary (Full Text)

{0}

K961628 (Miniflex Coil) - Requested Information
W.L. Gore & Associates, Inc.
August 21, 1996
Confidential Information

SEP 5 1996

K961628

# PREMARKET NOTIFICATION SUMMARY

1. Applicant: W.L. Gore & Associates, Inc.
4747 Beautiful Lane, Bldg II
Phoenix, AZ 85044
Phone: [phone]

Contact: Dawn Lopez, Associate
Date of Preparation: August 20, 1996

2. Applicant Device: Miniflex Coil

Common Name: MRI Surface Coil

Classification
Name: Magnetic Resonance Imaging Accessory

3. Predicate Devices:

For the purposes of determining substantial equivalence cites the following as predicate devices:

| Predicate Device | Reference | Manufacturer |
| --- | --- | --- |
| General Purpose Flex Coil | K924349 | General Electric Medical System |
| Phased Array Torso Coil | K911806A | General Electric Medical System |

4. Applicant Device Description:

The Miniflex Coil is a receive-only coil designed for use with General Electric Medical System's 1.5T SIGNA MRI Scanner. The coil is designed to give better imaging quality than would be possible with the Body Coil, by maximizing signal reception by closely conforming to the specific body part to be imaged.

The physical structure of the antenna consists of two figure-eight shaped coils in a flexible, fabric-covered material. This allows the coil to bend, making it easy to wrap around the anatomy of interest. The coil is fastened to the patient with flexible straps. All patient-contact materials are biocompatible

{1}

K961628 (Miniflex Coil) - Requested Information
W.L. Gore & Associates, Inc.
August 21, 1996
Confidential Information
K16 102P

and were chosen to maximize patient comfort. User instructions are contained in the User Manual provided with each device.

## 5. Intended Use:

The Miniflex Coil is indicated for use in magnetic resonance imaging of the elbow, wrist, ankle, foot, orbits, or other body parts where a flexible coil may be employed.

## 6. Technological Characteristics:

The table below presents some of the basic comparative characteristics of the applicant device and its cited predicate devices:

| Parameter | Applicant Device: Miniflex Coil | Predicate Device: General Purpose Flex Coil | Predicate Device: Phased Array Torso Coil |
| --- | --- | --- | --- |
| Method of Market Entry | K961628 | K924349 | K911806A |
| Patient-Contact Material | GORE-TEX® Fabric | Same | Same |
| Compatible MRI System | GE SIGNA 1.5T MRI Scanner | Same | Same |
| Mode of Operation | Receive Only | Same | Same |
| Method of Decoupling | Active or passive diode decoupling | Active diode decoupling | Active diode decoupling |
| Formation of resonant loops | Length of cable is sized to prevent formation of resonant loops | Same | Same |
| Potential for RF burns | Coil does not transmit RF - decoupling isolates elements from transmitted RF | Same | Same |
| Imaging Quality | Good to Excellent, compared to predicate devices | N/A | N/A |