MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL

K964854 · Medrad, Inc. · MOS · Feb 11, 1997 · Radiology

Device Facts

• Record ID: K964854
• Device Name: MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Feb 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of shoulder region and the upper and lower extremities with a specific size and shape to facilitate placement on the anatomy area of interest. This placement results in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices. The intended ROI for imaging includes the anterior and posterior musculoskeletal area of the shoulder and the upper and lower extremities. The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremity regions. Patient fitness and suitability for MRI must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.

Device Story

Rigid RF receive-only magnetic field pickup coil; interfaces with GEMS Signa System multi-coil port. Captures RF excitation from hydrogen nuclei protons; enhances signal-to-noise ratio (SNR) for high-resolution diagnostic imaging of shoulder, upper, and lower extremities. Used in clinical MRI settings under supervision of trained diagnostic imaging physicians. Output is high-resolution MR image data; aids physician diagnosis of musculoskeletal anatomy. Benefits include improved image clarity and morphological detail via smaller field of view and thinner slices.

Clinical Evidence

Bench testing included SNR evaluation per NEMA Standard No. 6, image non-uniformity characterization, temperature rise testing under moderate duty cycles, and IEC 601-1 dielectric strength testing. Clinical evidence consisted of imaging studies comparing the subject device to the predicate to substantiate equivalent SNR and morphological detail.

Technological Characteristics

Rigid RF receive-only phased array coil; ABS outer housing; Velcro fasteners. Compatible with GEMS 1.5T Signa Super Conductor scanners. Phased array architecture; dual loop anterior with optional posterior paddle. No external tuning/matching required. Designed to limit surface temperature to <41°C. Non-ferrous construction.

Indications for Use

Indicated for anatomical imaging of the shoulder region and upper and lower extremities in patients undergoing MRI procedures on GEMS 1.5T Super Conductor systems. Patient suitability for MRI must be determined by a physician trained in Diagnostic Magnetic Resonance Imaging.

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

• Medrad Phased Array 1.5T Shoulder Imaging Surface Coil (K960901)

Submission Summary (Full Text)

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FEB 11 1997

K964854

# ATTACHMENT VIII

## SMDA 510(K) SUMMARY

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MEDRAD TECHNOLOGY FOR PEOPLE®

# 510(k) SUMMARY

## MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL

| OFFICIAL CONTACT: | Rodney J. Rylands
Medrad, Inc.
One Medrad Drive
Indianola, PA 15051
[phone] Ext. 3778 |
| --- | --- |
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory[21 CFR 892.1000] |
| COMMON/USUAL NAME: | MRI Surface Coil |
| PROPRIETARY NAME: | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil |
| PREDICATE DEVICES: | Medrad Phased Array 1.5T Shoulder Imaging Surface Coil - K960901 |

## DEVICE DESCRIPTION:

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is a rigid RF receive only magnetic field pickup coil that is designed to enhance imaging of the human shoulder and the upper and lower extremities. It consists of an anterior and posterior coils which interfaces with the multi-coil port on the GEMS Signa System. The coil is intended for use in all imaging planes, with a field of view (FOV) of at least 12 centimeters and less than 25 centimeters.

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is designed to provide high resolution diagnostic images under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.

The ABS outer housing of the coil has been designed to provide an enduring enclosure for the coil electrical components. Durability tests are conducted to verify the integrity of the coil structure. Additionally, the coil will not contain any ferrous nickel, ferrite or other magnetic materials which would negatively impact coil performance. The coil is also designed to assure that the components of the coil that come into contact with the patient will not have surface temperatures exceeding 41 degrees Celsius as a result of heating due to dielectric losses.

Medrad, Inc. • 271 Kappa Drive • Pittsburgh, PA 15238-2870 • [phone] • FAX [phone]
Quality for Life

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medrad TECHNOLOGY FOR PEOPLE.

# DEVICE DESCRIPTION (cont.):

Medrad, Inc. believes the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is substantially equivalent to the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil identified in 510(k) - K960901. The proposed Phased Array 1.5T Shoulder Imaging Surface Coil is the same coil that was determined Substantially Equivalent in 510(k) - K96090. This 510(k) is being submitted for addition of upper and lower extremities imaging to the Intended Use of the device and for the addition of an optional third coil(posterior paddle) to the device.

# INTENDED USE:

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is for use only with the GEMS family of Super Conductor MR Systems. An anterior loop pair is combined with a posterior loop. The coil is designed to receive RF excitation from the protons of the hydrogen nuclei as a result of the scanner exciting these protons. The coil is designed for anatomical imaging of shoulder region and the upper and lower extremities with a specific size and shape to facilitate placement on the anatomy area of interest. This placement results in a higher Signal To Noise Ratio(SNR) in the region near the surface coil. The greater SNR permits more effective imaging through the use of a smaller FOV and thinner slices.

The intended ROI for imaging includes the anterior and posterior musculoskeletal area of the shoulder and the upper and lower extremities.

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil is intended to aid physician diagnosis in the shoulder, upper, and lower extremity regions.

Patient fitness and suitability for MRI must be determined by the individual physician trained in the field of Diagnostic Magnetic Resonance Imaging.

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MEDRAD
TECHNOLOGY FOR PEOPLE

# TECHNOLOGICAL CHARACTERISTICS
## COMPARISON WITH PREDICATE DEVICES:

| PHASED ARRAY SHOULDER COIL | PHASED ARRAY SHOULDER COIL |
| --- | --- |
| Proposed Device | K960901 - Predicate Device |
| Compatible with GE 1.5T Signa, Super Conductor Scanners - Phased Array Architecture. | Same |
| Receive only dual loop anterior phased array coil. | Receive only dual loop anterior phased array coil with an optional third loop - posterior coil. |
| Plugs into GE Signa System via Phased Array quick disconnect port. | Same |
| No external tuning or matching is necessary. | Same |
| Intended Uses:
Anatomical Region - Shoulder
Nuclei Excited - Hydrogen 2D and 3D Imaging | Intended Uses:
Anatomical Region - Shoulder, Upper and lower extremities
Nuclei Excited - Hydrogen 2D and 3D Imaging |
| PATIENT CONTACTING MATERIALS COMPARISON INFORMATION | |
| ABS | ABS |
| Velcro Hook/ Latch Fastener | Velcro Hook/ Latch Fastener |

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medrad

PERFORMANCE TEST DATA:

## SIGNAL TO NOISE RATIO(SNR):

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated using National Electric Manufacturer's Association (NEMA) Standard No. 6, Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images.

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated with a loaded phantom to determine the SNR.

## IMAGE NON-UNIFORMITY TESTING:

The Medrad Phased Array 1.5T Shoulder Imaging Surface Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image, and the coronal image.

## TEMPERATURE RISE AND DIELECTRIC STRENGTH SAFETY TESTS:

Safety tests were conducted to present temperature rise test results under moderate duty cycle scan conditions, and also to produce IEC 601-1 dielectric strength test results.

## CLINICAL TESTING:

Images were obtained with the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil to substantiate equivalent SNR and morphological detail with the predicate coil.

## CONCLUSION:

Extensive safety, verification, durability, and clinical testing was conducted with the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil to substantiate the claims of the proposed device and to verify that the proposed device is substantially equivalent to the predicate device.

Image clarity, morphological detail and increased SNR demonstrate that the Medrad Phased Array 1.5T Shoulder Imaging Surface Coil will produce the required detailed resolution in surface coil imaging.