MEDRAD PHASED ARRAY NEUROVASCULAR COIL

K984257 · Medrad, Inc. · MOS · Jan 25, 1999 · Radiology

Device Facts

• Record ID: K984257
• Device Name: MEDRAD PHASED ARRAY NEUROVASCULAR COIL
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jan 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy. The Medrad Phased Array Neurovascular Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

Device Story

Receive-only phased array MR imaging surface coil; enhances head and neck anatomy visualization. Input: hydrogen nuclei signals during MRI scan. Operation: coil captures signals for 2D/3D imaging; connects to GE Superconducting MRI scanners via phased array quick disconnect port. Used in clinical MRI suites; operated by trained MRI technicians/physicians. Output: raw signal data processed by MRI system into diagnostic images. Benefit: enables complete neurovascular/C-Spine imaging without patient repositioning. Healthcare providers use images for diagnostic assessment of neurovascular structures.

Clinical Evidence

Clinical images provided to demonstrate effectiveness. Bench testing included Signal-to-Noise Ratio (SNR) studies, NEMA-standard image uniformity evaluation, and assessment of static magnetic field/RF field distortion. No significant artifacts or geometric distortion observed.

Technological Characteristics

Receive-only phased array quadrature coil. Materials: Glass Filled Polyester (UL 94V-0), Kydex (UL 94V-0), cotton/urethane comfort pad (CAL 117). Connectivity: Phased array quick disconnect port for GE Superconducting MRI scanners. No external tuning/matching required. Passive device; no internal energy source.

Indications for Use

Indicated for patients requiring MR imaging of intracranial/extracranial neurovascular, skull base, and C-Spine anatomy. Intended for use under physician supervision.

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 Neurovascular Coil (K981094)
• Medrad Phased Array Shoulder Coil (K960901)

Submission Summary (Full Text)

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K984257

# 510(k) SUMMARY MEDRAD 1.5T PHASED ARRAY NEUROVASCULAR COIL

| OFFICIAL CONTACT: | Jim Ferguson, Jr.<br>Sr. Regulatory Affairs Associate<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] Ext. 3326 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Accessory<br>[21 CFR 892.1000} |
| COMMON/USUAL NAME: | MR Imaging Surface Coil |
| PROPRIETARY NAME: | Medrad Phased Array Neurovascular Coil |
| PREDICATE DEVICES: | Medrad Neurovascular Coil<br>Medrad Phased Array Shoulder Coil |

# DEVICE DESCRIPTION:

The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.

#### INTENDED USE:

The Medrad Quadrature CTL Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without need for repositioning the coil on the patient.

| Anatomical Region: | intracranial/extracranialNeurovascular, skull<br>base and C-Spine |
|--------------------|-------------------------------------------------------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |

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## 510(k) Summary Medrad PHASED ARRAY NEUROVASCULAR Page 2 of 3

### Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison To Predicate Device:

The following table compares claims made in regard to the Medrad 1.5T Neurovascular Coil to the Medrad 1.5T Neurovascular Array Coil

| Medrad 1.5T<br>Neurovascular Coil<br>(K981094) | Medrad Phased Array<br>Shoulder Coil (K960901) | Medrad 1.5T Neurovascular<br>Array Coil |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Quadrature Transmit-<br>Receive Coil | Phased Array Receive-Only<br>Coil | Phased Array Receive-only<br>Quadrature coil. |
| Region of interest covers<br>the top of the brain to the<br>aortic arch. | *N/A | Region of interest covers the<br>top of the brain to the aortic<br>arch. |
| The Neurovascular coil is<br>compatible with all Signa<br>System pulse sequences<br>and appropriate imaging<br>options. | *N/A | The Neurovascular Array coil is<br>compatible with all Signa<br>System pulse sequences and<br>appropriate imaging options. |
| No external tuning, or<br>matching, is necessary<br>since the coil is matched to<br>the recommended anatomy<br>of interest. | *N/A | No external tuning, or<br>matching, is necessary since<br>the coil is matched to the<br>recommended anatomy of<br>interest. |
| The coil plugs into the MRI<br>System by way of the Head<br>Coil quick disconnect port | *N/A | The coil plugs into the MRI<br>System by way of the Phased<br>Array quick disconnect port |

* This predicate device is being used to substantiate the technology equivalence to the proposed device only.

#### Proposed Medrad 1.5T Neurovascular Array Coil Technical Comparison to Predicate Devices (Cont.):

| Patient contacting materials comparison information | |
|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Medrad 1.5T Neurovascular Coil | Medrad 1.5T Neurovascular Array Coil |
| The housing material is made from Glass<br>Filled Polyester; Fire Rated UL 94V-0 | The housing material is made from Glass<br>Filled Polyester; Fire Rated UL 94V-0 and<br>Kydex, Fire Rated UL 94V-0 |
| Comfort pad material is made with a<br>Buellidyne coating and are fire rated UL-94<br>HFI. | Comfort Pad material is made with a cotton<br>material embedded with urethane and is fire<br>rated to CAL 117 |

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# PERFORMANCE TEST DATA:

SIGNAL TO NOISE RATIO (SNR) - A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio of the proposed Medrad 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device.

IMAGE UNIFORMITY - The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images.

GEOMETRIC DISTORTION: None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present.

TRANSMIT RF FIELD [B1] DISTORTION - Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging.

RESOLUTION. SLICE THICKNESS, AND CONTRAST - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad PHASED ARRAY NEUROVASCULAR.

CLINICAL EVALUATION - Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate Medrad devices. (K960901, K981094) The proposed device is deemed by Medrad to be substantially equivalent.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 25 1999

Jim Ferguson, Jr. Sr. Regulatory Affairs Associate Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780

Re:

K984257

Medrad 1.5T Phased Array Neurovascular Coil Dated: November 25, 1998 Received: November 30, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Mr. Ferguson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATION FOR USE

510(k) Number:_ K984257

Medrad 1.5T Phased Array Neurovascular Coil Device Name:

Indications for Use/Intended Use:

The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.

The Medrad Phased Array Neurovascular Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Seggern

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D

510(k) Number K984257

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)