MEDRAD QUADRATURE CTL ARRAY COIL

K984159 · Medrad, Inc. · MOS · Jan 12, 1999 · Radiology

Device Facts

• Record ID: K984159
• Device Name: MEDRAD QUADRATURE CTL ARRAY COIL
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jan 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Indications for Use

The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI I he Mediad Quad CTC Anay Coll is a receive and lumbar regions of the spinc anatomy. The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a The Median Quate Of Prefined of Diagnostic Magnetic Resonance Imaging.

Device Story

Receive-only quadrature phased array coil; designed for MR imaging of cervical, thoracic, and lumbar spine. Input: hydrogen nuclei signals during MRI scan. Operation: coil captures RF signals; interfaces with GE Signa and Contour MRI systems via Bendix connector. Output: raw signal data processed by MRI system into 2D/3D images. Used in clinical radiology settings; operated by MRI technicians/radiologists. Facilitates complete spine imaging without patient repositioning; improves diagnostic workflow efficiency.

Clinical Evidence

Bench testing included SNR studies, NEMA-standard image uniformity evaluation, and assessment of static magnetic field/RF field distortion. No significant artifacts observed. Clinical effectiveness demonstrated via submission of clinical images; performance deemed similar to predicate devices based on SNR and image quality results.

Technological Characteristics

Receive-only quadrature phased array coil. Housing: Polyurethane 30% glass-filled (UL 94.5V). Comfort pad: Unifoam S82N (UL 94 HF-1) with Nylon cover (CPAI-84). Interface: Bendix connector. Compatible with GE Signa/Contour MRI systems. No external tuning/matching required. Passive device; no internal energy source.

Indications for Use

Indicated for patients requiring MR imaging of the cervical, thoracic, and lumbar spine regions. Intended for use under the supervision of a physician trained in diagnostic MRI.

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

• Hitachi Quad C-Spine (K954952)
• General Electric (GE) Quad T/L with Positioner Coil (K902663)
• Medrad Phased Array Shoulder Coil (K960901)

Submission Summary (Full Text)

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K 98 4159

JAN 1 2 1999

# 510(k) SUMMARY MEDRAD 0.5T, 1.0T QUAD CTL COILS

| 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 Quadrature CTL Array Coil |
| PREDICATE DEVICES: | Hitachi Quad C-Spine<br>General Electric (GE) Quad T/L with Positioner<br>Coil<br>Medrad Phased Array Shoulder Coil |

# DEVICE DESCRIPTION:

The Medrad Quad CTL Array Coil is a receive only coil designed to enhance the MR Imaging of the thoracic and lumbar regions of the spine 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 is intended to facilitate complete MR imaging of the cervical, thoracic and lumbar regions of the spine without need of patient repositioning of the device.

| Anatomical Region: | cervical, thoracic and lumbar regions of the<br>spine anatomy. |
|--------------------|----------------------------------------------------------------|
| Nuclei Excited: | Hydrogen |
| Diagnostic Uses: | 2D and 3D Imaging |

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#### Proposed Medrad Quad CTL Coil Technical Comparison To Predicate Devices:

The following table compares claims made in regard to the Hitachi Quad C-Spine Coil and the Medrad Quad CTL Coil.

| Hitachi Quad C-Spine<br>Coil (K954952) | GE Quad T/L w/<br>Positioner Coil<br>(K902663) | Medrad PA<br>Shoulder Coil<br>(K960901) | Medrad Quad CTL Coil |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Receive-only Quadrature<br>coil | Receive-only<br>Quadrature coil | Receive-only,<br>Phased Array Coil | Receive-only, Phased<br>Array Quadrature coil. |
| Region of interest includes<br>the area superior to the top<br>of the sella turcica and<br>inferior to the third thoracic<br>vertebrae. Included is the<br>brachial plexus region,<br>nerve roots and CSF. | Region of interest<br>includes the thoracic<br>and lumbar regions of<br>the spine. | N/A | Region of interest includes<br>the cervical, thoracic, and<br>lumbar regions of the<br>spine. |
| The Quad C-Spine Coil is<br>compatible with the MRH-<br>1500 and Stratis system<br>pulse sequences and<br>imaging options. | The quad T/L w/<br>Positioner coil is<br>compatible with all<br>Signa and Contour<br>System pulse<br>sequences and<br>appropriate imaging<br>options. | The PA Shoulder coil<br>is compatible with all<br>Signa System pulse<br>sequences and<br>appropriate imaging<br>options. | The quad CTL coil is<br>compatible with all Signa<br>and Contour System pulse<br>sequences and<br>appropriate imaging<br>options. |
| No external tuning, or<br>matching, is necessary<br>since the coil is matched to<br>the recommended anatomy<br>of interest. | No external tuning, or<br>matching, is necessary<br>since the coil is<br>matched to the<br>recommended anatomy<br>of interest. | No external tuning,<br>or matching, is<br>necessary since the<br>coil is matched to the<br>recommended<br>anatomy of interest. | No external tuning, or<br>matching, is necessary<br>since the coil is matched<br>to the recommended<br>anatomy of interest. |
| The coil plugs into the<br>system via three BNC<br>connectors | The coil plugs into a<br>common slip connector. | The coil uses a<br>Bendix connector for<br>the MRI Scanner<br>interface. | The coil uses a Bendix<br>connector for the MRI<br>Scanner interface. |

### Proposed Medrad Quad CTL Coil Technical Comparison to Predicate Devices (Cont.):

| Patient contacting materials comparison information | | |
|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Hitachi Quad C-Spine Coil | GE Quad T/L w/ Positioner Coil<br>Medrad PA Shoulder Coil | Medrad Quad CTL Coil |
| The housing material is made<br>from Royalite ABS, Fire Rated<br>UL94V-0 | The housing material is made from<br>Royalite ABS, Fire Rated UL94V-0 | The housing material is made<br>from Polyurethane 30% Glass<br>Filled, Fire Rated UL 94.5V |
| Comfort pad material is made<br>of Unifoam S82N, Fire Rated<br>UL 94 HF-1 with a PVC Film<br>vinyl film fire rated cover. | Comfort pad material is made of<br>Recticel Foam (6 lb. density, Fire Rated<br>UL 94V HF1 with a PVC Film vinyl or<br>Nylon fire rated cover. | Comfort pad material is made<br>of Unifoam S82N, Fire Rated<br>UL 94 HF-1 with a Nylon cover,<br>Fire Rated CPAI-84. |

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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 1.0T QUADRATURE CTL ARRAY Coil. Due to the different platforms of the predicated devices, a direct comparison between the proposed device and the predicate devices could not be completed.

IMAGE UNIFORMITY - The Medrad Quad CTL Array 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.

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 Quad CTL Array Coil.

CLINICAL EVALUATION - Clinical images for the proposed 1.0T Quad CTL Array Coil have been provided with this submission to demonstrate the clinical effectiveness of the Quad CTL Array coils. Based on these results, and the SNR results for the proposed 1.0T Quad CTL Array Coils, Medrad concludes that the 0.5T and 1.0T Quad CTL Array Coils will produce similar clinical image results.

CONCLUSION - Extensive safety, verification, durability and clinical testing was conducted on the predicate GE and/or Hitachi devices. (K954952, K902663 and K960901) The proposed device is deemed by Medrad to be substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1999

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

Re:

K984159

Medrad Quadrature CTL Array Coil Dated: November 18, 1998 Received: November 19, 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 (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 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 requlatory 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.gov/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

Image /page/3/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird-like figure.

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# 510 (k) NUMBER (IF KNOWN): K 98 4159

Medrad Quad CTL Array Coil DEVICE NAME:

INDICATIONS FOR USE:

The Medrad Quad CTL Array Coil is a receive only coil intended to be used MRI I he Mediad Quad CTC Anay Coll is a receive and lumbar regions of the spinc anatomy.

The Medrad Quad CTI. Array Coil is intended for use only under the supervision of a The Median Quate Of Prefined of Diagnostic Magnetic Resonance Innaging.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--|--------------------------------------------------------|
|--|--------------------------------------------------------|

Prescription Use __________ OR Over-The Counter-Use __________

(Per 21 CFR 801.109) (Optional Format 1-2-96)

| | (Division Sign-Off) |
|---------------|--------------------------------------------------------------------|
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K984159 |