MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS

K052827 · Medrad, Inc. · MOS · Nov 1, 2005 · Radiology

Device Facts

• Record ID: K052827
• Device Name: MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.

Device Story

Receive-only phased array coil; used with Siemens 1.5T MRI scanners. Captures MR signals from intracranial, extracranial, neurovascular, skull base, and C-spine regions. Facilitates imaging and spectroscopy without patient or coil repositioning. Operated by MRI technicians/radiologists in clinical imaging environments. Output consists of raw MR signal data processed by the host MRI system to generate diagnostic images. Benefits include reduced scan time and improved workflow by eliminating need for scan room intervention between imaging sequences.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Phased array receive-only coil. Housing: Polyurethane (UL 94V-0). Pads: Polyurethane foam/Ethylene Vinyl Acetate foam with Guardian coating (C-117 fire rated). Connectivity: Cable sockets for Siemens 1.5T MRI table. No external tuning/matching required.

Indications for Use

Indicated for patients requiring MR imaging or spectroscopy of intracranial, extracranial, neurovascular, skull base, and C-spine regions using Siemens 1.5T MRI scanners.

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 8-Receiver Phased Array Neurovascular Coil (K023569)

Submission Summary (Full Text)

{0}------------------------------------------------

## K052827

## NOV - 1 2005

## 510(k) Summary

| OFFICIAL CONTACT: | Lisa A. Ewing<br>Regulatory Affairs Specialist<br>MEDRAD, INC.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] Ext. 3780 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Device<br>(21 CFR 892.1000, Product Code MOS) |
| COMMON NAME(S): | Magnetic Resonance Coil |
| PROPRIETARY NAME: | MEDRAD 8-Receiver Phased Array<br>Neurovascular Coil for Siemens |
| PREDICATE DEVICE: | MEDRAD 8-Receiver Phased Array<br>Neurovascular Coil (K023569) |
| INTENDED USE: | The MEDRAD Phased Array Neurovascular Coil<br>is a receive-only coil intended to be used with<br>Siemens 1.5T MRI Scanners. The coil will<br>facilitate complete MR imaging, including<br>spectroscopy, of the intracranial/extracranial,<br>neurovascular, skull base and C-spine regions<br>without moving the patient or the coil; i.e., no scan<br>room intervention. |
| | DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE: |

The MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.

The following comparison tables identify the similarities and differences between the new device and the predicate device.

{1}------------------------------------------------

Comparison of MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)

| Feature | (Predicate)<br>MEDRAD 8-Receiver Phased<br>Array Neurovascular Coil for<br>GE | (Proposed)<br>MEDRAD 8-Receiver Phased<br>Array Neurovascular Coil for<br>Siemens |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Coil Type | Phased array receive-only coil. | Phased array receive-only coil. |
| Region of Interest | Vertex of the skull to the aortic<br>arch | Vertex of the skull to the aortic<br>arch |
| Compatibility | All phased array GEMS 1.5T<br>Signa Excite platforms with 8-<br>receiver capability. All Signa<br>system pulse sequences and<br>appropriate imaging options. | All phased array Siemens 1.5T<br>platforms with 8-receiver<br>capability. All Siemens system<br>pulse sequences and<br>appropriate imaging options. |
| Tuning | No external tuning, or matching,<br>is necessary, since the coil is<br>matched to the recommended<br>anatomy of interest. | No external tuning, or matching,<br>is necessary, since the coil is<br>matched to the recommended<br>anatomy of interest. |
| System Connection | Coil plugs into the GE MRI<br>system by way of the phased<br>array quick disconnect port. | Coil plugs into the Siemens MRI<br>system by way of cable sockets<br>in the patient table. |
| Imaging<br>Configurations | High resolution head, parallel<br>imaging Fast Brain,<br>Neurovascular, C-Spine (user<br>optional), Volume Neck (user<br>optional), high resolution Head<br>and C-Spine (user optional) | High resolution Head, Neck, or<br>Head + Neck (Full), depending<br>on user-selected coil elements |

Comparison of Patient-Contacting Materials in MEDRAD 8-Receiver Phased Array Neurovascular Coil for GE (Predicate) and MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens (Proposed)

| | (Predicate)<br>MEDRAD 8-Receiver Phased<br>Array Neurovascular Coil for<br>GE | (Proposed)<br>MEDRAD 8-Receiver Phased<br>Array Neurovascular Coil for<br>Siemens |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Housing | Housing material is made from<br>polyurethane; fire rated UL 94V-0 | Housing material is made from<br>polyurethane; fire rated UL 94V-0 |
| Comfort pad,<br>positioning pads,<br>knee pad | Comfort, positioning and knee<br>pad material is made from<br>polyurethane foam sprayed with<br>a Guardian coating and is fire<br>rated to C-117 | Comfort, positioning and knee<br>pad material is made from<br>polyurethane foam sprayed with<br>a Guardian coating and is fire<br>rated to C-117 |
| Table pad | N/A | Table pad material is made from<br>Ethylene Vinyl Acetate foam<br>sprayed with a Guardian coating<br>and is fire rated to C-117 |

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Public Health Service

NOV - 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa A. Ewing Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780 Re: K052827

Trade/Device Name: MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 4, 2005 Received: October 7, 2005

Dear Ms. Ewing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number:

K052827

Device Name:

MEDRAD 8-Receiver Phased Array Neurovascular Coil for Siemens

Indications for Use:

The MEDRAD Phased Array Neurovascular Coil is a receive-only coil intended to be used with Siemens 1.5T MRI Scanners. The coil will facilitate complete MR imaging, including spectroscopy, of the intracranial/extracranial, neurovascular, skull base and C-spine regions without moving the patient or the coil; i.e., no scan room intervention.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lygum

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number

Page 1 of 1

- 6 -