MEDRAD 3.0T ECOIL IMAGING SYSTEM

K060401 · Medrad, Inc. · MOS · Mar 15, 2006 · Radiology

Device Facts

• Record ID: K060401
• Device Name: MEDRAD 3.0T ECOIL IMAGING SYSTEM
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Mar 15, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The eCoil Imaging System for the GE 3.0T family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.

Device Story

The MEDRAD 3.0T eCoil Imaging System is a receive-only MR diagnostic accessory. It functions as an interface device enabling the use of MEDRAD 3.0T disposable endorectal coils in conjunction with GE 3.0T scanner systems and GE 8-channel Torso Array coils. The system provides necessary support and interface functions, including RF signal pre-amplification for the endorectal coil. It utilizes active and passive decoupling. The device is operated by trained healthcare professionals in a clinical imaging environment. By facilitating high-resolution imaging and spectroscopy of the prostate and pelvic region, the system assists clinicians in diagnostic assessment. It does not require production-set tuning due to the integrated preamplifier.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only surface coil; active and passive decoupling; integrated RF signal pre-amplification; compatible with GE 3.0T scanner systems and GE 8-channel Torso Array coils; does not require production-set tuning.

Indications for Use

Indicated for high-resolution MRI and spectroscopy of human prostate and pelvic tissue. Intended for use by trained healthcare professionals in clinical settings using GE 3.0T scanner systems.

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, INC. 1.5T Pelvic Imaging System Interface Device (K053042)
• MEDRAD, INC. 3.0T Prostate Imaging System (K051349)

Submission Summary (Full Text)

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### Koco401

MAR 1 5 2006

# 510(k) Summary

#### OFFICIAL CONTACT: Lisa A. Ewing Regulatory Affairs Specialist MEDRAD, INC. One Medrad Drive Indianola, PA 15051 [phone] Ext. 3780 CLASSIFICATION NAME: Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Product Code MOS) COMMON NAME(S): Magnetic Resonance Diagnostic Accessory PROPRIETARY NAME: MEDRAD 3.0T eCoil Imaging System PREDICATE DEVICES: MEDRAD, INC. 1.5T Pelvic Imaging System Interface Device (K053042) MEDRAD, INC. 3.0T Prostate Imaging System (K051349) INTENDED USE: The eCoil Imaging System for the GE 3.0T family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The MEDRAD 3.0T eCoil Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate devices.

The following comparison table identifies the similarities and differences between the new device and the predicate devices.

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Comparison of Features and Principles of Operation in MEDRAD 1.5T Pelvic Interface Device for GE (Predicate)
MEDRAD 3.0T Prostale Imaging System Interface Device for Siemens

| Feature | (Predicate)<br>MEDRAD 1.5T Pelvic Imaging<br>System Interface Device | (Predicate)<br>MEDRAD 3.0T Prostate Imaging<br>System Interface Device | (Proposed)<br>MEDRAD 3.0T eCoil Imaging<br>System Interface Device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Coil Type | Receive-only surface coil | Receive-only surface coil | Receive-only surface coil |
| Scanner Interface | 1.5T GE Signa EXCITE<br>scanners | 3.0T Siemens Trio scanners | 3.0T GE family of scanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils,<br>GE 8- or 12-channel Body Array | MEDRAD 3.0T Endorectal Coils | MEDRAD 3.0T Endorectal Coils,<br>GE 8-channel Torso Array |
| Decoupling | Active and passive | Active and passive | Active and passive |
| RF Signal<br>Pre-Amplification | Performed by the interface<br>device for the Endorectal Coil<br>(RF output from Body Array is<br>already preamplified). | Performed by the interface<br>device for the Endorectal Coil | Performed by the interface<br>device for the Endorectal Coil<br>(RF output from Torso Array is<br>already preamplified). |
| Tuning | Does not require tuning to be set<br>in production since interface<br>device has a preamplifier. | Fixed tuning set in production. | Does not require tuning to be set<br>in production since interface<br>device has a preamplifier. |

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Image /page/2/Picture/1 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 symbol resembling a stylized eagle or bird in flight, composed of three curved lines.

Public Health Service

MAR 15 2006

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: K060401 Trade/Device Name: MEDRAD 3.0T eCoil Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 14, 2006 Received: February 15, 2006

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 complive of the Act s requirements, including, but not limited to registration and listing (21 CFR Part 807) valueling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality of your (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 mumber 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/industrv/support/index.html.

Sincerely vours.

. Nancy C. Brigdon

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

Enclosure

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## Indications for Use

KOG 0401 510(k) Number:

Device Name: MEDRAD 3.0T eCoil Imaging System

#### Indications for Use:

The eCoil Imaging System for the GE 3.0T family of scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for highresolution magnetic resonance imaging, including spectroscopy, of the human prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD 3.0T disposable endorectal coils with GE 3.0T family of scanner systems and Torso Array coils. Only trained healthcare professionals are intended to operate this device.

Prescription Use × (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)

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David A. Syam
(Division Sign-Off)

Division of Reproductive, Abdom and Radiological Devices 510(k) Number _

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