MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE

K053042 · Medrad, Inc. · MOS · Nov 17, 2005 · Radiology

Device Facts

• Record ID: K053042
• Device Name: MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Nov 17, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 1.5T Pelvic Imaging System 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 colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the 1.5T Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.

Device Story

The MEDRAD 1.5T Pelvic Imaging System Interface Device is an accessory for MRI systems. It functions as an interface between MEDRAD 1.5T disposable endorectal coils and GE Signa EXCITE 1.5T MRI scanners. The device enables the use of endorectal coils in conjunction with GE 8- or 12-channel body array coils. It provides RF signal pre-amplification for the endorectal coil, unlike the predicate which relied on the scanner's preamplifier. The device is operated by trained healthcare professionals in a clinical imaging environment. By facilitating the integration of specialized endorectal coils with high-performance scanners, it allows for high-resolution imaging and spectroscopy of pelvic structures, aiding in diagnostic assessment of the colon, cervix, and prostate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only surface coil interface. Integrates with 1.5T GE Signa EXCITE MRI scanners and 8- or 12-channel body array coils. Features active and passive decoupling. Includes an integrated RF signal preamplifier for the endorectal coil. Does not require production-set tuning.

Indications for Use

Indicated for high-resolution MRI and spectroscopy of the human colon, cervix, or prostate and surrounding pelvic tissue in patients requiring pelvic imaging. Intended for use by trained healthcare professionals.

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 ATD-T Interface Device (K974438)

Submission Summary (Full Text)

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## 510(k) Summary

## NOV 17 2005

KD53042

OFFICIAL CONTACT:

CLASSIFICATION NAME:

COMMON NAME(S):

PROPRIETARY NAME:

PREDICATE DEVICE:

INTENDED USE:

Lisa A. Ewing Regulatory Affairs Specialist MEDRAD, INC. One Medrad Drive Indianola, PA 15051 [phone] Ext. 3780

Magnetic Resonance Diagnostic Device (21 CFR 892.1000, Product Code MOS)

Magnetic Resonance Diagnostic Accessory

MEDRAD 1.5T Pelvic Imaging System Interface Device

MEDRAD, INC. 1.5T ATD-T Interface Device (K974438)

The 1.5T Pelvic Imaging System is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution maqnetic resonance imaqing. includina spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the 1.5T Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body array coils. Only trained healthcare professionals are intended to operate this device.

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The MEDRAD 1.5T Pelvic Imaging System Interface Device maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device.

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

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Comparison of Features and Principles of Operation in MEDRAD 1.5T ATD-T (Predicate) and MEDRAD 1.5T Pelvic Imaging System Interface Device (Propser)

| Feature | (Predicate)<br>MEDRAD 1.5T ATD-T | (Proposed)<br>MEDRAD Pelvic Imaging<br>System Interface Device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Scanner Interface | 1.5T GE Signa scanners | 1.5T GE Signa EXCITE<br>scanners |
| Coil Interfaces | MEDRAD 1.5T Endorectal Coils,<br>GE 4-channel Torso Array | MEDRAD 1.5T Endorectal Coils,<br>GE 8- or 12-channel Body Array |
| Decoupling | Active and passive | Active and passive |
| RF Signal<br>Pre-Amplification | Performed by the scanner for<br>both the Endorectal Coil and the<br>Torso Array. | Performed by the interface<br>device for the Endorectal Coil<br>(RF output from Body Array is<br>already preamplified). |
| Tuning | Requires tuning to be set in<br>production since ATD-T uses<br>system preamplifier for signal<br>amplification. | 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 a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle with three curved lines forming its body and wings. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged around the upper perimeter of the circle.

Public Health Service

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: K053042

NOV 1 7 2005

Trade/Device Name: MEDRAD 1.5T Pelvic Imaging System Interface Device Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: October 27, 2005 Received: October 28, 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 (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 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. Brigdon

Nancy 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

510(k) Number:

K 053042

Device Name: MEDRAD 1.5T Pelvic Imaging System Interface Device

## Indications for Use:

The 1.5T Pelvic Imaging System 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 colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the Pelvic Imaging System is to provide interface and support functions to allow the use of MEDRAD 1.5T disposable endorectal coils with GE Signa EXCITE 1.5T MRI scanner systems and body 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)

David R. Segerson

Division of Reproductive. 510(k) Numb

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