3.0T PROSTATE IMAGING SYSTEM

K051349 · Medrad, Inc. · MOS · Jun 23, 2005 · Radiology

Device Facts

• Record ID: K051349
• Device Name: 3.0T PROSTATE IMAGING SYSTEM
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Jun 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 3.0T Prostate 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 prostate gland and surrounding pelvic tissue. The 3.0T Prostate Imaging System is intended for use with Siemens 3.0T Trio scanner platforms only. Only trained healthcare professionals are intended to operate this device.

Device Story

The 3.0T Prostate Imaging System is a receive-only surface coil designed for high-resolution MRI and spectroscopy of the prostate gland and pelvic tissue. It functions as an accessory to Siemens 3.0T Trio MRI scanners. The system includes an endorectal coil (with an inflatable balloon for positioning) and an interface device. The endorectal coil is inserted into the rectum by a trained healthcare professional; the balloon is inflated with air or fluid to ensure proper contact. The device captures RF signals from the prostate region, which are pre-amplified by the interface device and transmitted to the MRI scanner for image reconstruction. The resulting high-resolution images assist clinicians in visualizing prostate anatomy and pathology, facilitating diagnostic decision-making. The device benefits patients by providing enhanced image quality compared to standard external coils, potentially improving the accuracy of prostate evaluations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Receive-only surface coil; materials include natural latex (balloon), PVC (shaft/migration stop), and Teflon/FEP (shrink tubing). Operates at 3.0T field strength. Features include passive decoupling for the endorectal coil, active/passive decoupling for the interface device, and integrated RF signal pre-amplification. Connects to Siemens 3.0T Trio scanners via a circular RF keyed connector. Fixed tuning set during production.

Indications for Use

Indicated for high-resolution MRI and spectroscopy of the human prostate gland and surrounding pelvic tissue in patients undergoing imaging on Siemens 3.0T Trio scanner platforms. 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 MRInnervu Endorectal Prostate Coil with Probe Interface Device (K926571)
• MEDRAD Flex Interface Device (K971380)

Submission Summary (Full Text)

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Ko51349

## 510(k) Summary

## JUN 2 3 2005

| 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: | 3.0T Prostate Imaging System |
| PREDICATE DEVICES: | MEDRAD MRInnervu Endorectal Prostate Coil<br>with Probe Interface Device (K926571)<br>MEDRAD Flex Interface Device (K971380) |
| INTENDED USE: | The 3.0T Prostate Imaging System is a receive-<br>only coil intended for use as a Magnetic<br>Resonance Diagnostic Device (MRDD) for high-<br>resolution magnetic resonance imaging, including<br>spectroscopy, of the human prostate gland and<br>surrounding pelvic tissue. The 3.0T Prostate<br>Imaging System is intended for use with Siemens<br>3.0T Trio scanner platforms only. Only trained<br>healthcare professionals are intended to operate<br>this device. |

DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE:

The MEDRAD 3.0T Prostate 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 tables identify 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 Endorectal Prostate Coil and Flex Interface Device (Predicates) and MEDRAD 3.0T Prostate Imaging System (Proposed)

| Feature | (Predicates)<br>MEDRAD 1.5T Endorectal Coil<br>and MEDRAD Flex Interface<br>Device | (Proposed)<br>3.0T Prostate Imaging System |
|-------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Coil Type | Receive-only surface coil. | Receive-only surface coil. |
| Region of Interest | Prostate gland and surrounding tissue. | Prostate gland and surrounding tissue. |
| System connection | 6-pin DIN connector from<br>interface device to scanner. | Circular RF keyed connector<br>from interface device to<br>scanner. |
| Endorectal Coil<br>Compatibility | 1.5T MRI scanner platforms. | 3.0T MRI scanner platforms. |
| Interface Device<br>Compatibility | Siemens Vision 1.5T MRI<br>scanners. | Siemens 3.0T Trio MRI<br>scanners. |
| Decoupling | Active and passive (interface<br>device). | Passive (endorectal coil); active<br>and passive (interface device). |
| Tuning | Fixed tuning set in production. | Fixed tuning set in production. |
| RF Signal<br>Pre-Amplification | Performed by the scanner. | Performed by the interface<br>device. |
| Endorectal Coil Inner<br>Balloon Inflation<br>Compatibility | Air. | Air or fluid. |

Comparison of Patient-Contacting Materials in MEDRAD 1.5T Endorectal Prostate Coil (Predicate) and MEDRAD 3.0T Endorectal Prostate Coil (Proposed)

| | (Predicate)<br>MEDRAD 1.5T Endorectal<br>Prostate Coil | (Proposed)<br>MEDRAD 3.0T Endorectal<br>Prostate Coil |
|--------------------------------------|--------------------------------------------------------|-------------------------------------------------------|
| Outer balloon | Natural Latex | Natural Latex |
| Shaft | PVC | PVC |
| Shrink tubing | Teflon (FEP) | Teflon (FEP) |
| Migration stop (affixes to<br>shaft) | PVC | PVC |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

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

Re: K051349 Trade/Device Name: MEDRAD 3.0T Prostate Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device -Regulatory Class: II Product Code: MOS Dated: May 23, 2005 Received: May 24, 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.

JUN 2 3 2005

:

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) This letter will anow you to begin matters. 37 your device of your device to a legally prematket noutication: "The PDF maing or our 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 If you desire specific acrree to your be 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 Also, prease note the regulation entitled, to mation on your responsibilities under the Act from the 807.77). Tournal 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. Brogdon

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

K051349 510(k) Number:

Device Name:

MEDRAD 3.0T Prostate Imaging System

## Indications for Use:

The 3.0T Prostate 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 prostate gland and surrounding pelvic tissue. The 3.0T Prostate Imaging System is intended for use with Siemens 3.0T Trio scanner platforms only. 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)

Nancy Broadon
(Division Sign-Off)

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

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