PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI

K011604 · Ge Medical Systems, Inc. · LNI · Aug 22, 2001 · Radiology

Device Facts

• Record ID: K011604
• Device Name: PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRI
• Applicant: Ge Medical Systems, Inc.
• Product Code: LNI · Radiology
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative acquilities of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.

Device Story

PROSE is an image-guided clinical imaging and spectroscopy software package for GE Signa Magnetic Resonance Scanners. It utilizes a PRESS (Point RESolved Spectroscopy) double spin echo pulse sequence with 90-degree and slice-selective refocusing RF pulses to generate spin echoes from localized prostate volumes. Input data includes localizer images used to prescribe the spectroscopic volume. The software performs water/lipid suppressed hydrogen spectroscopy and multi-voxel imaging. Operated by clinicians in a clinical environment, the system provides high-resolution anatomical images and metabolite concentration data. Physicians interpret these outputs to assist in the diagnosis of prostate diseases. The device enables non-invasive assessment of prostate tissue metabolism.

Clinical Evidence

Bench testing only. Performance verified in a clinical environment. Evaluated for safety per IEC 601-2-33 International medical equipment safety standards for Magnetic Resonance Systems.

Technological Characteristics

Software-based imaging and spectroscopy package for MRI systems. Utilizes PRESS (Point RESolved Spectroscopy) pulse sequence. Hardware requirements include endo-rectal coil with phased-array coils. Operates on GE Signa Magnetic Resonance Scanners.

Indications for Use

Indicated for patients requiring non-invasive imaging and spectroscopic analysis of the prostate gland to assist in the diagnosis of prostate diseases. Used in conjunction with a Magnetic Resonance Scanner and endo-rectal/phased-array coils.

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

• GE Medical Systems PROBE software option (K930265)

Submission Summary (Full Text)

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AUG 2 2 2001

GE Medical Systems

page 1 of 2

PO Box 414, W-709 Milwaukee, WI 53201 USA

## SUMMARY OF SAFETY AND EFFECTIVENESS

- This 510(k) summary of safety and effectiveness information is submitted in o accordance with the requirements of 21 CFR Part 807.87(h).
- o Identification of Submitter Larry A. Kroger, Ph.D., 262-544-3894
- o Identification of the Product PROstate Spectroscopy and imaging Exam (PROSE) software option

| Manufactured by: | GE Medical Systems |
|------------------|-------------------------|
| | 3200 N. Grandview Blvd. |
| | Waukesha, WI 53188 |

- 0 Device Description
PROSE is a version of the PRESS (Point RESolved Spectroscopy), "double" spin echo pulse sequence that uses a 90° and two slice selective refocusing RF pulses to generate a spin echo from a localized volume. PROSE utilizes the standard Graphic Prescription tools and one or more sets of localizer images to determine the size and location of the spectroscopic volume.

- 0 Indications for Use
PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical imaging and spectroscopy package which acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array coils. PROSE option can be used in conjunction with a Magnetic Resonance Scanner to permit non-invasive acquisition of high resolution images and spectral information about relative acquilities of metabolites of prostate gland that can be interpreted by a trained physician, and yield information that may assist in diagnosis of prostate diseases.

Image /page/0/Picture/14 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined in a stylized script. The letters are enclosed within a circular frame that has decorative swirls or flourishes around the perimeter. The logo is presented in black and white.

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GE Medical Systems

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are decorative swirls around the letters, adding a touch of elegance to the design.

page 2 of 2

o

PO Box 414, W-709 Milwaukee, WI 53201 USA

## Comparison with Predicate

The Prostate Spectroscopy and Imaging Exam (PROSE) software option is substantially equivalent to existing scanning, processing and display Substantially oquiration to E Medical Systems PROBE software option (K930265). The PROBE software is modified to deliver improved spatial (1000200). The PRESS volume and extend the use of the PROBE coverage through the Prostate Gland. PROBE is largely limited to the Brain.

## 0 Summary of Studies

The Prostate Spectroscopy and Imaging Exam (PROSE) software option was evaluated to the IEC 601-2-33 International medical equipment safety was Uraldatod to the Resonance Systems. Evaluation testing was done to verify the performance of the option in the clinical environment.

## 0 Conclusions

It is the opinion of GE Medical Systems that the Prostate Spectroscopy and Imaging Exam (PROSE) software option does not result in any new potential hazards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-709 MILWAUKEE WI 53201

Re: K011604

Prostate Spectroscopy and Imaging Exam (PROSE) (Magnetic Resonance Diagnostic System) Dated: May 23, 2001 Received: May 24, 2001_ Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNI

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Section J10(K) noutleation of misen to maxione) to legally marketed predicate devices device is substantally equivacing tor the nations by the enactment date of the Medical Device Amendments, or to devices marketed in interstale commerce provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that like been reclassified in accordance with the provisions of the Act. The general controls provisions of the Act therefore, market the device to the general estates pro not 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 If your device is classified (SC above) into blance electing 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 I tue 21, I als 800 to 092. 11 substantian (QS) for Medical Devices: General regulation (21 CFR Part Practice requirements, as set four in the Quality Dresson on Drug Administration (FDA) will verify such assumptions. Failure 020) and may with the GMP regulation artion. In regulators action. In addition, FDA may publish further announcements to compy with the Unit Togallion ing Teach . Please note: this response to your premarket notification submission does not concenting your dorine in nie i bave 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 I his tetter whi anow your device to a legally marked 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 If you don't sponne arroo to your your e 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number the receiner of 00 00000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

Sincerely yours.

Nanci brondon
U.S.D.A.

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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510(k) Number (if known):_ Kol 160 4 _________________________________________________________________________________________________________________________________________

Device Name: PROstate Spectroscopy and imaging Exam (PROSE) Package for GE Signa Magnetic Resonance Scanners

Indications For Use:

PROstate Spectroscopy and imaging Exam (PROSE) is an image guided, clinical I KOState Spectroscopy and "magmigh acquires high resolution anatomical images and volume localized, water/lipid suppressed hydrogen spectra and/or multi-voxel spectroscopic images of the prostate gland using an endo-rectal coil with phased-array specifosophe images of the probate gainmention with a Magnetic Resonance Scanner to colls. PROSE option can be used in colljances. In spectral information about penint non-mvasive acquisition of ingil reast gland that can be interpreted by a relative concentrations of invacomes of prosumes of prostate diseases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc Broglon

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K011604 |
|---------------|---------|
|---------------|---------|

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________