BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0

K061255 · Kyron Clinical Imaging, Inc. · LNH · Jun 13, 2006 · Radiology

Device Facts

• Record ID: K061255
• Device Name: BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0
• Applicant: Kyron Clinical Imaging, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jun 13, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Device Story

Software suite for fMRI and MRI data management; operates on PC. BrainAcquireRx presents synchronized visual/auditory stimuli and cognitive/motor tasks to patients during MRI scanning; captures patient responses and scanner image data. BrainProcessRx performs post-processing, quality control, and data preparation for viewing. Used in clinical settings by trained physicians to assist in diagnosing brain pathology and planning/monitoring treatments. Provides integrated anatomical, functional, and physiologic data (including MRS and diffusion) for physician interpretation.

Clinical Evidence

Bench testing only. Software verification and validation were conducted to confirm proper function of device features. No clinical data presented.

Technological Characteristics

PC-based software suite for MRI data acquisition and post-processing. Functions include stimulus presentation, data storage, quality control, and image viewing. Supports BOLD fMRI, MRS, and MR diffusion. No specific hardware materials or energy sources defined as it is software-only.

Indications for Use

Indicated for patients undergoing MRI scans to acquire and process BOLD fMRI, MRS, and MR diffusion data. Used to assist trained physicians in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

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

• Eloquence Integrated Functional Imaging System (K023130)
• MindState™ Functional Data Acquisition Device (fDAD™) (K043290)
• Syngo® Multimodality Workstation (K010938)
• Diffusion tensor imaging option for MRI (K003573)

Submission Summary (Full Text)

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

Kob/255

Image /page/0/Picture/1 description: The image shows the logo for Kyron Clinical Imaging. The logo is black and features the word "kyron" in a stylized font, with a star above the "k". Below "kyron" are the words "CLINICAL IMAGING" in a smaller font. The logo has a curved line underneath the word "kyron".

## 5 510(k) Summary

JUN 1 3 2006 - BrainAcquireRx™ / BrainProcessRx™ Data Suite K

### Contact Information 1.

- Contact Person Submitter James L. Reuss, Ph.D. (CTO) Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 Phone [phone] Wauwatosa, WI 53226 Fax
Date Summary Prepared: May 1st, 2006

#### 2. Device Name and Classification

The proprietary name of the device to be introduced into interstate commerce is the BrainAcquireRx™ / BrainProcessRx™ Data Suite. It is image reconstruction and processing software running on a personal computer, classified under product code 90 LNH (regulation # 892.1000), "Radiology, Magnetic Resonance Diagnostic Device" as a class II medical device.

#### Identification of Legally Marketed Equivalent Predicate Devices 3.

| Predicate System | Manufacturer | Reg. Data |
|-------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------|
| Eloquence Integrated<br>Functional Imaging<br>System | MRI Devices Corp.<br>1515 Paramount Dr.<br>Waukesha, WI 53186 | K023130<br>SE 10/11/2002<br>Product code LNH<br>Class II |
| MindState™ Functional<br>Data Acquisition Device<br>(fDAD™) | Neurognostics, Inc.<br>10437 Innovation Dr., Suite 309<br>Milwaukee, WI 53226 | K043290<br>SE 1/28/2005<br>Product code LNH<br>Class II |
| Syngo® Multimodality<br>Workstation | Siemens Medical Systems<br>186 Wood Ave. South<br>Iselin, NJ 08830 | K010938<br>SE 6/26/2001<br>Product code LLZ<br>Class II |
| Diffusion tensor imaging<br>option for MRI | GE Medical Systems<br>P.O. Box 414, W-709<br>Milwaukee, WI 53201 | K003573<br>SE 1/23/2001<br>Product code LNH<br>Class II |

#### Description of Device 4.

The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI

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

Image /page/1/Picture/1 description: The image shows the logo for Kyron Clinical Imaging. The logo is black and white and features the word "kyron" in a stylized font. The "k" is much larger than the other letters and has a curved line extending from the bottom of it. Below "kyron" are the words "CLINICAL IMAGING" in a smaller font.

studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.

#### Statement of Intended Use 5.

"The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.

The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments."

#### 6. Predicate Device Comparison of Technological Characteristics

The BrainAcquireRx application contains fMRI stimulus, acquisition and postprocessing capabilities that are substantially equivalent to the software provided with the MRI Devices Eloquence and the Neurognostics MindState workstations. BrainProcessRx also performs post-processing of other MRI data sets substantially equivalent to the MRI data post-processed by the Siemens syngo software and GE DTI option.

#### 7. Performance Study

FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features.

#### 8. Safety information

No new safety hazards are introduced by the use of the device in comparison to the software of the predicate devices.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 1 3 2006

James L. Reuss, Ph.D. Chief Technology Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 WAUWATOSA WI 53226

Re: K061255

Trade/Device Name: BrainAcquireRxTM / BrainProcessRxTM Data Suite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 1, 2006 Received: May 4, 2006

Dear Dr. Reuss:

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.

Image /page/2/Picture/10 description: The image shows a logo with the text "FDA Centennial 1906-2006". The logo is circular in shape and has stars around the edge. The text "Protecting and Promoting Public Health" is written in a cursive font below the logo.

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

Page 2 -

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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely vours.

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 4

510(k) Number (if known): K U

BrainAcquireRx™ / BrainProcessRx™ Data Suite Device Name:

# INDICATIONS FOR USE:

The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction The DramAcequirettx - 7 Drain 100000 and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.

The BrainAcquireRx software application presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by the I he patient's responses and image sportions post-processing for quality control and Drami rocesses upping of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and in scripted data acquisition and post nagnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.

Over-the-Counter Use OR X Prescription Use (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lappin

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

Kyron™ Clinical Imaging, Inc.

Confidential

4-1