PRISM VIEW, MODEL

K063031 · Kyron Clinical Imaging, Inc. · LLZ · Nov 2, 2006 · Radiology

Device Facts

• Record ID: K063031
• Device Name: PRISM VIEW, MODEL
• Applicant: Kyron Clinical Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). 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

Prism View is image processing software for personal computers; enables visualization and manipulation of clinical imagery. Inputs include anatomical, physiologic, and functional brain imaging data (BOLD fMRI, MRS, MR diffusion, DTI). Software aligns and integrates these datasets; provides display and analysis tools for interpreting relationships between images. Used in clinical settings by trained physicians; output assists in diagnosis of brain pathology and planning/monitoring of medical treatments. Device facilitates integration of complex imaging data to support clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only; software verification and validation conducted to confirm proper function of device features.

Technological Characteristics

Image processing software for PC platform. Functionality includes alignment, visualization, and analysis of BOLD fMRI, MRS, and MR diffusion/DTI data. Regulatory class II, product code LLZ (PACS).

Indications for Use

Indicated for patients requiring visualization and analysis of functional and physiologic brain imaging data (BOLD fMRI, MRS, MR diffusion/DTI) to assist physicians in diagnosing brain pathology and planning/monitoring medical treatments.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• BrainViewRx™ (a/k/a Prism View) (K052467)

Submission Summary (Full Text)

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Kob 3031

NU . 2 2006

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# 510(k) Summary 5

- Kyron™ Clinical Imaging Prism ViewTM Special 510(k) K

#### 1. Contact Information

Submitter Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 Wauwatosa, WI 53226

Contact Person James L. Reuss, Ph.D. Phone Phone [phone] Fax [phone]

Date Summary Prepared: September 1st 2006

#### 2. Device Name and Classification

The proprietary name of the device to be introduced into interstate commerce is the Prism View software package. It is image processing software running on a personal computer platform, and is classified under regulatory product code 90 LLZ (regulation # 892.2050), "Picture archiving and communications systems" as a class II medical device.

## 3. Identification of Legally Marketed Equivalent Predicate Devices

| Predicate System | Manufacturer | Reg. Data |
|------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------|
| BrainViewRx™<br>(a/k/a Prism View) | Kyron Clinical Imaging, Inc.<br>2457 N. Mayfair Rd., Suite 202<br>Wauwatosa, WI 53226 | K052467<br>SE 12/20/2005<br>Product code LLZ<br>Class II |

## 4. Description of Device

Prism View is an image processing software package for the visualization and manipulation of clinical imagery of multiple kinds. It brings sets of anatomical, physiologic and/or functional imagery into alignment and provides a variety of display and analysis options for utilizing the imagery relationships.

9/2006

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Image /page/1/Picture/1 description: The image shows the logo for Kyron Clinical Imaging. The logo features the word "Kyron" in a stylized font, with the "K" enclosed in a partial circle. Below "Kyron" are the words "CLINICAL IMAGING" in a smaller font. Underneath that is the phrase "THE PHYSICIANS' PARADIGM" in a smaller font.

## 5. Statement of Intended Use

"Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). 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."

## Predicate Device Comparison of Technological Characteristics 6.

The technological characteristics of Prism View are the same as the original device. Incremental revisions to the software have been made.

## 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 Prism View software package in comparison to the software of the predicate devices.

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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 features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Michael Schmainda President & Chief Operating Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Road, Suite 202 WAUWATOSA WI 53226

# NOV - 2 2006

Re: K063031

Trade/Device Name: Kyron™ Clinical Imaging, Inc. - Prism View™ Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2006 Received: October 3, 2006

Dear Mr. Schmainda:

We have reviewed your Section 510(k) premarket notification of intent to market the device w & no referenced your over (1) for device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce allow to May 28, 1976, the caachment date of the Medical Device Amendments, or to devices that prov to that 20, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic nu ro occh that do not require approval of a premarket approval application (PMA). You may, the of too, market the device, subject to the general controls provisions of the Act. The general therefore, mainer me are roo, 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 ir your do roo is okesting (10 such additional controls. Existing major regulations affecting your Applorary, it may of other of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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noting Public J

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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 (\$1 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/cdrlv/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 4

510(k) Number (if known): K O 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

Kyron™ Clinical Imaging, Inc. - Prism View™ Device Name:

# INDICATIONS FOR USE:

Prism View™ provides visualization of functional and physiologic brain imaging data. The software package provides both analysis and viewing capabilities that promote the integration of physiologic and functional imaging data sets, including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), and MR diffusion including diffusion tensor imaging (DTI). 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.

X Prescription Use (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K063031 |

Kyron™ Clinical Imaging, Inc. - 9/2006 Confidential