PHILIPS EASYVISION WORKSTATION

K990329 · Philips Medical Systems North America, Inc. · LNH · Dec 7, 1999 · Radiology

Device Facts

• Record ID: K990329
• Device Name: PHILIPS EASYVISION WORKSTATION
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The BOLD Analysis option for the Easy Vision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.

Device Story

The BOLD Analysis package is a software option for the Philips EasyVision Workstation. It processes dynamic MRI data acquired via the BOLD (Blood Oxygen Level Dependent) function of a Gyroscan NT system. The device analyzes variations in blood oxygenation occurring during subject task performance (e.g., finger tapping). It applies standard statistical methods to quantify susceptibility changes in the brain. The system is used by clinicians in a diagnostic or research setting to visualize and analyze functional MRI data. The output provides quantitative information regarding brain activity, which assists healthcare providers in evaluating functional brain responses. No new hazards are introduced by this software addition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing package for the EasyVision Workstation. Utilizes standard statistical methods for BOLD MRI data analysis. Operates on dynamic MRI input data. No specific hardware materials or energy sources are described as the device is a software option for an existing workstation.

Indications for Use

Indicated for the analysis of MRI images to quantify small susceptibility changes in the human brain associated with specific task execution. Intended for prescription use.

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

• Philips Easyvision Workstation
• GE Advantage Windows (Functool) Workstation

Submission Summary (Full Text)

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203 926 7933 TO 91 301 48047

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# 510 (k) Summary

1990329

## Philips Medical Systems

| Company Name: | Philips Medical Systems North America Company |
|----------------------|--------------------------------------------------------------------------------|
| Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | January 21, 1999 |
| Device Name: | Philips Easy Vision Family Workstation Option<br>BOLD Analysis Package |
| Classification Name: | Image Processing System (90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Philips Easyvision Workstation,<br>GE Advantage Windows (Functool) Workstation |

上一了

### System Description:

The BOLD Analysis package supports the visualization and analysis of dynamic MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs over dynamic scans as a result of the variation of blood oxygenation through task performance by the subject (e.g. finger tapping). BOLD data can be processed with the BOLD Analysis package to provide data analysis based on standard statistical methods.

#### Intended Use:

The BOLD Analysis option for the Easy Vision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.

### Safety Information:

No new hazards are introduced by the addition of the BOLD Analysis Option to the Easy Vision Workstation.

> hilios Modical Systems th America Commans [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 7 1999

Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917

Re:

K990329

BOLD Analysis Package for EasyVision Workstation Dated: September 30, 1999 Received: October 1, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Mr. Altman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drup Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990329

Philips EasyVision Workstation BOLD Analysis Option Device Name :

Indications For Use :

The BOLD Analysis option for the EasyVision is intended for use in analyzing images created using the BOLD function of a Gyroscan NT system. The BOLD Analysis option is useful in quantifying small susceptibility changes in the human brain, created by the execution of specific tasks.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elinid G. Glynn

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K990329

Prescription Use
(Per 21 CFR 801.109
✓

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)