PHILIPS EASYVISION WORKSTATION:

K990335 · Philips Medical Systems North America, Inc. · LNH · Sep 9, 1999 · Radiology

Device Facts

• Record ID: K990335
• Device Name: PHILIPS EASYVISION WORKSTATION:
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.

Device Story

Quantitative MT Analysis option is a software package for the Philips EasyVision Workstation. It processes MR system-generated Magnetization Transfer Contrast (MTC) images. The device calculates a ratio image using scans with and without the MT effect, defined by the formula (MT image - non-MT image) / MT image. This transformation produces a percentile MT effect map, effectively eliminating T1 and T2 relaxation time influences to isolate MT effects. The workstation is used in clinical settings by healthcare professionals to visualize MT effects in sensitive tissues. The resulting images assist clinicians in identifying lesions, particularly in white matter and cartilage, thereby supporting diagnostic decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing package for MR workstations. Operates by calculating pixel-wise ratios of MT-weighted and non-MT-weighted MR images to isolate Magnetization Transfer effects. Independent of T1 and T2 relaxation times.

Indications for Use

Indicated for the quantification of Magnetization Transfer in tissue to improve lesion conspicuity in MT-sensitive tissues such as white matter and cartilage.

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 (K990335)

Submission Summary (Full Text)

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## 510 (k) Summary

# Philips Medical Systems

K990335

| 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 27, 1999 |
| Device Name: | Philips Easy Vision Family Workstation Option<br>Quantitative MT Analysis Package |
| Classification Name: | Image Processing System (90 LLZ) |
| Common/Usual Name | Workstation |
| Predicate Device | Philips Easyvision Workstation |

### System Description:

The Quantitative MT Analysis option uses MTC images created by an MR system and transferred to the EasyVision. The image contrast can be changed by calculating the ratio (based on (MT image- non-MT image)/MT image)) of the scans with and without the MT effect. The resultant image represents the percentile MT effect. The image contrast therefore becomes independent of the T1 (spin-lattice) and T2 (spin-spin) relaxation times and is defined by the MT effect alone.

### Intended Use:

The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spin-spin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.

### Safety Information:

No new hazards are introduced by the addition of the Quantitative MT Analysis Option to the EasyVision Workstation.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-09 Tel: [phone] Fax: [phone]

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Image /page/1/Picture/0 description: The image is a black and white emblem for the Department of Health & Human Services - USA. The emblem features a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 1999 SEP

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

Re:

K990335 Ouantitative NT Analysis Package for Easy Vision Workstation Dated: June 10, 1999 Received: June 11, 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 redassified 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 III (Premarket Aproval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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 regulation 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,

OART Daniel C. Schultz, M.D.

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

i
K

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips EasyVision Workstation Quantitative MT Analysis Option Device Name : Indications For Use:

The Quantitative MT Analysis option on the Easy Vision is intended for use in quantifying the Magnetization Transfer in tissue. The ratio image enhances the image contrast of MT sensitive tissue by the elimination of the T1 and T2 (spin-lattice and spinspin relaxation time) effect. Visualization of Magnetization Transfer effects in sensitive tissue can improve lesion conspicuity, e.g., in white matter and cartilage.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| | <img alt="Signature" src="signature.png"/> |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K990335 |

| Prescription Use (Per 21 CFR 801.109 | <img alt="Check Mark" src="check_mark.png"/> | OR | Over-The-Counter Use |
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