DUFFUSION-WEIGHTED MR IMAGING PACKAGE

K974530 · Philips Medical Systems (Cleveland), Inc. · LNH · Feb 6, 1998 · Radiology

Device Facts

• Record ID: K974530
• Device Name: DUFFUSION-WEIGHTED MR IMAGING PACKAGE
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity. Diffusion-weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.

Device Story

Software package for existing Picker MR systems; utilizes echo-planar imaging (EPI) single-shot pulse sequences; applies large gradient pulses before and after 180° RF refocusing pulse to measure diffusive mobility of water/proton-containing molecules. Input: MR signal data; Output: images showing areas of decreased diffusion (acute infarcts) as higher intensity. Used in clinical settings by radiologists/technicians to identify acute stroke within 24 hours of onset. Benefits: improved accuracy over conventional MRI for early stroke detection.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Software-based MR imaging package; utilizes echo-planar imaging (EPI) single-shot sequences; spin-echo based with large gradient pulses; fixed and variable b-value options; semi-automatic prescan process for data correction; operates on existing Picker MR system hardware.

Indications for Use

Indicated for patients suspected of acute stroke to visualize water molecule mobility in brain tissue and identify acute cerebral infarcts within 24 hours of symptom onset.

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

• Picker EPI-II Option (K954646)
• Siemens DWI (K971055)

Submission Summary (Full Text)

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K974530.

#### 6 1998 FEB

# SUMMARY OF SAFETY AND EFFECTIVENESS

(As required by 21 CFR 807.92)

#### General Information 1.

| Classification: | Class II<br>Magnetic Resonance (MR) Diagnostic Device |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance (MR) Device Option |
| Proprietary Name: | Diffusion-Weighted MR Imaging Package |
| Establishment Registration: | Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>FDA Owner Number: #1580240<br>FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been<br>issued under section 514 of the Food, Drug and<br>Cosmetic Act. |

#### Intended Uses 2.

The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.

Diffusion-weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.

#### Device Description 3.

The Picker Diffusion-Weighted MR Imaging Package does not change the technological characteristics of the Picker MR Systems. This package consists of echo-planar imaging (EPI) single-shot based sequences which have selectable directionality and either fixed or selectable b-values. The sequences are basically spin-echo sequences which have large gradient pulses or lobes before and after the 180° RF refocusing pulse.

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#### Safety and Effectiveness 4.

The Picker Diffusion-Weighted Imaging Package is similar in technological characteristics and intended use to Picker MR systems with Echo-Planar Imaging Capability and the Siemens Diffusion-Weighted Imaging Package. The following table has been created to demonstrate their substantial equivalence.

| Parameter | Diffusion-Weighted MR<br>Imaging Package | Predicate Devices<br>Picker EPI-II Option - K954646<br>Siemens DWI - K971055 |
|-----------------------------|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Sequence Description | Same. | Echo-Planar Sequence with large<br>magnetic field gradient pulse<br>before and after the 180°<br>refocusing RF pulse. (K971055) |
| b-value | Fixed and variable sequences<br>available. | Siemens -- unknown. |
| Data Correction Calibration | Same. | Semi-automatic prescan process<br>(K954646) |
| Performance Specifications | Same. | (K954646) |
| Safety Parameters | Same. | (K954646) |

## SUBSTANTIAL EQUIVALENCE TABLE

(

(DWI)

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| Intended Use / Indications<br>for Use | Same. | The Siemens Diffusion-Weighted<br>MR Imaging Package has been<br>designed to image the diffusive<br>mobility of water or other proton-<br>containing molecules. One<br>important clinical application is to<br>visualize the apparent loss of<br>mobility by water molecules in<br>brain tissue affected by acute<br>stroke. Areas of decreased<br>diffusion, as is observed in acute<br>cerebral infarcts, appear as areas of<br>higher image intensity. |
|---------------------------------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Diffusion-weighted MR pulse<br>sequences are more accurate than<br>conventional MRI pulse sequences<br>in identifying the occurrence of<br>acute stroke during the first 24<br>hours after onset of symptoms.<br>(K971055) |

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(DWI) 1 1/25/97 .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 FEB

Elaine K. Keeler Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights. Ohio 44143 Re:

K974530 Diffusion Weighted MRI Package Dated: November 25, 1997 Received: December 2, 1997 Regulatory class: II 21 CFR 8921000/Procode: 90 LNH

Dear Ms. Keeler:

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 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 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 virgo diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/dsmamain.html".

Sincerely yours.

h. Tiau Yu.

Lillian Yin, Ph.D. 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Diffusion Weighted Imaging Package

### Indications for Use:

ﮐﻢ ﻣﯿﮟ ﻣﯿﮟ ﻭﺍﻗﻊ ﮨﮯ۔

The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity.

Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Ferguson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 97453 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)