IMAGE POST-PROCESSING TECHNIQUES

K980831 · Philips Medical Systems (Cleveland), Inc. · LNH · Aug 27, 1998 · Radiology

Device Facts

• Record ID: K980831
• Device Name: IMAGE POST-PROCESSING TECHNIQUES
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

ProPak Techniques The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged. Apparent Diffusion Coefficient Mapping 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. Post-processing using ADC mapping produces parametric images with further contrast manipulation. 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

Device consists of software post-processing techniques for existing, reconstructed MR images; includes ProPak for temporal datasets and ADC mapping for diffusion-weighted images. Operates on Picker MR systems or workstations; used by clinicians to analyze contrast changes or water molecule mobility. Inputs: MR images, single/multi-slice datasets. Processing: pixel-by-pixel or region-of-interest analysis; generates parametric images, time-intensity plots, or tabular data. Output: visual parametric maps and quantitative data. Assists clinicians in evaluating perfusion and identifying acute cerebral infarcts; provides supplemental diagnostic information without changing primary MR system indications.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Software-based post-processing for MR images. Features include semi-automated analysis, color parametric imaging, and time-intensity plotting. Operates on existing reconstructed MR datasets. No specific hardware materials or energy sources; software-only enhancement package.

Indications for Use

Indicated for patients undergoing MR imaging, specifically for visualizing contrast changes over time in temporal datasets (ProPak) and imaging diffusive mobility of water molecules in brain tissue to identify acute stroke (ADC Mapping).

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

• GE FuncTool Option (K960265)
• Philips Quantitative Analysis Package (K971965)
• Picker Diffusion-Weighted Imaging Package (K974530)

Submission Summary (Full Text)

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AUG 27 1998

# K 980831

# 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: | Image Post-Processing Techniques |
| 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 intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.

### ProPak Techniques

The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.

## Apparent Diffusion Coefficient (ADC) Mapping

This submission adds the following sentence to the indications for use statement for Picker's Diffusion-Weighted MR Imaging Package.

Post-processing using ADC mapping produces parametric images with further contrast manipulation.

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#### Device Description 3.

There are two basic types of post-processing techniques included in this submission. The first type is known as ProPak and is a set of techniques for processing temporally resolved image data sets and performing general perfusion analysis. The second type of technique is called ADC mapping and is for processing data from diffusion-weighted imaging sequences. All of the techniques included in this submission are for processing existing images that have already been reconstructed.

#### Safety and Effectiveness 4.

The Post-Processing Techniques described in this submission are substantially equivalent in technological characteristics and intended use to the GE Functool Option, the Philips Quantitative Analysis Package and the Picker Diffusion-Weighted Imaging Package. The following table has been compiled in order to demonstrate this substantial equivalence.

| Parameter | Image Post-Processing<br>Techniques | Predicate Devices<br>GE FuncTool Option (K960265),<br>Philips Quantitative Anal. (K971965),<br>Diffusion Imaging (K974530), |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility | Same. | Available on Independent Workstations<br>or the MR System Operator's Console<br>(See K960265) |
| Inputs | • MR images<br>• Single or multi-slice datasets<br>with equally spaced time<br>intervals (ProPak)<br>• Diffusion-weighted images<br>(ADC Mapping) | • CT and MR images<br>• Single or multi-slice datasets with<br>equally spaced time intervals<br>(See K960265) |
| Features | • Semi-automated<br>• Color parametric images<br>(optional)<br>• Analysis on a pixel-by-pixel<br>basis or region of interest<br>• Time intensity information in<br>plot or tabular form | • Automated<br>• Color parametric images<br>• Overlay of parametric images on to<br>anatomical reference images<br>• Analysis on a pixel-by-pixel basis or<br>region of interest<br>• Time intensity information in plot or<br>tabular form<br>(See K960265 and K971965) |

# SUBSTANTIAL EQUIVALENCE CHART

PICKER INTERNATIONAL, INC.

(POSTPRO)

3/3/98

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| Parameter | Image Post-Processing<br>Techniques | Predicate Devices<br>GE FuncTool Option (K960265),<br>Philips Quantitative Anal. (K971965),<br>Diffusion Imaging (K974530), |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Filming and Archiving | Same. | Images can be filmed, stored in image<br>database or archived with rest of patient<br>exam. (See K960265) |
| Anatomy of Interest | Same. | Brain and Body Imaging<br>(See K960265) |
| Processing Algorithms | • Area Mapping<br>• Time to Peak Mapping<br>• ADC Mapping | • Negative Enhancement Integral<br>• Mean Time to Enhance<br>(See K960265) |
| Indications for Use | ProPak Techniques<br>The ProPak Package for Picker<br>MR systems or workstations<br>provide supplemental<br>information regarding contrast<br>changes over time for those<br>images extracted from MR<br>temporal datasets. The<br>indications for use for the MR<br>system remain unchanged. | FuncTools (K960265)<br>The FuncTool option to the Advantages<br>Windows workstation is a software<br>module that provides supplemental<br>information to those images extracted<br>from CT and MR temporal datasets.<br>Quantitative Analysis (K971965)<br>The CT/MR Quantitative Analysis<br>Package is intended for use where<br>visualization and analysis of CT and MR<br>dynamic studies, showing changes in<br>contrast over time, are useful or<br>necessary. |

ﺰ

/

, ジ

(POSTPRO)

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| Parameter | Image Post-Processing<br>Techniques | Predicate Devices<br>GE FuncTool Option (K960265),<br>Philips Quantitative Anal. (K971965),<br>Diffusion Imaging (K974530), |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>(cont.) | ADC Mapping<br>Same as Diffusion Imaging with<br>the addition of the following<br>sentence: Post-processing using<br>ADC mapping produces<br>parametric images with further<br>contrast manipulation. | Diffusion Imaging (K974530)<br>The Picker Diffusion-Weighted MR<br>Imaging Package has been designed to<br>image the diffusive mobility of water or<br>other proton-containing molecules. One<br>important clinical application is to<br>visualize the apparent loss of mobility of<br>water molecules in brain tissue affected<br>by acute stroke. Areas of decreased<br>diffusion, as is observed in acute<br>cerebral infarcts, appear as areas of<br>higher image intensity. Diffusion<br>weighted MR pulse sequences are more<br>accurate than conventional MRI pulse<br>sequences in identifying the occurrence<br>of acute stroke during the first 24 hours<br>after onset of symptoms. |

PICKER INTERNATIONAL, INC.

)

(POSTPRO)

3/3/98

I - 4

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1998

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143

K980831 Re:

Image Post-Processing Techniques (ProPak and Apparent Diffusion Coefficient Mapping) Dated: June 8, 1998 Received: June 9, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

### Dear Mr. 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 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 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/cdch/dsmaldsmamain.html".

Sincerely yours,

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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K980831 510(k) Number (if known): _

Image Post-Processing Techniques Device Name:

### Indications for Use:

The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.

### ProPak Techniques

The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.

# Apparent Diffusion Coefficient Mapping

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. Post-processing using ADC mapping produces parametric images with further contrast manipulation.

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)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980831

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)