QUANTITATIVE FLOW

K992225 · Philips Medical Systems (Cleveland), Inc. · LNH · Sep 7, 1999 · Radiology

Device Facts

• Record ID: K992225
• Device Name: QUANTITATIVE FLOW
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Sep 7, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

Device Story

Quantitative Flow is an MRI software option for cardiovascular assessment; inputs include MRI signals acquired via 2D Phase Contrast or FAST sequences with ECG or PPG cardiac gating. Device transforms raw NMR data into reference magnitude, phase velocity, phase contrast, and velocity images. Operator defines up to eight regions of interest (ROIs) on phase velocity images to perform quantitative measurements. Outputs include velocity vs. time graphs, volume vs. time graphs, pixel velocity histograms, ROI statistics, Qp/Qs ratios, and regurgitant volumes. Used in clinical settings by trained operators; output assists clinicians in evaluating cardiovascular flow dynamics and hemodynamics. Benefits include non-invasive assessment of vessel flow and velocity throughout the cardiac cycle.

Clinical Evidence

In vivo testing performed to validate flow measurement accuracy. Subject device demonstrated flow measurement accuracy of 3.9% ± 0.8% for constant flow and 3.5% ± 2.2% for pulsatile flow. Predicate device (GE Flow Analysis Option) demonstrated 5.26% ± 3.77% for constant flow and 5.73% ± 3.0% for pulsatile flow.

Technological Characteristics

MRI-based software option for 1.5T Edge Eclipse and 1.0T Vista Polaris systems. Utilizes 2D Phase Contrast and FAST sequences. Supports ECG-triggered and PPG-triggered cardiac gating. Enables manual definition of up to eight ROIs. Outputs include velocity/volume graphs, histograms, and ROI statistics. Operates via NMR principles.

Indications for Use

Indicated for non-invasive acquisition and mapping of quantitative flow and velocity measurements from vessels during a cardiac cycle in patients undergoing MRI assessment.

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 Flow Analysis Option (K924605)

Submission Summary (Full Text)

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7 1999 SEP

## SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

| 1. | General Information<br>Classification: | Class II<br>Magnetic Resonance Imaging (MRI) System |
|----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option |
| | Proprietary Name: | Quantitative Flow |
| | Establishment Registration: | Picker International, Inc.<br>World Headquarters<br>595 Miner Road<br>Highland Heights, Ohio 44143<br>Contact: Elaine K. Keeler, Ph.D<br>Phone: [phone]<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. |

#### 2. Intended Uses

The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

### 3. Device Description

Picker's Quantitative Flow functionality includes the ability to create reference magnitude, phase velocity, phase contrast, phase contrast velocity and reference magnitude velocity images. The operator can define up to eight regions of interest on the phase velocity images and perform several quantitative measurements. When combined with cardiac gating, the operator can observe changes in velocity and flow throughout the cardiac cycle.

#### 4. Safety and Effectiveness

The Quantitative Flow functionality included in Picker's Application Suite for Cardiovascular Assessment is similar in technological characteristics and intended use to the GE Flow Analysis Option. The following table has been created to demonstrate their substantial equivalence.

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| Parameter | Quantitative Flow | Predicate Device - GE Flow Analysis Option (K924605) |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Compatibility | 1.5T Edge Eclipse and 1.0T Vista Polaris | 1.5T Signa Advantage |
| Sequences | 2D Phase Contrast, FAST | 2D and 3D Phase Contrast, Cine Phase Contrast |
| Acquisition Options | ECG-triggered cardiac gating,<br>PPG-triggered cardiac gating and<br>phase encode grouping. | Flow compensation, respiratory<br>compensation, ECG-triggered<br>cardiac gating, peripheral-triggered<br>cardiac gating, graphic prescription,<br>spatial presaturation, no phase<br>wrap, rectangular FOV. |
| Image Types<br>Produced | Reference Magnitude Image, Phase<br>Velocity, Phase Contrast, Phase<br>Contrast Velocity, and Reference<br>Magnitude Velocity. | Magnitude, Flow and Speed Images |
| Range of Velocities | 5-600 cm/sec | Approx. 20-400 cm/sec |
| Accuracy of Flow<br>Measurements | In vivo testing demonstrated that<br>flow could be measured to within<br>$3.9% \pm 0.8$ for constant flow and<br>$3.5% \pm 2.2$ for pulsatile flow. | In vivo testing demonstrated that<br>flow could be measured to within<br>$5.26% \pm 3.77$ for constant flow and<br>$5.73% \pm 3.0$ for pulsatile flow. |
| Parameter<br>Requirements | Cine images for quantitative<br>analysis can only be sensitized in<br>one direction. | Images must be acquired in the<br>CINE mode and the flow axis must<br>represent through-plane flow. The<br>slice thickness must be less than<br>20mm. |
| ROI Drawing | User can manually draw up to<br>eight ROIs for flow measurements. | User can manually draw up to four<br>ROIs for flow measurements. |
| Data Output | Outputs include:<br>- avg. velocity vs. time graph<br>- volume vs. time graph<br>- histogram of pixel velocities<br>- ROI statistics (mean, STD)<br>- Qp/Qs ratio calculations<br>- Regurgitate volumes | Outputs include:<br>- avg. velocity graph<br>- avg. flow graph<br>- ROI statistics (mean, max, min)<br>- Flow calculations (positive<br>volume, negative volume,<br>cardiac output, stroke volume) |
| Intended Use and<br>Indications for Use | The intended use of Quantitative<br>Flow is to non-invasively obtain<br>and map quantitative flow and<br>velocity measurements from a<br>vessel during a cardiac cycle using<br>the principles of NMR. | The Signa Advantage Flow Analysis<br>Option charts flow and velocity<br>changes during the cardiac cycle.<br>This post processing technique<br>provides flow information acquired<br>non-invasively during the cardiac<br>cycle. |

# Substantial Equivalence Chart

PICKER INTERNATIONAL, INC.

(QFLOW)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

SEP 7 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, OH 44143 Re:

K992225 Quantitative Flow Dated: July 2, 1999 Received: July 2, 1999 Product Code: 90 LNH Requlatory Class: Il (two) 21.CFR 892.1000

Dear Dr. 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 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 II (Special Controls) or dass 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 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,

CAPT 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

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510(k) Number (if known):

Quantitative Flow Device Name:

### Indications for Use:

ﻠﻤ

The intended use of Quantitative Flow is to non-invasively obtain and map quantitative flow and velocity measurements from a vessel during a cardiac cycle using the principles of NMR.

(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 | K992225 |
|---------------|---------|
|---------------|---------|

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