MRI- FLOW ANALYTICAL SOFTWARE PACKAGE

K994282 · Medis Medical Imaging Systems BV · LNH · Mar 2, 2000 · Radiology

Device Facts

• Record ID: K994282
• Device Name: MRI- FLOW ANALYTICAL SOFTWARE PACKAGE
• Applicant: Medis Medical Imaging Systems BV
• Product Code: LNH · Radiology
• Decision Date: Mar 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

FLOW has been developed for the objective and reproducible analysis of velocityencoded cine MR imaging studies of arterial vessels and heart valves. Intended purposes are: - 1. supporting clinical diagnoses about the status of the function of the cardiac cambers: - 2. supporting clinical diagnoses about the flow velocity and volume flow through cardiac and peripheral vessels, both under basal and increased flow conditions; - 3. supporting subsequent clinical decision making purposes; - 4. supporting the use in clinical research trials, directed at studying changes in function of the heart chambers and in the flow through cardiac and peripheral vessels as a result of interventions.

Device Story

FLOW is an analytical software package for UNIX and Linux platforms; imports velocity-encoded cine MRI studies via CD-ROM or network. Device functions independently of MRI hardware. Software performs semi-automated analysis of velocity and volume flow within user-defined regions of interest (ROI). Outputs include mean/min/max velocity, volume flow over time, stroke volume, and cardiac output. Used by cardiologists and physicians in clinical settings to support diagnosis and clinical decision-making. Provides objective, reproducible quantitative data to assess cardiac chamber function and vascular flow; aids in evaluating interventions in clinical research.

Clinical Evidence

No clinical trials or prospective studies provided. Safety and effectiveness supported by hospital evaluations and literature review, alongside software verification and validation testing.

Technological Characteristics

Standalone analytical software for UNIX/Linux platforms. Performs semi-automated image processing and quantitative analysis of velocity-encoded cine MRI data. Independent of MRI scanner vendor. Software level of concern is 'minor'.

Indications for Use

Indicated for clinicians, including cardiologists and referring physicians, for the noninvasive assessment of flow and flow velocity in arterial vessels and heart valves using velocity-encoded cine MRI studies. Used to support clinical diagnosis of cardiac chamber function, flow velocity, and volume flow under basal and increased flow conditions, and for clinical research trials.

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

• General Electric: Flow Analysis Option for Advantage Windows 2.0 and 3.1 (K924605)

Submission Summary (Full Text)

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# MAR = 2 2000

## MRI - FLOW 510(k) Premarket Notification

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 12

Submission in accordance with the requirements of 21 CFR Part 807.87(h)

| 1) Submitter | : MEDIS medical imaging systems B.V. |
|----------------|---------------------------------------|
| Address | : Poortgebouw Rijnsburgerweg 10 |
| | : 2333 AA Leiden |
| | : The Netherlands |
| Telephone | : + 31 71 5223244 |
| Fax | : + 31 71 5215617 |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : December 15, 1999 |

| 2) Device Name | : MRI - FLOW analytical software package |
|--------------------|------------------------------------------|
| Common Name | : FLOW |
| Device Class. Name | : System, Image Processing; |
| Regulation Number | : 21 CFR 892.2050 (90 LLZ; Class II) |

- 3) Predicate Device : General Electric: 510(k) K924605
#### 4) Description of the device:

FLOW is a state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. FLOW facilitates the import and visualization of velocity-encoded cine MRI imaging studies via CD-ROM and digital network. This FLOW functionality is independent of the MRI equipment vendor. FLOW provides objective and reproducible data on velocity and volume flow as a function of time, and other derived data such as mean velocity and volume flow, stroke volume and cardiac output. FLOW is intended to support all clinicians, i.e. cardiologists, and referring physicians involved in the noninvasive assessment of flow and flow velocity in arterial vessels and at heart valves.

### 5) Intended use:

FLOW has been developed for the objective and reproducible analysis of velocityencoded cine MR imaging studies of arterial vessels and heart valves. Intended purposes are:

- 1. supporting clinical diagnoses about the status of the function of the cardiac cambers:
- 2. supporting clinical diagnoses about the flow velocity and volume flow through
- cardiac and peripheral vessels, both under basal and increased flow conditions;
- 3. supporting subsequent clinical decision making purposes;
- 4. supporting the use in clinical research trials, directed at studying changes in function of the heart chambers and in the flow through cardiac and peripheral vessels as a result of interventions.

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## 6) Substantial equivalence Information:

The FLOW software is substantially equivalent to the predicate devices of General Electric K924605 "Flow Analysis Option for Advantage Windows™ 2.0 and 3.1" by using the same technological characteristics and intended use.

## Conclusion respecting safety and effectiveness:

It is the opinion of MEDIS medical imaging systems B.V. that FLOW is safe and potential hazards are controlled by a risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluation by hospitals and literature (see Appendix F) support this statement.

In MEDIS opinion the level of concern for the standalone software to view images is 'minor' and that the use of FLOW software does not change the intended use of magnetic resonance scanners in practice, nor does the use of software result in any new potential hazards.

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Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Image /page/2/Picture/2 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around a symbol. The symbol consists of three stylized, curved lines that appear to be flowing or moving upwards. The logo is black and white and has a somewhat grainy quality.

MAR - 2 2000

J.J. Hollander Quality Coordinator Medis Medical Imaging Systems, B.V. Poortgebouw, Rijnsburgerweg 10 2333 AA Leiden The Netherlands

Re:

K994282 MRI-FLOW Analytical Software Packager for MRI Dated: December 16, 1999 Received: December 20, 1999 Regulatory class: II 21 CFR 892.1000/90 LNH

Dear Mr. Holland:

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 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 requlatory 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" (21CFR 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,

Daniel G. Schultz, M.D Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page / of

510(k) NUMBER (IF KNOWN): K Q942 82 Flow Analytical Software Po DEVICE NAME: ICATIONS FOR USE:

FLOW has been developed for the objective and reproducible analy sis of volocity - encoded cine MR imaging studies of arterial vessels and heart valves. The FlOW software package enables to sem-automatically calculate and display of various parameters such as : Mean velocity (also minimum, maximum and Standard deviation) and volume flow in different reqion of interest CROI); Velocity and volume . unction of time; Stroke volume and cardiac but put When interpreted by a trained physician these ameters may be useful in supporting the determination of a diagnosis .

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

ncurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109 OR

Over-The-Counter-Use Optional Format 1-2

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994282