MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM

K994283 · Medis Medical Imaging Systems BV · LNH · Aug 30, 2000 · Radiology

Device Facts

• Record ID: K994283
• Device Name: MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM
• Applicant: Medis Medical Imaging Systems BV
• Product Code: LNH · Radiology
• Decision Date: Aug 30, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular from cardiac MR data sets. The software enables the display of images for use by trained medical personnel. Intended purposes are: supporting clinical diagnoses about the status of the global and regional function and anatomy of the cardiac chambers; supporting the subsequent clinical decision making processes; supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of interventions.

Device Story

MASS is analytical software for UNIX/Linux platforms; imports multi-slice, multi-phase MRI cardiac data via CD-ROM or network. Device performs semi-automatic calculation of ventricular parameters (volumes, mass, wall thickness/motion). Clinicians (cardiologists, radiologists) review generated contours and measurements; operator may accept or reject outlines. Output supports clinical diagnosis, decision-making, and research trials regarding cardiac function and anatomy. Benefits include objective, reproducible assessment of heart chambers independent of MRI vendor.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by risk management plan, hazard analysis, verification and validation testing, and hospital evaluations/literature review.

Technological Characteristics

Software-based analytical tool for UNIX/Linux platforms. Facilitates import/visualization of MRI data. Performs semi-automatic contouring and quantification of cardiac parameters. Standalone software; vendor-independent. Level of concern: minor.

Indications for Use

Indicated for trained medical personnel to perform objective, reproducible analysis of multi-phase left and right ventricular function from cardiac MR data sets. Used to calculate parameters including EDV, ESV, stroke volume, ejection fraction, myocardial mass, regional wall thickness, wall thickening/thinning, and regional wall motion to support clinical diagnosis.

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

• QLV-CMS (Quantitative Left Ventriculography-Cardiovascular Measurement System) (K993765)

Submission Summary (Full Text)

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K994283

AUG 3 0 2000

**medical imaging systems**

# 510(k) Premarket Notification

12 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 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<br>: 2333 AA Leiden, The Netherlands |
| Telephone | : [phone] |
| Fax | : [phone] |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : December 15, 1999 |
| 2) Device Name | : MRI - Magnetic resonance Analytical Software System |
| Common Name | : MASS |

Device Class. Name Regulation Number

System, Image Processing; : 21 CFR 892.2050 (90 LLZ; Class II)

. Medis: 510(k) K993765; 3) Predicate Device(s)

4) Description of the device:

MASS is a professional state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. MASS facilitates the import and visualization of multi-slice, multiphase MRI data sets encompassing the cardiac chambers via CD-Rom and digital network. This MASS functionality is independent of the MRI equipment vendor. MASS provides objective and reproducible global and regional two-, three- and fourdimensional clinically relevant parameters describing left and right ventricular heart as ventricular volumes, regional wall thickness and function. such wall MASS is intended to support all clinicians, i.e. cardiologists, thickening/thinning radiologists, and referring physicians involved in the noninvasive assessment of heart function.

### 5) Intended use:

MASS, including its option, has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular from cardiac MR data sets. The software enables the display of images for use by trained medical personnel.

Intended purposes are:

supporting clinical diagnoses about the status of the global and regional function and ﮩ anatomy of the cardiac chambers;

2. supporting the subsequent clinical decision making processes;

supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of interventions.

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medical imaging syst

# MRI- MASS 510(k) Premarket Notification

## 6) Substantial equivalence Information:

MASS is substantially equivalent to the Predicate Devices of MEDIS medical imaging systems B.V., K993765 "QLV-CMS" (Quantitative Left Ventriculography-Cardiovascular Measurement System)

# Conclusion respecting safety and effectiveness:

It is the opinion of MEDIS medical imaging systems B.V. that MASS is safe and potential hazards are controlled by a risk management plan for the software development procease (see Appendix C), Including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluations by hospitals and literature (see Appendix F) support this statement. The software package MASS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions and regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines, and then decide to use the derived data to compare against earlier images or images from other patients.

in MEDIS opinion the level of concern for the stand alone software to view images is 'minor' and that the use of MASS 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 0 2000

Mr. J. I. Hollander Quality Coordinator MEDIS Medical Imaging Systems B.V. Poortgebouw Rijnsburgerweg 10 2333 AA Leiden NETHERLANDS

Re: K994283 MRI-MASS (analytical software) Dated: June 22, 2000 Received: June 26, 2000 Regulatory Class: II 21 CFR §892.1000/Procode: 90 LNH

#### Dear Mr. Hollander:

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 pror 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalion 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 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 C. Schultz, M.D.

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

Enclosure(s)

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510(k) Number (if known):

Device Name:

Indications For Use:

MASS, including its option, has been developed for the objective and reproducible analysis of multi-shase left and right ventricular function from cardiac MR data sets. The MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, ESV, stroke volume, ejection fraction, peak thisksping(this) = = = = ; myocardial mass; regional wall thickness, as well as wall thickening/thinning, and regional wall motion.

When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

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| | Concurrence of CDRH, Office 9&Device Evaluation (ODE) | | |
|---------------|---------------------------------------------------------------------------------------------------------------------|---|--|
| | 1<br>(Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices<br>510(k) Number_ | | |
| scription Use | OD | A | |

Pres (Per 21 CFR 801.109)

S

Over-The-Counter Use

(Optional Format 1-2-96)