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.

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.

Device Description

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.

AI/ML Overview

The provided documentation for K994283 does not contain specific acceptance criteria, detailed study results, or the other requested information for a clinical performance study. The submission primarily focuses on establishing substantial equivalence to a predicate device and discussing the safety and intended use of the MASS software.

Therefore, many of the requested fields cannot be filled. Based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The document describes the device's functionality and intended use but does not present a table of specific performance metrics (e.g., accuracy, precision, repeatability) with corresponding acceptance thresholds or reported device performance values.

2. Sample Size Used for the Test Set and Data Provenance

Not available in the provided document. The document mentions "Evaluations by hospitals and literature" in a general statement about supporting safety and effectiveness, but it does not specify any test set sample sizes, nor does it provide details about their origin (country, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not available in the provided document. There is no mention of specific experts or their qualifications used to establish ground truth for any test set. The document states that the "regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines," implying human interaction in the final interpretation but not a formal ground truth establishment process for a study.

4. Adjudication Method for the Test Set

Not available in the provided document. No information is provided regarding an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not available in the provided document. There is no mention of an MRMC comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is described as an analytical tool that aids trained medical personnel, but not in the context of comparative effectiveness.

6. Standalone (Algorithm Only) Performance Study

Partially available/Inferred: The document describes MASS as "stand alone software to view images" and states that "This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions." This suggests that the algorithm does perform its calculations and display in a "standalone" fashion. However, there is no performance study presented to quantify its standalone accuracy, precision, sensitivity, or specificity against any ground truth. The "verification and validation tests" mentioned (Appendix E, not provided) likely cover internal software functionality rather than external clinical performance.

7. Type of Ground Truth Used

Not available in the provided document for any formal study. While the software aims to provide "objective and reproducible global and regional... parameters" for "left and right ventricular volumes, regional wall thickness and function," the basis for validating these against a "ground truth" (e.g., pathology, advanced imaging, clinical outcomes) in a formal study is not described. The document implies that a "trained physician" interprets the parameters derived by the software.

8. Sample Size for the Training Set

Not available in the provided document. There is no mention of a training set or its sample size. This suggests the device might use more traditional algorithmic approaches or was developed without a machine learning training phase in the current understanding.

9. How the Ground Truth for the Training Set Was Established

Not available in the provided document. As there is no mention of a training set, the method for establishing its ground truth is also not provided.

Summary

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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: 2333 AA Leiden, The Netherlands
Telephone	: +31 71 522 3244
Fax	: +31 71 521 5617
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)

Description of the device:

5) Intended use:

Intended purposes are:

supporting clinical diagnoses about the status of the global and regional function and ﮩ 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.

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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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three stylized human figures.

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 (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

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

	Concurrence of CDRH, Office 9&Device Evaluation (ODE)
	1(Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices510(k) Number_
scription Use	OD	A

Pres (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.