(254 days)
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No
The document describes semi-automatic calculations and analysis based on image processing, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a software tool for analysis and display of cardiac MRI data to support diagnosis and research, not to provide therapy.
Yes
This device calculates and displays parameters from cardiac MR data sets to support clinical diagnoses and decision-making about the function and anatomy of cardiac chambers, which are key characteristics of a diagnostic device.
Yes
The device description explicitly states "MASS is a professional state-of-the-art analytical software tool designed for UNIX as well as Linux platforms." and describes its function as facilitating the import, visualization, and analysis of MRI data. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that MASS analyzes cardiac MR data sets. This is image data acquired from the patient's body using an MRI scanner. It does not involve the analysis of biological samples taken from the body.
- Intended Use: The intended use is to analyze and display parameters derived from these MR images to support clinical diagnoses and decision-making regarding the function and anatomy of the heart. This is a form of medical image analysis, not in vitro testing.
Therefore, while it is a medical device used for diagnosis and clinical decision support, it falls under the category of medical image analysis software rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
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.
Mentions image processing
System, Image Processing
Mentions AI, DNN, or ML
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Input Imaging Modality
MRI - Magnetic resonance
Anatomical Site
cardiac chambers, left and right ventricular heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the noninvasive assessment of heart function.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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:
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;
- 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.
1
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.
2
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)
3
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.
(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 Devices | |||
| 510(k) Number_ | |||
| scription Use | OD | A |
Pres (Per 21 CFR 801.109)
S
Over-The-Counter Use
(Optional Format 1-2-96)