K Number

Device Name

CT-MASS

Manufacturer

MEDIS MEDICAL IMAGING SYSTEMS, B.V.

Date Cleared

2004-03-02

(90 days)

Product Code

JAK

Regulation Number

892.1750

Intended Use

CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The CT-MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, BSV, stroke volume, ejection factor, peak ejection and filling rates, myocardial mass, regional wall thickness, as well as well as wall thickening/thinning, and regional wall motion. This is including the axial to short axis reformat. When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

Device Description

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K013422, K020796

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a software tool for semi-automatic analysis of cardiac CT data, focusing on calculating parameters and visualization. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML models, or image processing techniques that would strongly suggest AI/ML. The description emphasizes "objective and reproducible analysis" and "semi-automatically calculate," which are consistent with traditional image analysis algorithms rather than AI/ML.

Therapeutic

No.
The device is a software tool used for analysis and diagnosis, not for treatment or therapy. It provides parameters to support diagnosis when interpreted by a trained physician.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states: "When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis." This explicitly indicates its role in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that CT-MASS is a "professional state-of-the-art analytical software tool designed for UNIX, Linux as well as Windows platforms." It describes its function as facilitating the import, visualization, and analysis of CT data sets, and its output is parameters and displays. There is no mention of any accompanying hardware component that is part of the device itself.

IVD (In Vitro Diagnostic)

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.
CT-MASS Function: CT-MASS analyzes imaging data (CT scans) of the heart. It does not process biological samples taken from the patient.
Intended Use: The intended use clearly states it analyzes "cardiac CT data sets" and provides parameters based on these images to support diagnosis.

Therefore, CT-MASS falls under the category of medical imaging analysis software, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

90 JAK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Anatomical Site

cardiac chambers, human heart, left and right ventricles

Indicated Patient Age Range

Not Found

Intended User / Care Setting

cardiologists, radiologists, and referring physicians

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

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K013422, K020796

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

MAR - 2 2004

CT-MASS 510(k) Pre-market Notification

K033774

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 bv
Address	: Schuttersveld 9
: 2316 XG Leiden, The Netherlands
Telephone	: +31 71 522 3244
Fax	: +31 71 521 5617
Contact Person	: J.I. Hollander, Quality Coordinator
Prepared	: December 01, 2003
2. Device Name	: Medis CT-MASS
Common Name	: CT-MASS
Device Class. Name	: Computed Tomography x-ray systems
Regulation Number	: 21 CFR 892.1750 (90 JAK; Class II)
3. Predicate Device(s)	: GEMS: 510(k) K013422: K020796

4. Description of the device:

5. Intended use:

CT-MASS has been developed for the objective and reproducible analysis of multislice, multi-phase left and right ventricular function from cardiac CT data sets. The itended purposes are:

1. Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart;
1. Supporting the subsequent clinical decision making processes;
1. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

CT MASS 510(k) Premarket Notification

6. Substantial equivalence Information:

CT-MASS is substantially equivalent to the Predicate Devices of General Electric Medical Systems, K013422 "CardIQ Function" and K020796 "CardIQ Analysis III", using the same technological technique for the same intended use.

Conclusion respecting safety and effectiveness:

It is the opinion of Medis medical imaging systems bv that CT-MASS 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). Evaluations by hospitals and literature (See Appendix F) support this statement. The software package CT-MASS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricles. The ventricular contpurs and regions-of-interest will be interpreted by the operator, who can choose to acceet or reject the outlines, and then decide to use the derived data to compare against earlier images or images from other patients.

It is the opinion of Medis medical imaging systems bv that the level of concern for the stand alone software to view images is 'minor' and that the use of CT-MASS software does not change the intended use of computed tomography scanners in practice, nor does the use of software result in any new potential hazards.

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems, B.V. Schuttersveld 9 2316XG Leiden P.O. Box 384 2300 AJ Leiden THE NETHERLANDS

Re: K033774 Trade/Device Name: CT-MASS Analytical Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 1, 2003 Received: December 3, 2003

Dear Mr. Hollander:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you ve organization of substantial equivalence of your device to a legally premarket noticate 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), please If you doom bpooms at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Addisonaly and Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compharios as ( notification" (21CFR Part 807.97) you may obtain. Other general of receibled to premainted new rehe Act may be obtained from the Division of Small ntormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 11andiaetarere, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number (if known):

Device Name: CT-MASS

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 of Device Evaluation (ODE

(Optional Format 3-10-98)

Prescription Use

Manayc Brogdon

(Division Sign-Off) Division of Reproductive, Abdo and Parliological Devices 5 (O(k) Number