CT-MASS

K033774 · Medis Medical Imaging Systems BV · JAK · Mar 2, 2004 · Radiology

Device Facts

• Record ID: K033774
• Device Name: CT-MASS
• Applicant: Medis Medical Imaging Systems BV
• Product Code: JAK · Radiology
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

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; 2. Supporting the subsequent clinical decision making processes; 3. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

Device Story

CT-MASS is analytical software for UNIX, Linux, and Windows platforms; imports multi-slice, multi-phase cardiac CT data via CD-ROM or network. Software performs semi-automatic calculation of ventricular parameters: EDV, ESV, stroke volume, ejection fraction, peak ejection/filling rates, myocardial mass, regional wall thickness, wall thickening/thinning, and regional wall motion. Operator reviews, accepts, or rejects generated ventricular contours and regions-of-interest. Used by cardiologists, radiologists, and referring physicians in clinical or research settings. Output assists in noninvasive assessment of heart function, supporting diagnosis and clinical decision-making by providing objective, reproducible measurements.

Clinical Evidence

Evaluations by hospitals and literature review were used to support safety and effectiveness. No specific clinical trial metrics (e.g., sensitivity, specificity) are provided in the summary; the device relies on operator interpretation of semi-automatically generated contours.

Technological Characteristics

Analytical software package; vendor-independent; compatible with UNIX, Linux, and Windows. Features semi-automatic calculation of cardiac parameters from CT data sets, including axial to short-axis reformatting. Software development follows a risk management process including hazard analysis and verification/validation testing. Regulatory level of concern is 'minor'.

Indications for Use

Indicated for the analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets to support clinical diagnosis, decision-making, and research trials regarding heart anatomy and function.

Regulatory Classification

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.

Predicate Devices

• GEMS CardIQ Function (K013422)
• GEMS CardIQ Analysis III (K020796)

Submission Summary (Full Text)

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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<br>: 2316 XG Leiden, The Netherlands |
| Telephone | : [phone] |
| Fax | : [phone] |
| 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:

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.

#### 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;
- 2. Supporting the subsequent clinical decision making processes;
- 3. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

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# 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.

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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.

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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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Addisonaly and Compliance at [phone]. 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 [phone] 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

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510(k) Number (if known):

Device Name: CT-MASS

Indications For 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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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