CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING

K083446 · Ziosoft, Inc. · LLZ · Mar 31, 2009 · Radiology

Device Facts

• Record ID: K083446
• Device Name: CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
• Applicant: Ziosoft, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Cardiac Function Analysis The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation. Calcium Scoring The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Device Story

Add-on software for Ziostation PACS; processes DICOM-compliant cardiac CT images. Cardiac Function Analysis: processes ECG-gated multi-phase CT data; semi-automatically calculates left ventricular parameters (ejection fraction, volumes, cardiac output, wall motion/thickness). Calcium Scoring: processes CT images; evaluates coronary artery calcified plaques; provides Agatston and Volume scores based on user-selected regions of interest. Used by clinicians in clinical settings to assist cardiac evaluation. Output displayed on workstation to aid clinical decision-making regarding cardiac health and coronary artery disease risk.

Clinical Evidence

No clinical data. Bench testing only; software integration and verification testing performed; Beta validation completed.

Technological Characteristics

Software-only device; no physical materials. Operates as an add-on to Ziostation image management system. Processes DICOM-compliant cardiac CT images. Functions include semi-automated calculation of cardiac parameters and calcium scoring.

Indications for Use

Indicated for patients undergoing cardiac CT imaging for evaluation of cardiac function or coronary artery calcified plaques. Cardiac Function Analysis provides functional parameters for cardiac evaluation; Calcium Scoring evaluates calcified plaques as a risk factor for coronary artery disease.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• CT Cardiac Function Analysis Software (K023760)
• CSCS-001 A Calcium Scoring (K072737)
• Calcium Scoring (K020140)

Submission Summary (Full Text)

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K08 3446
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## 510(k) Summary

MAR 3 1 2009

This 510(k) summary is prepared in accordance with 21 CFR 807.92.

#### General Information

| Trade Name | Cardiac Function Analysis<br>Calcium Scoring |
|---------------------|------------------------------------------------------------------|
| Common Name | Picture Archiving and Communications System (PACS) |
| Classification Name | System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ) |

Applicant:

Ziosoft, Inc. 1000 Bridge Parkway, Ste. 100 Redwood City, CA 94065 Tel [phone] Fax [phone]

Contact

Richard Ball Director, Regulatory and Quality Affairs

#### Intended Use

#### Cardiac Function Analysis

The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

#### Calcium Scoring

The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

#### Predicate Device

| Ziosoft tool | Manufacturer<br>of Predicate<br>Device | Device Name | 510(k)<br>Number |
|---------------------------|----------------------------------------|------------------------------------------|------------------|
| Cardiac Function Analysis | Toshiba | CT Cardiac Function Analysis<br>Software | K023760 |
| Calcium Scoring | Toshiba | CSCS-001 A Calcium Scoring | K072737 |
| Calcium Scoring | Voxar | Calcium Scoring | K020140 |

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## Device Description

Cardiac Function Analysis and Calcium Scoring are add-on software packages designed to be used with the basic Ziostation image management system to further aid clinicians in their analysis of anatomy and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation software. The additional capabilities provided by these two new devices are:

## Cardiac Function Analysis

Cardiac Function Analysis software post-processes ECG-gated cardiac CT images and extracts the following left ventricular parameters from multi-phase data.

- Left ventricular ejection fraction
- End diastolic volume
- End systolic volume
- Stroke volume
- Cardiac output
- Cardiac Index
- Wall thickness
- Wall thickness ratio
- Wall movement .
- . Volume Curve

## Calcium Scoring

Calcium Scoring software post-processes DICOM-based cardiac CT images and evaluates calcified plaque in the coronary arteries, providing the clinician with both Agatston and Volume calcium scores. These regions of interest are selected by the user.

## Materials

The Cardiac Function Analysis and Calcium Scoring tools consist entirely of software. No materials are contained in this product.

## Testing Summary

The Cardiac Function Analysis and Calcium Scoring software packages will successfully complete integration testing/verification testing prior to Beta validation. Software Beta testing/validation will be successfully completed prior to release. In addition, potential hazards have been addressed by a Risk Management process.

## Summary of Substantial Equivalence

Cardiac Function Analysis and Calcium Scoring are substantially equivalent in intended use and function to their respective predicate devices and other devices already marketed in the US.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Ball Director, Regulatory and Quality Affairs Ziosoft, Inc. 1000 Bridge Parkway, Suite 100 REDWOOD CITY CA 94065-1186

MAR 3 1 2009

Re: K083446

Trade/Device Name: Cardiac Function Analysis and Calcium Scoring · Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system

Regulatory Class: II

Product Code: LLZ

Dated: March 25, 2009

Received: March 26, 2009

#### Dear Mr. Ball:

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.

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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) premarket notification. The FDA finding os 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. Youmay obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janina M. Morris

anine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

## 510(k) Number (if known): KOS 3446

#### Cardiac Function Analysis and Calcium Scoring Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Indications for Use:

#### Cardiac Function Analysis

The Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac CT images to semi-automatically calculate and display various functional parameters, such as left ventricular ejection fraction, end diastolic volume, end systolic volume, stroke volume, cardiac output, cardiac index, wall thickness, wall thickness ratio and regional wall motion display. These measurements can be used to assist the clinician in a cardiac evaluation.

#### Calcium Scoring

The Calcium Scoring software option for use with Ziostation is a non-invasive post processing software tool that can be used with CT images to evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hula Heme

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 10/k) Number

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510(k) Submission Ziosoft, Inc.

Cardiac Function Analysis & Calcium Scoring for ZIOSTATION