(130 days)
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.
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 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 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.
The provided text does not contain detailed acceptance criteria for the "Cardiac Function Analysis" and "Calcium Scoring" software, nor does it describe a specific study proving the device meets acceptance criteria in terms of performance metrics like sensitivity, specificity, or agreement with ground truth.
The document mainly focuses on the regulatory submission process, intended use, device description, and substantial equivalence to predicate devices, rather than detailed performance studies against specific acceptance criteria.
Therefore, many of the requested sections cannot be filled from the given text.
Here's what can be extracted based on the provided information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria (e.g., minimum accuracy, sensitivity, or agreement percentages) are stated, and no specific performance metrics are reported in the provided text. The document states "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." This indicates that internal testing was conducted, but no results are presented.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not mentioned in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not mentioned in the document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not mentioned in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not mentioned in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Intended Use" section for both Cardiac Function Analysis and Calcium Scoring states that the software is intended for semi-automatic calculations and is a post-processing software tool where "regions of interest are selected by the user." This implies that the device is not purely standalone but is designed to assist a human user (human-in-the-loop). However, no standalone performance study results are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the document.
8. The sample size for the training set
Not mentioned in the document.
9. How the ground truth for the training set was established
Not mentioned in the document.
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K08 3446
Page 1 of 2
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 AnalysisCalcium 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 650-413-1300 Fax 650-596-7319
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 | Manufacturerof PredicateDevice | Device Name | 510(k)Number |
|---|---|---|---|
| Cardiac Function Analysis | Toshiba | CT Cardiac Function AnalysisSoftware | 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.
{3}------------------------------------------------
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) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 (800) 638-2041 or (240) 276-3150 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
{4}------------------------------------------------
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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hula Heme
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 10/k) Number
Page ⊥ of ⊥
510(k) Submission Ziosoft, Inc.
Cardiac Function Analysis & Calcium Scoring for ZIOSTATION
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).