(130 days)
Not Found
No
The summary describes semi-automatic calculations and post-processing based on user-selected regions of interest, without mentioning any AI/ML techniques or algorithms.
No
The device is a software tool for analysis and post-processing of medical images to assist clinicians in diagnosis and evaluation, not for treating or preventing diseases.
Yes
The device is a diagnostic device because it processes cardiac CT images to calculate various functional parameters and evaluate calcified plaques in the coronary arteries. It states, "These measurements can be used to assist the clinician in a cardiac evaluation," and "evaluate calcified plaques in the coronary arteries, which may be a risk factor for coronary artery disease," both of which indicate diagnostic intent.
Yes
The device is described as "add-on software packages" designed to be used with an existing image management system. The description focuses solely on the software's functions and capabilities, with 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 this device is a software option for post-processing of DICOM compliant cardiac CT images. It analyzes images generated by a CT scanner, which is an in-vivo imaging modality (meaning it images the body directly).
- No Sample Analysis: There is no mention of analyzing any biological samples from the patient. The input is image data, not biological specimens.
Therefore, while this device provides diagnostic information to assist clinicians, it does so by analyzing medical images, not by performing in vitro tests on biological samples.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
DICOM compliant cardiac CT images
ECG-gated cardiac CT images
Anatomical Site
cardiac / coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Analysis
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 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 | Manufacturer
of Predicate
Device | Device Name | 510(k)
Number |
|---------------------------|----------------------------------------|------------------------------------------|------------------|
| Cardiac Function Analysis | Toshiba | CT Cardiac Function Analysis
Software | K023760 |
| Calcium Scoring | Toshiba | CSCS-001 A Calcium Scoring | K072737 |
| Calcium Scoring | Voxar | Calcium Scoring | K020140 |
1
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.
2
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