(61 days)
Not Found
No
The summary describes semi-automatic calculations based on image post-processing, but there is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with such technologies.
No
The device is a software for post-processing cardiac MR images to calculate functional parameters, which assists clinicians in evaluation but does not directly treat or prevent a medical condition.
Yes
The device is described as "post-processing of DICOM compliant cardiac MR images to semi-automatically calculate and display various functional parameters... for use to assist the clinician in a cardiac evaluation." This function of calculating and displaying parameters to assist in evaluation aligns with the definition of a diagnostic device that aids in identifying or characterizing a medical condition.
Yes
The device is described as an "add-on software package" that works with an existing "image management system" to perform "post-processing" of images and calculate parameters. There is no mention of any hardware component being part of this specific device submission.
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 MR Cardiac Function Analysis software processes medical images (MR images), not biological samples. It analyzes the images to calculate functional parameters of the heart.
- Intended Use: The intended use clearly states it's for "noninvasive post-processing of DICOM compliant cardiac MR images." This is image analysis, not in vitro testing.
Therefore, this device falls under the category of medical image processing software, not an IVD.
N/A
Intended Use / Indications for Use
The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR 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.
Product codes
LLZ
Device Description
MR Cardiac Function Analysis is an add-on software package 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 this new device are:
MR Cardiac Function Analysis software post-processes ECG-gated cardiac MR 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
- Peak Ejection Rate
- Peak Filling Rate
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images
Anatomical Site
cardiac
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 MR Cardiac Function Analysis software package 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 the Ziosoft 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).
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K091262
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510(k) Summary
JUN 29 2009
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
General Information
Trade Name
MR Cardiac Function Analysis
Common Name Classification Name
Picture Archiving and Communications System (PACS) 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
MR Cardiac Function Analysis
The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR 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.
Predicate Device
| Ziosoft tool | Manufacturer of
Predicate Device | Device Name | 510(k)
Number |
|---------------------------------|---------------------------------------|----------------------------------------------------------|------------------|
| MR Cardiac Function
Analysis | Medis Medical
Imaging Systems B.V. | MRI-FLOW Analytical Software
Package (a.k.a. QMassMR) | K994282 |
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Device Description
MR Cardiac Function Analysis is an add-on software package 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 this new device are:
MR Cardiac Function Analysis software post-processes ECG-gated cardiac MR 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
- Peak Ejection Rate
- Peak Filling Rate
Materials
The MR Cardiac Function Analysis tool consists entirely of software. No materials are contained in this product.
Testing Summary
The MR Cardiac Function Analysis software package 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 the Ziosoft Risk Management process.
Summary of Substantial Equivalence
MR Cardiac Function Analysis is substantially equivalent in intended use and function to the predicate device and other devices already marketed in the US.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUN 2 9 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Ball Director, RA/OA Ziosoft, Inc. 1000 Bridge Parkway, Suite 100 REDWOOD CITY CA 94065
Re: K091262
Trade/Device Name: MR Cardiac Function Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 28, 2009 Received: April 29, 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. Iisting 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 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); medical device reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KO91262
Device Name: __ MR Cardiac Function Analysis
Indications for Use:
MR Cardiac Function Analysis
The MR Cardiac Function Analysis software option for use with Ziostation is intended for noninvasive post-processing of DICOM compliant cardiac MR 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.
Prescription Use (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)
| (Division Sign Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | R091262 |
Page ______ of ______510(k) Submission Ziosoft, Inc.
MR Cardiac Function Analysis for ZIOSTATION
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