(182 days)
Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources.
This application software receives medical images from modalities (mage scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication, printing, and management of medical images.
This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered.
Note: The clinician retains the ultimate responsibility for making the proper diagnosis based on standard radiological practices and visual comparison of the separate, unprocessed images. Ziostation2 is a tool to be used in support of those standard practices and visual comparisons.
ZIOSTATION2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RT Image.
The provided text is a 510(k) premarket notification for the Ziostation2, an image processing application software. It focuses on establishing substantial equivalence to existing predicate devices rather than directly presenting explicit acceptance criteria and a detailed study proving device performance against those criteria in a typical clinical performance study format.
However, based on the information provided, we can infer some aspects relevant to your request, especially concerning the "Testing Summary" section.
Here's an analysis based on your questions, extracting what's available and noting what is not explicitly stated in the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding performance metrics (e.g., sensitivity, specificity, accuracy) for the Ziostation2 for specific clinical tasks. The submission focuses on demonstrating substantial equivalence to predicate devices for various image processing functionalities.
The "Testing Summary" states: "The ZIOSTATION2 software package successfully completed integration testing/verification testing prior to Beta validation. Regression testing was also performed on all functionality present on Ziostation. Software Beta testing/validation was successfully completed prior to final testing and release. In addition, potential hazards have been addressed by the Qi Imaging Risk Management process."
This statement confirms that internal testing was performed, but it lacks specific quantitative acceptance criteria and their corresponding results. The acceptance criteria for these internal tests would likely be related to software functionality, accuracy of calculations (e.g., volume, perfusion parameters), visualization correctness, data integrity, and system stability, demonstrating that the new features perform as intended and comparably to the predicate devices. However, these specific criteria and results are not detailed in this public document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not explicitly stated in the provided text. The document refers to "integration testing/verification testing" and "Software Beta testing/validation," which would have used some form of test data, but the sample size, provenance, or type of data (e.g., real patient data, synthetic data, specific types of scans) are not disclosed. Given the nature of a 510(k) for an image processing system, it's probable that DICOM datasets were used, but details are absent.
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)
This information is not explicitly stated in the provided text. For a device like Ziostation2, which is an image processing application, ground truth for verification testing would likely involve validation against known phantom measurements or expert measurements performed on clinical images, but the details of such expert involvement are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not explicitly stated in the provided text.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The document focuses on showing substantial equivalence of the software's processing and visualization capabilities to those of predicate devices, not on the impact of the device on human reader performance in a controlled study. The device is intended "to supplement generally accepted methods of interpreting radiological images," implying it's a tool, not an AI for diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
While the "Testing Summary" mentions "integration testing/verification testing," "regression testing," and "Software Beta testing/validation," these are described as internal software tests. It's highly probable these included "standalone" evaluations of the algorithms for their intended functions (e.g., accuracy of measurements, correct rendering of images, proper application of filters). However, specific metrics and results of such standalone performance (e.g., a standalone AUC for a diagnostic task) are not provided, as the device is not presented as an AI diagnostic algorithm, but rather an image processing and visualization tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for the internal testing (integration, verification, beta testing) is not explicitly stated. Given the functionalities of Ziostation2 (e.g., CT Coronary Analysis, CT Colon Analysis, CT Perfusion Analysis, MR Tractography), ground truth could involve:
- Known phantom data: for quantitative measurements (e.g., volumes, distances).
- Expert measurements/annotations: on clinical images for comparison with the software's automated or semi-automated tools.
- Previous gold standard software outputs: especially for regression testing against the predecessor Ziostation.
- Pathology or follow-up outcomes data: less likely for general image processing tools, but could be relevant for specific modules if they had a diagnostic claim, which is not the primary focus here.
8. The sample size for the training set
This information is not applicable or not explicitly stated. Ziostation2 is described as an "image processing application software," and its features are discussed in terms of "workflow enhancements" and equivalency to existing functionalities (e.g., data reconstruction, vessel labeling, measurement, display tools). There is no indication that this product is a machine learning or AI model trained on a specific dataset that would require a "training set" in the conventional sense of AI/ML development. Its functionality seems to be based on established algorithms in image processing.
9. How the ground truth for the training set was established
This information is not applicable or not explicitly stated, for the same reasons as in point 8.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 4, 2015
Qi Imaging, LLC % Mr. Richard Ball Director, Regulatory & Quality Affairs 1301 Shoreway Road. Suite 325 BELMONT CA 94002
Re: K151212 Trade/Device Name: Ziostation2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2015 Received: October 14, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K151212
Device Name Ziostation2
Indications for Use (Describe)
Ziostation2 is an image processing application software available for installation onto customer owned hardware. This application software can be networked to provide for sharing of resources.
This application software receives medical images from modalities (mage scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication, printing, and management of medical images.
This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary Ziostation2 Qi Imaging, LLC
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
General Information
| Trade Name | Ziostation2 |
|---|---|
| Common NameClassification Name | Picture Archiving and Communications System (PACS)System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ) |
| Applicant: | Qi Imaging, LLC1301 Shoreway Road, Suite 325Belmont, CA 94002Tel 650-413-1364Fax 650-596-7319 |
| Contact | Richard BallSr. Director, Regulatory and Quality Affairs |
Intended Use
- . Ziostation (hereinafter "this application software") is an image processing application software available for installation onto customer-owned hardware. This application software can be networked to provide for sharing of resources.
- This application software receives medical images from modalities (medical image scanning devices such as CT) or image archives such as PACS through network or media and provides for the viewing, quantification, manipulation, communication, printing, and management of medical images.
- . This application software is intended for use by trained medical professionals to supplement generally accepted methods of interpreting radiological images.
- . Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor whose characteristics are approved by the regulatory agency governing the market within which Ziostation2 is being offered.
Note: The clinician retains the ultimate responsibility for making the proper diagnosis based on standard radiological practices and visual comparison of the separate, unprocessed images. Ziostation2 is a tool to be used in support of those standard practices and visual comparisons.
{4}------------------------------------------------
Predicate Devices
Predicate devices to Ziostation2 Software Tool
| Device Name | 510(k)Number |
|---|---|
| Ziostation(Multiple Protocol Enhancements) | K070205 |
| Ziostation withCardiac Function Analysis and Calcium Scoring Software | K083446 |
| CARDIQ Express v2.0 | K073138 |
| EBW NM 2.0 | K111336 |
| PET VCAR | K063324 |
| CT Perfusion 4 | K052839 |
| Vitrea CT Myocardial Analysis | K112531 |
| Syngo Volume Perfusion, CT Body | K092013 |
| AW Volume Share 5 | K110834 |
| Synapse 3D Liver Analysis | K110186 |
| Signa HDxT HD | K121676 |
| Achieva R2 1.5T/3.0T | K110151 |
| SureSubtraction Ortho CSSO-001A | K130960 |
| CardEP | K031261 |
| Vitrea CT Transcatheter Aortic Valve Replacement Planning | K122578 |
Device Description
ZIOSTATION2 is a basic DICOM image management system to further aid clinicians in their analysis of anatomy, physiology and pathology. Universal functions such as data retrieval, storage, management, querying and listing, and output are handled by the basic Ziostation2 software. Various imaging tools and techniques can be invoked to process images from the following image types: CT, MRI, Ultrasound, Digital X-ray X-ray Angiography, PET, SPECT, NM, SC, Mammography, X-ray Radiofluoroscopic image, RT Image.
New Features – Substantial Equivalence Discussion
| Image Viewing/Tool Enhancements – Ref. Ziostation K070205 and Ziostation w/ Cardiac Function | |
|---|---|
| Analysis K083446 as predicate devices | |
| Capability | Substantial Equivalence |
| Fusion Viewer | K070205 Fusion Viewer is a workflow enhancement and is substantially equivalent to the current Ziostation ability to fuse images. |
| PhyZiodynamics | K070205 PhyZiodynamics reconstructs data with the addition of noise reduction and motion coherence to improve image quality and is substantially equivalent to the current Ziostation data reconstruction capability. |
{5}------------------------------------------------
| CT CoronaryAnalysis | K070205 (Secondary K073138) Improvements to CT Coronary includeautomatic vessel labeling and color coding of HU ranges of specified areasfor easier visualization of suspected areas of interest. This tool with itsexpanded capabilities is substantially equivalent to the current Ziostationcoronary analysis tool. |
|---|---|
| CT Colon Analysis | K070205 (Secondary K110834) The added capability to automaticallymeasure and report on user-specified ROI's is a workflow enhancement.This capability is substantially equivalent to the current Ziostation CTColon tool. |
| CT/SPECT CardiacFusion | K070205 (Secondary K111336) The functionality being added to thealready cleared CT/SPECT Cardiac Fusion ability of the current Ziostationdevice is to provide data and polar maps of stress, rest, reversibility andwashout. This workflow enhancement is substantially equivalent to thecurrent Ziostation CT/SPECT Cardiac Fusion tool. |
| SUV Measurement | K070205 (Secondary K063324) Uses current multi-exam comparisoncapability of PET images to visualize and monitor disease progression orresponse to treatment or therapy. This workflow enhancement issubstantially equivalent to the current Ziostation PET imaging tool. |
| CT Subtraction | K070205 (Secondary K130960) CT Subtraction improves the currentcapability of contrast enhancement visualization. This improvement issubstantially equivalent to the current Ziostation contrast enhancementcapability. |
| EP Planning | K070205 (Secondary K031261) Using currently available display andmeasurement tools, EP Planning allows the physician to concentrate oncertain specific areas of the heart. This tool is substantially equivalent tothe current Ziostation display and measurement capability. |
| TAVR | K070205 (Secondary K122578) Using currently available display andmeasurement tools, TAVR allows the physician to concentrate on certainspecific areas of the heart, including aortic valve and surroundingstructures. This tool is substantially equivalent to the current Ziostationdisplay and measurement capability. |
| CT Cardiac RV | K083446 (Secondary K110834) Using currently available display andmeasurement tools, CT Cardiac RV adds the capability to calculate anddisplay various functional parameters of the right ventricle. This addedcapability is substantially equivalent to the current Ziostation capability toprovide functional ventricular information. |
Additional Image Processing Functionalities
| CT Perfusion Analysis | |
|---|---|
| CT PerfusionAnalysis | K052839 Both the Qi Imaging feature and the GE predicate feature areimage analysis software applications that allow evaluation of dynamic CTdata following the injection of a compact bolus of contrast material,generating information with regard to changes in image intensity overtime. Both features allow assessment of the type and extent of variousperfusion related parameters. The Qi Imaging CT Perfusion feature issubstantially equivalent to GE CT Perfusion 4. |
| CT VolumePerfusion | K052839 Both the Qi Imaging feature and the GE predicate feature areimage analysis software applications that allow evaluation of dynamic CTdata following the injection of a compact bolus of contrast material,generating information with regard to changes in image intensity over |
{6}------------------------------------------------
| time. Both features allow assessment of the type and extent of variousperfusion related parameters in user-specified planes of orientation. The QiImaging CT Volume Perfusion feature is substantially equivalent to GECT Perfusion 4. | |
|---|---|
| CT MyocardialPerfusion | K112531 Both the Qi Imaging feature and the Vital Images featureprovide color-coded polar maps of the contrasted myocardium based onthe calculation of transmural perfusion ratios. The Qi Imaging CTMyocardial Perfusion feature is substantially equivalent to Vital ImagesVitrea CT Myocardial Analysis |
| CT DynamicMyocardial Perfusion | K092013 Both the Qi Imaging feature and the Siemens feature provide 3-dimensional calculation of Blood Flow, Blood Volume and otherfunctional parameters by displaying color coded maps of individualparameters on user-specified regions of the myocardium. The Qi ImagingCT Dynamic Myocardial Perfusion feature is substantially equivalent toSiemens syngo Volume Perfusion – CT Body |
| CT Lesion Analysis | K110834 Both the Qi Imaging feature and the GE feature allow extractionand measurement of lesions, enabling observation of changes over time.The Qi Imaging CT Lesion Analysis feature is substantially equivalent toGE AW Volume Share 5 |
| CT Liver Analysis | K110186 Both the Qi Imaging CT Liver feature and the Fuji Film featureallow auto-segmentation/calculation of liver features such as liverstructure, volumes, tumors and manual definition of separation planeproposals. The Qi Imaging CT Liver Analysis feature is substantiallyequivalent to Fuji Film Synapse 3D Liver Analysis |
| MR Tractography | K121676 and K110151 Qi Imaging MR Tractography feature, the GEdevice and the Philips device all present DTI Tractography data showingcolored tracts of various anatomical fibers of interest overlaid onto thesurrounding anatomy. The Qi Imaging MR Tractography feature issubstantially equivalent to the comparable software features of both GESigna HDXT and Philips Achieva R41.5T & 3.0T. |
Materials
This software tool consists entirely of software. No materials are contained in this product.
Testing Summary
The ZIOSTATION2 software package successfully completed integration testing/verification testing prior to Beta validation. Regression testing was also performed on all functionality present on Ziostation. Software Beta testing/validation was successfully completed prior to final testing and release. In addition, potential hazards have been addressed by the Qi Imaging Risk Management process.
Summary of Substantial Equivalence
ZIOSTATION2 is substantially equivalent in intended use and function to the composite of predicate devices identified above.
§ 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).