(48 days)
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.
Here's an analysis of the acceptance criteria and study information for the Arterys Cardio DL device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary (K163253) for Arterys Cardio DL does not explicitly list specific quantitative acceptance criteria or their corresponding reported device performance values in a table format.
Instead, it indicates that "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing." The submission focuses on demonstrating substantial equivalence to predicate devices (Arterys Software v2.0 and Medis Imaging QMass) by comparing technological characteristics and asserting that it "raises no new questions of safety and effectiveness."
The "Features/Functions" table (pages 5-6) compares the proposed device's capabilities to its predicates but does not include quantitative performance metrics or acceptance criteria for those metrics.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set.
Data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated for any test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used to establish ground truth or their specific qualifications for any test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth on a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study investigating human readers' improvement with AI assistance. The focus is on the device's standalone performance and substantial equivalence to predicates.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Yes, a standalone study (algorithm-only performance) appears to have been done. The statement "Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing" (page 7) implies that the software's inherent capabilities were tested and validated. The entire submission focuses on the algorithm's functionality and its output.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for validation. While the device provides "clinically-relevant and reproducible, quantitative data," it doesn't specify if this was validated against expert consensus, pathology, or outcomes data. Given that it's a post-processing analysis software intended to quantify existing MR images, it's highly probable that some form of expert consensus or highly accurate manual measurements served as ground truth for quantitative validation (e.g., comparing algorithm-derived volumes or flow measurements to manually delineated ones). However, this is not stated.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given the "DL" (Deep Learning) in the product name, it's implied that machine learning was used, which would typically involve a training set with established ground truth, but the details are absent.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2017
Arterys Inc. % Ms. Golnaz Moeini, RAC Director of Quality and Regulatory 51 Federal Street, Suite 305 SAN FRANCISCO CA 94107
Re: K163253 Trade/Device Name: Arterys Cardio DL Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2016 Received: November 18, 2016
Dear Ms. Golnaz Moeini:
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.
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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,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Arterys Cardio DL
Indications for Use (Describe)
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Section 5. 510(k) Summary
1. General Information
| 510(k) Sponsor | Arterys Inc. |
|---|---|
| Address | 51 Federal St. Suite 305San Francisco, CA 94107 |
| Correspondence Person | Golnaz Moeini, RACDirector of Quality and RegulatoryArterys Inc. |
| Contact Information | Email: quality@arterys.comPhone: 408-504-3187 |
| Date Prepared | 11/17/2016 |
2. Proposed Device
Proposed Device:
| Proprietary Name | Arterys Cardio DL |
|---|---|
| Common Name | Arterys Cardio DL |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Predicate Device 3.
Primary Predicate Device:
| Proprietary Name | Arterys Software v2.0 |
|---|---|
| Premarket Notification | K162513 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Secondary Predicate Device:
| Proprietary Name | Medis Imaging QMass |
|---|---|
| Premarket Notification | K140587 |
| Classification Name | System, Image Processing, Radiological |
| Regulation Number | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Class | II |
Device Description 4.
Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize and quantify MRI data in DICOM format. Manual and semi-automatic border detection forms the basis for analysis. The software has features for loading, saving, generating screen displays, and
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aggregating quantitative data from cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL is intended for use in both pediatric (neonate, infant, child and adolescent) and adult populations.
The following visualization, quantification and data-reporting functionalities are provided by the software:
Visualization:
- 2D image review -
- 3D image review by means of MIP, Surface MinIP, Surface or Average -
- Multi-planer reconstruction (MPR) views (axial, coronal and sagittal) -
- Image navigation tools -
- -Cine play
- Cardiac views -
Quantification:
- Anatomy and tissue segmentation -
- -Distance and area measurements
- Cardiac function quantification including stroke volume, ejection fraction, cardiac output, end-diastolic mass and volume, end-systolic mass and volume
- -Flow quantification, including net flow, forward flow, reverse flow, regurgitation fraction, pressure gradient and primary flow direction, at user-specified locations where contours have been created (e.g. aortic valve, pulmonary valve, mitral valve, tricuspid valve, superior vena cava)
- -Phase correction
Data reporting:
The distance, area, volume, and blood flow statistics, along with user-selected, annotated images, are displayed to the user within the software client web browser. The user has the option to save the data for later use. The user can also send the data to the clinician database, such as PACS, for review.
5. Indications for Use
Arterys Cardio DL consists of software that analyzes DICOM-compliant cardiovascular images acquired from magnetic resonance (MR) scanners. Arterys Cardio DL specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0 T MR Scanners. The data produced by Arterys Cardio DL is intended to be used to support qualified cardiologist, radiologist, or other licensed professional healthcare practitioners for clinical decision-making. It is a support tool that provides relevant clinical data as a resource to the clinician and is not intended to be a source of medical advice or to determine or recommend a course of action or treatment for a patient.
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| Feature/Function | Proposed Device:Arterys Cardio DL | Primary PredicateDevice:Arterys Software v2.0(K162513) | Secondary PredicateDevice:Medis ImagingQMass(K140587) |
|---|---|---|---|
| Operating System | Linux | Linux | Not Applicable |
| Platform | Client-server, ChromeDesktop | Client-server, ChromeDesktop | Not Applicable |
| Scanners | Both 1.5T and 3.0T | Both 1.5T and 3.0T | Not Applicable |
| Image input | Supports DICOM 3.0 | Supports DICOM 3.0 | Not Applicable |
| Data acquisitionprotocol for flowand volume analysis | Cardiovascularimages: multi-phase,multi-slice andvelocity encodedimages acquired fromMRI scanners | Cardiovascularimages: multi-phase,multi-slice andvelocity encodedimages acquired fromMRI scanners | Not Applicable |
| Workflows | Basic 2D, Basic 3D,4D Flow, 2D PhaseContrast | Basic 2D, Basic 3D,4D Flow, 2D PhaseContrast | Not Applicable |
| Image display mode | Static and cine | Static and cine | Not Applicable |
| Image NavigationTools | Pan, zoom, rotate,maximize/minimize,slice scroll (viewmultiple slices),adjust window/level,slab thickness, flowdirection and timescroll (view multiplephases), image ROIplacement; automated2D ROI (with editfunctions); 2D speedcolor map. | Pan, zoom, rotate,maximize/minimize,slice scroll (viewmultiple slices),adjust window/level,slab thickness, flowdirection and timescroll (view multiplephases), image ROIplacement; automated2D ROI (with editfunctions); 2D speedcolor map. | Not Applicable |
| 3D (volumerendered) imagereview | Yes | Yes | Not Applicable |
| Cardiac View | Yes | Yes | Not Applicable |
| Orientation label | Yes | Yes | Not Applicable |
| Feature/Function | Proposed Device:Arterys Cardio DL | Primary PredicateDevice:Arterys Software v2.0(K162513) | Secondary PredicateDevice:Medis ImagingQMass(K140587) |
| Cross-referenceindicator | Yes | Yes | Not Applicable |
| View DICOM data | Yes, users can viewthe DICOMinformation about thepatient, study andcurrent image | Yes, users can viewthe DICOMinformation about thepatient, study andcurrent image | Not Applicable |
| Secondary Capture | Yes | Yes | Not Applicable |
| Segmentation ofregion of interest | Manual and semi-automatic | Manual and semi-automatic | Not Applicable |
| Phase errorcorrection | Yes | Yes | Not Applicable |
| QuantitativeAnalysis, flow | Yes, 4D Flow and 2DPhase Contrast | Yes, 4D Flow and 2DPhase Contrast | Not Applicable |
| QuantitativeAnalysis, area | Yes | Yes | Not Applicable |
| QuantitativeAnalysis, distance | Yes | Yes | Not Applicable |
| QuantitativeAnalysis, Volume in4D Flow Workflow | Yes | Yes | Not Applicable |
| QuantitativeAnalysis, Volume in3D Workflow for ashort axis stack | Yes | Not Applicable | Yes |
| Directional/vectordisplay of the bloodparticle travel | Yes | Yes | Not Applicable |
| Flow quantificationof valves | Yes | Yes | Not Applicable |
| Feature/Function | Proposed Device:Arterys Cardio DL | Primary PredicateDevice:Arterys Software v2.0(K162513) | Secondary PredicateDevice:Medis ImagingQMass(K140587) |
| Automatic selectionof the TemporalLandmark timepoints | Yes | Yes | Not Applicable |
6. Comparison of Technological Characteristics with the Predicate Devices
Arterys Inc., Traditional 510(k)
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7. Performance Data
Safety and performance of Arterys Cardio DL has been evaluated and verified in accordance with software specifications and applicable performance standards through software verification and validation testing. Additionally, the software validation activities were performed in accordance with IEC 62304:2006/AC: 2008- Medical device software - Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
8. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Arterys Cardio DL raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.
§ 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).