(114 days)
Not Found
Yes
The summary explicitly states that the submission introduces "deep learning-based segmentation algorithms" and that a "non-adaptive deep learning-based algorithm is applied to the CT imaging data to automatically segment lung regions." Deep learning is a subset of machine learning.
No
The device is used to support diagnosis, documentation, and treatment planning, but it does not directly apply therapy to a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images." Additionally, the "Device Description" elaborates that it can "support the physician in the diagnosis, treatment planning, and documentation of chest diseases, including lung cancer, asthma, COPD, interstitial lung disease and other lung abnormalities." These statements clearly indicate its role in assisting with diagnoses.
Yes
The device is described as a "self-contained image analysis software package" that processes CT data and provides analysis and reporting tools. While it interacts with CT data (which comes from a hardware device), the device itself is the software package performing the analysis and visualization. There is no mention of accompanying hardware components that are part of the device being submitted.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- VIDA|vision's Function: VIDA|vision analyzes imaging data (CT scans) of the pulmonary tissue. It does not analyze specimens taken from the body. It processes existing medical images to provide quantitative information and support the physician's interpretation of those images.
- Focus on Image Analysis: The description repeatedly emphasizes image analysis, segmentation, volumetric analysis, and density evaluations based on CT data.
- No Mention of Specimen Analysis: There is no mention of collecting, preparing, or analyzing biological specimens.
Therefore, while VIDA|vision is a medical device used to aid in diagnosis, its function falls under the category of medical image analysis software, not In Vitro Diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA vision software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two dimensional images into a three-dimensional image format.
Product codes
JAK
Device Description
VIDA|vision is a self-contained image analysis software package. This real-time interactive evaluation in space and time of CT volume datasets provides the reconstruction of two-dimensional images into a three-dimensional image format.
VIDA|vision can be used to support the physician in the diagnosis, treatment planning, and documentation of chest diseases, including lung cancer, asthma, COPD, interstitial lung disease and other lung abnormalities e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets.
Evaluation (3D segmentation & isolation of sub-compartments, volumetric analysis, density evaluations, and low density cluster analysis), editing, and reporting tools are combined with a dedicated workflow.
VIDA|vision is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
VIDA|vision provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. VIDA|vision provides imaging of bronchial airways that can be used to assess therapy effectiveness and treatment plan based on CT scan data. VIDA|vision reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches.
VIDA|vision provides quantitative measurements and tabulates quantitative properties. VIDA|vision focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error prone manual tasks.
VIDA|vision has functions for loading, analyzing, and saving datasets, and will generate screen displays, computations and aggregate statistics. VIDA|vision data output may be exported in pdf format or to a csv file.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT
Anatomical Site
pulmonary tissue, lung, thoracic tissue, lung parenchyma, bronchial airways
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Non-clinical testing:
The device labeling contains instructions for use and any necessary precautions and warnings to support the safe and effective use of the device. Known hazards were identified and mitigated in accordance with the ISO 14971 standard. Verification and validation activities were performed in accordance with FDA QSR and the IEC 62304 standard. Testing consisted of unit, regression, performance, and integrated system testing. Lung and lobe segmentation performance was tested against the predicate performance to demonstrate substantial equivalence. Results of testing demonstrate that the device has met all product specifications and user needs within its intended use.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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VIDA Diagnostics Inc. % Alex Morris Director, Quality and Regulatory 2500 Crosspark Road, W250 BioVentures Center CORALVILLE IA 52241
August 7, 2020
Re: K200990
Trade/Device Name: VIDA|vision Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 19, 2020 Received: May 20, 2020
Dear Alex Morris:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200990
Device Name VIDA|vision
Indications for Use (Describe)
The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA vision software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two dimensional images into a three-dimensional image format.
| 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
K200990
| Submitter: | VIDA Diagnostics, Inc.
500 Crosspark Rd.
W250 BioVentures Center
Coralville, IA 52241 USA |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 25, 2020 |
| Contact Person: | Alex Morris, Director, Quality and Regulatory
VIDA Diagnostics, Inc.
2500 Crosspark Rd.
W250 BioVentures Center
Coralville, IA 52241 USA
Cell Phone: (647) 470.4363
Office Phone: (855) 900.8432
Email: amorris@vidalung.ai |
| Submission Date: | May 19, 2020 |
| Trade Name: | VIDA vision |
| Regulation
Description: | Computed tomography x-ray system |
| Common Name: | Medical Imaging Software for Computed Tomography Devices |
| Regulation: | 21 CFR 892.1750 |
| Product Code: | JAK |
| Regulatory Class: | Class II |
| Predicate Device: | Pulmonary Workstation 2 (PW2) by VIDA Diagnostics Inc.
Regulation: 21 CFR 892.1750
Product Code: JAK
Regulatory Class: Class II
Regulation Description: Computed tomography x-ray system
Submission Number: K083227 |
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Image /page/4/Picture/1 description: The image shows the word "VIDA" in a sans-serif font. The letters are all capitalized and in a light blue color. There is a registered trademark symbol to the right of the letter A. The letters are bold and the image is clear.
Description of Device:
VIDA|vision is a self-contained image analysis software package. This real-time interactive evaluation in space and time of CT volume datasets provides the reconstruction of two-dimensional images into a three-dimensional image format.
VIDA|vision can be used to support the physician in the diagnosis, treatment planning, and documentation of chest diseases, including lung cancer, asthma, COPD, interstitial lung disease and other lung abnormalities e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets.
Evaluation (3D segmentation & isolation of sub-compartments, volumetric analysis, density evaluations, and low density cluster analysis), editing, and reporting tools are combined with a dedicated workflow.
VIDA|vision is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry.
VIDA|vision provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. VIDA|vision provides imaging of bronchial airways that can be used to assess therapy effectiveness and treatment plan based on CT scan data. VIDA|vision reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches.
VIDA|vision provides quantitative measurements and tabulates quantitative properties. VIDA|vision focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error prone manual tasks.
VIDA|vision has functions for loading, analyzing, and saving datasets, and will generate screen displays, computations and aggregate statistics. VIDA|vision data output may be exported in pdf format or to a csv file.
Indications for Use Statement:
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Image /page/5/Picture/1 description: The image shows the word "VIDA" in a sans-serif font. The letters are all capitalized and in a light blue color. There is a registered trademark symbol to the right of the letter A. The image is simple and clean, with a focus on the word itself.
The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. VIDA|vision can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA|vision software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two dimensional images into a three-dimensional image format.
Comparison to Predicate:
The focus of this submission is to introduce deep learning-based segmentation algorithms to the proposed software to automatically segment lung regions.
| 510(k) Submitter | Predicate | Differences | |
|---|---|---|---|
| Manufacturer | VIDA Diagnostics, Inc. | VIDA Diagnostics, Inc. | |
| Trade Name | VIDA vision (formerly VIDA | ||
| Pulmonary Workstation 2 | |||
| (PW2)) | VIDA Pulmonary | ||
| Workstation 2 (PW2) | |||
| 510(k) Number | K200990 | K083227 | |
| Product Code | JAK | JAK | n/a |
| Regulation | |||
| Number | 21 CFR 892.1750 | 21 CFR 892.1750 | n/a |
| Regulation | |||
| Name | System, X-Ray, Tomography, | ||
| Computed | System, X-Ray, | ||
| Tomography, Computed | n/a | ||
| Intended | |||
| Use/Indications | |||
| for Use | The VIDA vision software | ||
| provides reproducible CT | |||
| values for pulmonary tissue, | |||
| which is essential for | |||
| providing quantitative | |||
| support for diagnosis and | |||
| follow up examinations. | |||
| VIDA vision can be used to | The VIDA Pulmonary | ||
| Workstation 2 (PW2) | |||
| software provides | |||
| reproducible CT values for | |||
| pulmonary tissue, which is | |||
| essential for providing | |||
| quantitative support for | |||
| diagnosis and follow up | |||
| examinations. The PW2 can | n/a | ||
| support the physician in the | |||
| diagnosis and | |||
| documentation of | |||
| pulmonary tissue images | |||
| (e.g., abnormalities) from CT | |||
| thoracic datasets. Three-D | |||
| segmentation and isolation | |||
| of sub-compartments, | |||
| volumetric analysis, density | |||
| evaluations, low density | |||
| cluster analysis and | |||
| reporting tools are | |||
| combined with a dedicated | |||
| workflow. The VIDA vision | |||
| software package is also | |||
| intended to be a real-time | |||
| interactive evaluation in | |||
| space and time for CT | |||
| volume data sets that | |||
| provides the reconstruction | |||
| of two dimensional images | |||
| into a three-dimensional | |||
| image format. | be used to support the | ||
| physician in the diagnosis | |||
| and documentation of | |||
| pulmonary tissue images | |||
| (e.g., abnormalities) from | |||
| CT thoracic datasets. | |||
| Three-D segmentation and | |||
| isolation of | |||
| sub-compartments, | |||
| volumetric analysis, density | |||
| evaluations, low density | |||
| cluster analysis and | |||
| reporting tools are | |||
| combined with a dedicated | |||
| workflow. The VIDA | |||
| Pulmonary Workstation 2 | |||
| (PW2) software package is | |||
| also intended to be a | |||
| real-time interactive | |||
| evaluation in space and | |||
| time for CT volume data | |||
| sets that provides the | |||
| reconstruction of two | |||
| dimensional images into a | |||
| three-dimensional image | |||
| format. | |||
| Image Source | |||
| Modalities | СТ | СТ | n/a |
| DICOM | |||
| Conformance | Yes | Yes | n/a |
| Comparative | |||
| Review | 2D, 3D | 2D, 3D | n/a |
| 3D Lung | |||
| mapping | yes | yes | n/a |
| 3D | |||
| measurements | Volume | ||
| Effective Diameter | Volume | ||
| Effective Diameter | n/a | ||
| 2D | Line and ROI tools with | Line and ROI tools with | n/a |
| measurements | statistics | ||
| Diameter 2D | |||
| Area | statistics | ||
| Diameter 2D | |||
| Area | |||
| Density | |||
| measurements | Minimum, maximum and | ||
| average HU | Minimum, maximum and | ||
| average HU | n/a | ||
| Deployment | Standalone computer/ | ||
| distributed | Standalone computer | Subject device | |
| offers | |||
| distributed | |||
| configuration in | |||
| addition to | |||
| standalone, | |||
| unlike the | |||
| predicate device | |||
| OS | Windows | Linux | transitioned |
| from Linux to | |||
| Windows. | |||
| User Interface | yes - w/ limited | ||
| modifications | yes | limited | |
| modifications to | |||
| improve the | |||
| user experience | |||
| and | |||
| accommodate | |||
| new | |||
| functionality | |||
| and a newer | |||
| operating | |||
| system. | |||
| Algorithm | Each voxel of the scan is | ||
| measured by Hounsfield | |||
| units (HU), a measurement | |||
| of x-ray attenuation that is | |||
| applied to each volume | |||
| element in three | |||
| dimensional space ("voxel"). | |||
| The HU are utilized to | |||
| distinguish between air, | |||
| water, tissue and bone, such | Each voxel of the scan is | ||
| measured by Hounsfield | |||
| units (HU), a measurement | |||
| of x-ray attenuation that is | |||
| applied to each volume | |||
| element in three | |||
| dimensional space ("voxel"). | |||
| The HU are utilized to | |||
| distinguish between air, | |||
| water, tissue and bone, | Unlike the | ||
| predicate | |||
| device, the | |||
| subject device | |||
| provides deep | |||
| learning-derived | |||
| segmentation. | |||
| distinction is common in the | |||
| industry. | |||
| A non-adaptive deep | |||
| learning-based algorithm is | |||
| applied to the CT imaging | |||
| data to automatically | |||
| segment lung regions. | such distinction is common | ||
| in the industry. | |||
| Workflow | Automated contouring | ||
| Automated measurements | |||
| Manual Correction | |||
| Distinct user workflows: | |||
| Airway Mapping and Lung | |||
| Volume Analysis | Automated contouring | ||
| Automated measurements | |||
| Manual Correction | Subject device | ||
| offers | |||
| functionality to | |||
| support distinct | |||
| user workflows, | |||
| unlike predicate. | |||
| Graphic User | |||
| Interface | Yes | Yes | n/a |
| Interactive 3D | |||
| Visualization | Yes | Yes | n/a |
| Input/Output | Users can browse, select, | ||
| and load CT scan files. Users | |||
| can save and load analyses, | |||
| export via reporting tools. | |||
| CT scan files can be | |||
| organized by user-defined | |||
| projects, and tracked by | |||
| usage. User can generate a | |||
| report that displays | |||
| quantitative data items that | |||
| can be saved. DICOM info | |||
| displayed. Data import | |||
| through DICOM query/ | |||
| retrieve available. | Users can browse, select, | ||
| and load CT scan files. Users | |||
| can save and load analyses, | |||
| export via reporting tools. | |||
| CT scan files can be | |||
| organized by user-defined | |||
| projects, and tracked by | |||
| usage. User can generate a | |||
| report that displays | |||
| quantitative data items that | |||
| can be saved. DICOM info | |||
| displayed. | Unlike the | ||
| predicate | |||
| device, the | |||
| subject device | |||
| supports DICOM | |||
| query/retrieve | |||
| data | |||
| importation. | |||
| predicate, the | |||
| subject device | |||
| provides path | |||
| planning to | |||
| airway | |||
| segments. | |||
| Unlike the | |||
| predicate, the | |||
| subject device | |||
| includes path | |||
| planning to a | |||
| region of | |||
| interest in the | |||
| lung tissue. | |||
| User editing | yes | yes | n/a |
| Reports | yes - csv and pdf format | ||
| configurable for specific use | |||
| cases | yes - csv only | Unlike the | |
| predicate, the | |||
| subject device | |||
| offers | |||
| pre-existing | |||
| metrics and | |||
| visualizations | |||
| packaged for | |||
| specific use | |||
| cases | |||
| Scan quality | |||
| assessment | Scan protocol is | ||
| assessed for | |||
| compatibility with | |||
| software incompatibility issues | |||
| flagged during | |||
| import and on report Scanner calibration | |||
| assessment Warning issued for | |||
| out-of-range | |||
| air/blood | |||
| measurements | Scan protocol is | ||
| assessed for PW2 | |||
| compatibility incompatibility | |||
| issues flagged during | |||
| import and on | |||
| report Scanner calibration | |||
| assessment Warning issued for | |||
| out-of-range | |||
| air/blood | |||
| measurements | n/a |
Table 1 - Comparison of Characteristics
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Image /page/8/Picture/1 description: The image shows the word "VIDA" in a sans-serif font. The letters are a bright blue color. There is a registered trademark symbol to the right of the letter A.
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Clinical Testing:
No human clinical testing was required to support a substantial equivalence finding.
Non-clinical testing:
The device labeling contains instructions for use and any necessary precautions and warnings to support the safe and effective use of the device. Known hazards were identified and mitigated in accordance with the ISO 14971 standard. Verification and validation activities were performed in accordance with FDA QSR and the IEC 62304 standard. Testing consisted of unit, regression, performance, and integrated system testing. Lung and lobe segmentation performance was tested against the predicate performance to demonstrate substantial equivalence. Results of testing demonstrate that the device has met all product specifications and user needs within its intended use.
Consensus Standards:
- ISO 14971:2007 Medical devices -- Application of risk management to medical devices.
- IEC 62304:2006Amd2015 Medical device software -- Software lifecycle processes. .
- NEMA PS 3.1--3.20 (2016) Digital Imaging and Communication in Medicine (DICOM) Set ●
- ISO 15223-1:2016 Medical devices -- Symbols to be used with medical device labels,
- labelling and information to be supplied -- Part 1: General requirements. ●
Statement of Substantial Equivalence:
The subject device, VIDA|vision, is substantially equivalent to the predicate device. Differences do not raise new issues about the safety and effectiveness of the software.