(15 days)
No
The description focuses on image analysis, segmentation, volumetric analysis, and density evaluations using standard CT data processing techniques (Hounsfield units). There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML models. The statement that the software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods further suggests the absence of AI/ML.
No
The device is used for image analysis, diagnosis, and documentation of pulmonary tissue, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software "can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets."
Yes
The device is described as a "self-contained image analysis software package" that imports data files and does not interface directly with hardware. Its function is to process and analyze existing CT data, which aligns with the definition of a software-only medical device.
Based on the provided information, the VIDA Pulmonary Workstation 2 (PW2) software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The PW2 software analyzes CT images of the pulmonary tissue, which are generated by a medical imaging device (CT scanner). It does not directly analyze biological samples like blood, urine, or tissue biopsies.
- The intended use and device description focus on image analysis and processing. The software provides tools for segmentation, volumetric analysis, density evaluations, and reporting based on CT data. These are functions related to interpreting medical images, not performing tests on biological specimens.
- There is no mention of analyzing biological samples or performing laboratory tests. The input is CT volume data, not biological samples.
Therefore, the VIDA Pulmonary Workstation 2 (PW2) software falls under the category of medical image analysis software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
90 JAK
Device Description
VIDA Pulmonary Workstation 2 (PW2) is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. VIDA Pulmonary Workstation 2 (PW2) can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D seamentation & isolation of sub-compartments. volumetric analysis, density evaluations, and low density cluster analysis) and reporting tools are combined with a dedicated workflow.
The PW2 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 threedimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. Figure 1 shows the basic Input/ Output of the CT volume converting to a digitized, colorized picture.
PW2 provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. PW2 provides imaging of bronchial airways that can be used to assess therapy effectiveness based on CT scan data. PW2 reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches.
PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment.
PW2 provides quantitative measurements and tabulates quantitative properties. PW2 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 errorprone manual tasks.
The software has functions for loading, analyzing, saving datasets and will generate screen displays, computations and aggregate statistics.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed tomography x-ray system
Anatomical Site
pulmonary tissue (i.e. lung parenchyma), chest
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)
Not Found
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.
0
γ0γ3227
Image /page/0/Picture/1 description: The image shows the logo for VIDA Diagnostics. The logo is in black and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "V" to the right of the "A".
NOV 1 8 2008
VIDA Pulmonary Workstation 2 (PW2)
5 510(k) Summary 510(k) Summary of Safety and Effectiveness [As required by 21 CFR 807.92(c)]
General information regarding the VIDA Diagnostics, Inc., Inc., VIDA Pulmonary Workstation 2 (PW2) is contained in the following table 1.
Table 1: General Information
| Manufacturer | VIDA Diagnostics
100 Oakdale Campus, Suite 225 TIC
lowa City, IA 52242
USA
FDA Establishment Registration No. Pending |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name, Title
and Phone Contact | Jack Slovick, RA/QA, 763-639-0238 (phone)
RA/QA Affairs
Fax: 763-434-0966
VIDA Diagnostics
100 Oakdale Campus,
Suite 225 Technology Innovation Center
lowa City, IA 52242 |
| Trade Name | VIDA Pulmonary Workstation 2 (PW2) |
| Common Name | Computed tomography x-ray system |
| Classification | This device has been classified by the Reproductive,
Abdominal and Radiological Panel into Class II (21 CFR
892.1750), Product Code 90 JAK Class 11 |
| Date Prepared | October 13, 2008 |
| Intended Use | 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 be
used to support the physiclan 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 |
1
Image /page/1/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo is in black and white and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "V" to the right of the "A", with a dot at the end.
VIDA Pulmonary Workstation 2 (PW2)
| data sets that provides the reconstruction of two- dimensional images into a three-dimensional image format. | ||
|---|---|---|
| Identification of Equivalent | ||
| Devices | Manufacturer: | Siemens Medical Solutions |
| Trade name: | InSpace 4D - Software Package with | |
| Extended Functionality | ||
| 510(k) Number: | K071513 | |
| Date Cleared: | June 26, 2007 | |
| Compliance with Special | ||
| Controls or Performance | ||
| Standards | Special Controls: No special controls or mandatory | |
| performance standards for this device have been | ||
| established. Voluntary standards were used throughout | ||
| the development; testing and manufacturing processes | ||
| (see section 9.0 for detailed list of voluntary standards that | ||
| were used) | ||
| Product Code | 90 JAK, Class II | |
| Regulation Number | 21 CFR 892.1750 | |
| Reason for Premarket | ||
| Notification | VIDA Diagnostics, Inc. intends to introduce the VIDA | |
| Pulmonary Workstation 2 (PW2) into interstate commerce | ||
| for commercial distribution. |
1 General Safety and Effectiveness Concerns
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, VIDA Diagnostics adheres to recognized and established industry practice and standards.
2 Substantial Equivalence
The VIDA Pulmonary Workstation 2 (PW2), addressed in this pre-market notification, is substantially equivalent to the following commercially available software package.
3 Manufacturer Product 510(k) Clearance date
Siemens InSpace 4D K071513 June 26, 2007
2
Image /page/2/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo consists of the word "VIDA" in large, bold, sans-serif font, with a swoosh-like line extending from the bottom of the "A" to the right, ending in a solid circle. Below the word "VIDA" is the word "Diagnostics" in a smaller, serif font.
VIDA Pulmonary Workstation 2 (PW2)
In summary, VIDA Diagnostics is of the opinion that VIDA Pulmonary Workstation 2 (PW2) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.
3. Intended Use
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 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.
4. Device Description
VIDA Pulmonary Workstation 2 (PW2) is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. VIDA Pulmonary Workstation 2 (PW2) can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D seamentation & isolation of sub-compartments. volumetric analysis, density evaluations, and low density cluster analysis) and reporting tools are combined with a dedicated workflow.
The PW2 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 threedimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. Figure 1 shows the basic Input/ Output of the CT volume converting to a digitized, colorized picture.
3
Image /page/3/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo is in black and features the word "VIDA" in large, bold letters. A curved line extends from the bottom of the "V" to the right of the "A", with a dot at the end. Below the word "VIDA" is the word "Diagnostics" in a smaller font.
VIDA Pulmonary Workstation 2 (PW2)
Image /page/3/Figure/2 description: The image shows a diagram of an airway tree extraction process. On the left side of the image, the input is a CT volume with dimensions 512x512x550 voxels, a voxel size of 0.65x0.65x0.6 mm^3, a 16-bit gray-scale, and a size of 250-300 MByte. On the right side of the image, the output is a binary image of the airway tree.
Figure 1: Input/ Output
PW2 provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. PW2 provides imaging of bronchial airways that can be used to assess therapy effectiveness based on CT scan data. PW2 reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches.
PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment.
PW2 provides quantitative measurements and tabulates quantitative properties. PW2 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 errorprone manual tasks.
The software has functions for loading, analyzing, saving datasets and will generate screen displays, computations and aggregate statistics.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms. The symbol is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 8 2008
VIDA Diagnostics, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K083227
Trade/Device Name: VIDA Pulmonary Workstation 2 (PW2) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 31, 2008 Received: November 3, 2008
Dear Mr. Job:
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.
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Page 2
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 of 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 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. 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/odrh/industry/support/index.html.
Sincerely yours.
forque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO83227
Image /page/6/Picture/1 description: The image shows the logo for VIDA Diagnostics. The logo is in black and white and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "D" in VIDA to the right, ending in a small circle.
VIDA Pulmonary Workstation 2 (PW2)
4 Indications for Use Statement
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 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.
Hills Penn
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
Prescription Use __ (per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
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