VIDA PULMONARY WORKSTATION 2 (PW2)

K083227 · Vida Diagnostics, Inc. · JAK · Nov 18, 2008 · Radiology

Device Facts

• Record ID: K083227
• Device Name: VIDA PULMONARY WORKSTATION 2 (PW2)
• Applicant: Vida Diagnostics, Inc.
• Product Code: JAK · Radiology
• Decision Date: Nov 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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.

Device Story

PW2 is a self-contained image analysis software package for pulmonary CT thoracic datasets. It imports 2D CT slice data to reconstruct 3D models. Physicians use the workstation to visualize and analyze lung parenchyma and bronchial airways. Core functions include 3D segmentation, isolation of sub-compartments, volumetric analysis, density evaluations (Hounsfield units), and low-density cluster analysis. The software automates tedious manual tracing tasks to provide quantitative measurements and aggregate statistics, assisting in therapy effectiveness assessment and clinical decision-making. It does not interface directly with CT scanners; it processes previously generated data files. The output is displayed to the physician for diagnostic support and documentation.

Clinical Evidence

No clinical data. Bench testing only, including software development, verification, and validation testing to ensure performance and safety.

Technological Characteristics

Software-based image analysis workstation. Processes CT voxel data using Hounsfield units (HU) for tissue characterization. Features 3D segmentation, volumetric analysis, and airway tree extraction. Operates on imported CT datasets. No direct hardware interface. Voluntary standards used for development and manufacturing processes.

Indications for Use

Indicated for use by physicians to support diagnosis and documentation of pulmonary tissue abnormalities in CT thoracic datasets. Provides quantitative support for diagnosis and follow-up examinations of chest diseases.

Regulatory Classification

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.

Predicate Devices

• Siemens InSpace 4D (K071513)

Submission Summary (Full Text)

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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<br>100 Oakdale Campus, Suite 225 TIC<br>lowa City, IA 52242<br>USA<br>FDA Establishment Registration No. Pending |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name, Title<br>and Phone Contact | Jack Slovick, RA/QA, 763-639-0238 (phone)<br>RA/QA Affairs<br>Fax: [phone]<br>VIDA Diagnostics<br>100 Oakdale Campus,<br>Suite 225 Technology Innovation Center<br>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,<br>Abdominal and Radiological Panel into Class II (21 CFR<br>892.1750), Product Code 90 JAK Class 11 |
| Date Prepared | October 13, 2008 |
| Intended Use | The VIDA Pulmonary Workstation 2 (PW2) software<br>provides reproducible CT values for pulmonary tissue,<br>which is essential for providing quantitative support for<br>diagnosis and follow up examinations. The PW2 can be<br>used to support the physiclan in the diagnosis and<br>documentation of pulmonary tissue images (e.g.,<br>abnormalities) from CT thoracic datasets. Three-D<br>segmentation and isolation of sub-compartments,<br>volumetric analysis, density evaluations, low density<br>cluster analysis and reporting tools are combined with a<br>dedicated workflow. The VIDA Pulmonary Workstation 2<br>(PW2) software package is also intended to be a real-time<br>interactive evaluation in space and time for CT volume |

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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<br>Devices | Manufacturer: | Siemens Medical Solutions |
| | Trade name: | InSpace 4D - Software Package with<br>Extended Functionality |
| | 510(k) Number: | K071513 |
| | Date Cleared: | June 26, 2007 |
| Compliance with Special<br>Controls or Performance<br>Standards | Special Controls: No special controls or mandatory<br>performance standards for this device have been<br>established. Voluntary standards were used throughout<br>the development; testing and manufacturing processes<br>(see section 9.0 for detailed list of voluntary standards that<br>were used) | |
| Product Code | 90 JAK, Class II | |
| Regulation Number | 21 CFR 892.1750 | |
| Reason for Premarket<br>Notification | VIDA Diagnostics, Inc. intends to introduce the VIDA<br>Pulmonary Workstation 2 (PW2) into interstate commerce<br>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

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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.

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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.

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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 [phone] or [phone] 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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