VIATRONIX V3D EXPLORER, REVISION 1.2

K032483 · Viatronix, Inc. · LLZ · Aug 22, 2003 · Radiology

Device Facts

• Record ID: K032483
• Device Name: VIATRONIX V3D EXPLORER, REVISION 1.2
• Applicant: Viatronix, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.

Device Story

V3D Explorer is a software module for the V-3D visualization system; processes DICOM-compliant CT, MRI, PET, SPECT, and X-ray images. Core technology converts DICOM data into internal volume format; provides interactive orthogonal, multiplanar, and 3D renderings. Features include volume, linear, and angular measurements; interactive segmentation for structure removal. Used in clinical settings by radiologists and physicians to evaluate, quantify, and document organ abnormalities, masses, or lesions. Output includes rendered images and quantitative data for clinical decision-making; supports archiving, printing, and distribution. Benefits include enhanced visualization and standardized quantification of anatomical structures.

Clinical Evidence

Clinical evaluation compared V3D Explorer against predicate devices using patient-derived CT/MRI/X-ray datasets. Results showed no significant differences in evaluation and quantification of organ abnormalities between the subject and predicate devices. Non-clinical phantom testing confirmed measurement accuracy correlated with pre-calculated values. Software development followed standard unit and system integration testing protocols.

Technological Characteristics

Software-based image processing system; operates on PC hardware. Utilizes direct volume rendering for 3D visualization. Supports DICOM 3.0 standard. Features include interactive segmentation, multiplanar reformatting, and measurement tools (volume, linear, angular).

Indications for Use

Indicated for display and 2D/3D visualization of medical images (CT, MRI, PET, SPECT, X-Ray) for any human organ. Used by radiologists, clinicians, and referring physicians for evaluation and quantification of tumors, polyps, lesions, masses, implants, fractures, aneurysms, and stenoses. Supports interactive segmentation for critical evaluation of hard and soft tissues.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• G.E. Navigator (K954355)
• Vital Images Vitrea 2, Version 2.1 (K002519)
• Viatronix Visualization System (K002780)

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:

## Submitter's Identification: 1.

Viatronix Inc. 25 East Loop Road Suite 203/ 204 Stony Brook, NY 11790 Establishment Registration number- 2438935

Contact: Baman Pattanayak, Regulatory Consultant

Date Summary Prepared:

July 19, 2003

## Name of the Device: 2.

a) Device trade name: Viatronix V3D Explorer, revision 1.2 b) Device common name: Medical Image processing software system c) Classification name: 90LLZ- Image Processing system

#### 3. Predicate Device Information:

Predicate Device #1: G.E. Navigator, 510(k) # K954355. This system is an add-on to the Advantage Windows Workstation. Many features in the manual reference the base workstation manuals.

Predicate Device #2: Vital Images Vitrea 2, Version 2.1, 510(k) # K002519.

Predicate Device #3: Viatronix Visualization System, 510(k) # K002780. This system name is sometimes abbreviated as VVS.

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## 4. Device Description:

The V-3D Explorer is a software device for evaluating CT/MRI scanned and X-Ray images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT / MR scan image or X-Ray image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images or X-Ray images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

## 5. Indications for Use:

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp. lesion. mass. implants. fracture, aneurysms. stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

## 6. Comparison to Predicate Devices:

The Viatronix V3D Explorer Module (V3D Explorer) utilizes the same technological characteristics as the three predicate devices. All provide multi-view user

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interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. All provide window/level adjustment of the 2D and 3D views to enhance features, provide measurement tools for analysis of the observed structures, provide region of interest selection tools to isolate specific features, provide annotation tools to help indicate and describe findings, and provide integrated reporting to distribute the findings.

V3D Explorer and all three predicates provide external 3D views. As with Vitrea 2 and VVS, the V3D Explorer Module utilizes direct volume rendering for all of its 3D views, including transparent volume images and visible surface views. G.E. Navigator utilizes surface extraction techniques for all 3D views. For changing the mapping to opacity during translucent views, V3D Explorer is similar to Vitrea 2 and VVS devices because all use the same technique of volume rendering.

We conclude that the subject device, the Viatronix V3D Explorer, is as safe and effective as the predicate devices and poses no new questions of safety and effectiveness.

## 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Scanned image or X-Ray datasets of various patients organs with known abnormalities or status were used as input for testing of software functionalities in accordance with a test protocol. The V3D Explorer software module provided interactive orthogonal and multiplanar reformatted 2D and 3D images from datasets to detect and evaluate the known abnormalities or status of organs. The volume, linear and angular measurement features provided in the software were used to evaluate and quantify any abnormality of organs or status of any internal organ structures.

The V3D Explorer Module has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. Testing on phantom datasets has determined its level of accuracy, which correlates perfectly with pre-calculated values. The product has shown itself to be reliable, easy to use and capable of evaluating DICOM 3.0 compliant scanned images or X-Ray images of any human organs.

We conclude from these tests that V3D Explorer module is substantially equivalent to the predicate devices in its ability to evaluate any human organs.

## 8. Discussion of Clinical Tests\Evaluations Performed:

Tests and validations on Patients' various organs were performed per protocol. Loaded Patients' scanned organs images to the predicate device. Evaluated various organs using the predicate device and recorded the results of evaluation and quantification.

Same scanned organ images were loaded into the Viatronix V3D Explorer application. Evaluated all Patients' various organs using V3D Explorer application, and

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recorded the results of evaluation and quantification. DICOM compliant X-Ray images data were loaded intoV3D Explorer application and ensured that the X-Ray data source is processed and converted correctly. Evaluated various organs. Evaluation results indicated that 2D projection cases as well as 3D reconstructed cases were correctly processed and converted, allowing for an accurate display and evaluation. In addition phantom data showed that the measurements are accurate and the V3D Explorer is evaluated to be safe and effective.

Evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected in the results of evaluation.

In conclusion, it was established that the V3D Explorer application is substantially equivalent to the predicate devices.

### 9. Conclusions:

The Viatronix V3D Explorer has the same intended use and similar technological characteristics as the GE Navigator (K # 954355) Vital Images Vitrea 2. Version 2.1 (K # 002519) and Viatronix Visualization System ( K# 002780). Moreover, tests and validations using Patients' Image data and non-clinical tests performed demonstrated that the Viatronix V3D Explorer application is substantially equivalent to the predicate devices in its ability to review, analyze and evaluate CT/ MR scan images or X-Ray images of various organs to facilitate analysis and evaluation of abnormality or malformation in organs by a trained physician. The Viatronix V3D Explorer application does not raise any new questions of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 2 2003

Viatronix, Inc. % Mr. Jeff D. Rongero Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709 Re: K032483

Trade/Device Name: Viatronix V3D Explorer Revision 1.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: August 11, 2003 Received: August 12, 2003

Dear Mr. Rongero:

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 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); 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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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

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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

to proceed to the market.

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# INDICATIONS FOR USE

Exhibit B

Page 1 of of 1

510(k) Number (if known): _ K U 3 2 48 3

Device Name: Viatronix V3D Explorer, revision 1.2

# Indications For Use:

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET, SPECT scans and X-Ray of the human body including any organ. The volume, linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning and/or X-Ray. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM compliant specified organ image studies, utilizing PC hardware.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Over-The-Counter Use (Optional Format 1-2-96)