3DNET SUITE

K063107 · Biotronics3D, Ltd. · LLZ · Oct 27, 2006 · Radiology

Device Facts

• Record ID: K063107
• Device Name: 3DNET SUITE
• Applicant: Biotronics3D, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Oct 27, 2006
• 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 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans. The 3Dnet Suite provides several levels of functionality to the user: - basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc. - tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc. - Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography.

Device Story

3Dnet Suite is a software-based medical image processing system; operates on off-the-shelf hardware with Windows OS. Inputs: DICOM-compliant medical images (CT, MRI, Ultrasound). Processing: software modules perform 2D/3D visualization, multiplanar reconstruction (MPR), segmentation, boundary detection, and path definition. Outputs: processed images, measurements, and annotations displayed to clinicians for review and analysis. Used in clinical settings by physicians to aid in the evaluation of anatomy and pathology. Benefits: facilitates clinical workflow, enhances visualization of structures, and supports detection of abnormalities like colonic polyps or tumors.

Clinical Evidence

No clinical data. Evidence based on bench testing using phantom datasets and scanned image datasets of human organs with known abnormalities. Testing validated software functionality, measurement accuracy (volume, linear, angular), and DICOM conformance. Results showed accuracy correlating with pre-calculated values and reliable performance in evaluating organ status.

Technological Characteristics

Software-based medical image processing system; operates on off-the-shelf hardware running Windows OS. DICOM-compliant. Features include 2D/3D visualization, MPR (orthogonal, oblique, curved, Slab), MIP, MinIP, segmentation, and volume rendering. Connectivity via network for DICOM image retrieval/distribution.

Indications for Use

Indicated for physicians to display and analyze 2D/3D DICOM-compliant medical images (CT, MRI, Ultrasound). Includes tools for review, measurement, segmentation, and visualization (MPR, MIP, MinIP, VR). Includes specialist workflow for colon screening to identify polyps, tumors, and lesions via tomographic colonography.

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

• Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV) (K963697)
• Voxar Limited, Plug n View, version 1.0 (K992654)

Submission Summary (Full Text)

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OCT 2 7 2006

Medicine in Three Dimensions

# 510(k) SUMMARY

This summary of 510(k) safety and efficiency information is been submitted in accordance with the requirements of SMDA 1990 and 21 CFR \$807.92.

The assigned 510(k) number is ........................

## 1. Submitter's identification:

Biotronics3D Ltd. 31 Ferry Street Isle of Dogs Docklands London E14 3DT UK

Contact: Dr Haralambos Hatzakis, Managing Director.

Date Summary prepared: 15 May 2006.

### 2. Name of Device

- a) Device trade name: 3Dnet Suite.
- b) Device common name: Medical Image Processing software system.
- c) Classification name: LLZ Image processing system Class II, CFR 21 892.2050.

## 3. Predicate Device Information:

Predicate Device #1: Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), 510(k) #K963697

Predicate Device #2 : Voxar Limited, Plug n View, version 1.0, 510(k) #K992654

#### 4. Device Description :

The 3Dnet Suite is a software device for evaluating scanned images of selected human organ. The basic visualization module of 3Dnet Suite is Examiner.

The Examiner allows the processing, review, analysis, communication and media interchange of multi dimensional digital images acquired from a variety of imaging devices.

It provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The 3Dnet user interface follows typical clinical workflow patterns to process, review and analyze digital images including:

- Retrieve image data over the network via DICOM ﮯ
- Select images for closer examination from a gallery of 2D and 3D views -
- -Interactively manipulate an image in real time to visualize anatomy and pathology
- Annotate, tag, measure and record selected views -

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- Output selected views to DICOM and JPEG files or expert views to another DICOM device.
# 5. Indications for use:

The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.

The 3Dnet Suite provides several levels of functionality to the user:

- basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP. MinIP, measurements, annotations, reporting, distribution etc.
- tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, = grayscale VR slab. 3D volume review, path definition and boundary detection etc.
- Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography.

# 6. Comparison to predicate devices:

The 3Dnet Suite utilizes the same technological characteristics as the two predicate devices. All provide multi-view user 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 tools to isolate specific features and provide annotation tools to help indicate and describe findings.

All devices support the DICOM protocol for the communication of images with other medical devices.

| Company | Biotronics3D | Voxar Limited | Bio-Vascular, Inc. |
|------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| System | 3Dnet Suite | Plug n View, version<br>1.0 | Advanced Diagnostic<br>Viewer (ADV) |
| 510(k) no: | | K992654 | K963697 |
| Function: | • 2D/3D image viewing<br>• Segmentation<br>• Measurements<br>• Data Analysis<br>• Multi-Planar<br>reformatting (MPR) | • 2D image<br>viewing<br>• Measurement<br>• Multi-Planar<br>reformatting<br>(MPR) | • Display<br>• Segmentation<br>• Manual<br>Measurements<br>• Data analysis<br>• Archive |

# Substantial Equivalence Comparison Chart

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| | Volume rendering Maximum Intensity Projection (MIP) Image Editing Printing | Volume rendering Maximum Intensity Projection (MIP) Image Editing Printing | |
|----------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Intended Use: | Display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans. | Display and 3D visualization of medical image data derived from CT and MRI scans. | Create 2D,3D images of the anatomy for clinician viewing analysis |
| Data Source: | MR,CT,3D US scanners | MR, CT, NM, CR, and US Scanners | MR, CT Scanners |
| Physical Characterization: | Software package Operates on off the self hardware Windows operating system DICOM compatible | Software package Operates on off the self hardware Windows operating system DICOM compatible | Software package Operates on off the self hardware Windows operating system DICOM compatible |

We conclude that the subject device, the 3Dnet Suite, 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 the determination of substantial equivalence are as follows:

Scanned image datasets of various patient organs with known abnormalities or status used as input for testing of software functionalities in accordance with a test protocol. The application provided interactive orthogonal and multiplanar reformatted 2D and 3D image from datasets to detect and evaluate the known abnormalities or status of organs. The volume, linear and angular measurements features, provided in the software, were used to evaluate and quantify any abnormality of organs or status of any internal organ structures. The 3Dnet Suite has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. Testing of 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 compliant scanned images of any human organs. We conclude from these tests that 3Dnet Suite is substantially equivalent to the predicated devices in its ability to evaluate any human organs.

- 8. Conclusions:

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# Biotronics 3D

The 3Dnet Suite has the same indented use and similar technological characteristics as the Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), (#K963697) and Voxar Limited, Plug n View 3D, version 1.0 (#K992654). Moreover, test and validations using Patients Image Data in our installations in Europe and non-clinical tests performed in-house demonstrated that the 3Dnet Suite is substantially equivalent to the predicate devices in its ability to review, and evaluate DICOM scan images of various organs to facilitate analysis and evaluation of abnormality or malformation in organs by a trained user. The DICOM functionality with regards to DICOM SOP classes as stated in the DICOM conformance statement was validated with a number of other DICOM compliant applications and DICOM validation tools as part of the development and testing process. 3Dnet Suite does not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

# OCT 2 7 2006

Biotronics 3D. Ltd. % Ms. Patricia L. Murphy Official Correspondent KEMA Quality B.V. 4377 County Line Road CHALFONT PA 18914

Re: K063107

Trade/Device Name: 3Dnet Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 4, 2006 Received: October 11, 2006

# Dear Ms. Murphy:

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 commerco 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, Or Lovecs and 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. TToe general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulter vi on.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affective 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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*Protecting and Promoting Public Health*

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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). 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/cdrh/industry/support/index.html.

Sincerely vours.

Nancy Cbrogdon

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

Enclosure

Page 2 -

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# Indications for Use

510(k) Number (if known):

Device Name: 3Dnet Suite

Indications For Use:

The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.

The 3Dnet Suite provides several levels of functionality to the user:

- basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc.
- tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc.
- Specialist tools and workflow enhancements for specific clinical applications ﺖ which provide target workflows, custom U1, measurement and visualization. including colon screening which is indented for the reviewing of patients for colonic polyps, tumors and other lesions using tomographic colonography.

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seaman

(Division Sign-Off) Page 1 of 1 Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _