3VISEON/SURGERY

K072653 · 3Mensio Medical Imaging BV · LLZ · Jan 24, 2008 · Radiology

Device Facts

• Record ID: K072653
• Device Name: 3VISEON/SURGERY
• Applicant: 3Mensio Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

Device Story

3viseon/surgery™ is a software-based PACS application for 2D/3D medical image visualization. It ingests DICOM images from CT and MR scanners via network or physical media (CD/DVD). The software runs on standard Windows-based PCs with 3D graphics cards. It provides tools for 2D review, orthogonal/oblique/curved MPRs, slab MPRs, MIP, MinIP, and vascular measurements. Surgeons use the software to combine 2D slices into 3D models for surgical planning. The device does not perform automated diagnosis; it serves as a visualization aid for clinicians. It is intended for use in clinical environments by physicians or trained professionals. It does not contact patients or control life-sustaining equipment. The software facilitates clinical decision-making by providing enhanced anatomical visualization for pre-surgical preparation.

Clinical Evidence

No clinical data provided. Bench testing only. Hazard analysis performed; software level of concern classified as minor.

Technological Characteristics

Software-based PACS application; runs on standard Windows-based PCs with 3D graphics cards. Supports DICOM standard for image input/output. Features include 2D review, MPR (orthogonal, oblique, curved, slab), MIP, MinIP, and measurement tools. No patient contact. Not life-sustaining. Minor level of concern.

Indications for Use

Indicated for use by physicians or trained professionals to receive, store, communicate, process, and display digital medical images (CT, MR) for review and surgical preparation. Contraindicated for primary interpretation of digitized film screen images and mammographic images. Not for use during surgical procedures.

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

• VOXAR 3D ENTERPRISE, MODEL 6.1 (K060505)
• 3VISEON (K043097)

Submission Summary (Full Text)

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JAN 2 4 2008

K072653

1

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

Date Prepared: November 24, 2007

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Ernst-Jan Viergever Manager R&D 3mensio Medical Imaging BV Jan Steenlaan 3 3723 BS Bilthoven Netherlands Email: ernstjan [e-mail]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name: 3viseon/surgery™ Common Name: Picture Archiving Communications System 892.2050 LLZ Device Classification: Name: System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | System, Image<br>Processing,<br>Radiology | System, Image<br>Processing,<br>Radiology |
|-----------------------------------|-------------------------------------------|-------------------------------------------|
| Regulation Number | 892.2050 | 892.2050 |
| 510(k) Number | K060505 | K043097 |
| Device Name | VOXAR 3D<br>ENTERPRISE,<br>MODEL 6.1 | 3VISEON |
| Product Code | LLZ | LLZ |
| Decision | SUBSTANTIALLY<br>EQUIVALENT<br>(SE) | SUBSTANTIALLY<br>EQUIVALENT<br>(SE) |
| Classification Advisory Committee | Radiology | Radiology |
| Review Advisory Committee | Radiology | Radiology |

#### Device Description: 21 CFR 807 92(a)(4)

3viseon/surgery™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital Mammograms). 3surgery is an advanced 2D and 3D visualization solution that enables surgeons to quickly and reliably prepare for various types of surgery, by combining 2D scan slices into comprehensive 3D models of the patient.

The software device should not be used during a surgical procedure.

3viseon/surgery™ works with all major medical image formats and can access multiple data stores, across networks or on CD-ROM / DVD. The software runs on any modern Windows based computer with a 3D graphics card that meets the minimum requirements, eliminating the need for specialized hardware.

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# 510(k) Summary of Safety and Effectiveness

#### Indications for Use: 21 CFR 807 92(a)(5)

3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

### Technological Characteristics: 21 CFR 807 92(a)(6)

3viseon/sugery™ is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

#### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification 3viseon/sugery™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

3viseon/sugery™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem depicts a stylized image of three human profiles facing right, overlaid with three parallel lines that resemble the wings of a bird.

2 4 2008 JAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3mensio Medical Imaging BV c/o Carl Thomas, Consultant OTech, Inc. 1600 Manchester Way DENTON TX 76210

K072653. Re:

Trade/Device Name: 3viseon/surgery" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2008 Received: January 17, 2008

Dear Mr. Thomas:

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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C Brogdon

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

Enclosure

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### 510(k) Number: K072653

Device Name: 3viseon/surgery™

Indications for Use:

3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP, MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc.

Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.

Digitized film screen images must not be reviewed for primary image interpretation.

Mammographic images must not be interpreted using this system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR - Over-The-Counter Use

(21 CFR 807 Subpart C)

thom Whay

Division of Reproductive. Ab and Radiological Devices 510(k) Number