ADVANTAGE WINDOWS VOLUME RENDERING OPTION

K972399 · Ge Medical Systems, Inc. · JAK · Sep 23, 1997 · Radiology

Device Facts

• Record ID: K972399
• Device Name: ADVANTAGE WINDOWS VOLUME RENDERING OPTION
• Applicant: Ge Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).

Device Story

Software package for Advantage Windows workstation; processes CT or MR image data transferred via DICOM or Ethernet. Transforms 2D image slices into translucent 3D models; allows operator to select regions of interest for visualization of depth and position of overlapping structures. Used by clinicians in radiology, surgery, and treatment planning. Output displayed on workstation monitor; assists in diagnostic confidence and surgical planning. Benefits patient through improved visualization of anatomical structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-only package; operates on Advantage Windows workstation (Sun Sparc 20, Mod 40 or higher). Uses DICOM/Ethernet for image input. No internal energy source; relies on input CT/MR image data. Principle of operation is volume rendering for translucent 3D reconstruction.

Indications for Use

Indicated for visualization of 3D structures from CT or MR images for diagnostic confidence or surgical treatment planning in radiology and surgery.

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

• Advantage Windows 3D (K923077)
• Advantage Windows 3D with Navigator Option (K954355)
• Advantage CT (9800 Quick) 3D (K871859)

Reference Devices

• CT/MR Advantage Windows Diagnostic Workstation (K913770)

Submission Summary (Full Text)

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# 9723999

SEP 2 3 1997

GE Medical Systems

### Summary of Safety & Effectiveness

This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Identification of Submitter.

Larry A. Kroger, Ph.D. [phone] Summary prepared 24 June 1997

Product Identification:

Name: Advantage Windows Volume Rendering Option General Electric Medical Systems Manufacturer. 16800 W. Ryerson Road New Berlin, WI 53151

Marketed Devices: The Advantage Windows Valume Rendering Option is substantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859)

Indications for Use Advantage Windows Volume Rendering Option is intended to provide fast, easy volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resoriance (MR) system. It is dedicated to clinical and disgnostic applications in radiology, surgery, and treatment planning. It runs on Advantage Windows independent workstations

Device Description: Design: The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.

Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT or MR diagnostic images.

Principals of Operation: The same as Advantage Windows 3D. Features: To provide translucent 3D models of areas of interest selected by the operator. Accessories: None

Adverse fifteds on Health: The package itself will not have any adverse affects on health. This woll reconstructs and displays a translucent 3D model of a region of interest selected by the operator. The selection of the region of interest is up to the operator who can choose to accept or reject the region selected.

Conclusions: The Advantage Windows Volume Rendering Option enbances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures. It is substantially equivalent to the Advantage Windows 3D package in design, construction, principle of operation, and features.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1997

Larry A. Kroger, Ph.D. Regulatory Program Manager GE Medical Systems P.O. Box 414 Milwaukee, WI 53201

Re: K972399

Advantage Windows Volume Rendering Option (CT/MR Accessory) Dated: June 24, 1997 Received: June 26, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK 21 CFR 892.1000/Procode: 90 LNH

#### Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prediction 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 and additionally 809.10 for in yitto diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

h.7.liau Yu
Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number (if known):

Advantage Windows Volume Rendering Option Device Name:

## Indications For Use:

The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> |
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| (Per 21 CFR 801-109) | |

OR

| Over-The Counter Use | <span></span> |
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K972399 |
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