ADVANTAGE 3D XR

K974715 · GE Medical Systems · JAK · Jul 6, 1998 · Radiology

Device Facts

• Record ID: K974715
• Device Name: ADVANTAGE 3D XR
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Jul 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.

Device Story

Advantage 3D XR is an X-ray imaging software option; constructs 3D models from images acquired during single 200-degree rotational Digital Subtracted Angiography (DSA) spin; utilizes LC gantry system. Software processes data on acquisition system or Advantage Windows workstation; generates 3D vasculature model within 10 minutes. Physician uses Navigator software to interactively view 3D structure; performs length and volume measurements; identifies optimal gantry angles for subsequent 2D DSA acquisition. Used in clinical settings by physicians to assist in neuro-angiographic diagnosis and procedure planning; provides 3D spatial information to optimize 2D imaging viewpoints.

Clinical Evidence

Validation performed via two clinical studies. Study 1: Morphometer device (X-ray tube on CT gantry) used at two sites (Rennes, Lyon, France); >200 examinations. Study 2: LC angiographic system gantry used at two sites (Rennes, Saint-Julien, France); 250 examinations over one year. Results documented in medical publications. Safety and efficacy supported by hazard analysis and external algorithm validation.

Technological Characteristics

Software-based 3D reconstruction from rotational X-ray (DSA) data. Operates on LC gantry systems and Advantage Windows workstations. Connectivity via standard imaging network. Software-based measurement tools for length and volume. Risk management includes hazard analysis and external algorithm validation.

Indications for Use

Indicated for patients undergoing neuro-angiographic procedures requiring 3D reconstruction of vasculature from rotational digital subtracted angiography (DSA) images.

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 with Navigator Option (K954355)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'g' and 'e' intertwined within a circular shape. The circle has a decorative border with small, rounded elements around its perimeter.

JUL 6 1998 GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

# ADVANTAGE 3D XR SUMMARY OF SAFETY AND EFFECTIVENESS

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

#### Identification of Submitter:

Larry A. Kroger, Ph.D. Senior Manager of Regulatory Programs Telephone: [phone] Date Prepared: December 5, 1997

### Identification of Product:

| Name : | Advantage 3D XR |
|----------------|-------------------------------------------------|
| Manufacturer : | General Electric Medical Systems |
| | 283, rue de la Miniere |
| | 78533 Buc Cedex, FRANCE |
| Distributor : | General Electric Medical Systems, Milwaukee, WI |

#### Marketed Devices:

The Advantage 3D XR is substantially equivalent to the device listed below:

| Model: | Advantage Windows 3D with Navigator Option |
|---------------|--------------------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510(k) #: | K954355 |

#### Device Description:

The Advantage 3D XR is an X-ray imaging software option that allows the interactive display of a structure from any point of view. This is accomplished by constructing a 3D model from images taken during a single Digital Subtracted Angiography (DSA) rotation (200 degrees). A spin acquisition is performed with an LC gantry system using a specific mode (predefined start and stop positions). The data is available for diagnosis on the acquisition system and may be sent to the Advantage Windows workstation. Within 10 minutes, a 3D construction of the vasculature is available and the Navigator software package (K954355) is used to interactively create views of this object. The software allows the ability to make measurements ( length and volume) on the 3D structure. The gantry angles for each view are displayed and the physician may use them to make a DSA acquisition on the patient to get an optimized 2d image of the desired viewpoint.

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GE Medical Systems

P.O. Box 414, W-709 Milwaukee, WI 53201 USA

### Indications for Use :

The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuro-angiographic cases.

## Comparison with Predicate:

The Advantage 3D XR option allows 3D construction of X-ray images similar to 3D images created with CT/MR images.

## Summary of studies :

The Advantage 3D XR option has been successfully validated :

- · using a device called a morphometer that consists of an X-ray tube mounted on a CT gantry to acquire views at multiple angles. Two morphometer's have been built and installed on two clinical sites: Hopital Ponchaillou, Rennes, France and HCL, Lyon, France. More than 200 examinations have been done and medical publications on the obtained results are available in Attachment #9.
- using an LC angiographic system gantry. Two experimental clinical sites: Hopital pontchaillou, Rennes, France and CHU Saint-Julien, France have been running for a year and have performed 250 examinations. A publication from Pr Picard, CHU Saint-Julien, France is available in Attachment #9.

### Conclusions :

The Advantage 3D XR option provides 3D information from an X-ray spin sequence. The potential hazards (wrong measurements, misdiagnosis) are controlled by a risk management plan including :

- a Hazard Analysis
- a Software Development and Validation Process .
- · external validations of the algorithms by different research hospitals to assess the validity of the 3D information.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 1998 JUL

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

Re:

K974715

Advantage 3D XR (3D Image Processing Software) Dated: June 6, 1998 Received: June 17, 1998 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

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 II (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 requirements, as set forth in the Quality System Regulation (OS) 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 the Electronic Product 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (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/odrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yi

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

Enclosure

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510(k) Number (if known):

Device Name: Advantage 3D XR

## Indications for Use

The Advantage 3D XR is an X-ray imaging software option that offers the ability to construct a 3D model from images taken during a single DSA rotational angiography. The product is optimized for neuroangiographic cases.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ X (Per 21 CFR 801-109)

OR Over-The-Counter Use_

David G. Seymore
Division Sign Off

Division Sign-Off) Division of Reproductive, Abdominal, E. and Radiological Dev 510(k) Number