ADVANTAGE SIM 6.0

K021780 · General Electric Medical Systems · KPQ · Jul 29, 2002 · Radiology

Device Facts

• Record ID: K021780
• Device Name: ADVANTAGE SIM 6.0
• Applicant: General Electric Medical Systems
• Product Code: KPQ · Radiology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning. Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage. Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

Device Story

Advantage Sim 6.0 is a radiation therapy simulation system used to prepare geometric and anatomical data for external beam radiotherapy. It takes CT images as input, allowing clinicians to define anatomical volumes in 3D and select geometric parameters for treatment fields. The system enables non-dosimetric, interactive optimization of field coverage. Outputs include displays of anatomical structures and treatment fields on transverse, reformatted (sagittal, coronal, oblique), 3D, and beam's-eye-view images, including digitally reconstructed radiographs (DRRs). The device operates on a validated Advantage Workstation. It supports DICOM V3.0 data export/import for integration with external treatment planning systems and laser controllers. It replaces traditional simulators by providing complete volume definition and beam placement capabilities. Clinical benefit includes improved accuracy in treatment field planning and patient setup.

Clinical Evidence

No clinical data. The device relies on bench testing, including a hazard analysis, risk management summary, and software verification/validation processes to demonstrate safety and effectiveness.

Technological Characteristics

Radiation therapy simulation system; software-based; runs on validated Advantage Workstation with single/dual color monitors. Connectivity via DICOM V3.0 for image/volume/plan data. Supports hardcopy output via laser camera or Postscript printer. Data storage via CD-R. No specific materials or energy sources listed as the device is a software-based planning workstation.

Indications for Use

Indicated for patients undergoing external beam radiotherapy planning. Used by clinicians to define anatomical volumes and geometric treatment fields in 3D using CT images to optimize field coverage prior to dosimetry.

Regulatory Classification

Identification

A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Advantage Sim 1.2 (K951830)

Submission Summary (Full Text)

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K021780

JUL 2 9 2002

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**General Electric Medical Systems**

Attachment 3 pg 1 of 4

# Advantage Sim 6.0 510 (k) 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)

- 1. Identification of submitter: Larry A. Kroger, Ph.D. Senior Regulatory Program Manager 3000 N. Grandview Blvd Waukesha, 53188 USA Telephone: [phone] Fax: [phone] Date Prepared: February 26. 2002
#### 2. Identification of Product:

| Device name | Advantage Sim 6.0. |
|---------------------|-------------------------------------------------------------------|
| Classification name | Radiation therapy simulation system<br>per 21CFR Section 892 5840 |
| Manufacturer/ | General Electric Medical Systems |
| Distributor | 283, Rue de la Minière<br>78533 BUC Cedex France |

#### 3. Marketed Devices

Advantage Sim 6.0 is substantially equivalent to the device listed below:

| Model: | Advantage Sim 1.2 |
|---------------|----------------------------------|
| Manufacturer: | General Electric Medical Systems |
| 510 (k): | K951830 |

#### 4. Device Description :

Advantage Sim 6.0. is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The

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Attachment 3 page 2 of 4

geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage.

Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display of defined structures with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

The GE Advantage Sim 6.0 has to ensure relations with the following external systems:

#### Data Export

Image, volume and plan data are exported in accordance with DICOM V3.0.

Implementation profile is available on request. NOTE: Any treatment planning system connected to Advantage Sim 6.0. must be DICOM 3.0 compatible and capable of reading DICOM RT Plan and RT Structure Set.

Export of treatment plan data to any external system, and its correct interpretation by that system, must be fully validated before use. Advantage Sim 6.0 stores isocenter coordinates and user defined marker coordinates onto an external accessible directory using a published protocol readable bv external mobile laser controller.

#### RT Data Import

Image, volume and plan data can be imported in accordance with the RT objects of the DICOM Standard. Import of treatment plan data from an external system, and its correct interpretation by Advantage Sim 6.0, must be validated before use.

#### Hardcopy

Hardcopy of all displays and plan data can be made at selected magnification on paper or transparency material. Users can print DRR to film at user defined SID if equipped with an Advantage Workstation 6.0. compatible Laser camera** (** Laser camera must be adequate for scaled printing), with the appropriate AW Laser Camera Interface. (AW Option). Hardcopy of beam parameters and of isocenter coordinates, using IEC standard, can be made on an optional Postscript printer

#### Archiving

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Advantage Sim 6.0 can save DICOM images and DICOM RT objects on single-session DICOM CD R using an optional CD ROM writer.

#### Configuration Requirements

Advantage Sim 6.0 can be installed only on validated Advantage Workstation with single or dual color monitor.

The GE Advantage Sim 6.0 is designed and produced by GE Medical Systems and has been previously submitted to PMN (K951830).

#### 5. Indications for Use

Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage.

Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

#### 6. Comparison with Predicate Device

The GE Advantage Sim 6.0 is substantially equivalent to the following device:

> Advantage Sim 1.2 Manufacturer: GE Medical Systems 510(k): K951830

Both of Advantage Sim 6.0 and Advantage Sim 1.2 provides complete volume definition and geometric beam placement capability for radiotherapy. It is then able to compute a DRR for any type of patient set-up and fully replaces a classic simulator

#### 7. Conclusions

The entire potential new hazards has been studied and controlled by a Risk Management Plan:

- · A hazard analysis/ Risk Management Summary

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Artach ment 3 lg : 4 of 4

- A software development and validation process
- A software verification plan

Advantage Sim 6.0 provides images comparable to the predicate device.

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Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 9 2002

General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K021780

Trade/Device Name: Advantage SIM 6.0 Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: II Product Code: 90 KPO Dated: July 15, 2002 Received: July 16, 2002

Dear Mr. Gmelin:

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 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:

| 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" (21 CFR Part 807.97). 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

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

Attachment 1

### STATEMENT OF INTENDED USE

Device name: Advantage Sim 6.0

#### Indication For Use:

Advantage Sim 6.0 is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning.

Anatomical volumes can be defined in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. The geometric parameters of a proposed treatment field are selected to allow non-dosimetric, interactive optimization of field coverage.

Defined anatomical structures and geometric treatments fields are displayed on transverse CT images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the CT images, or on a beam eye's view display with or without the display of defined structures with or without the display of digittaly reconstructed radiograph.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -OR-Over-The-Counter Use (Per 21 CFR 801.109) (Division Sian-Off) Division of Reproductive, and Radiological De 510(k) Number 1/1PAGENOMFICHIER