ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS

K132045 · Ge Hungary Kft · KPQ · Sep 4, 2013 · Radiology

Device Facts

• Record ID: K132045
• Device Name: ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS
• Applicant: Ge Hungary Kft
• Product Code: KPQ · Radiology
• Decision Date: Sep 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5840
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

AdvantageSim™ MD 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 automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT, MR or PET studies that have been co-registered with the planning CT scan. Additionally, CT & PET data from a respiratory tracked examination may be used to allow the user define the target or treatment volume over a defined range of the respiratory cycle. 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 images, on reformatted sagittal, coronal or oblique images, on 3 D views created from the images, or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radiograph.

Device Story

AdvantageSim™ MD is an oncology software application for radiation therapy simulation. It processes CT, MR, and PET images to assist clinicians in defining anatomical volumes and geometric treatment fields for external beam radiotherapy. Inputs include primary planning CT scans, co-registered multi-modality images (CT/MR/PET), and respiratory-tracked data. The system enables manual or automated contouring of anatomical structures and interactive optimization of treatment field parameters. Outputs include 2D (transverse, sagittal, coronal, oblique) and 3D visualizations, as well as beam's-eye-view displays and digitally reconstructed radiographs (DRRs). Used in clinical settings by radiation oncology staff to facilitate non-dosimetric treatment planning. The device aids in target volume definition and field coverage optimization, supporting clinical decision-making prior to final dosimetry planning.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, verification, and validation activities, including risk analysis and design reviews.

Technological Characteristics

Software-based radiation therapy simulation system. Features CT atlas-based contouring and re-planning modules. Operates on standard clinical workstations. Complies with voluntary standards for software development and quality assurance. No specific hardware materials or energy sources defined as it is a software-only modification to an existing platform.

Indications for Use

Indicated for clinicians (radiologists, radiation oncologists, medical oncologists, nuclear medicine physicians) to assist in preparing geometric and anatomical data for external beam radiotherapy treatment planning. Applicable to patients requiring radiotherapy planning using CT, MR, or PET imaging.

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

• AdvantageSim™ MD (K052345)
• RTx (Mirada Medical Ltd. LLC) (K130393)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a document with the text "K132045 Page 1 of 2" written on it. The text is handwritten in black ink and is located at the top of the page. Below the text is a circular logo with the letters "GE" inside. The logo is also in black ink and appears to be a stamp or seal.

GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options 510(k) Premarket Notification Submission

## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | June 25, 2013 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Hungary Kft.<br>Akron utca 2<br>2040 Budörs, Hungary |
| Primary Contact<br>Person: | Peter Uhlir<br>Regulatory Affairs Leader<br>Tel: [phone]<br>Fax: [phone] |
| | SEP 0 4 2013 |
| Secondary Contact<br>Person: | Stephen G. Slavens, RAC<br>Regulatory Affairs Director<br>GE Healthcare<br>Tel: [phone]<br>Fax: [phone] |
| Device Trade Name: | AdvantageSim™ MD with CT Atlas-based Contouring and Re-<br>planning Options |
| Common/Usual Name: | AdvantageSim™ MD with CT Atlas-based Contouring and Re-<br>planning Options |
| Classification Names: | 21CFR 892.5840, Radiology |
| Product Code: | KPQ |
| Predicate Device(s): | K052345 - AdvantageSim™ MD<br>K130393 - RTx (Mirada Medical Ltd. LLC) |
| Device Description /<br>Intended Use: | AdvantageSim™ MD is a CT/MR/PET oncology application used by<br>clinicians (radiologist, radiation oncologist, medical oncologist,<br>nuclear medicine physicians and trained healthcare professional) to<br>assist treatment planning. |
| Indications for Use: | AdvantageSim™ MD is used to prepare geometric and anatomical<br>data relating to a proposed external beam radiotherapy treatment<br>prior to dosimetry planning. Anatomical volumes can be defined<br>automatically or manually in three dimensions using a set of CT<br>images acquired with the patient in the proposed treatment<br>position. |

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Image /page/1/Picture/0 description: The image shows the text "K132045 Page 2 of 2" in a handwritten style. Below the text is the GE logo, which is a circular emblem with the letters "GE" intertwined in the center. The logo is black and white and appears to be a stamp or seal.

## GE Healthcare AdvantageSim™ MD with CT Atlas-based Contouring and Re-planning Options 510(k) Premarket Notification Submission

| | Definition of the anatomical volumes may be assisted by additional<br>CT, MR or PET studies that have been co-registered with the<br>planning CT scan. Additionally, CT & PET data from a respiratory<br>tracked examination may be used to allow the user define the<br>target or treatment volume over a defined range of the respiratory<br>cycle.<br>The geometric parameters of a proposed treatment field are<br>selected to allow non-dosimetric, interactive optimization of field<br>coverage. Defined anatomical structures and geometric treatments<br>fields are displayed on transverse images, on reformatted sagittal,<br>coronal or oblique images, on 3 D views created from the images, | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | or on a beam eye's view display with or without the display of<br>defined structures with or without the display of digitally<br>reconstructed radiograph. | |
| Technology: | The AdvantageSim MD with CT Atlas-based Contouring and Re-<br>planning Options software employs the same fundamental<br>scientific technology as that of the AdvantageSim MD on its<br>predicate devices. | |
| Determination of | Summary of Non-Clinical Tests: | |
| Substantial<br>Equivalence: | The AdvantageSim MD with CT Atlas-based Contouring and Re-<br>planning Options software complies with voluntary standards as<br>detailed in Section 9, 11 and 16 of this premarket submission. The<br>following quality assurance measures were applied to the<br>development of the system:<br>Risk Analysis Requirements Reviews Design Reviews Integration testing (System verification) Performance testing (Bench testing, verification) Safety testing (Verification) | |
| | Summary of Clinical Tests: | |
| | The subject of this premarket submission, AdvantageSim MD with<br>CT Atlas-based Contouring and Re-planning Options software did<br>not require clinical studies to support substantial equivalence since<br>the two new features have triggered this 510(k) notification, CT<br>atlas-based contouring and CT based re-planning options are part<br>of Mirada's FDA cleared product. | |
| Conclusion: | GE Healthcare considers the AdvantageSim MD with CT Atlas-based<br>Contouring and Re-planning Options software application to be as<br>safe, as effective, and performance is substantially equivalent to<br>the predicate devices. | |

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2013

GE Hungary Kft. % Mr. Stephen Slavens Regulatory Affairs Director GE Medical Systems - dba GE Healthcare 3000 N. Grandview Blvd. WAUKESHA WI 53188

Re: K132045

Trade/Device Name: AdvantageSim™ MD with CT Atlas-based Contouring and Replanning Options Regulation Number: 21 CFR 892.5840 Regulation Name: Radiation therapy simulation system Regulatory Class: 11 Product Code: KPQ Dated: June 25, 2013 Received: July 5, 2013

Dear Mr. Slavens:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 or any with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Slavens

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicallDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Melvin D. Dixon

for

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K132045

Device Name: AdvantageSim™ MD with CT Atlas-based Contouring and Replanning Options

Indications for Use:

AdvantageSim™ MD is used to prepare geometric and anatomical data relating to a . proposed external beam radiotherapy treatment pror to dosimetry planning. Anotomical volumes can be defined automatically or manually in three dimensions using a set of CT images acquired with the patient in the proposed treatment position. Definition of the anatomical volumes may be assisted by additional CT. MR or PET studies that have been coregistered with the planning CT scan. Additionally CT & PET data from a respratory tracked examination may be used to allcw the user define the target or treatment volume cver o defined range of the respiratory cycle

The geometric parameters of a proposed treatment field are selected to allow nondosimetric, interactive optimization of field coverage. Defined anatomical structures and aecmetric treatments fields are displayed on transverse images. In reformatted sagittal. coronal or obligue images. on 3D views created from the images. or on a beam eye's view display with or without the display of defined structures with or without the display of digitally reconstructed radicgraph.

Prescription Use イ (Part 21 CFR 801 Subpart D) AND/OR

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 In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In I'itro Diagnostic and Radiological Health

510(k)_K132045

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