MONACO RTP SYSTEM

K110730 · Computerized Medical Systems, Inc. · MUJ · Jun 24, 2011 · Radiology

Device Facts

• Record ID: K110730
• Device Name: MONACO RTP SYSTEM
• Applicant: Computerized Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: . contouring . image manipulation simulation . image fusion . . plan optimization QA and plan review .

Device Story

Monaco RTP System is a software-based radiation treatment planning system. It accepts patient diagnostic imaging data and dosimetry data from linear accelerators. Dosimetrists or Medical Physicists use the system to define target volumes and critical structures via contouring on images. The system enables creation of treatment scenarios by adjusting beam number, position, and energy, and configuring multileaf collimators (MLC). It calculates and displays 2D/3D radiation dose distributions. The user selects the optimal plan to maximize target dose while minimizing healthy tissue exposure. The system is used in clinical settings by qualified professionals. It does not directly control the linear accelerator; plans are reviewed and approved by clinicians before treatment delivery. The device benefits patients by facilitating precise, optimized radiation therapy planning.

Clinical Evidence

No clinical trials were performed. Safety and effectiveness were demonstrated through non-clinical verification testing and algorithm testing comparing calculated doses against measured doses. Clinically oriented validation test cases were executed in-house to ensure the system is fit for clinical use.

Technological Characteristics

Software-based radiation treatment planning system running on Windows OS. Features Monte Carlo (photon) and Pencil Beam (optimization) dose calculation algorithms. Supports DICOM RT standards, MLC configuration, and image fusion. Operates as a standalone planning workstation. Major level of concern software.

Indications for Use

Indicated for patients with prescriptions for external beam radiation therapy requiring radiation treatment planning, including contouring, image manipulation, simulation, image fusion, plan optimization, and QA/plan review.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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

• Monaco RTP System (K091179)
• ERGO++RTP System (K080601)
• Eclipse Treatment Planning System (K102011)

Submission Summary (Full Text)

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JUN 2 4 2011

## K110730

June 14, 2011

# Monaco RTP System Premarket Notification (510(k)) Summary of Safety and Effectiveness

## INTRODUCTION

This document summarizes the safety and effectiveness information contained within this Premarket Notification. The Summary of Safety and Effectiveness contains no confidential or trade secret information and is intended for full public disclosure and distribution.

## PREMARKET NOTIFICATION INFORMATION

- 1. Product Information:
- a. Product Trade Name
- b. Release Version Number
- 2. Classification Information:
- a. Classification Name
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- e. Reference
- f. Review Panel
- 3. Establishment Information:
- a. Submitter
- b. Submitter Address
- c. Establishment Number
- d. Contact
- e. Contact Phone
- Contact Fax f.

Monaco RTP System DCAT feature added in rel. 3.0.0

Medical charged-particle radiation therapy system Radiation Treatment Planning System Class II MUJ

21 CFR 892.5050 Radiology

Computerized Medical Systems, Inc. 13723 Riverport Dr. , Suite 100 Maryland Heights, MO 63043 1937649 Kathryn Stinson, RA Specialist 314-993-0003 314-993-1175

!

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## PREDICATE DEVICE INFORMATION

The Monaco RTP System with dynamic conformal (DCAT) functionality is substantially equivalent to the following devices that the FDA has cleared for distribution and are currently being actively marketed in the United States.

- 1. Monaco RTP System Computerized Medical Systems, Inc. K091179
- 2. ERGO++RTP System Computerized Medical Systems, Inc. K080601
- 3. Eclipse Treatment Planning System Varian Medical Systems K102011

## MONACO INTENDED USE

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

- . contouring
- . image manipulation
- simulation .
- image fusion .
- . plan optimization
- QA and plan review .

## DESCRIPTION OF THE PRODUCT

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data

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from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images.

Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a multileaf collimator (MLC) between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

#### LEVEL OF CONCERN

Item 4b of Table 1 in the FDA Guidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices asks, "Does the Software Device control the delivery of potentially harmful energy that could result in death or serious injury, such as radiation treatment systems ... " Monaco does not directly control the linear accelerator that delivers the radiation. Once completed, plans are reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place. There is no automatic link between the Monaco software and the linear accelerator. However, should a flaw in the treatment plan escape the notice of the qualified professionals using the Monaco system, serious injurv or death could result. Therefore, we believe Monaco to be of major level of concern.

### SUMMARY OF CLINICAL TESTING

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Algorithm testing was performed to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinically oriented validation test cases were written and executed in-house by CMS customer support personnel. The product was deemed fit for clinical use.

### SUMMARY OF NON-CLINICAL TESTING

Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in section 18 of this submission. Monaco successfully passed verification testing.

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# SUBSTANTIAL EQUIVALENCE COMPARISON

Table 5-1 compares Monaco with Dynamic Conformal capability to its predicate devices. A more detailed discussion of substantial equivalence is contained in Section 12 of this submission.

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| | Monaco w/DCAT<br>Functionality | Monaco (w/VMAT)<br>(K091179) | ERGO++<br>(K080601) | Eclipse TPS<br>(K102011) |
|--------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|---------------------|-----------------------------------------------------------------|
| Intended Use and Indications for Use | | | | |
| Contouring | Yes | Yes | Yes | Yes |
| Dose Calculation | Yes | Yes | Yes | Yes |
| Plan Optimization | Yes | Yes | Yes | Yes |
| Image Manipulation & Fusion | Yes | Yes | Yes | Yes |
| CT Simulation | Yes | Yes | No | Yes |
| QA/Plan Review | Yes | Yes | Yes | Yes |
| Brachytherapy | No | No | No | No |
| Statement specifies that system is for IMRT only | No | No | No | No |
| Basic System: Technological Characteristics | | | | |
| Dose Calculation Algorithms | Monte Carlo (photon) &<br>Pencil Beam (optimization only) | Monte Carlo (photon) & Pencil<br>Beam (optimization only) | Pencil Beam | Pencil Beam, Electron Monte Carlo,<br>Convolution Superposition |
| Local Biological Measure Optimization | Yes | Yes | No | Yes |
| MLC Support | Yes | Yes | Yes | Yes |
| Support of Other Treatment Aids | No | No | Yes | Yes |
| Support for Dynamic Delivery Methods | Yes | Yes | Yes | Yes |
| Operating System | Windows | Windows | Linux | Windows |
| DICOM RT Support | Yes | Yes | Yes | Yes |
| Modalities Supported: Full RTP Workflow | Photon Only | Photon Only | Photon Only | Electron, Photon, Proton |
| Modalities Supported: Partial Workflow* | Electron, Photon, Proton | Electron, Photon, Proton | N/A | Electron, Photon, Proton |
| New Features: Technological Characteristics | | | | |
| Includes Dynamic Conformal Capability | Yes | Yes | Yes | Yes |
| Stereotactic Localization | No | No | Yes | Yes |
| Support for Cone-Based Stereotactic | No | No | Yes | Yes |

able 5-1: Substantial Equivlaence to Predicate Device:

* A partal world include only the finctions of Monaco that are shared with Focal, such as ontention, and plan review. Clinicans who use only the Focal
finctions within Monaco

5-5

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

JUN 2 4 2011

Ms. Kathryn Stinson Regulatory Affairs Specialist Elekta, Inc., CMS Software 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043

Re: K110730

Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 10, 2011 Received: May 12, 2011

#### Dear Ms. Stinson:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in. Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vito Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number (if known): K110730

Device Name: Monaco RTP System

Indication for Use:

The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.

The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:

- contouring
- image manipulation
- simulation
- image fusion
- plan optimization
- QA and plan review

Prescription Use (21 CFR Part 801 Subpart D And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, OIVI

Mary Stottle

Division of Badiologic Office of In Vitro

510K K116736