MONACO RTP SYSTEM, VMAT OPTION

K091179 · Computerized Medical Systems, Inc. · MUJ · Jul 16, 2009 · Radiology

Device Facts

• Record ID: K091179
• Device Name: MONACO RTP SYSTEM, VMAT OPTION
• Applicant: Computerized Medical Systems, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jul 16, 2009
• 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 create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup. The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

Device Story

Monaco RTP System is a software-based radiation treatment planning system; creates IMRT plans using multileaf collimators. VMAT option enables planning for beam-delivery devices in motion during radiation emission. System inputs include patient imaging data; performs contouring, image manipulation, simulation, image fusion, and plan optimization. Produces 2D/3D radiation dose distributions for clinician review. Used in clinical settings by medical physicists and radiation oncologists; output informs radiation therapy delivery. Does not directly control linear accelerators; plans require manual review and approval by qualified professionals. Benefits include optimized radiation dose delivery to target tissues while sparing healthy anatomy.

Clinical Evidence

No clinical trials performed. Evidence consists of bench-top verification testing and clinically oriented validation test cases executed in a simulated clinical environment by support personnel. Algorithm accuracy validated by medical physicists using measured data from clinical facilities.

Technological Characteristics

Software-based radiation treatment planning system. Features VMAT planning capability for dynamic beam delivery. Utilizes local biological measures for optimization. Operates as a standalone planning workstation. Major level of concern due to potential for serious injury if planning flaws occur.

Indications for Use

Indicated for cancer patients prescribed external beam intensity modulated radiation therapy (IMRT). No specific age or gender contraindications provided.

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 (K071938)
• ERGO++ 3D Line Medical Systems (K080601)
• Eclipse Treatment Planning System Varian Medical Systems (K073020)

Submission Summary (Full Text)

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K091179

## JUL 1 6 2009

#### April 22, 2009

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

### INTRODUCTION

This document summarizes the safety and effectiveness information contained within the Monaco VMAT Premarket Notification (510(k)). 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 system
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- Reference e.
- f. Review Panel
- 3. Establishment Information:
- a. Submitter
- b. Submitter Address
- c. Establishment Number
- d. Contact
- e. Contact Phone
- f. Contact Fax

VMAT functionality added in release 2.0.0

Monaco RTP System

Medical charged-particle radiation therapy

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 Associate 314-993-0003 314-993-0075

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## PREDICATE DEVICE INFORMATION

ﻤﻰ ﺑ

The Monaco RTP System is substantially equivalent to the following device(s) that the Food and Drug Administration (FDA) has cleared for distribution and are currently being actively marketed in the United States. Monaco is substantially equivalent to these product(s) in intended use and safety and effectiveness.

- 1. Monaco RTP System Computerized Medical Systems. Inc. K071938
- 2. ERGO++ 3D Line Medical Systems K080601
- 3. Eclipse Treatment Planning System Varian Medical Systems K073020

## MONACO INTENDED USE

The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup.

The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

#### DESCRIPTION OF THE PRODUCT

Monaco uses local biological measures for optimization to create intensity modulated radiation therapy (IMRT) plans using Multileaf Collimators. With the addition of VMAT planning capability, Monaco also allows users to creatment plans in which the devices that aim and shape the beam are in motion while the beam is on.

#### 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

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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 injury 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 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. Clinically oriented validation test cases were written and executed inhouse by Customer Support personnel in a simulated clinical environment. Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities. Test reports are included in section 20 of this submission.

Monaco with the VMAT option successfully passed both testing efforts and 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 the Monaco Verification Test Report, which is included in section 18 of this submission.

Monaco with the VMAT option successfully passed verification testing.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 6 2009

Ms. Kathryn Stinson Regulatory Affairs Associate Computerized Medical Systems, Inc. 13723 Riverport Dr., Suite 100 MARYLAND HEIGHTS MO 63043

Re: K091179

Trade/Device Name: Monaco RTP System - VMAT Option Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 22, 2009 Received: April 23, 2009

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. Ilsting 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); medical device reporting (reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 ride Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko91179

Statement of Indication for Use · Monaco RTP System - VMAT Option 510(k)

The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup.

The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

## Concurrence of the Center for Devices and Radiological Health, Office of Device Evaluation (ODE)

Prescription Use *X*

OR Over the Counter Use per 21 CFR 801.109

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

4-I