MONACO

{0}------------------------------------------------ NOV 2 0 2013 K13297/ September 20, 2013 # Monaco RTP System Premarket Notification (510(k)) Summary of Safety and Effectiveness ## INTRODUCTION This document summarizes the safety and effectiveness information contained within the Monaco RTP System 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 - l . 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. - ﯾﺖ Review Panel - 3. Establishment Information: - a. Submitter - b. Submitter Address - Monaco Release 5.0 Medical charged-particle radiation therapy Radiation Treatment Planning Svstem Class II MUJ 21 CFR 892.5050 Radiology IMPAC Medical Systems, Inc. 13723 Riverport Dr., Suite 100 Maryland Heights, MO 63043 - c. Establishment Number - d. Contact - e. Contact Phone - ি Contact Fax 1937649 Kathryn Stinson, RA Specialist 314-993-0003 314-993-0075 {1}------------------------------------------------ #### 24. 11. 15 PREDICATE DEVICE INFORMATION The Monaco RTP System is substantially equivalent to the following devices 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 products in intended use and safety and effectiveness. - 1. Monaco RTP System IMPAC Medical Systems, Inc. K110730 - 2. ERGO++ IMPAC Medical Systems, Inc. K080601 - 3. Eclipse Treatment Planning System Varian Medical Systems, Inc. K102011 - 4. Oncentra Nulcetron Corporation K121448 ## MONACO INTENDED USE/INDICATIONS 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 and electron 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 {2}------------------------------------------------ #### : 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ### 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) and again when Dynamic Conformal Arc planning was added (K110730). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data 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 beam modifiers 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 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 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. Validation testing involved simulated clinical workflows. and algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup. The product was deemed fit for clinical use. #### SUMMARY OF NON-CLINICAL TESTING {3}------------------------------------------------ - -- Verification tests were written and executed to ensure that the system is working as designed. Over 500 test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality. Monaco passed testing and was deemed safe and effective for its intended use. {4}------------------------------------------------ | | Monaco w/new<br>features | Monaco<br>(K110730) | ERGO++<br>(K080601) | Eclipse TPS<br>(K102011) | Oncentra<br>(K121448) | | |-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------| | Intended Use and Indications for Use | | | | | | | | Contouring | Yes | Yes | Yes | Yes | Yes | | | Dose Calculation | Yes | Yes | Yes | Yes | Yes | | | Plan Optimization | Yes | Yes | Yes | Yes | Yes | | | Image Manipulation & Fusion | Yes | Yes | Yes | Yes | Yes | | | CT Simulation | Yes | Yes | No | Yes | Yes | | | QA/Plan Review | Yes | Yes | Yes | Yes | Yes | | | Brachytherapy | No | No | No | Yes | Yes | | | Technological Characteristics | | | | | | | | Dose Calculation Algorithms | Monte Carlo<br>(electron &<br>photon),<br>Collapsed Cone<br>(photon), Pencil<br>Beam<br>(optimization<br>only) | Monte Carlo<br>(photon) &<br>Pencil Beam<br>(optimization<br>only) | Pencil Beam<br>(electron) | Pencil Beam,<br>Monte Carlo<br>(electron)<br>Acurus XB &<br>AAA (photon),<br>proton eye<br>algorithm | Monte Carlo<br>(electron), Collapsed<br>Cone (photon),<br>Pencil Beam | | | Calculation and display of standard ized<br>uptake value for contouring on PET images | Yes | No | No | Yes | No | | | Local Biological Measure Optimization | Yes | Yes | No | Yes | No | | | MLC Support | Yes | Yes | Yes | Yes | Yes | | | Support for Other Treatment Aids | Yes | No | Yes | Yes | Yes | | | Support for Dynamic Delivery Methods | Yes | Yes | Yes | Yes | Yes | | | Operating System | Windows | Windows | Linux | Windows | Windows | | | DICOM RT Support | Yes | Yes | Yes | Yes | Yes | | | Modalities Supported: Full RTP Workflow | Photon &<br>Electron | Photon Only | Photon Only | Electron,<br>Photon, Proton | Electron, Photon | | | | | | | | | くことここで、 | | Modalities Supported: Partial Workflow* | lectron, Photon<br>Proton | Photon, Protor<br>Electron, | N/A | Same as above | N/A | | | Can be used for stereotactic treatment<br>planning | Yes | Yes | Yes | Yes | No | | | Stereotactic Localization | No | No | Yes | Yes | No | | | Support for Cone-Based Stereotactic | Yes | No | Yes | Yes | No | | | . It is nessble to configure Manchoolity such as image fusion, contantine and simulation, not including MIRT optimization or dose | | | | | | | ﻪ .. ્ર-ર ・・・ · {5}------------------------------------------------ : It is posible to configure Nonality such as image fusion, contouring and initials, not intiding to taledning MNK opimized or dose • -------- ર-థ {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem. The logo is in black and white. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO6 Silver Spring, MD 20993-0002 November 20, 2013 IMPAC Medical Systems, Inc. % Ms. Kathryn Stinson Regulatory Affairs Specialist 13723 Riverport Drive. Suite 100 MARYLAND HEIGHTS MO 63043 Re: K132971 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: September 20, 2013 Received: September 23, 2013 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. 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 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 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. {7}------------------------------------------------ #### Page 2-Ms. Stinson .. ·· ······ If 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 (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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/Medicall.covices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, michal D. for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K 132971 Device Name: Monaco RTP System Indications 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 and electron 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 reading . It uses generally accepted methods for: - · contouring - · image manipulation - · simulation - · image fusion - · plan optimization - · QA and plan review Prescription Use (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 Center for Devices and Radiological Health (CDRH) Michael D.'Hara (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological HealthPage 1 of __1 510(k) ___K 132971