(60 days)
No
The document describes standard radiation treatment planning functionalities and does not mention AI, ML, or related concepts.
No.
The device is used to plan radiation therapy, not to deliver it. It is a treatment planning system, not a therapeutic device.
No
The device is a radiation treatment planning system that accepts diagnostic imaging data to create treatment plans and calculate dose distributions. It does not perform diagnosis itself.
No
The device description explicitly states that the system accepts "source" dosimetry data from a linear accelerator, which is a hardware component. While the core function is software-based planning, it interacts with and relies on data from a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Monaco System's Function: The Monaco system is a radiation treatment planning system. Its purpose is to create treatment plans for external beam radiation therapy based on patient imaging data. It calculates and displays radiation dose distributions inside the patient.
- Lack of Specimen Analysis: The system does not involve the collection, preparation, or analysis of any biological specimens from the patient. It works with imaging data and dosimetry data from a linear accelerator.
Therefore, the Monaco system falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Monaco system is used to make treatment plans 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
Product codes
MUJ
Device Description
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), when Dynamic Conformal Arc planning was added (K110730), and most recently when the system's intended use was expanded to include electron treatment planning, among other changes (K132971). 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. The Monaco system supports 3D conformal planning, IMRT, and Dynamic Conformal. It supports inverse and forward planning workflows.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
patient diagnostic imaging data
Anatomical Site
inside patients, target volume, surrounding structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dosimetrist or Medical Physicist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Verification tests were written and executed to ensure that the system is working as designed. Over 600 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.
Summary of Performance Studies
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, described in detail in section 20. The product was deemed fit for clinical use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
IMPAC Medical Systems, Inc. % Ms. Kathryn Stinson Regulatory Affairs Specialist 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043
Re: K151233
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 7, 2015 Received: May 8, 2015
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Monaco RTP System
Indications for Use (Describe)
The Monaco system is used to make treatment plans 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
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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.
Monaco
Release 5.10
PREMARKET NOTIFICATION INFORMATION
-
- Product Information:
- a. Product Trade Name
- b. Release Version Number
-
- Classification Information:
- Classification Name a. system
- b. Common/Usual Name
- c. Product Classification
- d. Product Code
- e. Reference
- Review Panel f.
-
- Establishment Information:
- a. Submitter
- b. Submitter Address
-
Class II MUJ 21 CFR 892.5050 Radiology
Radiation Treatment Planning System
Medical charged-particle radiation therapy
IMPAC Medical Systems, Inc. 13723 Riverport Dr., Suite 100 Maryland Heights, MO 63043
- c. Establishment Number
- d. Contact
- Contact Phone e.
- f. Contact Fax
1937649 Kathryn Stinson, RA Specialist 314-993-0003 314-993-0075
4
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.
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
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), when Dynamic Conformal Arc planning was added (K110730), and most recently when the
5
system's intended use was expanded to include electron treatment planning, among other changes (K132971). 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. The Monaco system supports 3D conformal planning, IMRT, and Dynamic Conformal. It supports inverse and forward planning workflows.
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, described in detail in section 20. 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. Over 600 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.
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| | Monaco w/new
features | Monaco
(K132971) | AdvantageSim MD
(K132944) |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|------------------------------|
| Intended Use and Indications for Use | | | |
| Contouring | Yes | Yes | Yes |
| Dose Calculation | Yes | Yes | No |
| Plan Optimization | Yes | Yes | No |
| Image Manipulation & Fusion | Yes | Yes | Yes |
| CT Simulation | Yes | Yes | Yes |
| QA/Plan Review | Yes | Yes | No |
| Brachytherapy | No | No | No |
| Technological Characteristics | | | |
| Dose Calculation Algorithms | Monte Carlo (electron &
photon), Collapsed Cone
(photon), Pencil Beam
(optimization only) | Monte Carlo (electron &
photon), Collapsed Cone
(photon), Pencil Beam
(optimization only) | N/A |
| Calculation and display of standardized uptake
value for contouring on PET images | Yes | Yes | No - Display only |
| Local Biological Measure Optimization | Yes | Yes | No |
| Support for various treatment aids | Yes | Yes | Yes |
| Support for Dynamic Delivery Methods | Yes | Yes | No |
| Operating System | Windows | Windows | Linux |
| DICOM RT Support | Yes | Yes | Yes |
| Modalities Supported: Full RTP Workflow | Photon & Electron | Photon & Electron | Not a full RTP system |
| Modalities Supported: Partial Workflow* | Electron, Photon, Proton | Electron, Photon, Proton | Electron, Photon |
| Can be used for stereotactic treatment planning
(including cone-based) | Yes | Yes | Unknown |
| Creates specialty images: MIP, MinIP, Avg | Yes | No | Yes |
or DIT ng TARKT optin IT is possible to conngure Monaton package' that does not include the ability to optimize or caculate dose
.