(100 days)
No
The document describes a standard radiation treatment planning system with features like contouring, image manipulation, simulation, image fusion, plan optimization, QA, and plan review. While it involves complex calculations and optimization, there is no mention of AI, ML, or related terms like deep learning or neural networks. The description of testing focuses on dose calculation accuracy and system functionality, not on the performance of an AI/ML algorithm.
No
The device is a radiation treatment planning system that calculates dose distributions for treatment plans; it does not directly apply therapy to a patient.
No
The device is a radiation treatment planning system that calculates dose distributions for treatment rather than diagnosing medical conditions.
No
The device description clearly states it is a "radiation treatment planning system" that accepts "patient diagnostic imaging data and 'source' dosimetry data from a linear accelerator." While it performs software functions like dose calculation and display, it is intrinsically linked to and processes data from hardware (linear accelerator and imaging modalities) for its intended use in radiation therapy planning. It is not solely software operating independently of physical medical devices.
Based on the provided information, the Monaco system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Monaco'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 and dosimetry data. It calculates and displays radiation dose distributions within the patient's body.
- No Specimen Analysis: The system does not analyze any biological specimens from the patient. Its inputs are imaging data and machine parameters, and its output is a treatment plan and dose distribution visualization.
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 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
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). 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
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. 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.
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.
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.
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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
-
- Product Information:
- a. Product Trade Name
- b. Release Version Number
-
- Classification Information:
- a. Classification Name
- b. Common/Usual Name
- Product Classification c.
- d. Product Code
- e. Reference
- f. Review Panel
-
- 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.
-
- Monaco RTP System Computerized Medical Systems, Inc. K091179
-
- ERGO++RTP System Computerized Medical Systems, Inc. K080601
-
- 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
2
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.
ﺃ
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| | Monaco w/DCAT
Functionality | Monaco (w/VMAT)
(K091179) | ERGO++
(K080601) | Eclipse TPS
(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) &
Pencil Beam (optimization only) | Monte Carlo (photon) & Pencil
Beam (optimization only) | Pencil Beam | Pencil Beam, Electron Monte Carlo,
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
5
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
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
6
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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