(127 days)
Not Found
No
The document describes standard radiation treatment planning software functionalities and algorithms (dose calculation, optimization, contouring tools) without mentioning AI or ML. The programming languages listed (C, C++) are common for traditional software development and don't inherently indicate AI/ML use. The description of the optimization process aligns with traditional algorithms used in radiation therapy planning, not necessarily ML-based optimization.
No.
The device is a treatment planning system, not a device that directly administers therapy. It aids in creating treatment plans for external beam radiation therapy but does not deliver the therapy itself.
No
The device is a treatment planning system for radiation therapy, which calculates dose distributions and optimizes treatment plans. It accepts existing diagnostic imaging data but does not perform diagnosis itself.
Yes
The device is described as software running on off-the-shelf computer hardware, accepting data from external imaging modalities and outputting treatment plans. It does not include any proprietary hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radiation treatment planning" and calculating dose distributions inside patients. This is a therapeutic planning tool, not a diagnostic tool that analyzes samples in vitro (outside the body) to provide diagnostic information about a patient's condition.
- Device Description: The device processes patient imaging data (CT and MR scans) and source dosimetry data to create treatment plans. It does not analyze biological samples or provide diagnostic results based on such analysis.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
The device is clearly a medical device used for planning radiation therapy, which falls under a different regulatory category than IVD devices.
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, electron, and proton treatment plans 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
The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically 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 then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities:
- Intensity Modulated Radiation Treatment (IMRT) planning
- Electron, photon and proton treatment planning
- Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, Volumetric Modulated Arc Therapy (VMAT))
- Stereotactic planning and support of cone-based stereotactic
- 3D conformal planning
- Adaptive planning (e.g. for the Elekta Unity MR-Linac)
Monaco basic systems tools, characteristics, and functions: - Plan review tools
- Manual and automated contouring tools
- DICOM connectivity
- Windows operating system
- Simulation
- Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.)
- Standardized uptake value (SUV)
- Specialty Image Creation (MIP, MinIP, and Avg)
- Monaco dose and Monitor Unit (MU) calculation:
- Dose calculation algorithms for electron, photon, proton planning
Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MR scans
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes.
Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with FDA guidance for devices that pose a major level of concern (Class C per IEC 62304).
Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices.
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that Monaco is as safe and effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Monaco RTP System (K213787)
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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February 23, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is in blue. The logo is simple and clean, and it is easily recognizable.
Elekta Solutions AB % Melinda Smith Director, Regulatory Affairs & Quality - Americas Elekta, Inc. 400 Perimeter Center Terrace NE Suite 50 ATLANTA GA 30346
Re: K223233
Trade/Device Name: Monaco RTP System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: January 26, 2023 Received: January 27, 2023
Dear Melinda Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is February 23, 2023, and the time is 14:51:34 -05'00'.
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223233
Device Name
Monaco RTP System
Indications for Use (Describe)
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic with three dots inside, followed by the word "Elekta" in a sans-serif font. The graphic and the text are both in a teal color.
TRADITIONAL 510(K) SUMMARY (21 CFR § 807.92)
| I. SUBMITTER | Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm, SE SE10393 |
|-------------------------------|----------------------------------------------------------------------------|
| Contact: | Melinda Smith, MS, RAC, CBA
Melinda.Smith@elekta.com |
| Establishment Registration #: | 3015232217 |
| 510(k) Number: | K223233 |
| Date Prepared: | 14 October 2022 |
| II. DEVICE | |
| Trade Name: | Monaco Radiation Therapy Planning (RTP) System |
| Product Classification: | Class II |
| Common Name: | Radiation Treatment Planning System |
| Regulation Number: | 21 CFR § 892.5050 |
| Regulation Description: | Medical charged-particle radiation therapy system |
| Product Code: | MUJ |
lll. PREDICATE DEVICE
Predicate Device: Monaco RTP System (K213787)
IV. DEVICE DESCRIPTION
The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically 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 then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities:
- . Intensity Modulated Radiation Treatment (IMRT) planning
- Electron, photon and proton treatment planning •
- Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, •
- Volumetric Modulated Arc Therapy (VMAT))
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Image /page/4/Picture/0 description: The image shows the logo for Elekta, a company that specializes in radiation therapy and oncology informatics. The logo consists of a stylized circle with three dots inside, followed by the word "Elekta" in a sans-serif font. The circle and the word "Elekta" are both in a teal color. The logo is simple and modern, and it is easily recognizable.
- . Stereotactic planning and support of cone-based stereotactic
- 3D conformal planning
- . Adaptive planning (e.g. for the Elekta Unity MR-Linac)
- Monaco basic systems tools, characteristics, and functions:
- Plan review tools
- Manual and automated contouring tools
- DICOM connectivity
- . Windows operating system
- Simulation
- Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.)
- . Standardized uptake value (SUV)
- . Specialty Image Creation (MIP, MinIP, and Avg)
- . Monaco dose and Monitor Unit (MU) calculation:
- . Dose calculation algorithms for electron, photon, proton planning
Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.
INTENDED USE / INDICATIONS FOR USE V.
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton 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
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE
Monaco RTP System version 6.2 is an updated version of the predicate device and has identical intended use and technological characteristics (identical designs, principles of operation, and use environments) as well as the same indications for use as the predicate device cleared per K213787.
The similarities and differences in key device characteristics and performance specifications of the current and predicate Monaco configuration are noted in the table below: Through adequate verification, validation and usability evaluations, Elekta has concluded that the differences do not impact the substantial equivalence with the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for Elekta, a company that specializes in precision radiation medicine. The logo consists of a circular graphic with three smaller circles inside, followed by the word "Elekta" in a bold, sans-serif font. The color of the logo is a teal or turquoise shade.
| Technological Characteristics Comparison | Monaco
(Subject Device) | Monaco
(K213787) | |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|----|
| Dose Calculation
Algorithms | Monte Carlo - electron & photon (extended to include
LET calculation for proton)
Collapsed Cone (photon)
Pencil Beam (optimization only) GPUMCD for MR-linac
GPUMCD for proton
Proton Pencil Beam | ✓ | ✓ |
| Proton Planning | Robustness optimization/evaluation, calculation using
GPU based
Monte Carlo & pencil beam algorithms and linear
energy transfer (LET) evaluation capabilities will be
available for Proton Arc Therapy planning. | ✓ | ✓* |
| MR-Linac dose
calculation | Calculates dose for MR-Linac dose calculation
(including magnetic field, coils & cryostat) | ✓ | ✓ |
| Modality support | Supports IMRT, IGRT, particle therapy, stereotactic
radiotherapy and MR-Linac treatments | ✓ | ✓ |
| Motion Management
for MR-LINAC
(Elekta Unity) | Adaptive Therapy with optional BLS (Baseline Shift)
Recovery | ✓ | X |
| Beam Modelling | Beam modeling is performed by Elekta personnel.
Standardized beam models are provided for some
Elekta linac energy options.
A new version of the Beam Modelling tool will be made
available for users of Monaco 6.2 with a new GPUMCD
dose calculator. | ✓ | ✓ |
| DICOM Connectivity | DICOM connectivity with compatible systems | ✓ | ✓ |
| Operating System | Windows operating system Support for Windows 10 | ✓ | ✓ |
*Same features made available to Proton Arc Therapy planning
SUMMARY OF PERFORMACE TESTING (NON-CLINICAL) VII.
Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes.
Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system, integration and system levels. Software verification testing was conducted and documented in accordance with FDA quidance 1 for devices that pose a major level of concern (Class C per IEC 62304).
Basic safety and essential performance have been satisfied through conformance with device-specific recognized consensus standards, as well as the general and collateral safety and essential performance standards for medical devices listed below.
1 Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and Food and Drug Administration Staff, May 2005
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| Standard No. | Standard Title |
|---|---|
| ISO 14971 | Medical Devices – Application of risk management to medical devices |
| IEC 62304 | Medical device software - Software life-cycle processes |
| ISO 62083 | Medical electrical equipment - Requirements for the safety of |
| radiotherapy treatment planning systems | |
| IEC 61217 | Radiotherapy equipment - Coordinates, movements and scales |
| IEC 62366-1 | Medical devices - Application of usability engineering to medical devices |
| ISO 15223 | Medical devices -Symbols to be used with medical devices, labeling and |
| information to be supplied - Part 1: General requirements |
VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL)
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that Monaco is as safe and effective and performs as well as the predicate device.
SUBSTANTIAL EQUIVALENCE CONCLUSION IX.
Monaco is substantially equivalent (SE) to the predicate device, Monaco (K213787). The intended use and indications for use are identical to the predicate device and the principles of operation remain unchanged.
The technological characteristics are substantially equivalent to the predicate device; the additional motion management strategies do not affect the fundamental scientific technology or raise different questions of safety or effectiveness of the device. The device safety and performance have been addressed by non-clinical testing in conformance with pre-determined performance criteria, FDA guidance, and recognized consensus standards.
The results of verification and validation as well as conformance to relevant safety standards demonstrate that Monaco meets the established safety and performance criteria and is substantially equivalent to the predicate device.