(154 days)
No
The document describes standard radiation treatment planning functionalities and does not mention AI or ML.
No
Explanation: The device is a planning system for radiation therapy, calculating dose distributions, but it does not directly deliver therapy or interact with the patient for therapeutic purposes. It aids in the planning of treatment, not the delivery of treatment.
No
The device is a radiation treatment planning system that calculates and displays radiation dose distributions for treatment plans. While it uses patient imaging data for contouring and plan optimization, its primary purpose is not to diagnose a disease but to plan a therapy.
Yes
The device description focuses entirely on the software's functionality for radiation treatment planning, image processing, and dose calculation. While it interacts with hardware (linear accelerators, imaging modalities), the device itself, as described, is the software system. The description does not mention any hardware components being part of the device being submitted for clearance.
Based on the provided text, the Monaco system is not an In Vitro Diagnostic (IVD) device.
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'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 within the patient's body.
- No Specimen Analysis: The description clearly states that the system accepts patient imaging data and "source" dosimetry data. There is no mention of collecting, preparing, or analyzing specimens taken from the patient's body.
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 and electron treatment plans and displays, on-screen and in hard-copy, twoor 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), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users.
The Monaco system accepts patient 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 beam modifier (MLC, block, etc.) 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 clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
Monaco 6.00 supports Proton Pencil Beam Scanning (Proton PBS) planning for IBA Proteus®ONE and Proteus®PLUS delivery systems (Ion Beam Applications S.A.).
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 / Not Found
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)
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 using actual patient data, such as patient images. Pre-defined pass/fail criteria were also equivalent to that of the previous version of Monaco. The product was deemed substantially equivalent and fit for clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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February 23, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Elekta Solutions AB % Irina Proutski Senior Regulatory Affairs Consultant Kungstensgatan 18, Box 7593 Stockholm, SE-103 93 SWEDEN
Re: K202789
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 18, 2021 Received: January 21, 2021
Dear Irina Proutski:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
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 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, twoor 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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Image /page/3/Picture/0 description: The image shows the Elekta company logo. The logo consists of a circular graphic to the left of the company name. The graphic is a teal circle with three smaller circles inside of it.
510(K) SUMMARY (21 CFR § 807.92)
| SUBMITTER | Elekta Solutions AB
Kungstensgatan 18 Box 7593
Stockholm, Stockholms lan [SE-01] SE SE10393 |
|-----------|---------------------------------------------------------------------------------------------------|
| Contact: | Nickie Power |
Nickie Power nickie.power@elekta.com
| Establishment
| Registration Number: | 3015232217 |
|---|---|
| 510(k) Number: | K202789 |
| Date Prepared: | 15 January 2021 |
II. DEVICE
| Trade Name: | Monaco RTP System |
|---|---|
| Release Version #: | Release 6.00 |
| 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
K190178 (Monaco RTP System) Predicate Device 1: Predicate Device 2: K190387 (RayStation 8.1)
IV. 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), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users.
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Image /page/4/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a teal circle with three smaller teal circles inside of it. The word "Elekta" is written in a teal sans-serif font.
The Monaco system accepts patient 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 beam modifier (MLC, block, etc.) 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 clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
Monaco 6.00 supports Proton Pencil Beam Scanning (Proton PBS) planning for IBA Proteus®ONE and Proteus®PLUS delivery systems (Ion Beam Applications S.A.).
LEVEL OF CONCERN
ltem 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.
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, proton, and electron treatment plans and displays, on-screen and in hard-copy, two- or threedimensional radiation dose distributions inside patients for given treatment plan setups.
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
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Image /page/5/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The graphic is a circle with three smaller circles inside of it. The word "Elekta" is written in a sans-serif font.
SUMMARY OF CLINICAL TESTING VI.
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 using actual patient data, such as patient images. Pre-defined pass/fail criteria were also equivalent to that of the previous version of Monaco. The product was deemed substantially equivalent and fit for clinical use.
VII. 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. Verification testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, IEC 62304 Software Life Cycle standard, and ISO 14971 Risk Management Standard, as was the predicate version. Quality System procedures governing the testing process, including pre-defined pass/fail criteria, were equivalent to procedures used in the testing of the previous Monaco version cleared. Conformity to the same pass/fail criteria as the predicate version of Monaco indicated that Monaco 6.00 was substantially equivalent in safety and effectiveness. Monaco 6.00 was deemed safe and effective for its intended use.
| Feature | Monaco
(subject device) | Monaco
Predicate Device
K190178 | RayStation 8.1
Predicate Device
K190387 |
|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Intended use and Indications for use | | | |
| Contouring | Yes | Yes | Yes |
| Dose Calculation | Yes | Yes | Yes |
| Plan Optimization | Yes | Yes | Yes |
| Image Manipulation & Fusion | Yes | Yes | Yes |
| CT Simulation | Yes | Yes | Yes |
| QA/Plan Review | Yes | Yes | Yes |
| Technological Characteristics | | | |
| Dose Calculation Algorithms | Monte Carlo
(electron & photon),
Collapsed Cone
(photon), Pencil
Beam (optimization
only), GPUMCD for
MR-linac, GPUMCD
for proton, Proton
Pencil Beam | Monte Carlo
(electron & photon),
Collapsed Cone
(photon), Pencil
Beam (optimization
only), GPUMCD for
MR-linac | Proton Pencil
Beam and Monte
Carlo, Collapsed
Cone for photon,
Monte Carlo for
electron |
| Calculates dose for MR-Linac
(including magnetic field, coils
& cryostat) | Yes | Yes | No |
| Adaptive therapy features | Yes | Yes | Yes |
| Calculation and display of
standardized uptake value | Yes | Yes | Yes |
| Feature | Monaco
(subject device) | Monaco
Predicate Device
K190178 | RayStation 8.1
Predicate Device
K190387 |
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Image /page/6/Picture/0 description: The image shows the logo for Elekta. The logo consists of a circular graphic to the left of the word "Elekta". The circular graphic is teal and has three smaller circles inside of it. The word "Elekta" is also teal and is written in a sans-serif font.
| Local Biological Measure
| Optimization | Yes | Yes | No |
|---|---|---|---|
| Support for various treatment | |||
| aids | Yes | Yes | Yes |
| Support for Dynamic Delivery | |||
| Methods | Yes | Yes | Yes |
| Operating System | Windows | Windows | Windows |
| DICOM RT Support | Yes | Yes | Yes |
| Modalities Supported | Photon, Electron, | ||
| Proton | Calculates dose for | ||
| photon and electron | |||
| plans only. For | |||
| users with Monaco | |||
| Sim only, partial | |||
| workflows with | |||
| limited functions are | |||
| available for proton | |||
| plans | Photon, Electron, | ||
| Proton | |||
| Support for brachytherapy | No | No | No |
| Interoperable with OIS system | Yes, including | ||
| support for | |||
| prescribed relative | |||
| offset (PRO) | Yes, including | ||
| support for | |||
| prescribed relative | |||
| offset (PRO) | Yes | ||
| Beam modeling | Beam modeling is | ||
| performed by Elekta | |||
| personnel. | |||
| Standardized beam | |||
| models are provided | |||
| for some Elekta | |||
| linac energy options. | Beam modeling is | ||
| performed by Elekta | |||
| personnel. | |||
| Standardized beam | |||
| models are provided | |||
| for some Elekta | |||
| linac energy options. | Unknown | ||
| Scripting | Yes | No | Yes |
| Archive/Retrieve | Yes | No | Yes |
CONCLUSIONS VIII.
Elekta's Monaco RTP System (subject device) is substantially equivalent to Elekta's Monaco RTP System predicate device cleared under K190178 and RaySerach Laboratories AB's RayStation 8.1 cleared under K190387.