Monaco Rtp System

K202789 · Elekta Solutions AB · MUJ · Feb 23, 2021 · Radiology

Device Facts

• Record ID: K202789
• Device Name: Monaco Rtp System
• Applicant: Elekta Solutions AB
• Product Code: MUJ · Radiology
• Decision Date: Feb 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

Monaco RTP System is a radiation treatment planning software; accepts patient imaging data and linear accelerator dosimetry data. Dosimetrists/Medical Physicists use system to contour target volumes/critical structures; define radiation beam parameters (number, position, energy, modifiers). System calculates dose distributions; displays 2D/3D dose maps. Clinicians review/approve plans to maximize target dose while minimizing healthy tissue exposure. Supports Proton Pencil Beam Scanning (PBS) for specific delivery systems. Used in clinical settings; no direct link to linear accelerator; output informs clinical decision-making for radiation therapy delivery.

Clinical Evidence

No clinical trials performed. Substantial equivalence demonstrated via verification testing using simulated clinical workflows and actual patient data. Over 600 test procedures executed, including regression and new functionality testing, meeting pre-defined pass/fail criteria equivalent to predicate.

Technological Characteristics

Software-based radiation treatment planning system; runs on Windows OS. Algorithms include Monte Carlo (electron/photon), Collapsed Cone (photon), Pencil Beam (optimization), and GPUMCD (MR-linac/proton). Supports DICOM RT. Compliant with IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management).

Indications for Use

Indicated for patients with prescriptions for external beam radiation therapy requiring treatment planning for photon, electron, or proton beams.

Regulatory Classification

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.

Predicate Devices

• Monaco RTP System (K190178)
• RayStation 8.1 (K190387)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K202789

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<br>Kungstensgatan 18 Box 7593<br>Stockholm, Stockholms lan [SE-01] SE SE10393 |
|-----------|---------------------------------------------------------------------------------------------------|
| Contact: | Nickie Power |

Nickie Power [e-mail]

| Establishment<br>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<br>(subject device) | Monaco<br>Predicate Device<br>K190178 | RayStation 8.1<br>Predicate Device<br>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<br>(electron & photon),<br>Collapsed Cone<br>(photon), Pencil<br>Beam (optimization<br>only), GPUMCD for<br>MR-linac, GPUMCD<br>for proton, Proton<br>Pencil Beam | Monte Carlo<br>(electron & photon),<br>Collapsed Cone<br>(photon), Pencil<br>Beam (optimization<br>only), GPUMCD for<br>MR-linac | Proton Pencil<br>Beam and Monte<br>Carlo, Collapsed<br>Cone for photon,<br>Monte Carlo for<br>electron |
| Calculates dose for MR-Linac<br>(including magnetic field, coils<br>& cryostat) | Yes | Yes | No |
| Adaptive therapy features | Yes | Yes | Yes |
| Calculation and display of<br>standardized uptake value | Yes | Yes | Yes |
| Feature | Monaco<br>(subject device) | Monaco<br>Predicate Device<br>K190178 | RayStation 8.1<br>Predicate Device<br>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<br>Optimization | Yes | Yes | No |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Support for various treatment<br>aids | Yes | Yes | Yes |
| Support for Dynamic Delivery<br>Methods | Yes | Yes | Yes |
| Operating System | Windows | Windows | Windows |
| DICOM RT Support | Yes | Yes | Yes |
| Modalities Supported | Photon, Electron,<br>Proton | Calculates dose for<br>photon and electron<br>plans only. For<br>users with Monaco<br>Sim only, partial<br>workflows with<br>limited functions are<br>available for proton<br>plans | Photon, Electron,<br>Proton |
| Support for brachytherapy | No | No | No |
| Interoperable with OIS system | Yes, including<br>support for<br>prescribed relative<br>offset (PRO) | Yes, including<br>support for<br>prescribed relative<br>offset (PRO) | Yes |
| Beam modeling | Beam modeling is<br>performed by Elekta<br>personnel.<br>Standardized beam<br>models are provided<br>for some Elekta<br>linac energy options. | Beam modeling is<br>performed by Elekta<br>personnel.<br>Standardized beam<br>models are provided<br>for some Elekta<br>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.