Monaco RTP System

K183037 · Elekta, Inc. · MUJ · Dec 4, 2018 · Radiology

Device Facts

• Record ID: K183037
• Device Name: Monaco RTP System
• Applicant: Elekta, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Dec 4, 2018
• 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. Inputs: patient imaging data; source dosimetry data from linear accelerators. Operation: user (dosimetrist/medical physicist) defines target volumes/critical structures via contouring; creates treatment scenarios (beam number, position, energy, modifiers). System calculates radiation dose distribution using Monte Carlo, Collapsed Cone, or Pencil Beam algorithms. Output: 2D/3D dose distribution displays (on-screen/hard-copy). Usage: clinical environment; supports radiation oncology workflows. Benefit: enables clinicians to select optimal treatment plans maximizing target dose while minimizing healthy tissue exposure. Does not directly control delivery hardware; requires clinician review/approval.

Clinical Evidence

No clinical trials performed. Substantial equivalence demonstrated via bench testing and simulated clinical workflows using actual patient data. Verification testing (over 600 procedures) confirmed accuracy of dose calculation algorithms and system requirements. Pass/fail criteria were equivalent to predicate K151233.

Technological Characteristics

Radiation treatment planning software; Windows-based. Algorithms: Monte Carlo (electron/photon), Collapsed Cone (photon), Pencil Beam (optimization), GPUMCD (MR-Linac). Connectivity: DICOM RT support. Standards: ISO 13485, IEC 62304, ISO 14971. Regulatory Class: II. Product Code: MUJ.

Indications for Use

Indicated for patients requiring external beam radiation therapy planning, including photon and electron treatment plans.

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 (K151233)
• ViewRay Treatment Planning and Delivery (K102915)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 4, 2018

Elekta. Inc % Ms. Kathryn Stinson Senior Regulatory Affairs Engineer 13723 Riverport Drive, Suite 100 MARYLAND HEIGHTS MO 63043

Re: K183037

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: October 30, 2018 Received: November 1, 2018

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. 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K183037

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, 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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October 30, 2018

#### K183037

# 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.

### PREMARKET NOTIFICATION INFORMATION

- Product Information: 1. Product Trade Name Monaco a. Release Version Number Release 5.40 ڪ 2. Classification Information: a. Classification Name Medical charged-particle radiation therapy system Common/Usual Name Radiation Treatment Planning System ﻗ Product Classification Class II C. d. Product Code MUJ 21 CFR 892.5050 Reference e. f. Review Panel Radiology 3. Establishment Information: a. Submitter Elekta, Inc. Submitter Address 13723 Riverport Dr., Suite 100 b. Maryland Heights, MO 63043 C. Establishment Number 1937649 Kathryn Stinson, Principal RA Engineer d. Contact Contact Phone [phone] e.
314-812-4496

- f. Contact Fax

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### 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.

- 1. Monaco RTP System Elekta, Inc. K151233
- 2. ViewRay Treatment Planning and Delivery ViewRav Inc. K102915

### 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), aqain when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Finally, specialty image creation was added in 2015 (K15123). 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.

Since the 2015 510(k) clearance, IMPAC Medical Systems, Inc. merged with Elekta, Inc., both wholly owned subsidiaries of Elekta AB. There were no changes in location, personnel, or quality system as a result of the merger. However, the name of the manufacturer for Monaco as changed from IMPAC Medical Systems, Inc, to Elekta, Inc.

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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.

### 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 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, described in detail in section 20. Algorithm testing verified the accuracy of the new dose calculation algorithm in Monaco 5.40 using the same test methods as the predicate version of Monaco. Pre-defined passifail criteria were also equivalent to that of the predicate, K151233. Equivalent accuracy was demonstrated, and the product was deemed substantially equivalent and 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. 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, K151233. Quality System procedures goverening the testing process, including pre-defined pass/fail criteria, were equivalent to procedures used in the testing of the previous Monaco version cleared under K151233. Conformity to the same passifail criteria as the predicated that Monaco 5.40 was substantially equivalent in safety and effectiveness. Monaco 5.40 was deemed safe and effective for its intended use.

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| | Monaco for Elekta<br>Unity MR-Linac | Monaco<br>(K151233) | ViewRay Treatment<br>Planning & Delivery<br>System<br>(K102915) |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Intended Use and Indications<br>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 |
| Integrated Planning and Delivery<br>Software | The Elekta MR-Linac<br>system uses Monaco for<br>planning and the MOSAIQ<br>OIS for delivery. The<br>products were designed to<br>work together and tested in<br>an integrated environment<br>to ensure seamless<br>interoperability. | No | The ViewRay system is<br>branded as a single device<br>that handles both planning and<br>delivery. |
| Technological Characteristics | | | |
| Dose Calculation Algorithms | Monte Carlo (electron &<br>photon), Collapsed Cone<br>(photon), Pencil Beam<br>(optimization only),<br>GPUMCD for MR-linac | Monte Carlo (electron<br>& photon), Collapsed<br>Cone (photon),<br>Pencil Beam<br>(optimization only) | Monte Carlo |
| Calculates dose for MR-Linac<br>(including magnetic field, coils &<br>cryostat) | Yes (GPUMCD algorithm) | No | Yes |
| Calculation and display of<br>standardized uptake value | Yes | Yes | Unknown |
| Local Biological Measure<br>Optimization | Yes | Yes | No |
| Support for various treatment aids | Yes | Yes | Yes |
| Support for Dynamic Delivery<br>Methods | Yes (conventional linacs<br>only, not for MR-linac<br>environment) | Yes | No |
| Operating System | Windows | Windows | Windows |
| DICOM RT Support | Yes | Yes | Yes |
| Modalities Supported: Full RTP<br>Workflow | Photon, Electron | Photon, Electron | Photon only |