MEVION S250i Proton Beam Radiation Therapy Device

K172848 · Mevion Medical Systems · LHN · Dec 27, 2017 · Radiology

Device Facts

• Record ID: K172848
• Device Name: MEVION S250i Proton Beam Radiation Therapy Device
• Applicant: Mevion Medical Systems
• Product Code: LHN · Radiology
• Decision Date: Dec 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MEVION S250i is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.

Device Story

MEVION S250i is a proton beam radiation therapy system; delivers therapeutic proton beams to localized tumors. System components: superconducting synchrocyclotron (230 MeV), gantry-mounted proton source, precision scanning beamline, patient positioning system (Verity), control software, and hard-wired safety system. Operates in clinical treatment settings; managed by trained healthcare professionals. Input: treatment planning images. Transformation: synchrocyclotron generates protons; scanning magnets and dynamic micro-MLC (Adaptive Aperture) shape beam; Verity system uses orthogonal X-rays or CT to align patient to isocenter. Output: controlled proton radiation dose to target site. Clinical benefit: precise, conformal radiation delivery to tumors while sparing surrounding tissue. Healthcare providers use system interface to coordinate treatment delivery; hard-wired interlocks ensure safety parameters.

Clinical Evidence

Bench testing only. Verification and validation activities included implementation of design changes, regression testing, satisfaction of performance requirements, software verification and validation, and electrical safety/EMC testing. No clinical data presented.

Technological Characteristics

Superconducting synchrocyclotron (230 MeV); gantry-mounted; pencil beam scanning modality; dynamic micro-MLC (Adaptive Aperture) for beam shaping; polycarbonate range shifter plates; robotic 6-DOF treatment couch; Verity patient positioning system (2D/3D radiographic/CT); hard-wired relay-based safety interlocks; chilled water/Gifford-McMahon cryocooler cooling; networked control system software.

Indications for Use

Indicated for patients with localized tumors or other conditions susceptible to treatment by radiation.

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

• MEVION S-250 (K120676)
• IBA Proteus One (Proteus 235) (K152224)

Submission Summary (Full Text)

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Mevion Medical Systems, Inc. % Mr. Thomas Faris VP Regulatory and Quality Assurance, Management Representative 300 Foster St. LITTLETON MA 01460

December 27, 2017

Re: K172848

Trade/Device Name: MEVION S250i Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2017 Received: December 4, 2017

Dear Mr. Faris:

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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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# Section 4

# Intended Use and Indications for Use Statement

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#### Indications for Use

510(k) Number (if known)

K172848

Device Name MEVION S250i

Indications for Use (Describe)

The MEVION S250i is intended to deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation.

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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# Section 5 510(k) Summary or 510(k) Statement

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Image /page/5/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular symbol on the left, with two curved shapes, one in gray and one in red. To the right of the symbol is the word "MEVION" in large, red letters, and below that, in smaller gray letters, is the phrase "medical systems."

## MEVION S250i, Proton Radiation Beam Therapy System Premarket Notification (510(k)) Summary

### Introduction

This document provides a high-level summary of the contents of the MEVION S250i Premarket Notification (510(k)), including a summary of the basis for the determination of Substantial Equivalence to the Predicate Devices.

This Premarket Notification (510(k)) Summary contains no confidential or trade secret information and is intended for full public disclosure and distribution. For addition information, please contact the Establishment's contact listed below, Thomas H. Faris.

#### Premarket Notification Information

#### Product Information

Product Name MEVON S250! (Also called MEVION S250i with Hyperscan) Common/Usual Name Proton Radiation Beam Therapy System

#### Classification Information

Classification Name Product Code CFR Reference Product Classification Review Panel

Charged Particle Radiation Therapy System LHN 21 CFR 892.5050 Class II Office of In Vitro Diagnostics and Radiological

#### Establishment Information

| Submitter | Mevion Medical Systems, Inc. |
|-----------------------|---------------------------------------|
| Submitter Type | Manufacturer (no sterilization) |
| Submitter Address | 300 Foster Street Littleton, MA 01460 |
| Submitter Phone | 978-540-1500 |
| Submitter Fax | 978-540-1501 |
| Establishment Number | 3007087027 |
| Establishment Contact | Thomas H. Faris, Esq. |
| Contact Title | VP RA/QA |
| Contact Phone | 650-996-1192 |
| Contact Email | [e-mail] |

Health, CDRH

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Image /page/6/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular symbol on the left, with the word "MEVION" in large, red, sans-serif letters to the right of the symbol. Below the word "MEVION" are the words "medical systems" in smaller, gray letters. The circular symbol is divided into two halves, with the left half being red and the right half being gray.

#### MEVION S250i Intended Use Statement / Indications for Use

The MEVION S250i is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation.

The Applicant Device has the same Intended Use / Indications for Use as the Predicate Devices: proton therapy for "… patients with localized tumors or any other conditions susceptible to treatment by radiation. Similarly, the Indications for Use are identical, as the conditions for treatment and potential patient populations remain as described in the Intended Use statement.

#### Description of the Product / Technological Characteristics

The MEVION S250i is a proton beam radiation therapy system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose and dose distribution to the prescribed patient treatment site. The MEVON S250i is a modern proton therapy system combining a patented, gantry-mounted proton source and a precision scanning beamline with a highly integrated, image-based workflow. The proton accelerator is a superconducting synchrocyclotron. The synchrocyclotron source generates protons of energy 230 MeV and is mounted in a high-precision concentric gantry system that rotates and points at treatment isocenter at all times. The system components include a Beam Generation System, Beam Delivery System, Structural Support and Alignment System, Patient Positioning System, Control System Software, and a Hard-wired Safety System (HSS).

A Beam Generation system, comprised of a 230MeV Synchrocyclotron, is used to generate a clinical useful proton beam with sufficient and adjustable beam current, range, and stability. The Beam Generation system includes a Superconducting Magnet, Synchrocyclotron, Ion Source, Radiofrequency System, Beam Extraction System, and Vacuum and Cooling Systems.

A Beam Delivery System measures, modifies, and shapes the proton beam so that delivered proton beam conforms to the prescribed target shape and dose. The Beam Delivery System includes Scanning Beam Forming, Dosimetry, and Treatment Nozzle subsystems. The HYPERSCAN pencil beam Scanning Beam Forming System consists of the scanning magnet, beam control, dosimetry, ion chambers, the energy modulation system (range shifter), and the adaptive aperture collimation (dynamic Micro-MLC) system.

A Patient Positioning System, the same as in the cleared S-250 (K120676), includes a Treatment Couch and offers a 2D and 3D patient setup system

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Image /page/7/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a stylized symbol on the left and the word "MEVION" in red capital letters on the right. Below the word "MEVION" are the words "medical systems" in a smaller, gray font. The symbol on the left is made up of two curved shapes, one gray and one red, that are intertwined.

(Called "Verity"). The robotic couch enables high precision 6 degree of freedom patient positioning. The Patient Setup System (Verity) is the on-board patient imaging based position correction system for the MEVON S250 Series. In its 2D/3D mode, the Verity System uses in-room orthogonal radiographic X-rays, and in 3D/3D mode, it uses in-room CT imaging, to match the patient images to the treatment planning images to calculate couch corrections required to align the patient to the treatment isocenter.

A structural support and alignment system includes a treatment gantry and treatment room enclosure. The previously cleared MEVION S-250 included the same Cyclotron Gantry support system, while the IBA Proteus ONE maintains the cyclotron in an adjacent cyclotron room.

Control System Software controls and coordinates the operation of all subsystems of the device, provides a user interface to the MEVION S250i, and ensure intended treatment setup and delivery of the treatment. Software updates have been made to facilitate the new Beam Scanning delivery modality for the MEVION S250i.

A Hard-wired Safety System (HSS) provides system performance monitoring and automatic interlocks that inhibit or interrupt beam, system motion, and/or other machine activity when machine performance may not satisfy defined treatment or operating parameters.

The above technological characteristics of the Applicant Device are Substantially Equivalent to the Predicate Devices, which demonstrate similar and equivalent design.

#### Predicate Devices

The MEVION S250i is Substantially Equivalent to the MEVION S-250 (K120676). The product design was changed to add a Beam Scanning modality configuration in addition to the previously cleared Double Scatter modality. These changes are not new or novel and raise no new issues of safety or efficacy. The lon Beam Application's (IBA's) Proteus One (Proteus 235) is a substantially equivalent and cleared (K152224) device that offers a Beam Scanning modality. The Technical Characteristics of the new MEVION S250i Beam Scanning Modality are Substantially Equivalent to the IBA Proteus One.

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Image /page/8/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular graphic on the left, with the word "MEVION" in large, red, bold letters to the right of the graphic. Below the word "MEVION" are the words "medical systems" in a smaller, gray font.

## Substantial Equivalence Comparison Matrix

| Characteristic | IBA<br>Proteus One<br>(Proteus 235) | MEVION<br>S-250 | MEVION S250i |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | Predicate Device | Predicate Device | Applicant Device |
| 510(k) Number | K152224 | K120676 | N/A- Proposed Device |
| Intended Use | The Proton Therapy<br>System - Proteus 235<br>(brand names: Proteus<br>Plus and Proteus ONE) is<br>a medical device designed<br>to produce and deliver a<br>proton beam for the<br>treatment of patients with<br>localized tumors and other<br>conditions susceptible to<br>treatment by radiation.<br>The PTS may include a<br>fixed small beam<br>treatment room dedicated<br>to the treatment of<br>patients with localized<br>tumors and other<br>conditions susceptible to<br>treatment by radiation<br>localized to the head and<br>neck | The S-250 is intended to<br>deliver proton radiation<br>treatment to patients with<br>localized tumors or any<br>other conditions<br>susceptible to treatment<br>by radiation. | The MEVION S250i is<br>intended to deliver proton<br>radiation treatment to<br>patients with localized<br>tumors or any other<br>conditions susceptible to<br>treatment by radiation. |
| Energy (MeV) at<br>Patient | 70-230 MeV | 70-250 MeV | 70-230 MeV |
| Particle | Proton | Proton | Proton |
| Accelerator | 230 MeV superconducting<br>synchrocyclotron | 250 MeV superconducting<br>synchrocyclotron | 230 MeV superconducting<br>synchrocyclotron |
| Beam Time<br>Structure | Pulsed Beam at 1000 Hz | Pulsed Beam at 500 Hz | Pulsed Beam at 750 Hz |
| lon Source | Cold Cathode PIG Ion<br>Source | Cold Cathode PIG Ion<br>Source | Cold Cathode PIG Ion<br>Source |
| Type of Coils | Superconducting Coils | Superconducting Coils | Superconducting Coils |
| Cooling Method | Chilled water and Gifford-<br>McMahon Cryocoolers | Chilled water and Gifford-<br>McMahon Cryocoolers | Chilled water and Gifford-<br>McMahon Cryocoolers |
| Beam Transport<br>and Switching<br>System | Beam transport system<br>from the dedicated<br>cyclotron containment<br>vault that transports the<br>proton beam to the<br>treatment room. | No beam switching or<br>transport system required.<br>An isocentric gantry<br>mounted cyclotron serves<br>a single treatment room<br>with a direct beam line | No beam switching or<br>transport system required.<br>An isocentric gantry<br>mounted cyclotron serves<br>a single treatment room<br>with a direct beam line |
| Characteristic | IBA<br>Proteus One<br>(Proteus 235) | MEVION<br>S-250 | MEVION S250i |
| Device | Predicate Device | Predicate Device | Applicant Device |
| Beam Transport<br>Magnets | Yes | No external steering<br>magnets required | No external steering<br>magnets required |
| Treatment<br>Configuration | Compact Single Room<br>Treatment Machine | Compact Single Room<br>Treatment Machine | Compact Single Room<br>Treatment Machine |
| Treatment Table | Robotic Couch with 6<br>degrees of freedom | Robotic Couch with 6<br>degrees of freedom | Robotic Couch with 6<br>degrees of freedom |
| Patient<br>Positioning<br>System | Radiographic or CT<br>assisted positioning<br>system | Radiographic or CT<br>assisted positioning<br>system | Radiographic or CT<br>assisted positioning<br>system |
| Bean Delivery<br>Modality | Pencil Beam Scanning | Double Scatter | Pencil Beam Scanning |
| Range in<br>patient | $5 g/cm^2 - 32 g/cm^2$ | $5 g/cm^2 - 32 g/cm^2$ | $0.8 g/cm^2 - 32.2 g/cm^2$ |
| Dose Rate | > 2Gy/Min | > 2Gy/Min | > 2Gy/Min |
| Spot Size | ≤ 15 mm on the range of<br>energies | Not Applicable | ≤ 5 mm at maximum<br>energy (depth) to 15 mm<br>at minimum energy<br>(depth) |
| Spot Position<br>Accuracy | ≤ 15% of beam sigma or <<br>to 1.5 mm | Not Applicable | ≤ 10% of beam size, max<br>0.9 mm |
| Range<br>Selection | Beryllium Wedge<br>Absorber | Carbon Wedge Absorber | Polycarbonate Range<br>shifter plates |
| Energy<br>Modulation | Beryllium Wedge<br>Absorber | Modulation wheels | Polycarbonate Range<br>shifter plates |
| Dose<br>Modulation | Individual Spot Dose<br>Control | Not Applicable | Individual Spot Dose<br>Control |
| Planar Beam<br>Shaping | None (Scanning Beam) | Brass Apertures | Dynamic Micro Multi-leaf<br>Collimator |
| Safety System | Hard-wired relay-based<br>interlock system and user<br>activated shut-offs | Hard-wired relay-based<br>interlock system and user<br>activated shut-offs | Hard-wired relay-based<br>interlock system and user<br>activated shut-offs |

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Image /page/9/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular graphic on the left, with the word "MEVION" in large, bold, red letters to the right of the graphic. Below the word "MEVION" are the words "medical systems" in a smaller, gray font.

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Image /page/10/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular symbol on the left, with the letters "MEVION" in red to the right of the symbol. Below the letters, the words "medical systems" are written in a smaller font size. The circular symbol is split into two halves, one gray and one red.

#### Discussion of the Design Change and Substantial Equivalence

The design change that triggered this submission is the offering of a new MEVION S250i Beam Delivery modality. Beam Scanning is a configuration option in addition to the Double Scatter Beam Delivery previously cleared by the FDA in K120676. Beam Scanning is a common Beam Delivery modality currently in use. Ion Beam Applications' (IBA's) Proteus One (Proteus 235) has been previously cleared by the FDA in K152224 and is compared as a Predicate Device in this Substantial Equivalence Analysis. In both the Applicant and IBA Predicate Device, Beam Scanning Magnets are used to create a proton Scanning Beam and range shifting/beam modulation technology, comprised of energy absorbing materials placed in the beam path, are used to produce a pencil beam scanning beam that can accurately deliver therapeutic radiation to desired treatment volumes and dose levels. The previously cleared S-250 design uses Brass Apertures to shape the planar treatment beam. The MEVION S250i incorporates a dynamic micro-MLC ("Adaptive Aperture") to provide a very accurately contoured edge for treatment of the target volume. The Adaptive Aperture provides treatment beam collimation in the same manner as the MEVION S-250 brass apertures.

#### Verification and Validation / Risk Management

Risk Management and Verification and Validation activities have been employed to ensure safe and effective implementation of the pertinent product Performance Requirements and technologies.

#### Risk Management

The MEVION S250i is a medical device that is to be used in a treatment or therapy setting under the supervision and control of appropriately trained health care professionals who are responsible for the correct performance and delivery of radiation therapy. The MEVION S250i System Hazard Analysis was performed to determine and evaluate all potential health and safety hazards associated with treatment system use and operation. All foreseeable system hazards, effects, and causes have been evaluated to determine necessary and appropriate risk mitigations. Verification and validation, risk mitigation traceability, design review, and final reporting have been performed to ensure effective implementation of the stated risk mitigations.

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Image /page/11/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a stylized, circular symbol on the left, with the word "MEVION" in large, red, bold letters to the right of the symbol. Below the word "MEVION" are the words "medical systems" in smaller, gray letters.

Verification and Validation

Design Reviews have been held at pertinent phase passage points to review and validate the fulfillment of all of the phase requirements and deliverables, always including product safety and efficacy consideration. Verification and Validation Protocols have been executed to ensure adequate testing of all defined product design requirements and specifications. A Traceability Matrix has been created to ensure fulfillment of all design requirements. Verification and Validation Test Reports have been created to evaluate the acceptability of test results and product module / product release preparedness. All applicable design and development and verification and validation activities and records have been completed to ensure safety and efficacy of the final MEVION S250i Proton Beam Radiation Therapy System

Verification and Validation Testing Performed:

- . Implementation of Design Changes
- Regression Testing, as appropriate
- . Satisfaction of all Performance Requirements
- Software Verification and Validation
- . Electrical Safety and Electromagnetic compatibility (EMC)

All technological characteristics and performance requirements identified in the Substantial Equivalence Comparison have been tested to ensure success of the design implementation. There are no new or different issues of safety or efficacy introduced by the stated design change. Risk Management and Verification and Validation activities confirm that the MEVION S250i is Substantially Equivalent to the Predicate Devices.

Pertinent Risk Management and Verification and Validation Records have been included in the Premarket Notification (510(k)), evidencing the conclusion of Substantial Equivalence.

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Image /page/12/Picture/0 description: The image shows the logo for Mevion Medical Systems. The logo consists of a circular symbol on the left, with the letters "MEVION" in red to the right of the symbol. Below the letters, the words "medical systems" are written in a smaller, gray font.

#### Conclusion of Substantial Equivalence

The MEVION S250i is Substantially Equivalent to the MEVION S-250 and the IBA Proteus One:

- The predicates are legally marketed, cleared by the FDA by Premarket ● Notification
- There are no new or novel Technical Characteristics
- The Intended Use and Indications for Use are identical .
- . There are no new or changed issues of safety or efficacy for consideration
- Risk Management and Verification and Validation data and records ● demonstrate Substantial Equivalence