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

Device Description

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).

AI/ML Overview

This document is a 510(k) summary for the Mevion S250i, a proton radiation beam therapy system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria, study details, and ground truth cannot be extracted directly from this document.

However, based on the provided text, I can infer some aspects related to acceptance criteria and the methods used to validate the device's substantial equivalence.

Here's a breakdown of the requested information, with disclaimers where the information is not explicitly provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" in the sense of predefined performance targets for a clinical study. Instead, it compares the technological characteristics of the MEVION S250i (Applicant Device) with two predicate devices. The implicit "acceptance criterion" for this 510(k) submission is that the technological characteristics of the MEVION S250i are "Substantially Equivalent" to the predicate devices and that there are "no new or different issues of safety or efficacy."

The table below summarizes the key technical characteristics provided in the document for comparison:

Characteristic	Acceptance Criteria (Predicate Device K152224/K120676 Values)	Reported Device Performance (MEVION S250i)
Intended Use	Deliver proton radiation treatment to patients with localized tumors or conditions susceptible to treatment by radiation.	Identical.
Energy (MeV) at Patient	70-230 MeV (IBA Proteus One), 70-250 MeV (MEVION S-250)	70-230 MeV
Particle	Proton	Proton
Accelerator	230 MeV superconducting synchrocyclotron (IBA), 250 MeV superconducting synchrocyclotron (MEVION S-250)	230 MeV superconducting synchrocyclotron
Beam Time Structure	Pulsed Beam at 1000 Hz (IBA), Pulsed Beam at 500 Hz (MEVION S-250)	Pulsed Beam at 750 Hz
Ion Source	Cold Cathode PIG Ion Source	Cold Cathode PIG Ion Source
Type of Coils	Superconducting Coils	Superconducting Coils
Cooling Method	Chilled water and Gifford-McMahon Cryocoolers	Chilled water and Gifford-McMahon Cryocoolers
Beam Transport and Switching System	Beam transport system from dedicated cyclotron vault (IBA); No beam switching/transport (MEVION S-250)	No beam switching or transport system required. An isocentric gantry mounted cyclotron serves a single treatment room with a direct beam line.
Beam Transport Magnets	Yes (IBA); No external steering magnets (MEVION S-250)	No external steering magnets required
Treatment Configuration	Compact Single Room Treatment Machine	Compact Single Room Treatment Machine
Treatment Table	Robotic Couch with 6 degrees of freedom	Robotic Couch with 6 degrees of freedom
Patient Positioning System	Radiographic or CT assisted positioning system	Radiographic or CT assisted positioning system (Verity: 2D/3D with X-rays, 3D/3D with CT)
Beam Delivery Modality	Pencil Beam Scanning (IBA); Double Scatter (MEVION S-250)	Pencil Beam Scanning
Range in patient	5 g/cm² - 32 g/cm²	0.8 g/cm² - 32.2 g/cm²
Dose Rate	> 2Gy/Min	> 2Gy/Min
Spot Size	≤ 15 mm on the range of energies (IBA); Not Applicable (MEVION S-250)	≤ 5 mm at maximum energy (depth) to 15 mm at minimum energy (depth)
Spot Position Accuracy	≤ 15% of beam sigma or < 1.5 mm (IBA); Not Applicable (MEVION S-250)	≤ 10% of beam size, max 0.9 mm
Range Selection	Beryllium Wedge Absorber (IBA); Carbon Wedge Absorber (MEVION S-250)	Polycarbonate Range shifter plates
Energy Modulation	Beryllium Wedge Absorber (IBA); Modulation wheels (MEVION S-250)	Polycarbonate Range shifter plates
Dose Modulation	Individual Spot Dose Control (IBA); Not Applicable (MEVION S-250)	Individual Spot Dose Control
Planar Beam Shaping	None (Scanning Beam) (IBA); Brass Apertures (MEVION S-250)	Dynamic Micro Multi-leaf Collimator
Safety System	Hard-wired relay-based interlock system and user activated shut-offs	Hard-wired relay-based interlock system and user activated shut-offs

2. Sample Size Used for the Test Set and Data Provenance

The document describes technical verification and validation activities rather than a clinical study with a "test set" of patient data. Therefore, there is no information on:

Sample size used for a test set (e.g., number of patients or cases).
Data provenance (e.g., country of origin, retrospective or prospective).

The testing performed includes "Implementation of Design Changes," "Regression Testing," "Satisfaction of all Performance Requirements," "Software Verification and Validation," and "Electrical Safety and Electromagnetic compatibility (EMC)." These tests would involve technical measurements and simulations, not patient data in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is not a clinical study involving diagnosis or interpretation, there is no information about:

Number of experts used to establish ground truth.
Qualifications of such experts.

The "ground truth" in this context would be engineering specifications and validated physical phenomena related to proton beam generation and delivery. Design reviews were held, involving unspecified "appropriately trained health care professionals" for treatment settings and internal company experts for design and engineering.

4. Adjudication Method for the Test Set

As there is no clinical "test set" in the diagnostic sense, there is no information on an adjudication method like 2+1 or 3+1. Adjudication would not apply to the technical verification and validation directly described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not performed, or at least not described in this 510(k) summary. This type of study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device (a radiation therapy system).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a proton radiation therapy system, not a diagnostic algorithm. Its performance is inherent in its engineering design and delivery capabilities, which are evaluated through standalone technical verification and validation. The document states that "Verification and Validation Protocols have been executed to ensure adequate testing of all defined product design requirements and specifications" and "All technological characteristics and performance requirements identified in the Substantial Equivalence Comparison have been tested to ensure success of the design implementation." This would be analogous to "standalone" performance for such a device, but it's not an "algorithm-only" performance in the AI sense.

7. The Type of Ground Truth Used

The "ground truth" for the verification and validation activities described in this document would be:

Engineering specifications and design requirements: The device's operation is designed to meet predefined technical parameters for beam energy, spot size, dose rate, accuracy, etc.
Physical principles and measurements: The ability to generate and deliver a proton beam with specific characteristics (e.g., within established safety limits, dose rates, spatial accuracy) is verified against known physical laws and validated measurement techniques.
Safety and efficacy standards: Compliance with relevant medical device standards and regulations.

There is no mention of pathology, expert consensus on images, or outcomes data being used to establish ground truth for this aspect of the device.

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of machine learning. The device is a physical system with integrated software, not an AI/ML model that learns from large datasets. Therefore, no information is available regarding a training set size.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" as understood in AI/ML, this question is not applicable. The "ground truth" for the device's design and operation is established through engineering principles, physical measurements, and regulatory standards, as discussed in point 7.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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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	tfaris@mevion.com

Health, CDRH

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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

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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(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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Substantial Equivalence Comparison Matrix

Characteristic	IBAProteus One(Proteus 235)	MEVIONS-250	MEVION S250i
Device	Predicate Device	Predicate Device	Applicant Device
510(k) Number	K152224	K120676	N/A- Proposed Device
Intended Use	The Proton TherapySystem - Proteus 235(brand names: ProteusPlus and Proteus ONE) isa medical device designedto produce and deliver aproton beam for thetreatment of patients withlocalized tumors and otherconditions susceptible totreatment by radiation.The PTS may include afixed small beamtreatment room dedicatedto the treatment ofpatients with localizedtumors and otherconditions susceptible totreatment by radiationlocalized to the head andneck	The S-250 is intended todeliver proton radiationtreatment to patients withlocalized tumors or anyother conditionssusceptible to treatmentby radiation.	The MEVION S250i isintended to deliver protonradiation treatment topatients with localizedtumors or any otherconditions susceptible totreatment by radiation.
Energy (MeV) atPatient	70-230 MeV	70-250 MeV	70-230 MeV
Particle	Proton	Proton	Proton
Accelerator	230 MeV superconductingsynchrocyclotron	250 MeV superconductingsynchrocyclotron	230 MeV superconductingsynchrocyclotron
Beam TimeStructure	Pulsed Beam at 1000 Hz	Pulsed Beam at 500 Hz	Pulsed Beam at 750 Hz
lon Source	Cold Cathode PIG IonSource	Cold Cathode PIG IonSource	Cold Cathode PIG IonSource
Type of Coils	Superconducting Coils	Superconducting Coils	Superconducting Coils
Cooling Method	Chilled water and Gifford-McMahon Cryocoolers	Chilled water and Gifford-McMahon Cryocoolers	Chilled water and Gifford-McMahon Cryocoolers
Beam Transportand SwitchingSystem	Beam transport systemfrom the dedicatedcyclotron containmentvault that transports theproton beam to thetreatment room.	No beam switching ortransport system required.An isocentric gantrymounted cyclotron servesa single treatment roomwith a direct beam line	No beam switching ortransport system required.An isocentric gantrymounted cyclotron servesa single treatment roomwith a direct beam line
Characteristic	IBAProteus One(Proteus 235)	MEVIONS-250	MEVION S250i
Device	Predicate Device	Predicate Device	Applicant Device
Beam TransportMagnets	Yes	No external steeringmagnets required	No external steeringmagnets required
TreatmentConfiguration	Compact Single RoomTreatment Machine	Compact Single RoomTreatment Machine	Compact Single RoomTreatment Machine
Treatment Table	Robotic Couch with 6degrees of freedom	Robotic Couch with 6degrees of freedom	Robotic Couch with 6degrees of freedom
PatientPositioningSystem	Radiographic or CTassisted positioningsystem	Radiographic or CTassisted positioningsystem	Radiographic or CTassisted positioningsystem
Bean DeliveryModality	Pencil Beam Scanning	Double Scatter	Pencil Beam Scanning
Range inpatient	$5 g/cm^2 - 32 g/cm^2$	$5 g/cm^2 - 32 g/cm^2$	$0.8 g/cm^2 - 32.2 g/cm^2$
Dose Rate	> 2Gy/Min	> 2Gy/Min	> 2Gy/Min
Spot Size	≤ 15 mm on the range ofenergies	Not Applicable	≤ 5 mm at maximumenergy (depth) to 15 mmat minimum energy(depth)
Spot PositionAccuracy	≤ 15% of beam sigma or <to 1.5 mm	Not Applicable	≤ 10% of beam size, max0.9 mm
RangeSelection	Beryllium WedgeAbsorber	Carbon Wedge Absorber	Polycarbonate Rangeshifter plates
EnergyModulation	Beryllium WedgeAbsorber	Modulation wheels	Polycarbonate Rangeshifter plates
DoseModulation	Individual Spot DoseControl	Not Applicable	Individual Spot DoseControl
Planar BeamShaping	None (Scanning Beam)	Brass Apertures	Dynamic Micro Multi-leafCollimator
Safety System	Hard-wired relay-basedinterlock system and useractivated shut-offs	Hard-wired relay-basedinterlock system and useractivated shut-offs	Hard-wired relay-basedinterlock system and useractivated 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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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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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

Regulation Number and Section

§ 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.