(99 days)
Not Found
No
The document describes a proton therapy system with a focus on hardware components, beam delivery, and control systems. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to deliver proton radiation therapy treatment, which is a therapeutic intervention for patients with localized tumors or other conditions susceptible to treatment by radiation.
No
Explanation: The device is a proton beam radiation therapy system intended for treatment delivery, not for diagnosing medical conditions. While it uses imaging for positioning, its primary function is therapeutic.
No
The device description clearly outlines a complex hardware system including a proton accelerator, gantry, beamline, and various physical systems, in addition to software.
Based on the provided information, the MEVION S250i is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation." This describes a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for generating and delivering a proton beam for treatment. It focuses on the physical components and their function in delivering radiation.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The MEVION S250i does not perform these functions.
The MEVION S250i is clearly a therapeutic medical device used for radiation therapy.
N/A
Intended Use / Indications for Use
The MEVION S250i is intended to deliver proton radiation therapy treatment to patients with localized tumors or other conditions susceptible to treatment by radiation.
Product codes (comma separated list FDA assigned to the subject device)
LHN
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).
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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic X-rays, CT imaging
Anatomical Site
Localized tumors
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained health care professionals who are responsible for the correct performance and delivery of radiation therapy, in a treatment or therapy setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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
1
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
2
Section 4
Intended Use and Indications for Use Statement
3
Indications for Use
510(k) Number (if known)
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
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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(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 | IBA
Proteus One
(Proteus 235) | MEVION
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
System - Proteus 235
(brand names: Proteus
Plus and Proteus ONE) is
a medical device designed
to produce and deliver a
proton beam for the
treatment of patients with
localized tumors and other
conditions susceptible to
treatment by radiation.
The PTS may include a
fixed small beam
treatment room dedicated
to the treatment of
patients with localized
tumors and other
conditions susceptible to
treatment by radiation
localized to the head and
neck | The S-250 is intended to
deliver proton radiation
treatment to patients with
localized tumors or any
other conditions
susceptible to treatment
by radiation. | The MEVION S250i is
intended to deliver proton
radiation treatment to
patients with localized
tumors or any other
conditions susceptible to
treatment by radiation. |
| Energy (MeV) at
Patient | 70-230 MeV | 70-250 MeV | 70-230 MeV |
| Particle | Proton | Proton | Proton |
| Accelerator | 230 MeV superconducting
synchrocyclotron | 250 MeV superconducting
synchrocyclotron | 230 MeV superconducting
synchrocyclotron |
| Beam Time
Structure | Pulsed Beam at 1000 Hz | Pulsed Beam at 500 Hz | Pulsed Beam at 750 Hz |
| lon Source | Cold Cathode PIG Ion
Source | Cold Cathode PIG Ion
Source | Cold Cathode PIG Ion
Source |
| 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 Transport
and Switching
System | Beam transport system
from the dedicated
cyclotron containment
vault that transports the
proton beam to the
treatment room. | No beam switching or
transport system required.
An isocentric gantry
mounted cyclotron serves
a single treatment room
with a direct beam line | No beam switching or
transport system required.
An isocentric gantry
mounted cyclotron serves
a single treatment room
with a direct beam line |
| Characteristic | IBA
Proteus One
(Proteus 235) | MEVION
S-250 | MEVION S250i |
| Device | Predicate Device | Predicate Device | Applicant Device |
| Beam Transport
Magnets | Yes | No external steering
magnets required | No external steering
magnets required |
| Treatment
Configuration | Compact Single Room
Treatment Machine | 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 | Robotic Couch with 6
degrees of freedom |
| Patient
Positioning
System | Radiographic or CT
assisted positioning
system | Radiographic or CT
assisted positioning
system | Radiographic or CT
assisted positioning
system |
| Bean Delivery
Modality | Pencil Beam Scanning | Double Scatter | Pencil Beam Scanning |
| Range in
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
energies | Not Applicable | ≤ 5 mm at maximum
energy (depth) to 15 mm
at minimum energy
(depth) |
| Spot Position
Accuracy | ≤ 15% of beam sigma or