Radiance 330 Proton Beam Therapy System

K191521 · Protom International Holding Corporation · LHN · Sep 27, 2019 · Radiology

Device Facts

• Record ID: K191521
• Device Name: Radiance 330 Proton Beam Therapy System
• Applicant: Protom International Holding Corporation
• Product Code: LHN · Radiology
• Decision Date: Sep 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ProTom Radiance 330® 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.

Device Story

Radiance 330 is a proton beam therapy system for treating solid tumors. It consists of six subsystems: beam production (synchrotron), beam transport (magnets), beam delivery (pencil beam scanning), gantry, patient positioning, and control. The system accelerates protons to 70-250 MeV, transporting them to a nozzle for delivery to the patient. Used in clinical settings by oncology staff, the system integrates with hospital oncology information systems. The control subsystem synchronizes operations, monitors dose delivery, and manages safety interlocks. Clinicians use the system to deliver precise radiation doses to target sites, potentially sparing healthy tissue. Patient positioning is facilitated by couch-mounted CBCT imaging for registration. The device provides a means to orient the beam and patient to achieve the prescribed dose distribution.

Clinical Evidence

Bench testing only. Verification and validation performed on all subsystems, including gantry motion, dosimetry, radiation shielding, gating, geometric accuracy, image quality, and X-ray registration accuracy. Human factors testing and software validation were conducted. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-64, IEC 60601-2-68, and IEC 60825-1 was demonstrated.

Technological Characteristics

Synchrotron-based proton accelerator; 70-250 MeV variable energy; pencil beam scanning nozzle; steel and concrete shielding; couch-mounted CBCT for positioning. Control system manages beam transport, delivery, and safety interlocks. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-64, IEC 60601-2-68, IEC 60825-1.

Indications for Use

Indicated for patients with localized tumors and 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

• ProTom International, Inc. Radiance 330® Proton Therapy System (K134052)

Submission Summary (Full Text)

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September 27, 2019

ProTom International Holding Corporation % Mr. Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street NW WASHINGTON DC 20004

Re: K191521

Trade/Device Name: Radiance 330™ Proton Beam Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN Dated: August 27, 2019 Received: August 27, 2019

Dear Mr. Kahan:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191521

Device Name

Radiance 330™ Proton Beam Therapy System

Indications for Use (Describe)

The ProTom Radiance 330 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other condition susceptible to treatment by radiation.

Type of Use (Select one or both, as applicable)Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

#### Radiance 330® Proton Therapy Device

## Submitter:

ProTom International Holding Corporation

500 Edgewater Place, Suite 522 Wakefield, MA 01880 Phone: [phone] Facsimile: None

Contact Person: Stephen L. Spotts Chief Executive Officer Phone: [phone]

Date Prepared: June 26, 2019

#### Name of Device:

Radiance 330™ Proton Beam Therapy System

#### Common or Usual Name:

Proton Beam Therapy Device

#### Classification Name:

System, Radiation Therapy, Charged-Particle, Medical

#### Regulatory Class:

Class II

# Product Code:

LHN

#### Predicate Devices:

ProTom International, Inc. Radiance 330® Proton Therapy System (K134052)

#### Device Description:

The ProTom Radiance 330® is a medical device designed to produce and deliver a proton beam for the treatment of patients with solid tumors or other diseases susceptible for treatment by radiation. The device includes a method for delivering an accelerated proton beam to the treatment station. The device also includes equipment to position the patient and direct the beam angle.

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The system is comprised of six main subsystems that function in tandem to generate the desired dose level and distribution at the target site.

- 1. Beam Production Subsystem. Produces a proton beam at the desired energy level
- 2. Beam Transport Subsystem. Transports the beam from the Beam Production Subsystem to the Beam Delivery Subsystem
- 3. Beam Delivery Subsystem. Monitors and steers the beam to the desired treatment location
- Gantry Subsystem. Mechanically orients the Beam Transport and Beam Delivery ধ: Subsystems: providing a means of patient x-ray registration
- 5. Patient Positioning Subsystem. Mechanically orients the patient; provide a separate and means of patient x-ray registration
- Control Subsystem. Synchronizes the various subsystem actions and connects with 6. hospital oncology information systems

# Intended Use / Indications for Use:

The ProTom Radiance 330® 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.

# Summary of Technological Characteristics and Comparison to the Predicate:

At a high level, the ProTom Radiance 330® and the cleared ProTom Radiance 330® (K134052), to which it is a modification, are based on the following same technological elements. The systems have the same primary components and achieve radiation therapy in the same way, namely by accelerating protons for delivery through a nozzle to the patient. The Radiance 330® Proton Therapy System and predicate are designed to deliver a prescribed dose of proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation. The current system in a single room application. Minor differences in the systems accommodate preferences of the clinical site installation including differences in certain suppliers and interfaces with existing hospital systems.

| Comparison Item | ProTom Radiance<br>330® | ProTom Radiance<br>330 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 510(k) Number | Subject of this application | K134052 |
| Intended Use/<br>Indications for Use | The Radiance 330 is a medical<br>device designed to produce and<br>deliver a proton beam for the<br>treatment of patients with<br>localized tumors and other<br>conditions susceptible to<br>treatment by radiation. | Same |
| Accelerator | Synchrotron | Same |
| Particle | Protons | Same |
| Accelerator Intensity/Time<br>Parameters | Variable in time | Same |

# Table 1: Substantial Equivalence Table

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| Comparison Item | ProTom Radiance 330® | ProTom Radiance 330 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Variable Energy | Yes; 70-250 MeV | Same |
| Cycle Time | Variable | Same |
| Beam<br>Transport and Switching<br>System | Yes | Same |
| Beam<br>Transport<br>Magnets | Bending and focusing magnets | Same |
| Nozzles | Pencil Beam Scanning | Same |
| Beam Range in Patient<br>(Tissue Depth) | 3 cm to 38 cm clinical use | Same |
| Collimator | Optional | Same |
| Range Verifier | Optional | Same |
| Control and<br>Safety System | Software controls accelerator, beam transport and delivery, sets operational parameters, monitors systems and provides alerts regarding error conditions. | Same other than integrated into fewer subsystem controls |
| Safety System | Distributed<br>Safety implementation | Same |
| Mechanical<br>Beam Stops | Yes | Same |
| Beam Intensities | Continuously<br>variable over range up to 1E10<br>protons per cycle time. | Same. |
| Shielding | Steel and Concrete | Same |
| Beam Lines | Yes | Same |
| Treatment Room(s) | Fixed beam orientation and<br>rotating gantry | Same |
| Patient Positioner | Yes - floor mounted (different<br>supplier) | Yes - floor mounted |
| Imaging for positioning | Yes - couch mounted CBCT | Yes - ceiling mounted CBCT |

# Performance Data:

Each individual subsystem of the device was verified and validated, and full system verification and validation was also performed. Specifically, device verification and validation testing was performed on gantry acceleration and de-acceleration, beam delivery rate dosimetry, radiation shielding, gating, geometric accuracy, image quality, image dose, accuracy of CT number and image, X-ray imaging device registration accuracy. Testing was also conducted to evaluate human factors considerations. Device software was verified and validated.

Basic Safety and Essential Performance of the device covered the intended use environment to fulfil the complete necessary workflow to deliver pencil beam patterns, control of all motion components, measure delivery dose, respond to interlocks and safety signals, and log data and errors. Product safety and essential performance testing was conducted based upon IEC 60601-1, IEC 6006-1-2, IEC 60601-2-64, IEC 60601-2-68, and IEC 60825-1.

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In all instances, the Radiance 330® Proton Therapy Device functioned as intended and was substantially equivalent in terms of performance and safety in comparison to the predicate.

# Conclusions:

The Radiance 330® is as safe and effective as the cleared Radiance 330 Proton Beam Therapy System to which it is a modification. The Radiance 330® has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Radiance 330® Proton Beam Therapy System and its predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that the Radiance 330® is as safe and effective as the cleared Radiance 330%. Thus, the Radiance 330 is substantially equivalent to its predicate.