PROBEAT-FR

K232032 · Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · LHN · Jan 12, 2024 · Radiology

Device Facts

• Record ID: K232032
• Device Name: PROBEAT-FR
• Applicant: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
• Product Code: LHN · Radiology
• Decision Date: Jan 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROBEAT-FR 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

PROBEAT-FR is a proton beam irradiation system for clinical radiation therapy. It utilizes a synchrotron accelerator to produce proton beams (70-230 MeV), which are transported to treatment rooms equipped with rotating gantries. The system features a scanning nozzle with a moving snout for discrete spot scanning. Patient positioning is managed via a robotic couch (6 degrees of freedom) and verified using an integrated X-ray imaging system, Cone Beam CT (CBCT) with a rapid mode, and a Positioning Image Analysis System (PIAS). A Real Time Image Gating System (RGPT) software is incorporated to manage beam delivery during patient motion. The system is operated by clinical staff in a hospital or oncology center. The device delivers prescribed radiation doses to tumors, enabling precise dose distribution. It is a modification of the PROBEAT-CR, featuring a larger gantry and enhanced CBCT capabilities.

Clinical Evidence

Bench testing only. Performance data included mechanical testing of the gantry, couch, and snout; beam dose shape and distribution evaluation; CBCT and PIAS imaging guidance validation; and safety interlock testing (beam stop, dose monitor, RGPT). Electrical safety and electromagnetic compatibility were verified per IEC 60601-1 and IEC 60601-1-2. No clinical data was required.

Technological Characteristics

Synchrotron-based proton beam therapy system. Energy range: 70-230 MeV. Components: accelerator, beam transport, rotating gantry, scanning nozzle with moving snout, robotic patient couch, X-ray/CBCT imaging, and treatment control/safety system. Connectivity: networked for treatment control. Software: Real Time Image Gating System. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for patients with localized tumors and other conditions susceptible to radiation therapy.

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

• PROBEAT-CR Proton Beam Therapy Device (K201042)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha % Lina Kontos Partner Hogan Lovells US LLP 555 THIRTEENTH STREET, NW WASHINGTON, DISTRICT of COLUMBIA 20004

Re: K232032

Trade/Device Name: Probeat-fr Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: LHN Dated: December 18, 2023 Received: December 19, 2023

Dear Ms. Lina Kontos:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

Digitally signed by Xin He -S Xin He -S

Lora Weidner Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Enclosure

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# Indications for Use

510(k) Number (if known) K232032

Device Name

PROBEAT-FR

Indications for Use (Describe)

The PROBEAT-FR 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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 510(k) SUMMARY Hitachi Ltd.'s PROBEAT-FR Proton Beam Therapy Device

#### Submitter

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 226-44-141-1, Wakashiba, Kashiwa-shi, Chiba-ken, 277-0871, Japan Contact Person: Tomoko Irisa

Date Prepared: January 9, 2024

#### Name of Device:

PROBEAT-FR 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, Classification Regulation:

LHN, 21 C.F.R. § 892.5050

#### Predicate Device

Hitachi Ltd., Healthcare Radiation Oncology Systems, Kashiwa, PROBEAT-CR Proton Beam Therapy Device (K201042)

#### Device Description

The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site.

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## Intended Use / Indications for Use

Hitachi's PROBEAT-FR 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

Consistent with the cleared PROBEAT-CR systems, the PROBEAT-FR comprises the following components and subsystems:

- . Beam production system
- Accelerator system (LINAC, Synchrotron).
- Beam transport system (Low/High Energy Beam Transport systems). O
- Beam delivery system in 4 separate treatment rooms. Each of 4 rooms will have a rotating ● qantry.
- o Gantry Room
- . Scanning Nozzle
- . Rotating Gantry
- . Patient Positioning System (Patient Couch)
- . X-ray Imaging System
- Cone Beam CT ●
- In-Room CT (Optional) .
- . Positioning Image Analysis System
- . Treatment Control and Safety System

The PROBEAT-FR is a modification to the cleared PROBEAT-CR system to include a somewhat larger gantry, moving snout and also a rapid mode for the CBCT. The system comprises the same components and subsystems as outlined above, with minor differences in design as summarized in the table below.

| Comparison Item | Hitachi PROBEAT-FR | Hitachi PROBEAT-CR |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K232032 | K201042 |
| Intended Use/<br>Indications for Use | The PROBEAT-FR is a medical<br>device designed to produce and<br>deliver a proton beam for the<br>treatment of patients with localized<br>tumors and other conditions<br>susceptible to treatment by<br>radiation. | The PROBEAT-CR is a medical<br>device designed to produce and<br>deliver a proton beam for the<br>treatment of patients with localized<br>tumors and other conditions<br>susceptible to treatment by<br>radiation. |
| Accelerator | Synchrotron | Synchrotron |
| Particle | Protons | Protons |
| Variable energy | 70-230 MeV | 70-230 MeV |
| Nozzles | Discrete Spot Scanning<br>Moving snout | Discrete Spot Scanning |
| Comparison Item | Hitachi PROBEAT-FR | Hitachi PROBEAT-CR |
| Support for patient<br>positioning | Gantry built-in type Cone Beam<br>CT is used to verify patient<br>positioning. Rapid mode can be<br>selected. A conventional x-ray<br>system can be also equipped in<br>the same treatment room.<br>A computer assisted patient<br>position system (PIAS) is<br>available for use. | Gantry built-in type Cone Beam<br>CT is used to verify patient<br>positioning.<br>A conventional x-ray system can<br>be also equipped in the same<br>treatment room.<br>A computer assisted patient<br>position system (PIAS) is<br>available for use |
| Treatment rooms | Typically 4 rotating gantry rooms. | Typically 3 rotating gantry rooms<br>and 1 fixed beam room. |
| Gantry and rotating<br>angle | Large gantry<br>360 degrees<br>(0-180 degrees, 180-359 degrees) | Compact gantry<br>360 degrees<br>(-180 – 180 degrees) |
| Patient Positioner | Rotating gantry room. | Rotating gantry room and fixed<br>room. |
| | a. Patient Couch<br>Swing type Robotic Patient<br>Positioning System with 6<br>degrees of freedom.<br>Isocentric rotating angle of the<br>couch is ± 95 degrees for<br>standard base and extension<br>configuration.<br>b. Laser Alignment System | a. Patient Couch<br>Swing type Robotic Patient<br>Positioning System with 6<br>degrees of freedom.<br>Isocentric rotating angle of the<br>couch is ±95 degrees for<br>standard base and extension<br>configuration.<br>With the optional couch top<br>extension, isocentric rotating<br>angle can be extended to ±90<br>degrees for short base and<br>overlay configuration, with a<br>±5 degree movement range<br>for the rolling and pitching<br>angles.<br>b. Laser Alignment System |
| Use of Image Gating<br>System Software | Real Time Image Gating System<br>software is incorporated into the<br>system. | Real Time Image Gating System<br>software is incorporated into the<br>system. |

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# Performance Data

The company performed testing, as follows:

- . The mechanical performance of the rotating gantry, patient couch and moving snout.
- Beam performance testing to evaluate beam dose shape and beam dose .
- Real time image gated particle therapy software test .
- . Imaging guidance function of CBCT and PIAS
- Safety interlock testing to evaluate beam stop control, dose monitor, area safety, . mechanical and RGPT interlocks.

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- . Comprehensive test depending on treatment workflow test.
Further, electrical safety and electromagnetic compatibility testing was also performed in accordance with IEC 60601-1 and IEC 60601-1-2.

In all instances, the PROBEAT-FR functioned as intended and met its specifications. Testing demonstrated substantial equivalence to the predicates.

## Conclusions

The PROBEAT-FR is as safe and effective as the predicate PROBEAT-CR System. PROBEAT-FR has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the PROBEAT-FR that is the subject of this submission and the cleared PROBEAT-CR do not raise different questions of safety or effectiveness. Performance data demonstrate that the PROBEAT-FR is as safe and effective as the cleared PROBEAT-CR system. Thus, the PROBEAT-FR is substantially equivalent to its predicates.