PROBEAT-CR

K191801 · Hitachi , Ltd. · LHN · Sep 13, 2019 · Radiology

Device Facts

• Record ID: K191801
• Device Name: PROBEAT-CR
• Applicant: Hitachi , Ltd.
• Product Code: LHN · Radiology
• Decision Date: Sep 13, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROBEAT-CR 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-CR is a proton beam therapy system for clinical treatment of localized tumors. System generates proton beams via synchrotron accelerator; transports beam to treatment rooms; delivers beam via scanning nozzle. Comprises beam production system, beam transport system, and beam delivery system (rotating gantries and fixed beam room). Includes patient positioning system, orthogonal X-ray, and Cone Beam CT for image guidance. Operated by clinical staff in a hospital/clinic setting. System delivers prescribed dose and distribution to treatment site. Output used by radiation oncologists/physicists to treat patients; enables precise radiation delivery to tumors while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only. Performance data included mechanical testing of the rotating gantry and patient couch, beam performance testing (dose shape and distribution), and safety interface testing (beam stop control, dose monitor, mechanical interlocks). Electrical safety and electromagnetic compatibility testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Proton beam therapy system; synchrotron accelerator; 70-230 MeV variable energy; discrete spot scanning nozzle. Includes rotating gantries (360-degree rotation) and fixed beam room. Patient positioning via computer-assisted system, orthogonal X-ray, and Cone Beam CT. System is networked for treatment control and safety. Complies with IEC 60601-1 (electrical safety) and 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

• Hitachi Ltd. PROBEAT-V (K151132)
• Hitachi Ltd. PROBEAT-V (K152592)

Submission Summary (Full Text)

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September 13, 2019

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Hitachi Ltd. % Mr. Jonathan Kahan Partner Hogan Lovells US LLP 555 Thirteenth Street, NW WASHINGTON DC 20004

Re: K191801

Trade/Device Name: PROBEAT-CR 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: July 3, 2019 Received: July 3, 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 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

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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 (QS) 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.

For

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) K191801

Device Name PROBEAT-CR Proton Beam Therapy System

Indications for Use (Describe)

The PROBEAT-CR 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)| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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### 510(k) SUMMARY

### PROBEAT-CR Proton Beam Therapy Device

#### Submitter Name, Address, Telephone Number, Contact Person and Date Prepared

Hitachi Ltd., Healthcare Hitachi Works 3-1-1 Saiwai-cho, Hitachi-shi lbaraki-ken, 317-8511, Japan Telephone: [phone] Facsimile: [phone]

Contact Person: Tomoyuki Seino

Date Prepared: July 3, 2019

#### Name of Device:

PROBEAT-CR 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:

Hitachi Ltd. PROBEAT-V (K151132) Hitachi Ltd. PROBEAT-V (K152592)

#### Device Description

The PROBEAT-CR 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. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site.

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# Intended Use / Indications for Use

The PROBEAT-CR 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

The PROBEAT-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems:

- . Beam production system
- o Accelerator system (LINAC, Synchrotron).
- Beam transport system (Low/High Energy Beam Transport systems). O
- Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam.
- o Gantry Room
- Scanning Nozzle ■
- 트 Rotating Gantry
- 트 Patient Positioning System
- 트 Orthogonal X-ray system
- Cone Beam CT
- o Fixed Beam Room
- Patient Positioning System .
- Orthogonal X-ray system .
- . Treatment Control and Safety System

The PROBEAT-CR is a modification to the cleared PROBEAT-V systems for use at a difference clinical facility. The system comprises the same components and subsystems as outlined above, with minor differences in design as summarized in the following table.

| Comparison Item | Hitachi PROBEAT-CR | Hitachi PROBEAT-V | Hitachi PROBEAT-V |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | - Pending - | K151132 | K152592 |
| Intended Use/<br>Indications for Use | The PROBEAT-CR is a<br>medical device<br>designed to produce<br>and deliver a proton<br>beam for the treatment<br>of patients with localized<br>tumors and other<br>conditions susceptible<br>to treatment by<br>radiation. | The PROBEAT-V is a<br>medical device<br>designed to produce<br>and deliver a proton<br>beam for the treatment<br>of patients with localized<br>tumors and other<br>conditions susceptible<br>to treatment by<br>radiation. | The PROBEAT-V is a<br>medical device<br>designed to produce<br>and deliver a proton<br>beam for the treatment<br>of patients with localized<br>tumors and other<br>conditions susceptible<br>to treatment by<br>radiation. |
| Accelerator | Synchrotron | Synchrotron | Synchrotron |

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| Comparison Item | Hitachi PROBEAT-CR | Hitachi PROBEAT-V | Hitachi PROBEAT-V |
|---------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Particle | Protons | Protons | Protons |
| Variable energy | 70-230 MeV | 70-230 MeV | 70-230 MeV |
| Nozzles | Discrete Spot Scanning | Discrete Spot Scanning | Discrete Spot Scanning |
| Support for patient positioning | Cone Beam CT Conventional x-ray system A computer assisted patient position system | Conventional x-ray system A computer assisted patient position system | Cone Beam CT Conventional x-ray system A computer assisted patient position system |
| Treatment rooms | 3 rotating gantry rooms and 1 fixed beam room (Maximum 5 total) | 4 rotating gantry rooms and 1 fixed beam room (Maximum 5 total) | 2 rotating gantry rooms and 1 fixed beam room (Maximum 5 total) |
| Gantry rotating angle | 360 degrees (-180 - 180 degrees) | 190 degrees (-5 - 185 degrees) | 190 degrees (-5 - 185 degrees) |

# Performance Data

The company performed testing, as follows:

- The mechanical performance of the rotating gantry and patient couch o
- Beam performance testing to evaluate beam dose shape and beam dose ●
- Safety interface testing to evaluate beam stop control, dose monitor, area safety, and 0 mechanical interlocks.

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-CR functioned as intended and met its specifications. Testing demonstrated substantial equivalence to the predicates.

## Conclusions

The PROBEAT-CR has the same intended use and indications for use, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT-V (K151132, K152592). Each of the systems comprises the same components of the beam production and beam delivery subsystems. The minor differences between the PROBEAT-CR that is the subject of this submission and the cleared PROBEAT-V do not raise different questions of safety or effectiveness. Performance data demonstrate that the PROBEAT-CR is as safe and effective as the cleared PROBEAT-V systems Thus, the PROBEAT-CR is substantially equivalent to its predicates.