Mini Ridge Filter and auxiliary functions for PROBEAT-V

K181676 · Hitachi Ltd. Healthcare Hitachi Works · LHN · Aug 15, 2018 · Radiology

Device Facts

• Record ID: K181676
• Device Name: Mini Ridge Filter and auxiliary functions for PROBEAT-V
• Applicant: Hitachi Ltd. Healthcare Hitachi Works
• Product Code: LHN · Radiology
• Decision Date: Aug 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROBEAT-V 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-V is a proton beam therapy system for treating localized tumors. System components include an accelerator (LINAC, synchrotron), beam transport system, rotating gantry or fixed beam room, scanning nozzle, patient positioning system, and imaging (CBCT/X-ray). The device delivers a prescribed proton dose to a target site. New optional features include a Mini Ridge Filter (mRF) to spread the Bragg peak along the beam axis, an interface for external beam gating systems to synchronize irradiation with respiration, and fluoroscopy for real-time treatment site observation. The system is operated by clinical staff in a radiation therapy environment. The mRF reduces beam energy in specific volumes; gating limits radiation to non-target regions; fluoroscopy aids in treatment monitoring and planning. These features allow for more precise dose delivery and improved patient safety during radiation treatment.

Clinical Evidence

Bench testing only. Testing evaluated the Mini Ridge Filter (mRF) for range loss, distal dose falloff, and beam spot size. Gating function testing verified signal interface and gating performance. Fluoroscopy testing ensured the feature could be enabled/disabled without compromising proton dose monitoring. All tests were successful.

Technological Characteristics

Proton beam irradiation system comprising an accelerator (LINAC, synchrotron), beam transport, gantry/fixed room, scanning nozzle, and patient positioning. Optional accessories: Mini Ridge Filter (mRF) for Bragg peak modulation, external beam gating interface, and fluoroscopy imaging. System is networked for beam control and imaging. Sterilization not applicable (fixed equipment).

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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August 15, 2018

Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Hitachi Ltd. Healthcare Hitachi Works % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016

# Re: K181676

Trade/Device Name: Mini Ridge Filter and auxiliary functions for PROBEAT-V Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: June 25, 2018 Received: June 25, 2018

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/cdrl/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert 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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510(k) Number (if known)

# K181676

Device Name

### PROBEAT-V

Indications for Use (Describe)

The PROBEAT-V 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)

Z 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-V

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

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

Contact Person: Tomoyuki Seino

Date Prepared: July 31, 2018

#### Name of Device and Name/Address of Sponsor

PROBEAT-V

Hitachi, Ltd. 3-1-1 Saiwai-cho, Hitachi-shi, Ibaraki-ken, 317-8511 Japan

#### Common or Usual Name

Proton beam therapy system

#### Classification Name

Medical Charged-Particle Radiation Therapy System, 21 CFR 892.5050, Product Code LHN

#### Predicate Devices

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

#### Intended Use / Indications for Use

The PROBEAT-V 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.

#### Technological Characteristics

The PROBEAT-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

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The beam delivery system is composed of the following components

- Gantry Room o
- . Rotating Gantry
- Scanning Nozzle .
- . Patient Positioning System
- Cone Beam CT / X-ray Imaging System .
- Fixed Beam Room o
- . Scanning Nozzle
- Patient Positioning System 트
- . Cone Beam CT / X-ray Imaging System

The beam production system is composed of the following components

- Accelerator system (LINAC, Synchrotron) o
- O Beam transport system (Low/High Energy Beam Transport systems)

The system incorporates several optional features and accessories, namely:

- The Mini Ridge Filter ("mRF") is an optional accessory to modify the beam of the o PROBEAT-V system. The mRF is installed manually and may be used in conjunction with the range shifters inside the nozzle or extended range shifter. The mRF can be added to the cleared PROBEAT-V nozzle to spread out the Bragg peak along the axis of the beam in order to reduce the amount of beam energy in the delivery of proton radiation to defined target volumes.
- Beam gating function allowing for interface with cleared external gating systems to o control the beam delivery for treatment such as to synchronize irradiation with respiration. Although the overall treatment time tends to be longer than the treatment time without gating, the extension of the treatment time will not affect irradiation performance to the target treatment site. Instead, the gating functionality may limit radiation exposure to regions outside of the target treatment volume.
- Allows for use of fluoroscopy during proton irradiation at the physician's discretion. o Fluoroscopy may be used for observation of treatment site during treatment, which could be used for interruption of the treatment or analysis for treatment planning.

## Performance Data

The company performed the following testing for the additional optional features described above.

- O With the mRF (mPF) installed in the nozzle to evaluate range loss, distal dose falloff, and beam spot size.

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- o The external beam gating function testing was performed to ensure that the PROBEAT-V system receives appropriate signals to interface with external gating systems and provide adequate gating function.
- Testing was performed to ensure that fluoroscopy could be enabled/disabled during o proton irradiation without compromising proton dose monitoring.

All tests were successful and confirmed the performance of these additional optional features.

# Substantial Equivalence

The modified PROBEAT-V with Mini Ridge Filter and auxiliary functions 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. The addition of the optional functions and accessories in the modified version of the system does not raise different questions of safety or effectiveness compared to the predicate. The testing to evaluate the modified device is substantially similar to the testing performed with the predicate device. Thus, the PROBEAT-V with the addition of these optional accessories and features is substantially equivalent to the previously cleared PROBEAT-V.