Extended Range Shifter for PROBEAT-V

K152207 · Hitachi, Ltd., Health Care Company · LHN · Oct 2, 2015 · Radiology

Device Facts

• Record ID: K152207
• Device Name: Extended Range Shifter for PROBEAT-V
• Applicant: Hitachi, Ltd., Health Care Company
• Product Code: LHN · Radiology
• Decision Date: Oct 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

Device Story

Extended Range Shifter (ERS) is an accessory for the Hitachi PROBEAT-V proton beam therapy system. It attaches to the system nozzle to modify proton beam characteristics; specifically, it suppresses beam spreading more effectively than the standard range shifter. Used in clinical radiation oncology settings by trained professionals to facilitate precise delivery of proton radiation to target volumes while sparing healthy tissue. The device functions as a physical beam-shaping component within the therapy delivery workflow. It does not involve software-based processing or automated decision-making; it is a hardware accessory that physically alters the beam path to improve dose distribution.

Clinical Evidence

Bench testing only. Performance evaluation included measurements of range loss, distal dose falloff, and beam spot size. All tests were successfully conducted and confirmed the performance of the ERS.

Technological Characteristics

Hardware accessory for the PROBEAT-V proton beam therapy system nozzle. Functions by suppressing beam spreading to a greater degree than the standard range shifter. No software or energy source; purely a physical beam-shaping component.

Indications for Use

Indicated for patients requiring proton radiation therapy, assisting radiation oncologists in delivering radiation to defined target volumes while sparing surrounding normal tissue and critical organs.

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)
• Varian Proton Therapy Multileaf Collimator (K093250)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2015

Hitachi, Ltd., Health Care Company % Mr. Jonathan Kahan Regulatory Counsel Hogan Lovells US LLP 555 13th Street NW WASHINGTON DC 20016

Re: K152207

Trade/Device Name: Extended Range Shifter Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: August 6, 2015 Received: August 6, 2015

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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)

# K152207

Device Name

Extended Range Shifter

Indications for Use (Describe)

The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess 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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# 510(k) SUMMARY

# Extended Range Shifter

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

Hitachi, Ltd., Health Care Company 4-14-1 Sotokanda, Chiyodaku,Tokyo, 101-8010, Japan Telephone: [phone] Facsimile: [phone]

Contact Person: Naoya Nishimura

Date Prepared: August 6, 2015

## Name of Device and Name/Address of Sponsor

Extended Range Shifter

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

# Common or Usual Name

Accessory to 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)

Varian Proton Therapy Multileaf Collimator (K093250)

## Intended Use / Indications for Use

The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

## Technological Characteristics

This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.

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# Performance Data

The company performed testing to evaluate range loss, distal dose falloff, and beam spot size. All the tests were successfully conducted and confirmed the performance of the ERS.

# Substantial Equivalence

The ERS is an accessory that may be used with the PROBEAT-V, and is substantially equivalent to the Range Shifter component of the PROBEAT-V (K151132) and the Varian Proton Therapy Multileaf Collimator (K093250). The ERS has the exact same intended use and substantially similar indications for use and technological characteristics as the previously cleared predicate devices. Any minor differences in the technology of these devices and how they are used in a proton beam therapy system do not raise different questions of safety or efficacy. Thus, the ERS is substantially equivalent to its predicates.