PROBEAT

K053280 · Hitachi, Ltd., Power Systems Group · LHN · Mar 9, 2006 · Radiology

Device Facts

• Record ID: K053280
• Device Name: PROBEAT
• Applicant: Hitachi, Ltd., Power Systems Group
• Product Code: LHN · Radiology
• Decision Date: Mar 9, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROBEAT 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 is a proton beam therapy system (PBTS) used to deliver therapeutic proton radiation to localized tumors. The system consists of two primary subsystems: a proton beam generation unit and a beam delivery system. The beam delivery system ensures the prescribed dose and dose distribution are accurately administered to the patient's treatment site. The device is operated by clinical staff in a medical facility. By precisely targeting tumors with proton beams, the system aims to treat conditions susceptible to radiation therapy while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only. The submission includes performance testing conducted by the manufacturer to demonstrate that the device meets its established performance specifications.

Technological Characteristics

Proton beam irradiation system comprising a beam generation unit and a beam delivery system. Designed for precise dose and dose distribution delivery. No specific materials, connectivity, or software architecture details provided.

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

• Optivus Technology, Inc.'s Proton Beam Therapy System (K992414)
• Ion Beam Applications S.A.'s, Proton Therapy System (K983024)

Submission Summary (Full Text)

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#### 2006 MAR 9

#### 510(k) SUMMARY

# Hitachi's PROBEAT

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

Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, chiyoda-ku Tokyo, 101-8608 Japan

011-81-3-4564-3565 Phone: Facsimile: 011-81-3-4564-2882

Naoya Nishimura Contact Person:

November 21, 2005 Date Prepared:

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

PROBEAT

Hitachi, Ltd., Power Systems Group Advanced Medical Technology and Solutions Division, Proton Therapy 18-13, Sotokanda 1-chome, chiyoda-ku Tokyo, 101-8608 Japan

#### Common or Usual Name

Proton Beam Therapy System ("PBTS")

#### Classification Name

Medical Charged-Particle Radiation Therapy System

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#### Predicate Devices

ﺮ ﭘﺮ

K053280

- Optivus Technology, Inc.'s Proton Beam Therapy System (K992414) 1)
- Ion Beam Applications S.A.'s, Proton Therapy System (K983024) 2)

## Intended Use / Indications for Use

The PROBEAT 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 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 and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.

#### Performance Data

The submission includes performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.

#### Substantial Equivalence

The PROBEAT is substantially equivalent to the Optivus Technology, Inc.'s Proton Beam Therapy System (K992414), and the Ion Beam Applications S.A.'s, Proton Therapy System (K983024). The PROBEAT has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the PROBEAT and its predicate devices raise no new issues of safety or effectiveness. Thus, the PROBEAT is substantially equivalent to its predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hitachi, Ltd., % Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004-1109

MAR 9 - 2006

Re: K053280

Trade/Device Name: PROBEAT Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: February 21, 2006 Received: February 21, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 Jagain This letter will anow you to begin harketing your united equivalence of your device to a legally premarket notification. The FDA inding of suestantial of a locked and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "finisornation on your responsibilities under the Act from the 807.97). You may obtain other general information on John of
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

3280 510(K) NUMBER (IF KNOWN):_

Device Name: PROBEAT

Indications for Use: Hitachi's PROBEAT is a medical device designed to produce and deliver a multations for USe. Intern of patients with localized tumors and other conditions susceptible to treatment by radiation.

Prescription Use *_*_
(Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use_X

# (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Sgroon

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number -