PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM

K073059 · Hitachi, Ltd., Power Systems Group · LHN · Dec 10, 2007 · Radiology

Device Facts

• Record ID: K073059
• Device Name: PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM
• Applicant: Hitachi, Ltd., Power Systems Group
• Product Code: LHN · Radiology
• Decision Date: Dec 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROBEAT with DSSS 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 with DSSS is a proton beam therapy system for treating localized tumors. It generates and delivers a therapeutic proton beam to a prescribed treatment site. The system includes a beam generation component and a beam delivery system, which now incorporates a Discrete Spot Scanning System (DSSS). The DSSS allows for precise delivery of the proton beam according to prescribed dose and distribution parameters. Operated by clinical staff in a radiation therapy setting, the device enables targeted radiation treatment, potentially improving dose conformity to the tumor while sparing surrounding healthy tissue.

Clinical Evidence

Bench testing only. The submission includes a summary of performance testing conducted 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. Features a Discrete Spot Scanning System (DSSS) for dose delivery. Operates as a medical charged-particle radiation therapy system (21 CFR 892.5050).

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

• PROBEAT (K053280)
• PROBEAT with MGCS (060834)
• IBA Proton Therapy System - Proteus 235 (K060695)

Submission Summary (Full Text)

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K073059

#### Attachment 6

## 510(k) SUMMARY PROBEAT with DSSS

# 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 DEC 1 0 2007 Japan

Phone : [phone] Facsimile: 011-81-3-4564-2882

Contact Person: Naoya Nishimura

Date Prepared: 30 October, 2007

# 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, Chivoda-ku Tokyo, 101-8608 Japan

Common or Usual Name: Proton Beam Therapy System ("PBTS") Classification Name: Medical Charged-Particle Radiation Therapy System Predicate Device: Hitachi's PROBEAT (K053280) Purpose of the Special 510(k) notice.

The PROBEAT with DSSS is a modification to Hitachi's cleared PROBEAT.

#### Intended Use

The PROBEAT with DSSS 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.

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## Technological Characteristics

The PROBEAT with DSSS 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 PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired 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 a summary of the performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications.

## Substantial Equivalence

PROBEAT with DSSS has the same intended use and indications, as well as substantially similar principles of operation and technological characteristics, as compared to Hitachi's cleared PROBEAT (K053280), PROBEAT with MGCS (060834), and IBA Proton Therapy System - Proteus 235 (K060695). The only difference between the PROBEAT with DSSS and the cleared PROBEAT is the addition of the Discrete Spot Scanning System ("DSSS"). Thus, the PROBEAT with DSSS is substantially equivalent to its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three lines representing human profiles, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 2007

Hitachi, Ltd., Power Systems Group % Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street NW WASHINGTON DC 20004

Re: K073059

Trade/Device Name: PROBEAT with DSSS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 30, 2007 Received: October 30, 2007

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 (PMA), 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.

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the 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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#### Attachment 7

#### Indications for Use Statement

073059 510(k) Number (if known):

#### Device Name: PROBEAT with DSSS

Indications for Use: Hitachi's PROBEAT with DSSS 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.

Prescription Use I (Per 21 C.F.R. 801.109)

AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number KD/3059