PROTON THERAPY SYSTEM

K062891 · Indiana University Cyclotron Facility · LHN · Dec 14, 2006 · Radiology

Device Facts

• Record ID: K062891
• Device Name: PROTON THERAPY SYSTEM
• Applicant: Indiana University Cyclotron Facility
• Product Code: LHN · Radiology
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IUCF PTS is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

Device Story

Proton Therapy System (PTS) delivers proton radiation to solid tumors; utilizes cyclotron to generate proton beam; beam directed via rotating gantry allowing multi-angle delivery. System comprises Cyclotron System (CYS), JUSTIS, and Treatment Systems (TS). TS includes subsystems for beam delivery, dose control, patient positioning, and safety interlocks. Operated by clinical staff in a treatment facility. Computer-controlled gantry and patient positioning systems ensure precise dose distribution. Output is controlled proton radiation beam; enables targeted tumor treatment while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by extensive bench testing at system and subsystem levels, including hardware and software verification, electromagnetic compatibility (EMC/EMI), and electrical safety testing.

Technological Characteristics

Charged-particle radiation therapy system. Components: Cyclotron, rotating gantry, beam delivery, dose delivery, patient positioning, and safety interlock systems. Features retractable gantry floor and digital radiography panel positioning. Computer-controlled via Patient Positioning System (PPS).

Indications for Use

Indicated for patients with solid tumors or other diseases susceptible to proton radiation therapy. Prescription use only.

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

• Loma Linda Medical Center Proton Beam Therapy System (K872369)
• Ion Beam Applications, SA's, Proton Therapy Systems (K983024)
• Ion Beam Applications, SA's, Proton Therapy Systems (K060695)

Submission Summary (Full Text)

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KDb289v

#### 510(k) SUMMARY

# Indiana University Cyclotron Facility's Proton Therapy System

DEC 1 4 2006

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

Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408

Phone: [phone] Facsimile: [phone]

Paul E. Sokol, IUCF Director Contact Person:

September 26, 2006 Date Prepared:

## Name of Device and Name/Address of Sponsor

Proton Therapy System (PTS)

Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408-1398

#### Common or Usual Name

Proton Beam Therapy System (PBTS)

#### Classification Name

Medical Charged-Particle Radiation Therapy System

## Predicate Devices

The Indiana University Cyclotron Facility PTS is substantially equivalent to the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695).

## Intended Use / Indications for Use

The IUCF PTS is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

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K062891

## Technological Characteristics

IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.

#### Performance Data

Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards. In all instances, the IUCF PTS functioned as intended.

## Substantial Equivalence

The IUCF PTS is as safe and effective as the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024. K060695). The IUCF PTS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the IUCF PTS and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the IUCF PTS is as safe and effective as the predicate devices listed above. Thus, the IUCF PTS is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Indiana University Cyclotron Facility c/o Jonathan S. Kahan Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004

DEC 1 4 2006

Re: K062891

Trade/Device Name: Proton Therapy System 、シ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2006 Received: December 4, 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 arior 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.

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rotecting and Promoting Puthic 9

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincercly yours,

Nancy C. Hogdon

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

510(k) Number (if known):___

Device Name: Proton Therapy System

Indications for Use:

Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

Prescription Use _X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (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)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________

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