IBA PROTON THERAPY SYSTEM - PROTEUS 235

K061913 · Ion Beam Applications S.A. · LHN · Jul 28, 2006 · Radiology

Device Facts

• Record ID: K061913
• Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
• Applicant: Ion Beam Applications S.A.
• Product Code: LHN · Radiology
• Decision Date: Jul 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PTS 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

Proton Therapy System (PTS) generates and delivers proton beams for radiation therapy of localized tumors. System comprises beam production equipment (cyclotron) and beam delivery equipment (nozzles, collimators, range verifiers) mounted on fixed stations or rotatable gantries. Operated by clinical staff in a hospital/clinic setting. Modification adds automatic network-based interface to Oncology Information System (OIS) for bidirectional data transfer: patient info input from OIS to PTS; treatment data output from PTS to OIS. Therapy Control System manages beam parameters; Therapy Safety System provides automatic/manual shutdown. Enables precise dose delivery to treatment site; supports horizontal patient rotation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Proton beam radiation therapy system. Components: cyclotron (beam production), beam delivery nozzles (scattering/scanning), collimators, range verifiers, rotatable/fixed gantries. Connectivity: network-based interface to Oncology Information System (OIS). Control: computer-based Therapy Control System and Therapy Safety System. No specific material standards or software architecture details provided.

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

• Loma Linda University Medical Center Proton Beam Therapy device (K872369)
• Harvard University Cyclotron Laboratory Proton Beam Therapy device (pre-1976)

Submission Summary (Full Text)

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## CONFIDENTIAL

JUL 2 8 2006

K061913

#### 510(k) SUMMARY

### Ion Beam Applications S.A.

#### Applicant

Ion Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve, Belgium Attention: Mr. Yves Jongen Phone: [phone] Facsimile: 32-10-47-58-10 E-mail:[e-mail]

#### Contact Person and Agent for Ion Beam Applications S.A.

John B. Reiss, Ph.D., J.D. Saul Ewing LLP Centre Square West, 38th Floor Philadelphia, PA 19102 Phone: [phone] Facsimile: [phone] E-mail:[e-mail]

#### Classification Name

Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050).

#### Predicate Devices

The PTS is substantially equivalent to the previously cleared Loma Linda University Medical Center ("Loma Linda") Proton Beam Therapy device (K872369) and the Harvard University Cyclotron Laboratory Proton Beam Therapy device, a pre-1976 device. The PTS and its predicate devices have the same intended use and principles of operation, and are substantially equivalent in terms of performance and technological characteristics.

#### Intended Use

The PTS 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

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The device is designed to: (1) create and deliver the proton beam to the patient treatment location; (2) produce a transverse and longitudinal dose distribution appropriate for the patient's treatment; and (3) deliver the designated dose to the patient's treatment site. The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and deliver it to the patient treatment locations. In addition to these primary components, the PTS includes a Therapy Safety System to protect against unsafe conditions, having both automatic and manual controls to shut down the PTS in the event problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam. The modification in this submission is the addition of an automatic network-based interface from an Oncology Information System (OIS) to the PTS for the input of patient information, which information initially is entered into the OIS by means of a Graphical User Interface. After the patient treatment is completed, the treatment data is transferred from the PTS to the OIS through the automatic network-based interface.

#### Substantial Equivalence Discussion

The PTS is substantially equivalent to both the Loma Linda (K872369) and the Harvard Cyclotron Laboratory ("HCL") proton therapy devices. The HCL is a pre-1976 device that was constructed in 1949.

Like its predicate devices, the PTS is a device designed to produce and deliver a proton beam for treatment of a patient. Also like its predicate devices, it is intended for use in the therapeutic application of a proton beam for the treatment of localized tumors or other diseases that are susceptible to treatment by radiation.

The predicate devices also provide the same or substantially equivalent functions. characteristics, and accessories as does the PTS. All these devices are comprised of beam delivery systems which shape, direct, and monitor the protons delivered to the patient. They are also comprised of beam production equipment which generates the beam used by the beam delivery systems.

The technological aspects of a patient treatment consist of protons generated by the beam production equipment, directed to the patient's treatment site by the beam shaping system which is either mounted on a rotatable gantry, or in a fixed position. The patient is put into the correct position relative to the beam by a positioning system, which system is not affected by the modification made by this submission.

The facilities include patient treatment rooms, with each having a different number of rooms. The PTS device may service three to seven rooms, the Loma Linda predicate has four rooms and the HCL predicate has two. Like the predicate Loma Linda and HCL devices, the PTS provides fixed beam treatment stations. The PTS also includes treatment rooms which have

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isocentric/rotatable gantries similar to those used in the Loma Linda facility, but the space enclosed by the gantry is larger than at Loma Linda so that the patient can be rotated horizontally, as at HCL, allowing more choice of treatment direction.

The PTS and predicate Loma Linda devices are equipped with nozzles that provide beam scattering and beam scanning; the nozzles for the HCL predicate use beam scattering. All three devices have beam-limiting collimators and range verifiers.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 28 2006

ION Beam Applications 6 John B. Reiss. Ph.D.. J.D. Registered Agent Saul Ewing LLP 1500 Market Street, 3811 Floor PHILADELPHIA PA 19102-2186

Re: K061913

Trade/Device Name: Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: July 5, 2006 Received: July 6. 2006

Dear Dr. Reiss:

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.

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Protecting and Promoting Public Health

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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/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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#### XI. STATEMENT OF INDICATIONS FOR INTENDED USE

510(k) Number (if known): K061913

Page 1 of 1

Device Name:

Proton Therapy System.

Indications for Use:

The PTS 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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Concurrence of CDRH, Office of Device Evaluations (ODE)

| Prescription Use | <div></div> | OR | Over-the-Counter Use |
|--------------------------|-------------|----|----------------------|
| (Per 21 C.F.R. 801.109) | | | |
| (Optional Format 1-2-96) | | | |

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

| 510(k) Number | K061913 |
|---------------|---------|
|---------------|---------|

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