IBA PROTON THERAPY SYSTEM - PROTEUS 235

K060695 · Ion Beam Applications S.A. · LHN · Apr 11, 2006 · Radiology

Device Facts

• Record ID: K060695
• Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
• Applicant: Ion Beam Applications S.A.
• Product Code: LHN · Radiology
• Decision Date: Apr 11, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Proton Therapy System - Proteus 235 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

The Proteus 235 is a proton therapy system using an isochronous cyclotron to generate proton beams for radiation therapy. Modifications introduce two delivery modes: Single Scattering and Uniform Scanning. Single scattering is used for fields <7cm diameter, reducing nozzle scattering for improved penumbra. Uniform scanning uses magnetic beam deflection in x and y axes to create a flat field via a saw-tooth pattern, building a Spread Out Bragg Peak through layered mini-irradiations. The system includes beam transport, magnets, patient positioners, and nozzles. It is operated by clinical staff in a hospital/clinic setting. The system uses software to control the accelerator, beam transport, and delivery, while verifying patient ID and monitoring operational parameters. The output is a controlled proton beam directed at the tumor site, enabling precise radiation delivery while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and bench-level comparison of beam delivery parameters.

Technological Characteristics

Isochronous cyclotron proton source (hot cathode PIG); variable energy 70-230 MeV; beam transport via quadrupole/dipole magnets; nozzle-based beam scattering or uniform scanning; software-controlled interlocks and operational parameters; steel/concrete shielding; isocentric/rotatable treatment stations.

Indications for Use

Indicated for patients with localized tumors and other conditions susceptible to treatment by radiation. No specific age or gender restrictions provided.

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

• PROTON THERAPY SYSTEM (K983024)
• IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641)

Submission Summary (Full Text)

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APR 1 1 2006

## 510(K) SUMMARY

## SUMMARY OF SAFETY AND EFFECTIVENESS

The following is based on the format of 21CFR807.92 Proton Therapy System -Proteus 235 Device modification - Kobolog S. [to be completed by FDA]

#### Applicant

Ion Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve, Belgium

Attention : Michel Baelen Phone : [phone] Facsimile : 32-10-47-59-86 E-Mail : [e-mail]

# Contact person and agent for Ion Beam Applications S.A.

John B. Reiss, Ph. D., J.D. Saul, Ewing, Remick & Saul 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 Device

PROTON THERAPY SYSTEM (K983024) and IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641)

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#### Description of the device modifications

Ko 60695

The device has been modified to introduce two additional treatment modes: the Single scattering and the Uniform scanning

- 1) The single scattering technique is a technique dedicated to the irradiation of fields smaller than seven centimeters in diameter. Single scattering decreases the amount of scattering in the nozzle compared to double scattering and lead to better lateral penumbra.
- 2) Uniform scanning is an active technique for spreading beam in a transversal direction. The incoming narrow beam, whose size is a significant fraction of the field to be treated, is moved by magnetic scanning so as to yield a flat field. The beam is deviated in x and y directions by two magnets, making the beam travel along a saw-tooth pattern with rounded corners. A patient specific aperture and bolus need therefore to be used just as in double scattering mode. A Uniform Scanning session is composed of several mini-irradiations that are used to build a Spread Out Bragg Peak within the treatment volume that is divided in a stack of layers, each of them corresponding to one penetration depth.

#### Intended Use

The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized turnors and other conditions susceptible to treatment by radiation.

#### Summary of technological characteristics

The substantial equivalence comparison chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Appendix 6 of the submission.

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Exhibit 6 - Substantial Equivalence Comparison

| | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Uniform Scanning new beam<br>delivery modality | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Single scattering new beam<br>delivery modality | IBA Proton Therapy System<br>(K983024) for the legally<br>marketed (unmodified) device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change | No Change | Treatment of patients with<br>localized tumors and other<br>conditions susceptible to treatment<br>by radiation |
| Accelerator | No Change | No Change | Isochronous cyclotron |
| Particle | No Change | No Change | Proton |
| Proton Source | No Change | No Change | Hot cathode PIG ion source |
| Accelerator<br>Parameters | No Change | No Change | Constant in time |
| Variable Energy | No change | No change | Yes (70-230 MeV), with Energy<br>Selection System's Degrader |
| Maximum Energy | No Change | No Change | 230 MeV |
| Injection Energy | No Change | No Change | N/A |
| Cycle Time | No Change | No Change | Constant in time |
| Beam Transport and<br>Switching System | No Change | No Change | Beampipe through quadrupole and<br>dipole magnet bore |

[phone] B Fat + 12 10 47 9 86 E-Mail : 161-2017 17:17 PM : 10:10 : 40 : Registered Office: Chemin du Cyclotron, 3 - 1348 Louvain
Ia-Neve, Beginn | RC Nivelles 5459

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| | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Uniform Scanning new beam<br>delivery modality | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Single scattering new beam<br>delivery modality | IBA Proton Therapy System<br>(K983024) for the legally<br>marketed (unmodified) device |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beam<br>Transport<br>Magnets | No Change | No Change | Bending and focusing |
| Treatment Stations | No Change | No Change | Isocentric/Rotatable |
| Nozzles | Beam Scattering | Beam Scattering | Beam Scattering |
| | Uniform Beam Scanning | | |
| Beam Range<br>Patient (Tissue<br>Depth) | 3.5 cm to 32 cm<br>in for 40x30cm field | 3.5 cm to 20 cm<br>for Maximum field size 6 cm<br>diameter field | 5 cm to 28 cm for $\Phi$ 10 cm field<br>5 cm to 24 cm for $\Phi$ 20 cm field |
| Collimator | No Change | No Change | Yes |
| Range Verifier | No Change | No Change | Yes |
| Control and Safety<br>System | No Change | No Change | Hardwired Interlock System |
| | | | Software controls accelerator<br>and beam operation including<br>beam transport and delivery,<br>verifies patient ID, sets<br>operational parameters,<br>monitors systems, and provides<br>alerts regarding excessive<br>parameters |
| | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Uniform Scanning new beam<br>delivery modality | IBA Proton Therapy System<br>including the Device<br>Modifications implementing the<br>Single scattering new beam<br>delivery modality | IBA Proton Therapy System<br>(K983024) for the legally<br>marketed (unmodified) device |
| Mechanical<br>Stops | No Change | No Change | Yes |
| Beam Intensities | No Change | No Change | Hardware-limited at 300 nA<br>continuous (1.1 x 1014<br>protons/min). ESS further limits<br>maximum possible patient dose<br>rate. |
| Shielding | No Change | No Change | Steel and Concrete around<br>accelerator, transport, and<br>treatment areas |
| Treatment Rooms | No Change | No Change | 3 (one with fixed horizontal beam<br>and two with isocentric gantry) |
| Patient Positioner | No Change | No Change | Yes |

43 10 4 7 7 5 D Fax: [phone] -Mail : interest : http://www.iha-wordpide.com | IBA SA - Registered Office: Chemin do Cyclorco, 1-1348 Lavain
ie-Neve, Belgium | RC N

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MID 8947

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, human services, and prevention. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ION Beam Applications S.A. % John B. Reiss, Ph.D., J.D. Official Correspondent Saul, Ewing, Attorneys at Law Centre Square West 1500 Market Street, 38th Floor PHILADELPHIA PA 19102-2186 Re: K060695 Trade/Device Name: IBA PROTON THERAPY SYSTEM-PROTEUS 235 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 15, 2006 Received: March 16, 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.

APR 1 1 2006

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) 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.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 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. Brigdon

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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### STATEMENT OF INDICATIONS FOR INTENDED USE

Kobo 69 510(k) Number (if known):

Page 1 of 1

Device Name:

#### IBA PROTON THERAPY SYSTEM - PROTEUS 235

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.

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

Concurrence of CDRH, Office of Device Evaluations (ODE)

Prescription Use __ V

OR

Over-the-Counter Use

(Per 21 C.F.R. 801.109) (Optional Format 1-2-96)

Nancy Evaglon