MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235

K101508 · Ion Beam Applications S.A. · LHN · Aug 6, 2010 · Radiology

Device Facts

• Record ID: K101508
• Device Name: MODIFICATION TO IBA PROTON THERAPY SYSTEM-PROTEUS 235
• Applicant: Ion Beam Applications S.A.
• Product Code: LHN · Radiology
• Decision Date: Aug 6, 2010
• 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 turnors and other conditions susceptible to treatment by radiation.

Device Story

Proton therapy system (PTS) generates and delivers proton beams for radiation treatment of localized tumors; utilizes cyclotron and beam delivery equipment to direct protons to treatment site. Modification adds Universal Beam Triggering Interface (UBTI) to allow external medical devices to signal beam start/stop. System includes Therapy Safety System for automatic/manual shutdown and computer-based Therapy Control System for beam parameter management. Operated by clinical staff in radiation oncology settings. Benefits include precise dose distribution to target tissue while sparing surrounding healthy anatomy.

Clinical Evidence

Bench testing only. Performance and safety test results provided to demonstrate that the modified system performs as well as the legally marketed predicate device.

Technological Characteristics

System comprises cyclotron (beam production), beam delivery equipment, Therapy Safety System, and computer-based Therapy Control System. Features include patient positioning systems, gantry, and various delivery modes (Single Scattering, Uniform Scanning, Pencil Beam Scanning). Connectivity includes DICOM-based integration with Treatment Planning Systems and Oncology Information Systems. Software-controlled interlocks and beam parameters.

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

• IBA proton therapy system (K983024)

Reference Devices

• PPVS (K053641)
• SIS and US (K060695)
• IOIS (K061913)
• Pencil Beam Scanning (K082416)
• Robotic PPS (K083058)
• Proteus RTT and patient gantry access upgrade (K091629)
• Inclined beam line (K092796)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a stylized text that appears to read "Iba". The letters are drawn in a bold, slightly rounded font, giving them a playful and informal appearance. Above the letters, there is a curved line with a small circle above it, adding a decorative element to the design.

# 510(k) SUMMARY lon Beam Applications S.A.

19 July 2010

K101508

M-Id 21784 Rev.B

Page 2

Applicant

lon Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve Belgium Attention : Mr Baelen Michel Phone : [phone]

Facsimile: E-mail:

32-10-47-58-10

[e-mail]

**AUG 06 2010**

## Contact 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]

{1}------------------------------------------------

### Classification Name

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

#### Predicate Device

The PTS (proton therapy system) is substantially equivalent to the previously cleared IBA proton therapy system (K983024). The current PTS and its predicate device have the same intended use and principles of operation, and are substantially equivalent in terms of performance and technological characteristics.

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

The predicate device also provides the same or substantially equivalent functions, characteristics, and accessories as does the currently modified PTS. All these devices are 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 delivery system. The patient is put into the correct position relative to the beam by a positioning system.

#### Indication for Use

The PTS 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.

#### Description of the device modifications

The scope of this change to the proton therapy system is an interface to an external medical device. This external medical device provides a signal upon which the PTS starts or stops the beam during treatment. This external medical device is not part of the proton therapy system. The new interface as part of the PTS is called universal beam triggering interface (UBTI).

The adequate performance and safety test results have been provided to the FDA in the submission. The conclusions drawn from those tests demonstrate that the device is as safe, as effective, and performs as well as the already legally marketed device.

#### Technological Characteristics

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

{2}------------------------------------------------

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.

Following the successive changes to the original 510(k) submission, several features have been already added:

(1) PPVS (K053641): The Patient positioning verification system (PPVS) is interfaced to a Treatment Planning System (TPS) or an Oncology Information System (OIS) for downloading the treatment plan and the associated Digitally Reconstructed Radiographs (DRR) from the TPS in DICOM format;

(2) SIS and US (K060695): addition of 2 treatment modes. The Single Scattering (SIS) technique is dedicated to the irradiation of fields smaller than seven centimetres, the Uniform Scanning (US) technique is an active technique for spreading beam in a transversal direction to large irradiation fields;

(3) IOIS (K061913) - An automatic network-based interface between 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 has been added.

(4) Pencil Beam Scanning (K082416) - The pencil beam scanning is defined as the act of moving a charged particle beam of particular properties and/or changing one or more of the properties of that beam (e.g. Intensity, size, position, etc.). The goal of this beam delivery is to deliver the appropriate proton fluence according to a prescription. This prescription provides a map of the fluence that is necessary to deliver at each location on the target. Thus the beam is moved to each location on the target and the appropriate fluence is deposited at each location.

(4) Robotic PPS (K083058) - The PTS includes new PPS. It is a SCARA-type arm robot. The X- and Y-translations from the current PPS have been replaced by two rotations around vertical axes. The vertical motion (Z-axis) from the current PPS remains a translation in the Robot PPS.

(5) Proteus RTT and patient gantry access upgrade (K091629) - The Proteus RTT and patient gantry access upgrade consists of a redesign of the gantry patient enclosure (PE) and an associated technology update of the PTS interlock controller.

(6) Inclined beam line (K092796) - The proton therapy system can be equipped with an inclined beam line enabling the beam delivery device to be positioned at two angles: 30° and 90°.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

ION Beam Applications S.A. % Mr. John B. Reiss Official Correspondent Saul Ewing LLP 1500 Market Street Centre Square West, 38th Floor PHILADELPHIA PA 19102

Re: K101508

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: July 23, 2010 Received: July 26, 2010

Dear Mr. Reiss:

This letter corrects our substantially equivalent letter of August 6, 2010.

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 (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.

NOV 1 7 2011

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{4}------------------------------------------------

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

Michael D O'Hare for

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

{5}------------------------------------------------

# Indications for Use Form

510(k) Number (if known): k101508

Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235

AUG D'6 2010

Indications for 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. »

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

David V.H.

Division Sign-Off/ Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K161508

Page 1 of