PROTEUS 235 PROTON THERAPY SYSTEM

K091629 · Ion Beam Applications S.A. · LHN · Aug 11, 2009 · Radiology

Device Facts

• Record ID: K091629
• Device Name: PROTEUS 235 PROTON THERAPY SYSTEM
• Applicant: Ion Beam Applications S.A.
• Product Code: LHN · Radiology
• Decision Date: Aug 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

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 medical charged-particle radiation therapy system. It generates and delivers a proton beam to treat localized tumors. The system is operated by trained clinical staff in a hospital or clinical setting. It functions by accelerating protons to specific energy levels to target diseased tissue, allowing for precise radiation delivery. The output is a controlled proton beam used by radiation oncologists to plan and execute cancer treatment, potentially sparing surrounding healthy tissue compared to conventional photon radiation.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Medical charged-particle radiation therapy system (Product Code: LHN). Operates as a proton beam delivery system. Class II device per 21 CFR 892.5050.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo with three curved lines that appear to be stylized feathers or waves. The lines are thick and black, and they are arranged in a parallel fashion, slightly overlapping each other. To the left of the lines, there is a faint, curved text that is difficult to read due to its small size and blurriness. The overall design is simple and abstract, suggesting a sense of movement or flow.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ion Beam Applications S.A. % Mr. Daniel W. Lehtonen Senior Staff Engineer-Medical Devices Intertek Testing Services 2307 E. Aurora Rd, Unit B7 TWINSBURG OH 44087

## AUG 1 1 2009

Re: K091629

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 10, 2009 Received: July 14, 2009

## Dear Mr. Lehtonen:

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 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); medical device reporting of medical

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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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Lamme M. Monul

Janine M. Morris Acting 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

510(k) Number (if known):

K091629

Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235

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 tumors and other conditions susceptible to treatment by radiation."

Prescription Use _X (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 IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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Hele Reeme
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Devices 510(k) Number

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570