(368 days)
Not Found
No
The summary describes a proton therapy system and its components, focusing on beam production and delivery. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is intended for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation, indicating a therapeutic purpose.
No
The device is described as a "Proton Therapy System" designed to "produce and deliver a proton beam for the treatment of patients with localized tumors," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly details hardware components such as a proton accelerator (cyclotron or synchro-cyclotron), beam lines, and treatment rooms, indicating it is a physical system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "Proton Therapy System" designed to "produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation." This is a therapeutic device that directly interacts with the patient's body for treatment, not for analyzing samples taken from the body.
- Intended Use: The intended use is for "treatment of patients," not for diagnostic testing of samples.
Therefore, based on the provided information, the Proton Therapy System - Proteus 235 is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
"The Proton Therapy System - Proteus 235 (brand names: Proteus ONE) 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck."
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
"The change introduced in the IBA Proton Therapy System - Proteus 235 and described in this filing is the introduction of an optionally new IBA Compact Beam Production System (CBPS). Compact Beam Production System (CBPS) feature consists of the introduction, as an option, of a SuperConducting Synchro-Cyclotron (S2C2), offering a compact and more affordable alternative to the isochronous cyclotron. Both synchrocyclotron and isochronous cyclotron are dedicated to the generation of high energy protons for protontherapy. This is accompanied by an adaptation of the beam delivery equipment, which directs the proton beam to the patient's treatment site, to process the beam produced by the S2C2."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
localized to the head and neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been performed at the system and sub-system level and demonstrated that the IBA Proton Therapy System - Proteus 235 with the CBPS new feature is substantially equivalent to the predicate device. Thus, this device is as safe, as effective and performs as well as the predicate device. From those testing, the following results have been obtained:
- Maximum Beam Range in Patient (Tissue depth): >= 32 cm
- Field Size: 24 cm x 20 cm
- Beam Distal Fall Off: = 2m
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of three human profiles facing to the right, with a wing-like shape extending from the back of the heads.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2016
Ion Beam Application S.A. % Mr. Bruce Armon Partner Saul Ewing LLP Center Square West, 1500 Market Street, 38th Floor PHILADELPHIA PA 19102-2186
Re: K15224
Trade/Device Name: Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: July 4, 2016 Received: July 8, 2016
Dear Mr. Armon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152224
Device Name
Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2)
Indications for Use (Describe)
"The Proton Therapy System - Proteus 235 (brand names: Proteus ONE) 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck."
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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M-Id 49380 Rev.B
Page 1
510(k) SUMMARY Ion Beam Applications S.A.
24 June 2016
Applicant
| Ion Beam Applications S.A. | ||||||
|---|---|---|---|---|---|---|
| Chemin du Cyclotron, 3 | ||||||
| B-1348 Louvain-la-Neuve | ||||||
| Belgium | ||||||
| Attention : | Mrs. Anne-Sophie Grell | |||||
| Phone : | 32-10-47-58-16 | |||||
| Facsimile: | 32-10-47-58-10 | |||||
| E-mail: | anne-sophie.grell@iba-group.com |
Contact and Agent for Ion Beam Applications S.A.
| Bruce D. Armon | |
|---|---|
| Saul Ewing LLP | |
| 1500 Market Street | |
| Centre Square West – 38th Floor | |
| Philadelphia, PA 19102 | |
| Phone: | (215) 972-7124 |
| Facsimile: | (215) 972-1906 |
| E-mail: | barmon@saul.com |
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Classification Name
Medical Charged-Particle Radiation Therapy Systems. (21 C.F.R. $892.5050, Product Code LHN)
Trade Name: Proton Therapy System - Proteus 235, Proteus One, Proteus Plus, Proteus TK2.
Common Name: Proton Therapy System
Predicate Device
The IBA Proton Therapy System – Proteus 235 (PTS) with the addition of the IBA Compact Beam Production System is substantially equivalent to the previously cleared IBA Proton Therapy System (K132919) and to the S-250 Proton Beam Radiation Therapy system (K120676) from Mevion Medical Systems that includes a super conducting synchrocyclotron accelerator. The current PTS and its predicate devices have the same intended use and principles of operation, and are substantially equivalent in terms of technological characteristics.
Indication for Use
The intended use of the product (wth the addition of the IBA Compact Beam Production Systems (CBPS) is not changed in respect to the previously cleared intended use (including no change in labelling that would affect it):
"The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) 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. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck."
Pre-market notification description
The change introduced in the IBA Proton Therapy System - Proteus 235 and described in this filing is the introduction of an optionally new IBA Compact Beam Production System (CBPS). Compact Beam Production System (CBPS) feature consists of the introduction, as an option, of a SuperConducting Synchro-Cyclotron (S2C2), offering a compact and more affordable alternative to the isochronous cyclotron. Both synchrocyclotron and isochronous cyclotron are dedicated to the generation of high energy protons for protontherapy. This is accompanied by an adaptation of the beam delivery equipment, which directs the proton beam to the patient's treatment site, to process the beam produced by the S2C2.
Description of the device modification
This PTS corresponds to the previously cleared IBA Proton Therapy System (K132919) with the addition of IBA Compact Beam Production System (CBPS) based on a Superconducting Synchro-cyclotron (S2C2), which produces and delivers a proton beam for the treatment of patients.
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M-Id 49380 Rev.B
Page 3
A Proteus 235 Proton Therapy System (PTS) includes one proton accelerator for the production of the beam which can be shared between several treatment rooms in the Proteus Plus configurations and directed towards one only room in the Proteus One configurations. With the actual change, the accelerator can be either the isochronous cyclotron (C230) as in the previously cleared IBA PTS, or a Superconducting Synchro-Cyclotron (S2C2). As before, the PTS can be equipped with treatment rooms of several types according to the range of beam incidences they offer: e.g. a fixed beam treatment room or a gantry treatment room. These rooms are connected to the beam line transporting the protons produced by the accelerator (C230 or S2C2).
This change has no impact on:
- . The intended use(including no changes in labelling that would affect it);
- The fundamental scientific technology of the Proteus 235 including operating ● principles and mechanism of action;
- The product's clinical efficacy.
Technological Characteristics of the modified device
The following table gives a high level overview of the main characteristics of the IBA Superconducting Synchro-cyclotron (S2C2), compared to the predicate conventional IBA isochronous cyclotron (C230), as in the previously cleared PTS, and the predicate synchro-cyclotron from Mevion Medical Systems already used in Proton Therapy.
| Characteristic | IBA Isochronous
cyclotron C230 | IBA Superconducting
synchrocyclotron S2C2 | Mevion Medical Systems
synchrocyclotron S-250 |
|----------------------------------------------|-----------------------------------------------|------------------------------------------------------|--------------------------------------------------|
| Accelerator | 230 MeV isochronous
cyclotron | 230 MeV superconducting
synchrocyclotron | 250 MeV superconducting
synchrocyclotron |
| Particle | Proton | Proton | Proton |
| Energy range | up to 230 MeV with
energy selection system | up to 230 MeV with
energy selection system | Up to 250 MeV |
| Ion Source | Hot cathode PIG ion
source | Cold cathode PIG source | Cold cathode PIG source |
| Type of coils | Resistive coils | Superconducting coils | Superconducting coils |
| Volume (m³) | ~30 | ~10 | 3-5 |
| Weight (tons) | ~230 | ~42 | ~20 |
| Estimated
Electrical power
consumption | 2258 MWh/year | 358 MWh/year | 100 MWh/year |
| Cooling method | Chilled water | Chilled water and
Gifford-Mc Mahon
cryocoolers | Gifford-Mc Mahon
cryocoolers |
Table 1: Overview of the main characteristics of the synchro-cyclotron versus the IBA Isochronous cyclotron and the Mevion synchrocyclotron
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M-Id 49380 Rev.B
Page 4
The Proteus 235 with the CBPS feature has the same intended use and indications, principles of operation, and technological characteristics as IBA Proton Therapy System (K132919) and to the S-250 Proton Beam Radiation Therapy system (K120676) from the Mevion Medical Systems for the synchrocyclotron accelerator.
Summary of Performance testing
Testing has been performed at the system and sub-system level and demonstrated that the IBA Proton Therapy System - Proteus 235 with the CBPS new feature is substantially equivalent to the predicate device. Thus, this device is as safe, as effective and performs as well as the predicate device. From those testing, the following results have been obtained:
| Characteristic | IBA Proteus Compact Gantry
Beam Line with Superconducting
synchrocyclotron (CBPS)
(K152224) | IBA Proteus Compact Gantry
Beam Line with C230 cyclotron
(K 132919) |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Maximum
Beam Range in
Patient (Tissue
depth) | > or = 32 cm | > or = 32 cm |
| Field Size | 24 cm x 20 cm | 24 cm x 20 cm |
| Beam Distal
Fall Off | ≤0.25 g/cm2 above the physical limit | ≤0.25 g/cm2 above the physical limit |
| Spot Size | ≤ 15 mm on the range of energies | ≤ 15 mm on the range of energies |
| Spot Position
Accuracy | ≤ 15 % of beam sigma or