(368 days)
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.
The Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) 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 system includes a proton accelerator (either an isochronous cyclotron (C230) or a Superconducting Synchro-Cyclotron (S2C2)) for beam production, which can be shared between several treatment rooms or directed to a single room. The system can be equipped with different types of treatment rooms, such as fixed beam or gantry rooms, connected to the beam line. The change introduced in this filing is the option of a new IBA Compact Beam Production System (CBPS) based on a Superconducting Synchro-Cyclotron (S2C2).
The provided text contains information about a 510(k) premarket notification for a Proton Therapy System, specifically focusing on the introduction of a new Compact Beam Production System (CBPS) feature. However, it does not include the type of study typically associated with device performance against acceptance criteria for diagnostic or AI-based devices (e.g., studies involving human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity/specificity).
Instead, the document details the technical specifications and comparative performance of a radiation therapy system, which is evaluated based on physical beam characteristics and operational parameters rather than diagnostic accuracy.
Therefore, many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance for diagnostic tasks, training set details) are not applicable or not present in the provided text for this type of medical device.
Here's an attempt to answer the applicable questions based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing key clinical beam performance characteristics. While not explicitly termed "acceptance criteria" in the context of diagnostic performance, these are the parameters against which the new CBPS feature is evaluated for equivalency to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K132919) | Reported Device Performance (IBA Proteus Compact Gantry Beam Line with Superconducting synchrocyclotron (CBPS) - K152224) |
|---|---|---|
| Maximum Beam Range in Patient (Tissue depth) | >= 32 cm | >= 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 < to 1.5 mm | <= 15 % of beam sigma or < to 1.5 mm |
| Irradiation Time | <2 minutes for delivering 2Gy to 1L volume (10 x 10 x 10 cm3) | <2 minutes for delivering 2Gy to 1L volume (10 x 10 x 10 cm3) |
| Effective SAD | >= 2m | >= 2m |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the text. The evaluation is based on "testing performed at the system and sub-system level" rather than patient or diagnostic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a radiation therapy system, not a diagnostic device requiring expert interpretation of images or patient data for ground truth. The 'ground truth' for this type of device would involve physical measurements and technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is a radiation therapy system, not an AI-assisted diagnostic device. The study is comparing the technical performance of a new component (CBPS) to an existing one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an AI algorithm, as this device is a physical system. The "standalone performance" is implicitly the performance of the system as described in the table, without human interaction in its beam delivery characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be established through physical measurements and engineering specifications (e.g., beam range, field size, spot size, irradiation time) using phantoms or measurement equipment, rather than expert consensus on diagnostic images or pathology. The text states "Testing has been performed at the system and sub-system level."
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This is not applicable.
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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
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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) |
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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M-Id 49380 Rev.B
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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 Isochronouscyclotron C230 | IBA Superconductingsynchrocyclotron S2C2 | Mevion Medical Systemssynchrocyclotron S-250 |
|---|---|---|---|
| Accelerator | 230 MeV isochronouscyclotron | 230 MeV superconductingsynchrocyclotron | 250 MeV superconductingsynchrocyclotron |
| Particle | Proton | Proton | Proton |
| Energy range | up to 230 MeV withenergy selection system | up to 230 MeV withenergy selection system | Up to 250 MeV |
| Ion Source | Hot cathode PIG ionsource | 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 |
| EstimatedElectrical powerconsumption | 2258 MWh/year | 358 MWh/year | 100 MWh/year |
| Cooling method | Chilled water | Chilled water andGifford-Mc Mahoncryocoolers | Gifford-Mc Mahoncryocoolers |
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
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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 GantryBeam Line with Superconductingsynchrocyclotron (CBPS)(K152224) | IBA Proteus Compact GantryBeam Line with C230 cyclotron(K 132919) |
|---|---|---|
| MaximumBeam Range inPatient (Tissuedepth) | > or = 32 cm | > or = 32 cm |
| Field Size | 24 cm x 20 cm | 24 cm x 20 cm |
| Beam DistalFall 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 PositionAccuracy | ≤ 15 % of beam sigma or < to 1.5 mm | ≤ 15 % of beam sigma or < to 1.5 mm |
| IrradiationTime | <2 minutes for delivering2Gy to 1L volume(10 x 10 x 10 cm3) | <2 minutes for delivering2Gy to 1L volume(10 x 10 x 10 cm3) |
| Effective SAD | ≥ 2m | ≥ 2m |
Table 2. Overview of the clinical beam performance characteristics of the IBA Proton Therapy System using a cyclotron versus synchrocyclotron
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Conclusion
The verification and validation activities ensure that the device is as safe, as effective, and performs as well as the predicate device.
§ 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.