(247 days)
The IBA Proton Therapy System (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. The PTS may include a fixed small beam treatment room dedicated to the treatment with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
IBA Proton Therapy System - Proteus 235 (PTS) is a proton beam irradiation system. 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 three primary components: (1) the beam management equipment, which includes a cyclotron, transport and delivery system to direct the proton beam to the patient's treatment location; (2) the position management equipment that allows bringing the patient and the proton beam in the adequate position for treatment and verifying the patient position; and (3) the treatment control system which controls the parameters of the proton beam treatment.
The scope of the current 510(k) premarket notification is to add a new version of the handpendant, which uses wireless and touch screen technologies to move equipment in the treatment room to the cleared IBA Proteus 235.
This document describes a 510(k) premarket notification for the "IBA Proton Therapy System - Proteus 235" with the addition of a wireless hand-pendant system. The submission aims to demonstrate substantial equivalence to a previously cleared device (K152224).
The acceptance criteria and device performance are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate device: Proteus 235 with wired hand-pendant - K152224) | Reported Device Performance (Proteus 235 with wireless hand-pendant) |
|---|---|---|
| Functional Equivalence | Deliver a proton beam for treating localized tumors and other conditions (Same) | Deliver a proton beam for treating localized tumors and other conditions (Same) |
| Principles of Operation | Create, deliver proton beam; produce dose distribution; deliver designated dose (Same) | Create, deliver proton beam; produce dose distribution; deliver designated dose (Same) |
| Energy Source to Patient | Proton beam (Same) | Proton beam (Same) |
| Clinical Performance | (Not explicitly detailed, but stated as "same") | (Not explicitly detailed, but stated as "same") |
| Hand-pendant weight | < 700 g | < 250 g |
| Hand-pendant volume | < 3500 cm³ | < 400 cm³ |
| Hand-pendant communication link | Wired communication link | Wireless communication link (complies with wireless coexistence, latency, operating distance, FCC regulations) |
| User interface | Passive display screen, Buttons for movement and selection | Touch screen (Human factor validation conducted for usability) |
| Electrical safety | Compliant with recognized standards | Compliant with recognized standards |
| Electromagnetic compatibility | Compliant with recognized standards | Compliant with recognized standards |
| Software performance | Performs as intended | Performs as intended (Software tests verified) |
| Hardware performance | Performs as intended | Performs as intended (Hardware verification and reliability testing ensured) |
2. Sample size used for the test set and the data provenance:
This document describes a premarket notification for a modification to an existing device (adding a wireless hand-pendant). It is not a study involving patient data or a "test set" in the traditional sense of diagnostic or treatment efficacy. The testing described is primarily non-clinical performance testing of the device's components and system.
Therefore, there is no "sample size" of patients or data provenance in terms of country of origin or retrospective/prospective data for a clinical study. The tests were performed on the device and its sub-systems.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert-established ground truth for a test set of medical cases. The "ground truth" for the non-clinical tests would be the established engineering specifications, recognized standards (e.g., electrical safety, EMC), and functional requirements of the device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no test set of medical cases requiring adjudication.
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:
Not applicable. This device is a proton therapy system for radiation treatment, not an AI-assisted diagnostic or interpretation tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a medical device for delivering radiation therapy, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" was based on:
- Recognized standards: For electrical safety and electromagnetic compatibility.
- Design requirements/specifications: For hardware performance, software functionality, latency, operating distance, and FCC radio frequency testing.
- Intended use and principles of operation: The fundamental basis for comparing the modified device to the predicate.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth established for one.
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Public Health Service
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Ion Beam Applications S.A. % Mr. Bruce Armon Partner Saul Ewing LLP 1500 Market Street, Centre Square West-38th Floor PHILADELPHIA PA 19102
Re: K163500
Trade/Device Name: IBA Proton Therapy System- Proteus 235 (Proteus One, Proteus Plus, Proteus TK2, Proteus Class) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: LHN Dated: December 9, 2016 Received: December 19, 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
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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 devicerelated 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 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,
Michael D. O'Hara
For
Robert A. 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)
K163500
Device Name
Proton Therapy System - Proteus One, Proteus Plus, Proteus Plus, Proteus TK2, Proteus Class)
Indications for Use (Describe)
The IBA Proton Therapy System (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. The PTS may include a fixed small beam treatment room dedicated to the treatment 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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Type of Use (Select one or both, as applicable)
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
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510(k) SUMMARY
In accordance with 21 CFR 807.92 the following summary of information is provided:
June 28th, 2017
1. 510(k) Holder
| Ion Beam Applications S.A. | |
|---|---|
| Chemin du Cyclotron, 3 | |
| B-1348 Louvain-la-Neuve | |
| Belgium | |
| Contact Person: | Mrs. Gaëtane Metz |
| Phone: | 32-10-47-58-60 |
| Facsimile: | 32-10-47-58-10 |
| E-mail: | IBA_RA@iba-group.com |
Contact and Agent for Ion Beam Applications S.A.: Bruce D. Armon
| Bruce D. Armon | |
|---|---|
| Saul Ewing LLP | |
| 1500 Market Street | |
| Centre Square West - 38th Floor | |
| Philadelphia, PA 19102 | |
| Phone: | (215) 972-7985 |
| Facsimile: | (215) 972-4155 |
| E-mail: | harmon@saul.com |
2. Device
| Trade Name: | Proton Therapy System - Proteus 235, Proteus One, ProteusPlus, Proteus TK2, Proteus Class. |
|---|---|
| Common Name: | Proton Therapy System |
| Classification Name: | Medical Charged-Particle Radiation Therapy Systems |
| Classification regulation: | 21 CFR § 892.5050 |
| Product Code: | LHN |
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3. Predicate Device
The IBA Proton Therapy System - Proteus 235 (PTS) with the addition of the IBA wireless handpendant System is substantially equivalent to the previously cleared IBA Proton Therapy System (K152224). The current PTS and its Primary predicate device have the same intended use and principles of operation, and are substantially equivalent. This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
4. Device Description
IBA Proton Therapy System - Proteus 235 (PTS) is a proton beam irradiation system. 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 three primary components: (1) the beam management equipment, which includes a cyclotron, transport and delivery system to direct the proton beam to the patient's treatment location; (2) the position management equipment that allows bringing the patient and the proton beam in the adequate position for treatment and verifying the patient position; and (3) the treatment control system which controls the parameters of the proton beam treatment.
The scope of the current 510(k) premarket notification is to add a new version of the handpendant, which uses wireless and touch screen technologies to move equipment in the treatment room to the cleared IBA Proteus 235.
5. Intended Use
The intended use of the product with the addition of the IBA wireless hand-pendant System 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."
6. Summary of Technological Characteristics compared to the predicate device
The IBA Proton Therapy System – Proteus 235 (PTS) with the addition of the IBA wireless handpendant System and the previously cleared IBA Proton Therapy System - Proteus 235 (K152224) are identical in terms of intended use, principles of operation, energy source delivered to the patient and clinical performance. The difference between both systems is the introduction of the wireless and touch screen technologies in the pationing management system.
The following table gives a high level overview of the main changes of the IBA wireless handpendant compared to the predicate IBA wired hand-pendant.
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| Characteristic | Predicate device: Proteus 235with wired hand-pendant(K152224) | Proteus 235 with wirelesshand-pendant |
|---|---|---|
| Hand-pendant weight | < 700 g | < 250 g |
| Hand-pendant volume | < 3500 cm³ | < 400 cm3 |
| Hand-pendantcommunication link | Wired communication link | Wireless communication link |
| User interface | Passive display screenButtons for movement andselection | Touch screen |
Table 1: Overview of the main changes of the new hand-pendant
The positioning management system remains iso-functional and the moving equipment control is not modified.
Summary of Non-Clinical Tests 7.
IBA Proton Therapy System - Proteus 235 with wireless hand-pendant System was tested to and complies with applicable voluntary standards detailed in this premarket submission.
lon Beam Applications conducted non-clinical tests at the system and sub-system levels. These tests assess the performance of Proteus 235 with wireless hand-pendant System. The following tests have been provided in support of the substantial equivalence determination.
- . Electrical safety was evaluated and electromagnetic compatibility testing was performed with the wireless hand-pendant system. The wireless hand-pendant was found to comply with recognized standards for electrical safety and electromagnetic compatibility.
- Human factor validation testing was conducted to assess usability of the system. Users conducted a series of movements under real and simulated conditions.
- Software tests verifying the software performs as intended.
- Hardware verification and reliability testing ensuring the wireless hand-pendant hardware ● performs as intended.
- . Performance testing was conducted to ensure the product meets intended performance design inputs during normal conditions of use. The performance testing includes wireless coexistence testing in accordance with the FDA guidance document Radio Frequency Wireless Technology in Medical Devices (August 14,2013), latency measurement, operating distance testing, and FCC radio Frequency testing according to 47 CFR Part 15 (§15.247).
Non-clinical testing was performed to confirm that the changes in IBA Proton Therapy System -Proteus 235 with wireless hand-pendant System met design requirements and did not affect the safety or effectiveness of the product.
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Summary of Clinical Tests 8.
The subject of this premarket submission, IBA Proton Therapy System – Proteus 235 (PTS) with the addition of the IBA wireless hand-pendant System, did not require clinical studies to support substantial equivalence.
9. Conclusion
The verification and validation activities ensure that the IBA Proton Therapy System – Proteus 235 (PTS) with the addition of the IBA wireless hand-pendant System is as safe, as effective, and performance is substantially equivalent to 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.