(296 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on hardware modifications to a previously cleared system.
Yes
The device is designed for the "treatment of patients with localized tumors and other conditions susceptible to treatment by radiation," which indicates a therapeutic purpose.
No
Explanation: The device is described as a medical device designed to produce and deliver a proton beam for the treatment of patients, indicating a therapeutic or treatment function, not a diagnostic one.
No
The device description explicitly states it is a "proton therapy system" and includes a "compact Gantry Beam line," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to "produce and deliver a proton beam for the treatment of patients." This describes a therapeutic device used for direct patient treatment, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical components and function of a proton therapy system, which is a type of radiation therapy equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a therapeutic medical device, specifically a radiation therapy system, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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 of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
Product codes
LHN
Device Description
The device corresponds to the previously cleared IBA proton therapy system (K101508) with the addition of a compact Gantry Beam line designed to produce and deliver a proton beam from various directions in a range of 220° for the treatment of patients. The IBA Proton Therapy System - Proteus 235 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 supply equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures that the clinical functions are properly and safely accomplished; and (2) the beam supply equipment, which includes a cyclotron, an energy selection system and a 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 that any problem occurs; and a computer-based Therapy Control System which controls the parameters of the proton beam. The change in the device that triggered this submission is the introduction of a Compact Gantry Beam Line (CGBL), which consists of: Another type of rotating isocentric gantry called Compact Gantry. Like . other gantries, already part of the current Proteus 235, the CGBL supports a beam line and an associated nozzle supporting the scanning delivery technique, plus it can optionally integrate the energy selection system for a one-room configuration. The new Compact Gantry Beam Line modification is a simplification of the already existing 360° gantry beam line. The changes are mainly limited to the gantry components and some of its interfaces. Compared to the beam line with a 360° gantry, the radius of the compact gantry beam line is reduced, but the modified product does not induce changes nor any new limitations for clinical use (and therefore all existing clinical evidence remains valid): a treatment fraction is still composed of one or more treatment fields where the proton beam will be pointed to the patient's tumor from one or more incidence angles. Those incidence angles are defined by both the direction of the beam realized by the gantry and the position and orientation of the patient support. To realize a particular incidence anale with respect to the patient, different combinations of gantry angles and patient positioner configurations are possible. Treatment rooms equipped with a 360° rotating gantry, promote gantry movements rather than patient support system movements. The compact gantry will use additional top rotations to cover the same range of beam incidences with respect to the patient in coplanar treatments. With the CGBL, the Pencil Beam Scanning delivery technique is the delivery technique of choice. It allows intensity modulated proton therapy which is the most advanced technique to treat in proton therapy today. The fact of supporting one delivery technique results in decreasing the size of the nozzle which is beneficial for the access around the patient. Despite the maximum field size has been decreased to 24 cm x 20 cm, the same tumor size coverage can be guaranteed as in the 360° gantry beam line by using matching fields. As for the previously cleared IBA proton therapy system, the CGBL is equipped with a patient positioning imaging system. With the CGBL, the nozzle is equipped with an Imaging Equipment insertion mechanism composed of 2 opposed moveable arms that can hold imaging equipment. These arms can be extracted from and retracted into the nozzle. Integrated with the appropriate imaging system (internal/external system) this allows planar X-ray imaging. In addition, thanks to the capability of pre-programmed gantry motion without continuous activation by the user, the compact gantry beam line is ready to support volumetric imaging at isocenter.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Planar X-ray imaging, volumetric imaging
Anatomical Site
Localized tumors or other diseases that are susceptible to treatment by radiation, specifically 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)
Not Found
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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JUL 1 0 2014 M-Id 40013 Rev.A Page 2
510(k) SUMMARY lon Beam Applications S.A.
13 September 2013
Applicant
lon Beam Applications S.A.
Chemin du Cyclotron, 3
B-1348 Louvain-la-Neuve
Belgium
32-10-47-58-45 Phone :
Facsimile: 32-10-47-58-10
E-mail: Michel,Baelen@iba-group.com
Contact and Agent for Ion Beam Applications S.A.
Bruce D. Armon Saul, Ewing, Remick & Saul Centre Square West 38th Floor Philadelphia, PA 19102-2186 Phone: (215) 972-7124 Facsimile: (215) 972-1906 barmon@saul.com E-mail:
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M-Id 40013 Rev
Image /page/1/Picture/2 description: The image shows a handwritten word "Iba" with a dot above the "I". The letters are in lowercase and have a cursive style. The dot above the "I" is slightly smudged, and the overall image has a grainy texture, suggesting it may be a scan or a low-resolution photograph of the handwriting.
Classification Name
Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
Predicate Device
The IBA Proton Therapy System - Proteus 235 (PTS) is substantially equivalent to the previously cleared IBA proton therapy
system (K101508). 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. As 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 technological aspects of a patient treatment consist of protons generated by the beam supply 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. The current IBA Proton Therapy System - Proteus 235 and its predicate device both consist of a beam production equipment which generates the beam used by a beam delivery systems including a patient positioning system.
The predicate device also provides the same or substantially equivalent functions, characteristics, and accessories as does the currently modified PTS.
Indication for Use
The 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 of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
The indication for use is identical to the one of the predicate device.
Pre-market notification description
The change introduced in the IBA Proton Therapy System - Proteus 235 and described in this filing is the availability of a new IBA 220° Compact Gantry. The IBA 220° Compact Gantry combines the following advantages:
- -Uncompromised positioning treatment options provided by a continuously adjustable treatment angle combined with 6° freedom of movement offered by the patient positioner. All treatment angle can be achieved;
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- The most compact gantry design ever developed for proton therapy, while still enabling easy patient access and non coplanar treatments.
Description of the device
The device corresponds to the previously cleared IBA proton therapy system (K101508) with the addition of a compact Gantry Beam line designed to produce and deliver a proton beam from various directions in a range of 220° for the treatment of patients.
Technological Characteristics
The IBA Proton Therapy System - Proteus 235 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 supply equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures that the clinical functions are properly and safely accomplished; and (2) the beam supply equipment, which includes a cyclotron, an energy selection system and a 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 that any problem occurs; and a computer-based Therapy Control System which controls the parameters of the proton beam.
The change in the device that triggered this submission is the introduction of a Compact Gantry Beam Line (CGBL), which consists of:
- Another type of rotating isocentric gantry called Compact Gantry. Like . other gantries, already part of the current Proteus 235, the CGBL supports a beam line and an associated nozzle supporting the scanning delivery technique, plus it can optionally integrate the energy selection system for a one-room configuration
The new Compact Gantry Beam Line modification is a simplification of the already existing 360° gantry beam line.
The changes are mainly limited to the gantry components and some of its interfaces.
Compared to the beam line with a 360° gantry, the radius of the compact gantry beam line is reduced, but the modified product does not induce changes nor any new limitations for clinical use (and therefore all existing clinical evidence remains valid):
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a treatment fraction is still composed of one or more treatment fields where the proton beam will be pointed to the patient's tumor from one or more incidence angles. Those incidence angles are defined by both the direction of the beam realized by the gantry and the position and orientation of the patient support. To realize a particular incidence anale with respect to the patient, different combinations of gantry angles and patient positioner configurations are possible. Treatment rooms equipped with a 360° rotating gantry, promote gantry movements rather than patient support system movements. The compact gantry will use additional top rotations to cover the same range of beam incidences with respect to the patient in coplanar treatments.
With the CGBL, the Pencil Beam Scanning delivery technique is the delivery technique of choice. It allows intensity modulated proton therapy which is the most advanced technique to treat in proton therapy today. The fact of supporting one delivery technique results in decreasing the size of the nozzle which is beneficial for the access around the patient. Despite the maximum field size has been decreased to 24 cm x 20 cm, the same tumor size coverage can be guaranteed as in the 360° gantry beam line by using matching fields.
As for the previously cleared IBA proton therapy system, the CGBL is equipped with a patient positioning imaging system. With the CGBL, the nozzle is equipped with an Imaging Equipment insertion mechanism composed of 2 opposed moveable arms that can hold imaging equipment. These arms can be extracted from and retracted into the nozzle. Integrated with the appropriate imaging system (internal/external system) this allows planar X-ray imaging. In addition, thanks to the capability of pre-programmed gantry motion without continuous activation by the user, the compact gantry beam line is ready to support volumetric imaging at isocenter.
In conclusion, based on the above description, the predicate device has been modified as follows:
- a smaller gantry structure by reducing the angular range .
- . optionally a shorter beamline by integrating the energy selection system into the beamline on the gantry for a one-room configuration
- . a smaller nozzle size by including only Pencil Beam Scanning delivery technique and reducing field size
The risk management approach that has been applied for the development of the Compact Gantry Beam Line is described in MID 38870. As described in this document, Risk Analyzes have been performed to identify possible risks associated with the Compact Gantry Beam Line and define appropriate risk mitigations. The main mitigation principles are already applied in the existing beam lines 360°.
Comparison table to predicate device
The following table gives an overview of the main characteristics of the conventional gantry which is already part of the IBA Proton Therapy System -Proteus 235 versus the Compact Gantry Beam Line
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Image /page/4/Picture/2 description: The image shows a handwritten word that appears to be "Iba". The letters are in a cursive style, with the 'I' having a dot above it. The writing is in black ink on a white background, and the style suggests it could be a signature or a casual note.
Table 1: Overview of the main characteristics of the 360° gantry beam line versus Compact Gantry Beam Line
| Characteristic | 360° Gantry Beam Line | Compact Gantry Beam Line |
|---|---|---|
| Angular position range | 360° | 220° |
| Isocenter accuracy (mechanical sphere of confusion radius) | 1 mm | 1 mm |
| Maximum rotation speed | 1 rpm | 1 rpm |
| Angle to get max speed | ≤30° | ≤ 30° |
| Maximum braking angle | 5° | 3° |
| Mechanical Angular repeatability | 0.25° | 0.25° |
| Brakes | Fail Safe | Same |
| Control for treatment mode | Multiple Access Point | Same |
| Motion modes | Goto, Jog | Goto, Jog, Trajectory |
| Treatment volume brought at isocenter | 100 cm X 50 cm X 40 cm | 100 cm X 50 cm X 40 cm |
| Collision prevention | By PPS load cell & proximity detection algorithm | By PPS load cell, proximity detection algorithm and sensors |
| Beam Range in Patient (Tissue depth) | Pencil Beam Scanning | |
| 0.5 to 32 cm | Pencil Beam Scanning | |
| 0.5 to 32 cm | ||
| Field size | 30 cm x 40 cm | 24 cm x 20 cm |
| Beam Distal Fall Off | ≤0.25 g/cm² above the physical limit | Same |
| Spot Size | ≤ 15 mm on the range of energies | Same |
| Spot Position accuracy | ≤ 15 % of beam sigma or |