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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the IBA Proton Therapy System - Proteus 235, specifically the introduction of a Compact Gantry Beam Line (CGBL). This document is primarily focused on demonstrating substantial equivalence to a predicate device rather than a comprehensive study report with detailed acceptance criteria and performance data from clinical trials.

Therefore, many of the requested sections about specific study methodologies, sample sizes, expert qualifications, and comparative effectiveness (MRMC) cannot be fully addressed from the provided text. The document focuses on comparing technological characteristics and functionality to establish equivalence.

Here's an attempt to extract the information based on the provided text, with significant limitations due to the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison of the modified device (Compact Gantry Beam Line) against the predicate device (360° Gantry Beam Line) for various characteristics. In the context of a 510(k), the "acceptance criteria" are implied by the predicate device's performance, meaning the new device must meet or be substantially equivalent to these values.

Characteristic	Acceptance Criteria (from 360° Gantry Beam Line)	Reported Device Performance (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 (Fail Safe)
Control for treatment mode	Multiple Access Point	Same (Multiple Access Point)
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 < to 1.5 mm	Same
Effective SAD	≥ 2m	Same
Irradiation time	≤2 minutes for delivering 2Gy to 1L volume (10 x 10 x 10 cm³)	Same

Study that proves the device meets the acceptance criteria:

The document states that 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°."

It also asserts that "the modified product does not induce changes nor any new limitations for clinical use (and therefore all existing clinical evidence remains valid)."

And concludes: "The new Compact Gantry fulfills the same primary functions as the 360° Gantry... It allows reaching the same clinical performances."

This suggests that the "study" proving the device meets the criteria is primarily an engineering and risk analysis comparison against an existing, cleared device, demonstrating that the changes do not negatively impact performance or safety in the context of its intended use. There is no mention of a
new clinical study with patient data for this 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a clinical test set with patient data for this 510(k) submission. The comparison is based on technical specifications and engineering assessments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The document does not describe a test set requiring expert-established ground truth. The technical specifications are objectively measurable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the clinical sense mentioned in the document.

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 radiation therapy system, not an AI or imaging diagnostic aid that would involve human readers. The document details a physical component modification to an existing therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for a clinical ground truth. The "ground truth" in this context refers to the established technical and functional performance of the predicate device (360° Gantry Beam Line) against which the modified Compact Gantry Beam Line is compared through engineering analysis and risk assessment.

8. The sample size for the training set

Not applicable. This device does not use machine learning, therefore, there is no training set mentioned or implied.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for machine learning.

Summary

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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 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

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 Scanning0.5 to 32 cm	Pencil Beam Scanning0.5 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 < to 1.5 mm	Same
Effective SAD	≥ 2m	Same
Irradiation time	≤2 minutes for delivering 2Gy to 1L volume (10 x 10 x 10 cm³)	Same

Impact on the existing IBA Proton Therapy System - Proteus 235

The predicate device architecture is not modified. The impacts are limited to some very specific areas.

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. A new beam line configuration is added to the product. When there are multiple rooms connected to the source (accelerator), it shall be possible to switch the beam to the Compact Gantry Beam Line (same principle as in Proteus 235 predicate device).
The building is adapted in order to offer the appropriate structural and . shielding interface with the Compact Gantry Beam Line.
- Nevertheless, there are no changes in the gantry fixation o technology to the building structure (anchors), the only adaptations are the smaller room dimensions and the interface dimensions due to the specific configuration.
The Beam Line equipments (magnets, monitors) use the same technology . and are adapted to the specific Compact Gantry Beam Line configuration (E.g. beam trajectories, interface assembly).
The specific equipments required for the energy selection system (ESS) . are optional on the gantry depending on the treatment center configuration

Conclusion

The new Compact Gantry fulfills the same primary functions as the 360° Gantry.

It provides an isocentric rotating structure that rotates the beam axis in a . plane perpenticular to the rotation axis, through a common isocenter within the required precision.
It supports the movable portion of the beam transport line, a nozzle and an . Imaging Equipment Insertion mechanism.
It quarantees the same patient clearance as with the 360° gantry. .
. It allows reaching the same clinical performances.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 10. 2014

lon Beam Application S.A. % Mr. Bruce D. Armon, Partner Saul Ewing LLP Centre Square West 1500 Market Street, 38th Floor PHILADELPHIA PA 19102

Re: K132919

Trade/Device Name: Compact Gantry Beam Line Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: February 10, 2014 Received: February 11, 2014

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 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.

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Page 2-Mr. Armon

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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 Small Manufacturers, International and Consumer Assistance 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,

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Proton Therapy System - Proteus 235

Indications for Use:

The PTS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized turnors 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 turnors and other conditions susceptible to treatment by radiation localized to the head and neck.

AND/OR Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Smh.7)

Division Sign-Off Office of In Vitro Devices and Radiologic Health

K132919 510(k)_

Page 1 of _ I _

Regulation Number and Section

§ 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.