(26 days)
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 device has been modified to introduce two additional treatment modes: the Single scattering and the Uniform scanning. The Single scattering technique is a technique dedicated to the irradiation of fields smaller than seven centimeters in diameter. Single scattering decreases the amount of scattering in the nozzle compared to double scattering and lead to better lateral penumbra. Uniform scanning is an active technique for spreading beam in a transversal direction. The incoming narrow beam, whose size is a significant fraction of the field to be treated, is moved by magnetic scanning so as to yield a flat field. The beam is deviated in x and y directions by two magnets, making the beam travel along a saw-tooth pattern with rounded corners. A patient specific aperture and bolus need therefore to be used just as in double scattering mode. A Uniform Scanning session is composed of several mini-irradiations that are used to build a Spread Out Bragg Peak within the treatment volume that is divided in a stack of layers, each of them corresponding to one penetration depth.
This document is a 510(k) summary for a device modification to the IBA PROTON THERAPY SYSTEM - PROTEUS 235. The modifications introduce two new treatment modes: Single scattering and Uniform scanning. The summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as typically found in clinical trials for new medical devices.
Therefore, the requested information elements cannot be fully extracted directly from the provided text, as this type of regulatory submission has a different focus.
However, based on the information provided, here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the newly introduced treatment modes. Instead, it relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence.
The table presented in the document (pages 2-4) focuses on comparing the new device modifications with the predicate device across various technical aspects. It primarily notes "No Change" for most characteristics, indicating that the core functionality and safety parameters are consistent with the legally marketed device. For the new features, it describes their characteristics rather than setting and meeting performance criteria against numerical targets.
For example, under "Beam Range Patient (Tissue Depth)", the document reports the following for the modified devices:
- Uniform Scanning: 3.5 cm to 32 cm in for 40x30cm field
- Single Scattering: 3.5 cm to 20 cm for Maximum field size 6 cm diameter field
- Predicate Device: 5 cm to 28 cm for Φ 10 cm field; 5 cm to 24 cm for Φ 20 cm field
However, these are descriptive specifications, not acceptance criteria with pass/fail thresholds. The "performance" is inherently implied to meet the design specifications of the new modalities.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of clinical or performance data for the device modifications. The submission is for a device modification based on engineering and physics principles, not a clinical study requiring patient data. Therefore, information on sample size or data provenance is not applicable or provided.
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. As this is not a study involving human interpretation or clinical data requiring ground truth establishment by experts, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring adjudication of findings is described.
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, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an automated system's performance, which is not the primary focus of this device modification (a physically controlled beam delivery system). The performance of the beam characteristics would be assessed through physical measurements and simulations, but the document does not detail these specific tests or their results beyond the reported specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for a proton therapy system's physical parameters (like range, field size, scattering properties) would be based on established physics principles, validated simulation models, and direct physical measurements with dosimetry equipment. The document doesn't detail the experimental setup for proving the device characteristics, but it would not involve expert consensus, pathology, or outcomes data in the traditional sense for these technical specifications.
8. The sample size for the training set
Not applicable. This device is not a machine learning or AI-based system that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
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APR 1 1 2006
510(K) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS
The following is based on the format of 21CFR807.92 Proton Therapy System -Proteus 235 Device modification - Kobolog S. [to be completed by FDA]
Applicant
Ion Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve, Belgium
Attention : Michel Baelen Phone : 32-10-47-58-45 Facsimile : 32-10-47-59-86 E-Mail : baelen@iba.be
Contact person and agent for Ion Beam Applications S.A.
John B. Reiss, Ph. D., J.D. Saul, Ewing, Remick & Saul Centre Square West, 38th Floor Philadelphia, PA 19102
Phone : (215) 972-7124 Facsimile : (215) 972-1906 E-Mail : jreiss@saul.com
Classification Name
Medical charged-particle radiation therapy systems (21 C.F.R. §892.5050)
Predicate Device
PROTON THERAPY SYSTEM (K983024) and IBA PROTON THERAPY SYSTEM-PROTEUS 235 (K053641)
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Description of the device modifications
Ko 60695
The device has been modified to introduce two additional treatment modes: the Single scattering and the Uniform scanning
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- The single scattering technique is a technique dedicated to the irradiation of fields smaller than seven centimeters in diameter. Single scattering decreases the amount of scattering in the nozzle compared to double scattering and lead to better lateral penumbra.
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- Uniform scanning is an active technique for spreading beam in a transversal direction. The incoming narrow beam, whose size is a significant fraction of the field to be treated, is moved by magnetic scanning so as to yield a flat field. The beam is deviated in x and y directions by two magnets, making the beam travel along a saw-tooth pattern with rounded corners. A patient specific aperture and bolus need therefore to be used just as in double scattering mode. A Uniform Scanning session is composed of several mini-irradiations that are used to build a Spread Out Bragg Peak within the treatment volume that is divided in a stack of layers, each of them corresponding to one penetration depth.
Intended Use
The Proton Therapy System - Proteus 235 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.
Summary of technological characteristics
The substantial equivalence comparison chart provides a comparison of the technological characteristics to those of the predicate device. This chart is located in Appendix 6 of the submission.
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Exhibit 6 - Substantial Equivalence Comparison
| IBA Proton Therapy Systemincluding the DeviceModifications implementing theUniform Scanning new beamdelivery modality | IBA Proton Therapy Systemincluding the DeviceModifications implementing theSingle scattering new beamdelivery modality | IBA Proton Therapy System(K983024) for the legallymarketed (unmodified) device | |
|---|---|---|---|
| Intended Use | No Change | No Change | Treatment of patients withlocalized tumors and otherconditions susceptible to treatmentby radiation |
| Accelerator | No Change | No Change | Isochronous cyclotron |
| Particle | No Change | No Change | Proton |
| Proton Source | No Change | No Change | Hot cathode PIG ion source |
| AcceleratorParameters | No Change | No Change | Constant in time |
| Variable Energy | No change | No change | Yes (70-230 MeV), with EnergySelection System's Degrader |
| Maximum Energy | No Change | No Change | 230 MeV |
| Injection Energy | No Change | No Change | N/A |
| Cycle Time | No Change | No Change | Constant in time |
| Beam Transport andSwitching System | No Change | No Change | Beampipe through quadrupole anddipole magnet bore |
+31 10 47 8 4 5 B Fat + 12 10 47 9 86 E-Mail : 161-2017 17:17 PM : 10:10 : 40 : Registered Office: Chemin du Cyclotron, 3 - 1348 Louvain
Ia-Neve, Beginn | RC Nivelles 5459
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| IBA Proton Therapy Systemincluding the DeviceModifications implementing theUniform Scanning new beamdelivery modality | IBA Proton Therapy Systemincluding the DeviceModifications implementing theSingle scattering new beamdelivery modality | IBA Proton Therapy System(K983024) for the legallymarketed (unmodified) device | |
|---|---|---|---|
| BeamTransportMagnets | No Change | No Change | Bending and focusing |
| Treatment Stations | No Change | No Change | Isocentric/Rotatable |
| Nozzles | Beam Scattering | Beam Scattering | Beam Scattering |
| Uniform Beam Scanning | |||
| Beam RangePatient (TissueDepth) | 3.5 cm to 32 cmin for 40x30cm field | 3.5 cm to 20 cmfor Maximum field size 6 cmdiameter field | 5 cm to 28 cm for $\Phi$ 10 cm field5 cm to 24 cm for $\Phi$ 20 cm field |
| Collimator | No Change | No Change | Yes |
| Range Verifier | No Change | No Change | Yes |
| Control and SafetySystem | No Change | No Change | Hardwired Interlock System |
| Software controls acceleratorand beam operation includingbeam transport and delivery,verifies patient ID, setsoperational parameters,monitors systems, and providesalerts regarding excessiveparameters | |||
| IBA Proton Therapy Systemincluding the DeviceModifications implementing theUniform Scanning new beamdelivery modality | IBA Proton Therapy Systemincluding the DeviceModifications implementing theSingle scattering new beamdelivery modality | IBA Proton Therapy System(K983024) for the legallymarketed (unmodified) device | |
| MechanicalStops | No Change | No Change | Yes |
| Beam Intensities | No Change | No Change | Hardware-limited at 300 nAcontinuous (1.1 x 1014protons/min). ESS further limitsmaximum possible patient doserate. |
| Shielding | No Change | No Change | Steel and Concrete aroundaccelerator, transport, andtreatment areas |
| Treatment Rooms | No Change | No Change | 3 (one with fixed horizontal beamand two with isocentric gantry) |
| Patient Positioner | No Change | No Change | Yes |
43 10 4 7 7 5 D Fax: +3 1 0 4 1 8 3 7 -Mail : interest : http://www.iha-wordpide.com | IBA SA - Registered Office: Chemin do Cyclorco, 1-1348 Lavain
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wings, representing health, human services, and prevention. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ION Beam Applications S.A. % John B. Reiss, Ph.D., J.D. Official Correspondent Saul, Ewing, Attorneys at Law Centre Square West 1500 Market Street, 38th Floor PHILADELPHIA PA 19102-2186 Re: K060695 Trade/Device Name: IBA PROTON THERAPY SYSTEM-PROTEUS 235 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: March 15, 2006 Received: March 16, 2006
Dear Dr. Reiss:
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.
APR 1 1 2006
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR INTENDED USE
Kobo 69 510(k) Number (if known):
Page 1 of 1
Device Name:
IBA 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 tumors and other conditions susceptible to treatment by radiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluations (ODE)
Prescription Use __ V
OR
Over-the-Counter Use
(Per 21 C.F.R. 801.109) (Optional Format 1-2-96)
Nancy Evaglon
§ 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.