(26 days)
Not Found
No
The description focuses on the physical mechanisms of beam delivery (scattering and scanning) and does not mention any AI/ML components for treatment planning, image analysis, or system control. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is designed for "treatment of patients with localized tumors and other conditions susceptible to treatment by radiation," which is a therapeutic purpose.
No
The device is described as a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors. Its function is therapeutic (treatment), not diagnostic.
No
The device description clearly describes a physical system (Proton Therapy System) that produces and delivers a proton beam using hardware components like magnets and a nozzle. The modifications described relate to the control and delivery of this physical beam, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation." This describes a therapeutic device used directly on a patient for treatment.
- Device Description: The description details the physical components and mechanisms for generating and delivering a proton beam for radiation therapy. It focuses on the technical aspects of beam production and delivery, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a therapeutic device used for direct patient treatment.
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.
Product codes (comma separated list FDA assigned to the subject device)
LHN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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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Image /page/0/Picture/0 description: The image shows the logo for IBA. The logo consists of a stylized cube with an arrow wrapping around it, followed by the letters "IBA" in a bold, sans-serif font. The background is black, and the logo elements are white.
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)
1
Image /page/1/Picture/0 description: The image shows a logo with a white graphic on the left and the letters "IBA" in white on the right, all set against a black background. The graphic on the left appears to be an abstract design, possibly representing a stylized arrow or a folded ribbon. The letters "IBA" are in a bold, sans-serif font, with each letter clearly defined and spaced evenly. The overall design is simple and modern, with a strong contrast between the white elements and the black background.
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
-
- 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.
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 System
including the Device
Modifications implementing the
Uniform Scanning new beam
delivery modality | IBA Proton Therapy System
including the Device
Modifications implementing the
Single scattering new beam
delivery modality | IBA Proton Therapy System
(K983024) for the legally
marketed (unmodified) device |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | No Change | No Change | Treatment of patients with
localized tumors and other
conditions susceptible to treatment
by 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 |
| Accelerator
Parameters | No Change | No Change | Constant in time |
| Variable Energy | No change | No change | Yes (70-230 MeV), with Energy
Selection 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 and
Switching System | No Change | No Change | Beampipe through quadrupole and
dipole 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
3
| --------
f
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
5
6
6
6
K
・・・
:
・・・・・・・・・・・・・
| | IBA Proton Therapy System
including the Device
Modifications implementing the
Uniform Scanning new beam
delivery modality | IBA Proton Therapy System
including the Device
Modifications implementing the
Single scattering new beam
delivery modality | IBA Proton Therapy System
(K983024) for the legally
marketed (unmodified) device |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Beam
Transport
Magnets | 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 Range
Patient (Tissue
Depth) | 3.5 cm to 32 cm
in for 40x30cm field | 3.5 cm to 20 cm
for Maximum field size 6 cm
diameter field | 5 cm to 28 cm for $\Phi$ 10 cm field
5 cm to 24 cm for $\Phi$ 20 cm field |
| Collimator | No Change | No Change | Yes |
| Range Verifier | No Change | No Change | Yes |
| Control and Safety
System | No Change | No Change | Hardwired Interlock System |
| | | | Software controls accelerator
and beam operation including
beam transport and delivery,
verifies patient ID, sets
operational parameters,
monitors systems, and provides
alerts regarding excessive
parameters |
| | IBA Proton Therapy System
including the Device
Modifications implementing the
Uniform Scanning new beam
delivery modality | IBA Proton Therapy System
including the Device
Modifications implementing the
Single scattering new beam
delivery modality | IBA Proton Therapy System
(K983024) for the legally
marketed (unmodified) device |
| Mechanical
Stops | No Change | No Change | Yes |
| Beam Intensities | No Change | No Change | Hardware-limited at 300 nA
continuous (1.1 x 1014
protons/min). ESS further limits
maximum possible patient dose
rate. |
| Shielding | No Change | No Change | Steel and Concrete around
accelerator, transport, and
treatment areas |
| Treatment Rooms | No Change | No Change | 3 (one with fixed horizontal beam
and 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
ie-Neve, Belgium | RC N
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MID 8947
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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.
6
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
7
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