(102 days)
No
The description focuses on the physical components and control systems for generating and delivering a proton beam, with no mention of AI or ML technologies for tasks like treatment planning, image analysis, or adaptive therapy.
Yes
The device is intended for the "treatment of patients with localized tumors and other conditions susceptible to treatment by radiation" and "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."
No
The device is described as a "Proton Therapy System" designed to produce and deliver a proton beam for the treatment of patients with localized tumors, not for diagnosis. Its functions are related to therapy delivery, dose distribution, and safety control during treatment.
No
The device description explicitly details significant hardware components, including beam production equipment (cyclotron), beam delivery systems, a positioning system, a Therapy Safety System, and a computer-based Therapy Control System. While there is a computer-based control system, the device is fundamentally a hardware system for generating and delivering a proton beam.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that the device produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions. It directly interacts with the patient's body for therapeutic purposes.
- Intended Use: The intended use is for treatment by radiation, not for analyzing samples outside the body for diagnostic purposes.
Therefore, the Proton Therapy System - Proteus 235 is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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 tumors and other conditions susceptible tc treatment by radiation."
Product codes
LHN
Device Description
The PTS has two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and 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 problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Localized tumours or other diseases that are susceptible to treatment by radiation.
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)
Reference Device(s)
K053641, K060695, K061913, K082416, K083058, K091629
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.
0
Exhibit 7: 510(k) Summary Inclined beam line
DEC 2 2 2009
M-Id 20861 Rev.A Page 2
510(k) SUMMARY
lon Beam Applications S.A.
14 August 2009
Applicant
lon Beam Applications S.A.
Chemin du Cyclotron, 3
B-1348 Louvain-la-Neuve
Belgium
| Attention : | Mr Baelen Michel |
|---|---|
| ------------- | ------------------ |
32-10-47-58-45 Phone :
32-10-47-58-10 Facsimile:
michel.baelen@iba-group.com E-mail:
Contact and Agent for lon 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: ireiss@saul.com
iba
1
Classification Name
Medical charged-particle radiation therapy systems. (21 C.F.R. §892.5050)
Predicate Device
The PTS is substantially equivalent to the previously cleared IBA proton therapy system (K983024). 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. Also like 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 predicate device also provides the same or substantially equivalent functions, characteristics, and accessories as does the currently modified PTS. All these devices are comprised of beam production equipment which generates the beam used by the beam delivery systems.
The technological aspects of a patient treatment consist of protons generated by the beam production 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.
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.
Description of the device modifications
The equipment to manage the beam incidence on the patient can be of several types. The beam line can have a fixed orientation with respect to the patient. Alternatively, in the existing proton therapy system, the room can be equipped with a gantry enabling the beam delivery device to rotate around the patient. In this way, the beam can be delivered in orientations ranging from 0-360°. The scope of the change covered in this submission is an inclined beam line which is a simplied gantry that accommodates only two beam orientations at 30° and 90°.
Technological Characteristics
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 two primary components: (1) the beam delivery equipment, which directs the proton beam to the patient's treatment site within the patient treatment location and ensures the patient critical functions are properly and safely accomplished; and (2) the beam production equipment, which includes a cyclotron and delivery system to produce the proton beam and
2
Image /page/2/Picture/2 description: The image shows a stylized handwritten word "Iba". The word is written in a cursive style with a slightly whimsical and artistic flair. The letters are connected, and there is a small dot or mark above the "I", adding a decorative element to the overall design.
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 problems occur; and a computer-based Therapy Control System which controls the parameters of the proton beam.
Following the successive changes to the original 510(k) submission, several features have been already added:
(1) PPVS (K053641): The Patient positioning verification system (PPVS) is interfaced to a Treatment Planning System (TPS) or an Oncology Information System (OIS) for downloading the treatment plan and the associated Digitally Reconstructed Radiographs (DRR) from the TPS in DICOM format;
(2) SIS and US (K060695): addition of 2 treatment modes. The Single Scattering (SIS) technique is dedicated to the irradiation of fields smaller than seven centimetres, the Uniform Scanning (US) technique is an active technique for spreading beam in a transversal direction to large irradiation fields;
(3) IOIS (K061913) - An automatic network-based interface between an Oncology Information System (OIS) to the PTS for the input of patient information, which information initially is entered into the OIS by means of a Graphical User Interface has been added.
(4) Pencil Beam Scanning (K082416) - The pencil beam scanning is defined as the act of moving a charged particle beam of particular properties and/or changing one or more of the properties of that beam (e.g. Intensity, size, position, etc.). The goal of this beam delivery is to deliver the appropriate proton fluence according to a prescription. This prescription provides a map of the fluence that is necessary to deliver at each location on the target. Thus the beam is moved to each location on the target and the appropriate fluence is deposited at each location.
(4) Robotic PPS (K083058) - The PTS includes new PPS. It is a SCARA-type arm robot. The X- and Y-translations from the current PPS have been replaced by two rotations around vertical axes. The vertical motion (Z-axis) from the current PPS remains a translation in the Robot PPS.
(5) Proteus RTT and patient gantry access upgrade (K091629) - The Proteus RTT and patient gantry access upgrade consists of a redesign of the gantry patient enclosure (PE) and an associated technology update of the PTS interlock controller
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered in the image and is the only element present.
Public Health Service
DEC 2 2 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ion Beam Applications, SA % John B. Reiss, Ph.D., J.D. Official Correspondent Saul Ewing LLP Centre Square West 1500 Market Street, 38th Floor PHILADELPHIA PA 19102-2186
Re: K092796
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: November 25, 2009 Received: November 30, 2009
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.
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
4
Page 2 -
Enclosure
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.html
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if known): K092796
Device Name: IBA PROTON THERAPY SYSTEM - PROTEUS 235
Indications For 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 tumors and other conditions susceptible tc treatment by radiation."
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ami M. Whang
(Division Sign-Off)
Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number _
Page 1 of 1