(113 days)
No
The description focuses on the physical delivery of a proton beam and its control parameters, with no mention of AI or ML for tasks like treatment planning, image analysis, or adaptive therapy.
Yes
The device is described as an "external beam irradiation system which provides a therapeutic proton beam for clinical treatment" for "localized tumors and other conditions susceptible to treatment by radiation," indicating its use in treating diseases.
No
The device is described as a system designed to product and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly outlines physical components like the Beam Delivery System (BDS) and Beam Supply System (BSS), which are hardware. The device is a proton therapy system, which is a complex hardware system with integrated software for control and delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is designed to "product 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 on a patient, not a diagnostic device used on samples taken from a patient.
- Device Description: The description details a system for generating and delivering a proton beam for external beam irradiation. This is consistent with a radiation therapy device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
Therefore, the device described is a therapeutic medical device used for radiation treatment, not an IVD.
N/A
Intended Use / Indications for Use
The PTS is a medical device designed to product and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Product codes
LHN
Device Description
The Proteus 235 system with Pencil Beam Scanning (PPBS) is an external beam irradiation system which provides a therapeutic proton beam for clinical treatment. It is designed to accurately provide beam to the designated patient treatment site with the assigned dose distribution. The equipment required to perform this work is comprised of several components. The Beam Delivery System (BDS) has the primary responsibility to ensure that the prescribed beam parameters are properly delivered. The Beam Supply System (BSS) generates the proton beam.
The pencil beam scanning is defined as the act of moving a charged particle beam of a given intensity by changing one or more of the properties of that beam (e.g. Intensity (e.g. # protons/second), size (e.g. 1 sigma), position etc.). The goal of this autonomy (e.g. is to deliver the appropriate proton fluence according to a prescription. The beam delivery process is to provide a map of the fluence that is necessary to deliver at each locations in the proton beam. The prescription is provided and the beam is moved to each location on the target and the appropriate fluence is deposited at each location.
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 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 from 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.
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K082416
CONFIDENTIAL
510(k) SUMMARY lon Beam Applications S.A.
DEC 1 2 2008
Applicant
Ion Beam Applications S.A. Chemin du Cyclotron, 3 B-1348 Louvain-la-Neuve Belgium Attention : Mr Yves Jongen 32-10-47-58-90 Phone : Facsimile: 32-10-47-58-10 E-mail: yves.jongen@iba-group.com
Contact Person and Agent for Ion Beam Applications S.A.
John B. Reiss, Ph.D., J.D. Saul, Ewing, Remick & Saul Centre Square West 3811' 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)
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1
Predicate Devices
The PTS is substantially equivalent to the previously cleared Loma Linda University The FTS is substantially Cquivalent to the provident to the provide (K872369) and the Medical Center ( Edma Linda ) Proton Beam Therapy device, a pre-1976 Harvard Oniversity Oyclouron Edicate devices have the same intended use and device. The TTO and the production in terms of performance and technological characteristics.
Intended Use
The PTS is a medical device designed to produce and deliver a proton beam for the The FTS is a medical occhio doclight to prossend other conditions susceptible to treatment by radiation.
Description of the device modifications
The Proteus 235 system with Pencil Beam Scanning (PPBS) is an external beam irradiation system which provides a therapeutic proton beam for clinical treatment. It in adation System while provins beam to the designated patient treatment site with the is accigned to annot dose distribution. The equipment required to perform this work presented door and components. The Beam Delivery System (BDS) has the ls comprised on the man other that the prescribed beam parameters are properly printaly respensibility to delivered. The Beam Supply System (BSS) generates the proton beam.
The pencil beam scanning is defined as the act of moving a charged particle beam of r ne perform beamling is anging one or more of the properties of that beam (e.g. Intensity (e.g. # protons/second), size (e.g. 1 sigma), position etc.). The goal of this Intonomy (6.g. is to deliver the appropriate proton fluence according to a prescription. beam donvory to to wides a map of the fluence that is necessary to deliver at each I mo prosofipion provided a the beam is moved to each location on the target and the appropriate fluence is deposited at each location.
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 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:
Page 2/3
2
(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 from 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.
Substantial Equivalence Discussion
The PTS is substantially equivalent to both the Loma Linda (K872369) and the Harvard Cyclotron Laboratory (« HCL ») proton therapy devices. The HCL is a pre-1976 device that was constructed in 1949.
Like its predicate devices, the PTS is a device designed to produce and deliver a proton beam for treatment of a patient. Also like its predicate devices, it is intended for use in the therapeutic application of a proton beam for the treatment of localized tumors or other disease that are susceptible to treatment by radiation.
The predicate devices also provide the same or substantially equivalent functions, characteristics, and accessories as does the 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 shaping system which is either mounted on a rotatable gantry, or in a fixed position. The patient is put into the correct position relative to the beam by a positioning system, which system is not affected by the modification made by this submission.
The facilities include patient treatment rooms, with each having a different number of rooms. The PTS device may service three to seven rooms, the Loma Linda predicate has four rooms and the HCL predicate has two. Like the predicate Loma Linda and HCL devices, the PTS provides fixed beam treatment stations. The PTS also includes treatment rooms which have isocentric/rotatable gantries similar to those used in the Loma Linda facility, but the space enclosed by the gantry is larger than at Loma Linda so that the patient can be rotated horizontally, as at HCL, allowing more choice of treatment direction.
The PTS and predicate Loma Linda devices are equipped with nozzles that provide beam scattering and beam scanning, the nozzles for the HCL predicate use beam scattering. All three devices have beam-limiting collimators and range verifiers.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ION Beam Applications S.A. % John B. Reiss, Ph.D., J.D. Attorney Saul Ewing LLP 1500 Market Street, Centre Square West - 38th Floor PHILADELPHIA PA 19102
Re: K082416
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: August 20, 2008
Received: September 3, 2008
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 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.
4
Page 2
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jogue M. thang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082416
Device Name: IBA Proton Therapy System (PTS)
Indications for Use:
The PTS is a medical device designed to product and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Prescription Use V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Pema
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device; 510(k) Number .
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