(85 days)
No
The summary describes a proton therapy system focused on beam delivery and control, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is described as providing "protons for precision radiotherapy of lesions, tumors, and conditions," indicating a direct therapeutic action for medical conditions.
No
The device is a proton therapy system designed to deliver radiation treatment, not to diagnose medical conditions.
No
The device description clearly outlines multiple hardware components (Cyclotron, Beam line, Treatment room, Control room) that are integral to the system's function. It is a complex hardware system with associated software, not a software-only device.
Based on the provided information, the ProBeam Proton Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "to provide protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated." This describes a therapeutic device that delivers radiation to treat conditions within the body.
- Device Description: The description details a system for generating and delivering a proton beam for radiation treatment. It focuses on the physical components and the mechanism of delivering radiation.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The ProBeam system does not perform any such analysis of specimens.
The ProBeam Proton Therapy System is clearly a therapeutic device used for delivering radiation treatment directly to the patient's body.
N/A
Intended Use / Indications for Use
ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Product codes
LHN
Device Description
ProBeam Proton therapy system, has been designed by Varian Medical Systems to deliver radiation treatment in accordance with a prescribed treatment plan. The system takes advantage of the characteristics of proton charged particle beam delivery. The major characteristic of proton radiation therapy utilizes the Bragg peak to prevent radiation of normal tissue outside the target volume. The system consists of 4 major components: 1) Cyclotron required to generate the proton beam (output 250MeV) 2) Beam line to transport beam from the cyclotron to the required treatment room 3) Treatment room where the patient is irradiated as per the prescribed treatment plan 4) Control room to select patient and activate treatment delivery
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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)
Testing has been performed at the system and sub-system level and demonstrated ProBeam is substantially equivalent to the predicate device.
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.
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K133191
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Premarket Notification [510(k)] Summary ProBeam Proton Therapy System
JAN 1 0 2014
The following information is provided following the format of 21 CFR 807.92.
Submitter's Name: Varian Medical Systems, Inc. 3100 Hansen Way e-110 Palo Alto. CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 Date: 9 October 2013 Proprietary Name: ProBeam Classification Name: Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: LHN Common/Usual Name: Proton Therapy System 1) ProBeam Proton Therapy System (K101294) Predicate Devices: 2) Varian On-board Imager Device (K042720) ProBeam Proton therapy system, has been designed by Varian Medical Device Description: Systems to deliver radiation treatment in accordance with a prescribed treatment plan. The system takes advantage of the characteristics of proton charged particle beam delivery. The major characteristic of proton radiation therapy utilizes the Bragg peak to prevent radiation of normal tissue outside the target volume. The system consists of 4 major components: 1) Cyclotron required to generate the proton beam (output 250MeV) 2) Beam line to transport beam from the cyclotron to the required treatment room 3) Treatment room where the patient is irradiated as per the prescribed treatment plan 4) Control room to select patient and activate treatment delivery ProBeam Proton Therapy System provides protons for precision Statement of Intended Use radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated. Statement of Indications for Use: ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
1
Technological Characteristics:
・
Refer to the Substantial Equivalence discussion in the table below:
| Feature | Predicate Device: | Modified Device: |
|---|---|---|
| ProBeam (K101294) | ||
| (Note: Also known as PT2 Varian Proton | ||
| Therapy System) | ProBeam | |
| Intended Use | PT2 Varian Proton Therapy System provides protons | |
| for precision radiotherapy of lesions, tumors, and | ||
| conditions anywhere in the body where radiation | ||
| treatment is indicated. | ProBeam Proton Therapy System provides protons | |
| for precision radiotherapy of lesions, tumors, and | ||
| conditions anywhere in the body where radiation | ||
| treatment is indicated. | ||
| Indications For Use | PT2 Varian Proton Therapy System, provides protons | |
| for precision radiotherapy of lesions, tumors, and | ||
| conditions anywhere in the body where radiation | ||
| treatment is indicated. | ProBeam Proton Therapy System provides protons | |
| for precision radiotherapy of lesions. tumors, and | ||
| conditions anywhere in the body where radiation | ||
| treatment is indicated. | ||
| Proton Accelerator | Isochronous Cyclotron (superconducting type using | |
| helium cryogen cooling) | No change | |
| Treatment Particle | Proton | Proton |
| Cyclotron energy | 250 MeV | No change |
| Proton Energy | ||
| Selection | 90-230 MeV (usable energy range) | 70 - 240 MeV (usable energy range) |
| Energy Selection | Via mechanical degrader system and Energy | |
| Selection System based on magnetic deflection | No Change | |
| Beam Transport | Standard beam optical system with quadrupoles and | |
| dipole magnets | No Change | |
| Number of beam | ||
| delivery rooms | 1 to 4 treatment rooms with isocentric gantries. | |
| No fixed beam treatment stations. | Customer can choose up to 6 beam delivery room | |
| modules. The facility would be comprised of a | ||
| combination of modules including Treatment rooms | ||
| (either Isocentric gantries or fixed beam) and/or | ||
| research rooms | ||
| Beam angle | ||
| adjustment | Adjustable via Rotating Isocentric Gantry | Adjustable only in Rotating Isocentric Gantry rooms |
| For fixed beam rooms the beam is provided at a | ||
| fixed angle | ||
| Beam Spot Scanning in all treatment stations | No change | |
| Beam delivery | Note: The beam spot scanning is defined as the act | |
| of moving a charged particle beam of particular | ||
| properties from one spot to the next over the whole | ||
| treatment volume and/or changing one or more of | ||
| the properties of that beam (e.g. Intensity (e.g. # | ||
| protons/second), position etc.). The charged | ||
| particle beam stops on each spot until the | ||
| predefined the proton fluence according to a | ||
| prescription is reached and moves to the next spot. | ||
| After one layer of spots is done the depth will be | ||
| changed by the change of the energy and the next | ||
| layer of spots will be executed. | Note: The beam spot scanning is defined as the act | |
| of moving a charged particle beam of particular | ||
| properties from one spot to the next over the whole | ||
| treatment volume and/or changing one or more of | ||
| the properties of that beam (e.g. Intensity (e.g. # | ||
| protons/second), position etc.). The charged | ||
| particle beam stops on each spot until the | ||
| predefined the proton fluence according to a | ||
| prescription is reached and moves to the next spot. | ||
| After one layer of spots is done the depth will be | ||
| changed by the change of the energy and the next | ||
| layer of spots will be executed. | ||
| Laser positioning | ||
| system | Included | Included |
| Beam characteristics: | ||
| spot shape | 4 mm (Sigma) in the specified range(tolerance | |
| range: for energies ≤100 MeV, beam spot size + | ||
| 30% / -20%, for energies> 100 MeV beam spot | ||
| sizes ± 20%) | 4.0 mm +/- 15% (Sigma) for beam energies equal | |
| or greater than 140 MeV to 240 MeV. | ||
| $(-0.02 * E / MeV + 6.8) +/- 15 % mm for beamenergies E from 70 MeV to less than 140 MeV.$ | ||
| Beam characteristics: | ||
| field size | Maximum field size is 25cm (x) x 25cm(y) | Maximum field size is 30cm (x) x 40cm(y) |
| Feature | Predicate Device: | Modified Device: |
| Maximum deviation of undeflected beam from isocenter | 3.0 mm | 1.0 mm |
| Value of energy dose rate at the Nominal Treatment Distance | >1 Gy/l /min | 2 Gy/l/min |
| Patient Positioning | Varian 6-Axis Treatment Table | Forte 6-Axis Robotic Treatment Table (K122413) |
| Maximum Load | 150Kg (330lbs) | 273 Kg (550lbs) |
| Pitch | $\pm$ 3° | No Change |
| Roll | $\pm$ 3° | No Change |
| Absolute positioning precision, radius sphere | ≤ 0.5 mm | No Change |
| Patient Position Verification System | Not included | Included |
| Varian On-board Imager Device (K042720) | ProBeam Device Component: kV Imaging | |
| Target localization technology | Single kV X-ray System | Dual kV X-ray System |
| 2D/3D Match | Not included | Included |
| X-ray source | Varian G-242 | Varian GS-20712 |
| Voltage | 40-150kV | 40-140kV |
| Exposure | 0.5-630 mAs | 0.1-370.1 mAs |
| Flat panel digital x-ray detector | Varian PaxScan 4030CB | No Change |
| Detector pixel elements | Amorphous Silicon (a-Si:H) photodiode plus thin film transistor | No Change |
| Type of digital image produced | digital radiographs or fluoroscopy | digital radiographs |
| Basis of image comparison | soft tissues, bony anatomy or fiducial markers | No change |
| Image comparison techniques | Fully automatic using mutual information. semi-automatic, or manual | No change |
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K133191
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Summary of Performance Testing:
Testing has been performed at the system and sub-system level and demonstrated ProBeam is substantially equivalent to the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 10, 2014
Varian Medical Systems % Ms. Vy H. Tran Vice President Corporate Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K133191
Trade/Device Name: ProBeam Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 18, 2013 Received: October 21, 2013
Dear Ms. Tran:
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.
4
Page 2-Ms. Tran
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/Medicall.ocvices/Resources/or You/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/dcfault.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/Industrv/default.htm.
Sincerely yours,
Michael D. O'Hara
for Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ProBeam Proton Therapy System
Indications for Use:
ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, turnors, and conditions anywhere in the body where radiation treatment is indicated.
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)
Michael D. O'Hara
Division Sign-Off Office of In Vitro Devices and Radiologic Health
K133191 510(k)__
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