(231 days)
Not Found
No
The summary describes a proton therapy system with standard components for generating and delivering radiation. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
Yes
The device is described as delivering "therapeutic radiation" for the treatment of "lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated," directly stating its purpose as a therapy.
No
The device is described as a proton radiation therapy system, used for treatment, not diagnosis.
No
The device description clearly outlines multiple hardware components (Cyclotron, Beam line, Treatment rooms, Treatment Control room) that are integral to the system's function. It is a physical radiation therapy system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "provides 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 therapeutic purposes. It focuses on the physical components involved in radiation therapy.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of bodily specimens.
Therefore, the PT2 Varian Proton Therapy System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
LHN
Device Description
PT2 Varian Proton Therapy System is a proton radiation therapy system which delivers therapeutic radiation in accordance with a physician's prescription.
The system consists of four major components,
- Cyclotron required to generate the photon beam
- Beam line - transports beam from the cyclotron to the required treatment room
- Up to 4 radiation treatment rooms
- Treatment Control room
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)
Results of verification and validation testing demonstrate that the PT2 Varian Proton Therapy System satisfies the intended use as described above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Premarket Notification [510(k)] Summary PT2 Varian Proton Therapy System
DEC 27 2010
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: 5 May 2010 | |
| Proprietary Name: | PT2 Varian Proton Therapy System | |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050, Class II
Product Code: LHN | |
| Common/Usual Name: | Proton Therapy System | |
| Predicate Devices: | Proteus 235 Proton Therapy System from Ion Beam Applications S.A.
(K082416). | |
| Device Description: | PT2 Varian Proton Therapy System is a proton radiation therapy system
which delivers therapeutic radiation in accordance with a physician's
prescription. | |
| | The system consists of four major components, | |
| | 1) Cyclotron required to generate the photon beam
2) Beam line - transports beam from the cyclotron to the required
treatment room
3) Up to 4 radiation treatment rooms
4) Treatment Control room | |
| Statement of 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. | |
| Statement of 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. | |
| Technological Characteristics: | See device comparison table below. | |
| Description | IBA Proton Therapy System - Proteus 235 | PT2 Varian Proton Therapy System |
| 510(k) Number | K082416 | K101294 |
| Intended 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. | PT2 Varian 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 | 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. | PT2 Varian 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 (not
superconducting) | Isochronous Cyclotron (superconducting
type using helium cryogen cooling) |
| Treatment Particle | Proton | Proton |
| Cyclotron energy | 230 MeV | 250 MeV |
| Proton Energy Selection | 70-230 MeV | 90-230 MeV (usable energy range) |
| Energy Selection | Via mechanical degrader system and Energy
Selection System based on magnetic
deflection | Via mechanical degrader system and Energy
Selection System based on magnetic
deflection |
| Beam Transport | Standard beam optical system with
quadrupoles and dipole magnets | Standard beam optical system with
quadrupoles and dipole magnets |
| Number of Treatment
Rooms | 3 to 7 treatment rooms with fixed beam
treatment stations or isocentric gantries. | 1 to 4 treatment rooms with isocentric
gantries.
No fixed beam treatment stations. |
| Beam angle adjustment | Fixed in Fixed Beam treatment stations
or adjustable via Rotating Isocentric Gantry | Adjustable via Rotating Isocentric Gantry |
| Beam delivery | Beam Scattering or
Pencil Beam Scanning
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 (e.g. # protons/second), size (e.g. 1
sigma), position etc.) | Beam Spot Scanning in all treatment
stations
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. |
| Patient Positioning | 6-Axis Treatment Table | 6-Axis Treatment Table |
| Patient Position
Verification System | Included | Not included |
| Laser positioning system | Included | Included |
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Summary of Performance Testing
Results of verification and validation testing demonstrate that the
PT2 Varian Proton Therapy System satisfies the intended use as described above.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Official Correspondent Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
L. 2.7 ..
Re: K101294
Trade/Device Name: PT2 Varian Proton Therapy System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: September 17, 2010 Received: September 22, 2010
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The word "VARIAN" is in large, bold letters, with a stylized "i" that has a dot above it. Below the word "VARIAN" are the words "medical systems" in smaller letters.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tcl. +1 650 493 4000 www.vatian.com
Indications for Use Statement
DEC 27 2010
510(k) Number: KIO1294 Device Name:
PT2 Varian Proton Therapy System
PT2 Varian Proton Therapy System, provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatmont is indicated.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Beatler Exchilder (OBE) OFF OD
(Division Sign-Off)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K161294
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