(69 days)
Not Found
No
The document describes a physical device (multileaf collimator) for shaping radiation beams and does not mention any software or algorithms that utilize AI or ML.
Yes
The device is used to assist in the delivery of proton radiation for cancer treatment, indicating a direct role in patient therapy.
No
Explanation: The device is described as an "accessory radiation collimator" used to "shape the treatment field perimeter" for proton radiation therapy. Its purpose is to deliver radiation to target volumes, not to diagnose conditions.
No
The device description clearly states it is a physical accessory (a collimator) designed to be mounted on a proton radiation therapy system and shape the treatment field. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of proton radiation therapy to defined target volumes in patients. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a physical accessory (a multileaf collimator) that shapes a proton beam for cancer treatment. It directly interacts with the patient's body (via the radiation beam) for therapeutic purposes.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens (blood, tissue, etc.) or to provide information about a patient's health status for diagnostic purposes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on the delivery of a therapeutic treatment.
N/A
Intended Use / Indications for Use
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
Product codes
LHN
Device Description
The Varian Proton Therapy Multileaf Collimator is an accessory proton beam collimator designed to be mounted on a proton radiation therapy system and is designed to shape the treatment field perimeter.
The Proton Therapy Multileaf Collimator is designed to shape a proton beam for cancer treatment. There are two operating modes:
- Pencil Beam Scanning (PBS) where proton therapy equipment nozzle scanning magnets direct a. the proton beam to the voxel of treatment while the Proton Therapy Multileaf Collimator is parked with the carriage fully retracted for largest possible exposure field.
- b. Beam Shaping where the Proton Therapy Multileaf Collimator collimates the beam for treatment, replacing the current patient-customized final collimator. This Proton Therapy Multileaf Collimator mode of operating is used for double and single scattering and uniform scanning proton treatment modes.
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
radiation oncologist
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)
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.
0
510(k) Summary
The information below is provided for the Varian Medical Systems Proton Therapy Multileaf Collinator following the format of 21 CFR 807.92.
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- Submitter: Varian Medical Systems 3100 Hansen Wav. M/S e110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: 650/424.5731 Fax: 650/842.5040 E-mail: vy.tran@varian.com
DEC 2 4 2009
.
| 2. Name of the Device: | Proton Therapy Multileaf Collimator | |
|---|---|---|
| Trade / Proprietary Names: | iPTMLC ; Proton Therapy Multileaf Collimator; Proton Multileaf | |
| Collimator; Proton MLC | ||
| Common or Usual Name: | Accessory to Proton Therapy System | |
| Classification Name: | Medical Charged Particle Radiation Therapy System | |
| 21 CFR §892.5050 | ||
| Class II | ||
| Product Code: | LHN |
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- Predicate Device to claim substantial equivalence: Varian Medical Systems Millennjum Multileaf Collimator - K050442
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- Description of the Device:
The Varian Proton Therapy Multileaf Collimator is an accessory proton beam collimator designed to be mounted on a proton radiation therapy system and is designed to shape the treatment field perimeter.
The Proton Therapy Multileaf Collimator is designed to shape a proton beam for cancer treatment. There are two operating modes:
- Pencil Beam Scanning (PBS) where proton therapy equipment nozzle scanning magnets direct a. the proton beam to the voxel of treatment while the Proton Therapy Multileaf Collimator is parked with the carriage fully retracted for largest possible exposure field.
- b. Beam Shaping where the Proton Therapy Multileaf Collimator collimates the beam for treatment, replacing the current patient-customized final collimator. This Proton Therapy Multileaf Collimator mode of operating is used for double and single scattering and uniform scanning proton treatment modes.
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- Intended Use Statement
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
1
Indications for Use Statement ن
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
7. Substantial Equivalence
The Varian Medical Systems Proton Therapy Multileaf Collimator submission illustrates substantial equivalence to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an 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 Vice President Corporate Regulatory Affairs Varian Medical Systems 3100 Hansen Way PALO ALTO CA 94304-1038
DEC 2 4 2009
Re: K093250
Trade/Device Name: Proton Therapy Multileaf Collimator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: October 14, 2009 Received: October 16, 2009
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 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
3
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Lucia M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/4/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "i" that has a curved line above it. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is black and white.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA Tel +1 650 493 4000 www.varian.com
Indications for Use Statement
510(k) Number (if known):
Device Name:
Proton Therapy Multileaf Collimator
Indications for Use:
The Varian Proton Therapy Multileaf Collimator is an accessory radiation collimator intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR § 801.109)
Over-the-counter
Armu M. Mothy
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K093250