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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Varian Medical Systems Proton Therapy Multileaf Collimator (K093252). However, this document does not contain information regarding acceptance criteria, device performance metrics, or any study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) related to proving the device meets acceptance criteria.

The document focuses on:

Identification of the device and submitter: Varian Medical Systems Proton Therapy Multileaf Collimator.
Classification details: Class II device, product code LHN.
Predicate device: Varian Medical Systems Millennium Multileaf Collimator (K050442).
Description of the device: An accessory proton beam collimator used to shape the treatment field perimeter, with two operating modes (Pencil Beam Scanning and Beam Shaping).
Intended Use Statement: To assist radiation oncologists in delivering proton radiation to target volumes while sparing normal tissue.
Substantial Equivalence: Claimed equivalence to the predicate device.
FDA Clearance Letter: Confirms substantial equivalence determination (K093250 - note: there's a discrepancy in the K number cited in the summary vs. the clearance letter, with the letter stating K093250).

Since the document is a 510(k) summary for a medical device accessory and not a diagnostic or AI-driven tool, the type of performance studies and acceptance criteria typically associated with such technologies (e.g., sensitivity, specificity, AUC, human reader improvement with AI) are not applicable or, at least, not detailed in this specific submission. The "substantial equivalence" claim is typically based on performance data (e.g., mechanical, electrical, software validation as appropriate for a mechatronic device) demonstrating that the new device is as safe and effective as the predicate, but these specific criteria and the studies proving them are not elaborated upon in this summary.

Therefore, I cannot provide the requested information based on the given text.

Summary

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K093252

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.

1. 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 MultileafCollimator; 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

1. Predicate Device to claim substantial equivalence: Varian Medical Systems Millennjum Multileaf Collimator - K050442
1. Description of the Device:

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.
1. Intended Use Statement

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Indications for Use Statement ن

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

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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):

K093256

Device Name:

Proton Therapy Multileaf Collimator

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Regulation Number and Section

§ 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.