The 4DITC function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

Device Description

The 4D Integrated Console provides the user with:

A treatment verification function to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set-up parameters
Treatment safety by preventing the radiation therapy device from commencing irradiation when a linear accelerator. MLC, or MV imager parameter is out of conformance with the treatment plan
The ability to select patients from a queue provided by the schedule
The ability to retrieve plans from an information system for the selected patient
The ability to evaluate a selected treatment plan to determine whether redefined dose limits will be exceeded
The ability to acquire and edit positional data from radiation therapy devices
The ability to override specific treatment parameters based on individual user rights
The ability to send treatment records to an information system
The ability to interact with the user controls of the PortalVision, the multi-leaf collimator system, the Patient Accessory Verification System, and the treatment verification function at a single workstation
Provides access to the following:
- Linear Accelerator
- On-Board Imager
- Trilogy RapidArc
  The 4D Integrated Treatment Console has been modified to include additional accessory support, treatment tasks and import/export interfaces.

AI/ML Overview

The provided text is a 510(k) summary for the "4D Integrated Treatment Console." This document describes a medical device, its intended use, and its substantial equivalence to previously cleared devices. It is a regulatory submission, not a study report.

Therefore, the input does not contain information about:

Acceptance criteria for device performance.
A study proving the device meets acceptance criteria.
Sample sizes for test or training sets.
Data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Type of ground truth used.
How ground truth for the training set was established.

This 510(k) submission focuses on demonstrating substantial equivalence to existing devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria in the manner typically seen for diagnostic AI/ML device clearances.

Conclusion:

Based on the provided document, it is not possible to complete the requested table and answer the questions regarding acceptance criteria and a study proving device performance. The information provided is a regulatory filing for a medical device that assists in radiation therapy treatment setup, not a clinical performance study.

Summary

{0}------------------------------------------------

K091132

Premarket Notification [510(k)] Summary 4D Integrated Treatment Console

JUN 1 7 2009

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: 16 April 2009

Proprietary Name:

Classification Name:

Common/Usual Name:

Predicate Devices;

Device Description:

4D Integrated Treatment Console

Medical charged-particle radiation therapy system 21 CFR 892.5050, Class II Product Code: MUJ

4DITC

4D Integrated Treatment Console, K050479 4D Integrated Treatment Console with PAVS, K081036

The 4D Integrated Console provides the user with:

A treatment verification function to assist the operator of D a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set-up parameters
Treatment safety by preventing the radiation therapy device ם from commencing irradiation when a linear accelerator. MLC, or MV imager parameter is out of conformance with the treatment plan
ם The ability to select patients from a queue provided by the schedule
The ability to retrieve plans from an information system for ם the selected patient
The ability to evaluate a selected treatment plan to ロ determine whether redefined dose limits will be exceeded
The ability to acquire and edit positional data from radiation ロ therapy devices
ଘ The ability to override specific treatment parameters based on individual user rights
ם The ability to send treatment records to an information system
The ability to interact with the user controls of the ם PortalVision, the multi-leaf collimator system, the Patient Accessory Verification System, and the treatment
- verification function at a single workstation

{1}------------------------------------------------

ם Provides access to the following:
- ם Linear Accelerator
- D On-Board Imager
- ם Trilogy RapidArc

The 4D Integrated Treatment Console has been modified to include additional accessory support, treatment tasks and import/export interfaces. For details, refer to the documentation in this submission.

Statement of Indications for Use:

The 4DITC function is designed to assist the operator of radiation therapy device in providing accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

Technological Characteristics:

Refer to the Substantial Equivalence Comparison Chart

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Vy Tran Vice President, Corporate Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way M/S E-110 PALO ALTO CA 94304-1129

JUN 1 7 2009

Re: K091132

Trade/Device Name: 4D Integrated Treatment Console Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE, MUJ Dated: May 26, 2009 Received: May 27, 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4D Integrated Treatment Console

Indications for Use

510(k) Number (if known): K691132

Device Name: 4D Integrated Treatment Console

Indications for Use:

The 4DITC function is designed to assist the operator of a radiation therapy device in providing. accurate treatment setups for each patient by monitoring setup parameters and preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.

ਮ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 201 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danny Sharpe

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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.