(28 days)
The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
The 4D Integrated Treatment Console provides the user with:
- a treatment verification function to assist the operator of a radiation . therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and to prevent the radiation therapy device from commencing irradiation while any 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 the 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 treatment parameters based on user rights .
- the ability to send treatment records to an information system i .
- the ability to interact with the user controls of the Portalvision, the multi-. the ability to microom and the treatment verification function on a single workstation.
- Provides access to the linear accelerator and the On-Board Imager. .
This document (K050479) is a 510(k) summary for the "4D Integrated Treatment Console." It's a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, not a study report proving specific device performance criteria with clinical data.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study specifics (MRMC, standalone performance) for the device's functionality is not available in the provided text.
The 510(k) summary focuses on:
- Device Description: What the device does (e.g., treatment verification, patient and plan management, interaction with other Varian systems).
- Intended Use Statement: The purpose of the device (to assist in accurate treatment setups by monitoring parameters and preventing irradiation when parameters are out of conformance).
- Technological Characteristics: Claims of substantial equivalence to its predicate device (Varian Medical Systems' Varis 1.4g, K001643), which are detailed in a separate "Substantial Equivalence Comparison Chart" (not provided in the input).
The FDA's letter (within the provided text) confirms that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This means the FDA found that the new device is as safe and effective as a legally marketed device and does not require a Premarket Approval (PMA).
In summary, the provided document does not contain the specific performance study details requested. Such details would typically be found in a separate validation or clinical study report, which is not part of this 510(k) summary.
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MAR 2 4 2005
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the 4D Integrated Treatment Console.
- Submitter: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: February 23, 2005
2. Name of the Device:
| Trade/Proprietary Name: | 4D Integrated Treatment Console |
|---|---|
| Common or Usual Name: | Accessory to Medical Linear Accelerator |
| Classification Name: | Medical Charged Particle Radiation TherapySystem21 CFR §892.5050Class IIProduct Code: 90 IYE |
- Predicate Devices to claim substantial equivalence:
- a. Varian Medical Systems' Varis 1.4g (K001643)
- Device Description: The 4D Integrated Treatment Console provides the user with:
- a treatment verification function to assist the operator of a radiation . therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and to prevent the radiation therapy device from commencing irradiation while any 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 the information system for the selected . patient
- the ability to evaluate a selected treatment plan to determine whether . redefined dose limits will be exceeded
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- the ability to acquire and edit positional data from radiation therapy . devices
- the ability to override treatment parameters based on user rights .
- the ability to send treatment records to an information system i .
- the ability to interact with the user controls of the Portalvision, the multi-. the ability to microom and the treatment verification function on a single workstation.
- Provides access to the linear accelerator and the On-Board Imager. .
-
- Intended Use Statement: 4D Integrated Treatment Console is designed to assist mentour Obe Baltimion therapy device in providing accurate treatment set-ups the operator of a rationing set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
-
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director of Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K050479 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 Dated: February 23, 2005 Received: February 24, 2005
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 (Premarket Approval), it may be subject to such 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); 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.
MAR 2 4 2005
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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse orgal finding of substantial equivalence of your device to a legally prematics notification: "The PDF management of 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 Part 801), please If you desire specific act not of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Act from be the regulation other general information on your responsibilities under the Act from the 001:27). I ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KOSO479 Device Name: 4D Integrated Treatment Console
Indications For Use:
The 4D Integrated Treatment Console is designed to assist the operator of a radiation therapy device in providing accurate treatment set-ups for each patient by monitoring set up parameters de hee in pro riains accurate therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
Thancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.