(28 days)
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.
The 4D Integrated Treatment Console (4DITC) has been modified to add a new capability called Patient Accessory Verification System (PAVS). PAVS is a feature set of 4D ITC that enhances treatment safety. This feature allows users to identify accessories (not connected to the linac) for patients and interlock the radiation beam until these devices have been acknowledged by the end-user. Also, PAVS allows patient verification between the patient on the treatment schedule with the patient in the treatment room. This is accomplished using a hand-held bar code scanner used in conjunction with software by trained clinical staff. Staff defines which accessories require a bar code label to be scanned. Clinical staff creates the labels for the accessories using label creation software in Practice Management and a label printer. Staff scans the appropriate accessories for each patient's treatment field for accessory selection verification.
The provided text is a 510(k) summary for a medical device (4D Integrated Treatment Console with Patient Accessory Verification System - PAVS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This document primarily focuses on:
- Device identification: Proprietary name, classification name, common name, predicate device.
- Device description: An explanation of the 4D Integrated Treatment Console (4DITC) and its new feature, Patient Accessory Verification System (PAVS), which enhances treatment safety by verifying patient accessories and patient identity using a bar code scanner.
- Indications for Use: Describes the purpose of the 4DITC in assisting radiation therapy operators with accurate treatment setups by monitoring parameters and preventing irradiation if parameters are out of conformance.
- Regulatory information: Mentions the FDA's review and determination of substantial equivalence to a predicate device, regulatory class, and general controls.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this data is not present in the provided text.
The text states "Refer to the Substantial Equivalence Comparison Chart" under the "Technological Characteristics" section, but this chart is not included in the provided document. Such a chart or other sections of the 510(k) submission would typically contain performance data and acceptance criteria.
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MAY - 9 2008
:
Premarket Notification 510(k) Summary
| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Vy TranPhone: (650) 424-5731Fax: (650) 424-5040Date: April 9, 2008 |
|---|---|
| Proprietary Name: | 4D Integrated Treatment Console |
| Classification Name: | Medical charged-particle radiation therapy system,21 CFR 892.5050, IYE, Class II |
| Common/Usual Name: | 4DITC |
| Predicate Devices: | 4D Integrated Treatment Console, K050479 |
| Device Description: | The 4D Integrated Treatment Console (4DITC) has beenmodified to add a new capability called Patient AccessoryVerification System (PAVS). PAVS is a feature set of 4D ITCthat enhances treatment safety. This feature allows users toidentify accessories (not connected to the linac) for patients andinterlock the radiation beam until these devices have beenacknowledged by the end-user. Also, PAVS allows patientverification between the patient on the treatment schedule withthe patient in the treatment room. This is accomplished using ahand-held bar code scanner used in conjunction with software bytrained clinical staff. Staff defines which accessories require abar code label to be scanned. Clinical staff creates the labels forthe accessories using label creation software in PracticeManagement and a label printer. Staff scans the appropriateaccessories for each patient's treatment field for accessoryselection verification. |
| Statement ofIndications for Use: | The 4DITC function is designed to assist the operator of aradiation therapy device in providing accurate treatment setupsfor each patient by monitoring setup parameters and preventingthe radiation therapy device from commencing irradiation whenany parameter is out of conformance with the treatment plan. |
| TechnologicalCharacteristics: | Refer to the Substantial Equivalence Comparison Chart. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304
Re: K081036
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: April 8, 2008 Received: April 11, 2008
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 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.
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Page 2
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.
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 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.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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours.
Nancy 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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4D Integrated Treatment Console
Indications for Use
081036
510(k) Number (if known):
Device Name:
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE, OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Torri McWhan
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Page of
ETPS_510(k) _IFU
Page 1 of 1
Date: May 10, 2007
§ 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.