(28 days)
Not Found
No
The description focuses on rule-based verification and barcode scanning, with no mention of AI/ML terms or concepts.
No
The device is designed to assist operators of radiation therapy devices by monitoring setup parameters and preventing irradiation when parameters are out of conformance, thus enhancing treatment safety. It does not treat or diagnose any disease or condition; rather, it is a control and verification system for other medical devices.
No
The device is designed to assist in preventing the radiation therapy device from commencing irradiation when parameters are out of conformance with the treatment plan and for verifying patient accessories and patient identity, not for diagnosing a disease or condition.
No
The device description explicitly mentions the use of a "hand-held bar code scanner" and a "label printer," which are hardware components. While the core functionality is software-based, the system relies on these physical devices for its operation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly indicate that this device is used to assist in radiation therapy treatment setups for patients, monitor setup parameters, and verify patient and accessory information. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device interacts directly with the patient and the radiation therapy equipment. Its function is to ensure accurate and safe delivery of radiation therapy, which is a clinical procedure performed on the patient.
The device described is a component of a radiation therapy system, focused on patient setup, verification, and safety during treatment delivery. This falls under the category of medical devices used in the treatment of patients, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes
IYE
Device Description
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.
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
operator of a radiation therapy device
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
Not Found
Key Metrics
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
MAY - 9 2008
:
Premarket Notification 510(k) Summary
| 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) 424-5040
Date: 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 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. |
| Statement of
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. |
| Technological
Characteristics: | Refer to the Substantial Equivalence Comparison Chart. |
1
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.
2
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
3
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
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ETPS_510(k) _IFU
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Date: May 10, 2007