(58 days)
Not Found
No
The description focuses on monitoring parameters, preventing irradiation based on conformance with a treatment plan, and interacting with existing radiation therapy devices and information systems. There is no mention of learning, adaptation, or complex pattern recognition that would typically indicate AI/ML.
No.
This device is designed to assist in therapy planning and safety by monitoring treatment parameters and preventing irradiation when parameters are out of conformance, but it does not directly apply therapy or alter the body, which are characteristics of a therapeutic device.
No
The device is described as assisting in accurate treatment setups and preventing irradiation when parameters are out of conformance with the treatment plan. It provides treatment verification and safety functions for a radiation therapy device, rather than diagnosing a medical condition or disease.
No
The device description explicitly mentions interacting with and controlling hardware components of a radiation therapy system (linear accelerator, MLC, MV imager, PortalVision, On-Board Imager, Trilogy RapidArc). While it is a console, it is integrated with and controls physical medical devices, making it more than just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The described device, the 4D Integrated Treatment Console, is designed to assist in radiation therapy treatment delivery. Its functions involve monitoring treatment parameters, preventing irradiation when parameters are out of conformance, managing treatment plans, and interacting with radiation therapy equipment.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens from a patient. Its focus is on the technical aspects of delivering radiation therapy.
Therefore, the device's purpose and operation clearly fall outside the scope of In Vitro Diagnostics.
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 (comma separated list FDA assigned to the subject device)
MUJ, IYE
Device Description
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
- 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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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