(90 days)
Not Found
No
The description focuses on verification of parameters against a treatment plan and does not mention any learning or adaptive capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is described as assisting with accurate treatment delivery by monitoring linear accelerator parameters and preventing irradiation when parameters are out of conformance with the treatment plan. It is a control system for a radiation therapy device, not a device that directly delivers therapy or performs a therapeutic function itself.
No
The device is described as assisting with accurate treatment delivery by monitoring linear accelerator parameters and preventing irradiation when parameters are out of conformance with the treatment plan. It is a control and verification system for radiation therapy, not a device that diagnoses a disease or condition.
No
The device description explicitly states that the software interacts with and controls a "radiation therapy device" (linear accelerator), which is a hardware component. The software's function is to monitor parameters of this hardware and prevent irradiation based on those parameters. While the 4DITC itself might be primarily software, its function is intrinsically tied to the operation and control of a physical medical device, making it more than just a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in accurate radiation therapy treatment delivery by monitoring linear accelerator parameters and preventing irradiation when parameters are out of conformance with the treatment plan. This is a function related to controlling and verifying a medical treatment device, not analyzing biological samples or providing diagnostic information about a patient's health status.
- Device Description: The description focuses on retrieving, verifying, and sending treatment parameters and history between different systems (OIS and TCS). It's about managing and controlling the treatment process, not performing in vitro tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a disease or condition.
In summary, the 4D Integrated Treatment Console is a device used in the delivery of radiation therapy, acting as a control and verification system for the linear accelerator. This falls under the category of a therapeutic or treatment delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by 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
Device Description
The 4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (IS) and send the plan and images to the Treatment Console System (TCS). The planned treatment parameters from the OIS are verified against the TCS delivery parameters for accuracy. All treatment parameters on the TCS must match the treatment parameters on the 4DITC before treatment can be delivered. After the treatment has been completed for the session, the user closes the session and treatment history is sent to the OIS to be recorded. The recorded treatment history can then be displayed and reviewed in the OIS.
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
Not Found
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)
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes.
Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device.
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
VARÍAN
Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731
JAN 27 2014
medical systems
4DITC 510(k) Summary as required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, M/S C-255
Palo Alto, CA 94304 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 650.424.5731
Fax: 650.842.5040 |
| Contact Name: | Peter J. Coronado
Director, Regulatory Affairs
submissions.support@varian.com |
| Date Prepared: | October 28, 2013 |
| Trade Name: | 4D Integrated Treatment Console |
| Common Name: | 4DITC |
| Classification Name: | Medical charged-particle radiation therapy system
21 CFR 892.5050
Class II, Product Code MUJ |
| Predicate Device: | Varian Medical Systems, Inc., 4D Integrated Treatment
Console (K091132) |
| Device Description: | The 4D Integrated Treatment Console (4DITC) allows the
user to retrieve treatment plans and images from the
Oncology Information System (IS) and send the plan and
images to the Treatment Console System (TCS). The
planned treatment parameters from the OIS are verified
against the TCS delivery parameters for accuracy. All
treatment parameters on the TCS must match the treatment
parameters on the 4DITC before treatment can be delivered.
After the treatment has been completed for the session, the
user closes the session and treatment history is sent to the
OIS to be recorded. The recorded treatment history can then
be displayed and reviewed in the OIS. |
The 4D Integrated Treatment Console has been modified to support additional treatment tasks and import/export interfaces. The following chart shows the new features as well as two features that have been removed in version 13.
1
. .
1
Varian Medical Systems, Inc. 3100 Hausen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 ww.varian.com
medical systems
VARŽAN
Technological Characteristics: Changes to the predicate devices are listed in the below table:
| Features | Predicate Device
4DITC (v8.8)
K091132 | Modified Device
4DITC (v 13) |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General description | The 4D Integrated Treatment
Console (4DITC) is designed to
allow treatment plans and images
to be retrieved from the Oncology
Information System (OIS) and
sent to the Treatment Console
System (TCS), planned treatment
plan parameters to be verified
against the TCS delivery
parameters for accuracy and
treatment history to be recorded
in the OIS for use and display. | The 4D Integrated Treatment
Console (4DITC) is designed to
allow treatment plans and
images to be retrieved from the
Oncology Information System
(OIS) and sent to the Treatment
Console System (TCS), planned
treatment plan parameters to be
verified against the TCS delivery.
parameters for accuracy and
treatment history to be recorded
in the OIS for use and display. |
| Indications for Use/Intended Use | The 4D Integrated Treatment
Console 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 provides assistance for
accurate treatment delivery by
monitoring linear accelerator
parameters and preventing the
radiation therapy device from
commencing irradiation when
any parameter is out of
conformance with the treatment
plan |
| General Usage | | |
| Imaging Only Sessions | No | Yes |
| Ad hoc kV imaging supported | No | Yes |
| Support the saving of
Acquisition Module images in
QA Mode | No | Yes |
| Conical Collimator support | Yes | Yes, Barcode Conical Collimator
Verification (BCCV) and
Integrated Conical collimator
Verification & Interlock system
(ICVI) |
| Bolus | Yes, Barcode verification | Yes, Barcode verification and
Manual verification |
| Gantry angle acquired for
treatment fields with adhoc CBCT
fields | Yes | No |
| Support for Unplanned
Treatments | No. | Yes |
| Support for Flattening Filter Free
treatments | No | Yes |
| Delta couch shift | No | Yes |
| Features | Predicate Device
4DITC (v8.8)
K091132 | Modified Device
4DITC (v 13) |
| Enter in treatment notes and
SSD's per plan/field | No | Yes |
| Support for multiple isocenters
with grouping in a single plan | No | Yes |
| Major plan edits | Yes | No |
| High Intensity Mode (HIM) Also
known as FFF (Flattening Filter
Free) | No | Yes |
| UNIQUE Support | No | Yes |
| Varian Volumetric Modulated Arc
Therapy (VVMAT vs. RapidArc
support) | No | Yes |
| National Language Support
(NLS) | No | Yes |
| Unicode Support | No | Yes |
| Stereotactic (SRS) - Dose Limit
support for High Dose Technique | No | Yes |
| Integrated Conical Collimator
Verification | No | Yes, Integrated Conical
Collimator Verification and
Interlock System (ICVI) |
2
Varian Medical Systems, Inc. 3100 Hansen Way, M/S C-255
Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com
Note the reasons for the removal of features:
-
- Major Plan Edits: We are no longer supporting major plan edits which were User Riahts controlled outside of Unplanned Treatment Mode. This change will assure that edits to major plan parameters occur only in the Treatment Planning/Oncology Information Planning software or in the 4D Unplanned Treatment Mode.
-
- Gantry angle acquired for treatment fields with adhoc CBCT fields: The intention of the feature was to allow the user to acquire the gantry angle on the adhoc CBCT field. The consequence was that the user could also acquire the new gantry angle for the treatment fields which is considered a major plan edit. Removing the capability to acquire the gantry angle for the treatment fields continues to allow the user to acquire the CBCT gantry angle, while honoring the Plan Edit Preferences in 4DITC Administration.
Verification and Validation Testing
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes.
Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
3
K133331
page 4 of 4
VARŽAN
medical systems
3100 Hansen Way, M/S C-255 Palo Alto, CA 94304-1038 USA tel. +1 650 424 5731 www.varian.com
Varian Medical Systems, Inc.
Verification &Validation Summary Report
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian, therefore, considers 4DITC to be safe and effective and to perform at least as well as the predicate device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human figure or a bird-like shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
January 27, 2014
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K133331
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: MUJ Dated: October 28, 2013 · Received: October 29, 2013
Dear Mr. Coronado:
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
5
Page 2 - Mr. Peter J. Coronado
. . . .. .. .. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/McdicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Richard D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K133331
Device Name: 4D Integrated Treatment Console (4DITC)
Indications For Use:
The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by preventing the radiation therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Page 1 of _ 1 __
K133331 510(k)