(51 days)
No reference devices were used in this submission
No
The description focuses on parameter verification and data transfer, with no mention of AI/ML terms or capabilities.
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. It does not actively treat or diagnose a disease.
No
The device is described as assisting with "accurate treatment delivery" 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." This indicates a function of control and verification for treatment rather than diagnosis of a condition.
No
The device description explicitly states it interacts with and verifies parameters from a "Treatment Console System (TCS)" and a "linear accelerator," which are hardware components. While the 4DITC itself might be primarily software, its function is intrinsically tied to controlling and monitoring hardware, making it a system that includes hardware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device provides assistance for accurate 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 radiation therapy delivery, not the examination of specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury.
- Device Description: The description focuses on retrieving and verifying treatment plans and parameters for radiation therapy. It does not mention any interaction with biological specimens or laboratory procedures.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic information, or any of the typical characteristics associated with IVD devices.
Therefore, the 4D Integrated Treatment Console is a device used in the context of radiation therapy treatment delivery, 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
4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (OIS) 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 Oll.
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)
Software verification and validation were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this pre-market submission.
The predicate device was cleared based only on non-clinical testing, and no animal or clinical studies were performed for the subject device. The non-clinical verification and validation data demonstrates that the subject device should perform as intended in the specified use conditions.
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.
No reference devices were used in this submission
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.
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February 12, 2021
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Varian Medical Systems, Inc. % Mr. Peter J. Coronado Senior Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K203766
Trade/Device Name: 4D Integrated Treatment Console v13.0 MR4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: December 22, 2020 Received: December 23, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203766
Device Name 4D Integrated Treatment Console v13.0 MR4
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
510(k) Summary
| The following information is provided as required by 21 CFR 807.92 | K203766 | |
|---|---|---|
| SUBMITTER | ||
| Name and Address: | Varian Medical Systems, Inc. | |
| 3100 Hansen Way, m/s E110 | ||
| Palo Alto, CA 94304 | ||
| Contact Person: | Peter J. Coronado | |
| Senior Director of Regulatory Affairs | ||
| Phone: 650-424-6320 Fax: 650-646-9200 | ||
| submissions.support@varian.com | ||
| Date Prepared: | December 22, 2020 | |
| DEVICE | ||
| Subject Device Name: | 4D Integrated Treatment Console v13.0 MR4 | |
| Common/Usual Name: | 4D Integrated Treatment Console | |
| Product Code and Classification: | Medical charged-particle radiation therapy system | |
| MUJ 21 CFR 892.5050 Class II | ||
| PREDICATE DEVICE | ||
| Predicate Device Name: | ||
| Reference Device(s): | 4D Integrated Treatment Console v13.0 (K133331) | |
| No reference devices were used in this submission |
DEVICE DESCRIPTION
4D Integrated Treatment Console (4DITC) allows the user to retrieve treatment plans and images from the Oncology Information System (OIS) 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 Oll.
4
Varian Medical Systems, Inc 3100 Hansen Way Palo Alto, CA 94304-1038 Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
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 therapy device from commencing irradiation when any parameter is out of conformance with the treatment plan.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modified device, referred to as the "subject device" throughout this summary, is release version v13.0 MR4 (Version 13.0 Minor Release 4) of the 4D Integrated Treatment Console with additional software changes incorporated since the release version of the predicate device, v13.0 (version 13.0; K133331).
The Changes in the subject device compared with the predicate device are as follows:
- Risk control measure of accidentally treating with a Quality Assurance (QA) / verification . plan changed from a warning message to blocking the use of QA / verification plans for treatment in clinical mode
- Shared Framework Integration ●
- Microsoft Windows Embedded Standard (WES) 7 Support ●
- IGMA 8913 workstation updated to IGMA 8110D ●
- Cybersecurity Enhancements ●
- WES7 Knowledge Base (KB) updates O
- o Application whitelisting (Applocker)
- USB mass storage hardening O
- MICAP firmware upgrade o
- Minor enhancements and bug fixes ●
PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Software Verification and Validation Testing
Software verification and validation were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
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Test results demonstrate conformance to applicable requirements and specifications. No animal studies or clinical tests have been included in this pre-market submission.
Standards Conformance
The subject device conforms in whole or in part with the following standards:
- IEC 62304:2006+A1:2015 Medical device software - Software lifecycle processes
- IEC 62366-1:2015 Medical device – Part 1: Application of usability engineering to medical devices
- IEC 61217:2011 Radiotherapy Equipment Coordinates, Movements and Scales .
- IEC 62274:2005 Medical electrical equipment - Safety of radiotherapy record and verify systems
CONCLUSION
The predicate device was cleared based only on non-clinical testing, and no animal or clinical studies were performed for the subject device. The non-clinical verification and validation data demonstrates that the subject device should perform as intended in the specified use conditions.
Therefore, Varian considers the subject device, 4D Integrated Treatment Console v13.0 MR4, is substantially equivalent to the predicate device 4D Integrated Treatment Console v13.0 (K133331).