(116 days)
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options. ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.
The provided FDA 510(k) summary for ARIA Radiation Therapy Management System (18.1) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and the study proving device performance.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states: "Test results demonstrate conformance to applicable requirements and specifications." However, it does not provide a specific table of acceptance criteria or reported device performance metrics. It implies that underlying V&V documentation exists that confirms the software meets its design requirements, but these details are not present in this summary.
2. Sample size used for the test set and the data provenance
The document states: "No animal studies or clinical tests have been included in this pre-market submission." This indicates that the validation was likely based on non-clinical software testing, not patient data. Therefore, there is no patient-specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective) mentioned. The testing would have involved simulated data, test cases, or internal datasets to verify software functionalities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Since the testing was non-clinical software verification and validation, there is no mention of experts establishing ground truth for a test set in the traditional sense of clinical evaluation. Software testing typically relies on predefined requirements, specifications, and expected outputs, rather than expert-adjudicated ground truth from medical images or patient cases.
4. Adjudication method for the test set
Similarly, because there are no clinical trials or expert-adjudicated test sets, there is no adjudication method (e.g., 2+1, 3+1) described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." Therefore, no MRMC comparative effectiveness study was conducted or reported for this submission. The device is a radiation therapy management system, not explicitly an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The submission indicates that the software underwent "Software Verification and Validation Testing" and was considered a "major" level of concern. This implies extensive standalone algorithm (software) testing to ensure it meets its functional and safety requirements. However, specific details of these tests (e.g., test cases, scenarios, and their results) are not provided in this summary. The device "does not directly act on the patient" and is "applied by trained medical professionals," suggesting it's an assistive tool within a human workflow, but its core functionalities are tested in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the non-clinical nature of the testing, the "ground truth" would have been established by the software requirements and specifications, test case design, and expected outputs defined by the developers. This is typical for software verification and validation, where the goal is to confirm the software performs as designed.
8. The sample size for the training set
The submission does not mention any training set as there is no indication of machine learning or AI models with external data training involved that would require such information. The changes appear to be feature enhancements to an existing software system.
9. How the ground truth for the training set was established
As no training set is mentioned, this information is not applicable.
In summary, the provided document focuses on the regulatory aspects of a software update (v18.1) to an existing device (v18.0) and highlights software verification and validation as the primary evidence of performance. It explicitly states that no clinical or animal studies were included. Therefore, the detailed performance metrics, test set characteristics, and expert involvement typically associated with clinical efficacy studies are not present.
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December 13, 2024
Varian Medical Systems, Inc Dr. Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 64304
Re: K242463
Trade/Device Name: ARIA Radiation Therapy Management System (18.1) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: November 15, 2024 Received: November 15, 2024
Dear Dr. Lynn Allman:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
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assistance/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,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
ARIA Radiation Therapy Management System (18.1)
Indications for Use (Describe)
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Premarket Notification - 510(k) Summary
Traditional 510(k) Submission for ARIA Radiation Therapy Management System v18.1
Legally Marketed Equivalent Device (Predicate)
| Product: | ARIA Radiation Therapy Management System v18.0 |
|---|---|
| 510(k) Number: | K230699 |
| Intended Use: | The ARIA Radiation Therapy Management product is a treatment plan and imagemanagement application. It enables the authorized user to enter, access, modify, storeand archive treatment plan and image data from diagnostic studies, treatment planningsimulation, plan verification and treatment. ARIA Radiation Therapy Management alsostores the treatment histories including dose delivered to defined sites and providestools to verify performed treatments. |
There is no change in intended use between the predicate and subject device.
l. Submitter's Name
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: August 19, 2024
II. Device Information
Proprietary Name: ARIA Radiation Therapy Management System v18.1 Classification Name: Medical charged-particle radiation therapy system Regulation Number: §892.5050 Product Code: MUJ
III. Predicate Device
ARIA Radiation Therapy Management System v18.0 (K230699)
IV. Device Description
ARIA Radiation Therapy Management (ARIA RTM) manages several treatment information such as images and treatment data to prepare plans created for treatment and review post-treatment images and records. It also provides quality assurance options.
ARIA RTM does not directly act on the patient. ARIA RTM is applied by trained medical professionals in the process of preparation and management of radiotherapy treatments for patients.
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Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
V. Intended Use
The ARIA Radiation Therapy Management product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Therapy Management also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments.
VI. Comparison of Technological Characteristics with the Predicate Device
The modified device, referred to as the "subject device" throughout this summary, is release version v18.1 (version 18.1) of the ARIA Radiation Therapy Management System with additional software changes incorporated since the release version of the predicate device, version 18.0 (K230699).
The changes in the subject device are as follows:
- Dynamic Collimator Support
- Multi-Institution
- . Integrated Patient Setup Documentation (CTH Integration)
- . Enhanced Calibration Curve Support
VII. Summary of Performance Testing (Non-Clinical Testing)
The following performance data was provided in support of the substantial equivalence determination.
Software Verification and Validation Testing:
Software verification and validation was 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.
Use of Consensus Standards:
The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy.
| ISO 14971:2019 | Medical devices - Application of risk management to medical devices |
|---|---|
| ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling andinformation to be supplied - Part 1: General requirements |
| ISO 20417:2021 | Information supplied by the manufacturer of medical devices |
| IEC 62304:2006 + A1:2016 | Medical Device Software - Software Lifecycle processes |
510(k) Summary
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Image /page/6/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is black and white.
| IEC 62366-1:2015+A1:2020 | Application of Usability Engineering to Medical Devices |
|---|---|
| IEC 82304-1:2016 | Health software Part 1: General requirements for product safety |
| AAMI RT2:2017 | Radiation Therapy Readiness Check |
| IEC 61217:2011 | Radiotherapy Equipment, Coordinates, Movements and Scales |
| IEC 62083:2009 | Medical electrical equipment - Requirements for the safety of radiotherapytreatment planning systems |
| UL ANSI 2900-1:2017 | Standard for Software Cybersecurity for Network-Connectable Products, Part 1:General Requirements |
| UL ANSI 2900-2-1:2017 | Software Cybersecurity for Network-Connectable Products, Part 2-1: ParticularRequirements for Network Connectable Components of Healthcare and WellnessSystems |
| IEC 81001-5-1:2021 | Health Software and Health IT Systems Safety, Effectiveness and Security - Part 5-1:Security - Activities In The Product Life Cycle |
VIII. Determination of Substantial Equivalence to the Predicate
A subset of software features and characteristics of the subject device are different from the predicate device. However, Varian considers these differences to be enhancements of the principle of operation of the subject device is the same as that of the existing predicate device. Verification and validation demonstrate that the subject device is as safe and effective as the predicate. Varian therefore believes that the subject device is substantially equivalent to the predicate device.
§ 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.