(17 days)
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No
The document does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning functionalities.
No
Explanation: This device is a treatment planning system (software) used by medical professionals to design and simulate radiation therapy treatments, but it does not directly deliver the therapy itself.
No
The device is described as a "Treatment Planning System" used by medical professionals to "design and simulate radiation therapy treatments." Its Intended Use explicitly states it is "used to plan radiotherapy treatments." This indicates it is for treatment planning, not for identifying, monitoring, or diagnosing diseases or conditions.
Yes
The device description explicitly states that the Eclipse Treatment Planning System (Eclipse TPS) is a "computer-based software device". The summary focuses on software verification and validation, and there is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Eclipse TPS Function: The Eclipse TPS is a software system used for planning radiation therapy treatments. It takes imaging data (like kV CBCT) and other patient information to design how radiation will be delivered to a specific area of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "planning radiotherapy treatments." This is a treatment planning function, not a diagnostic function based on analyzing biological samples.
Therefore, the Eclipse TPS falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Product codes
MUJ
Device Description
The Eclipse Treatment Planning System (Eclipse TPS) is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. It is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
kV CBCT imaging
Anatomical Site
Eye (specifically for proton treatment of neoplasms of the eye)
Indicated Patient Age Range
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Intended User / Care Setting
Trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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." No animal studies or clinical tests have been included with this pre-market submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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May 18, 2018
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K181145
Trade/Device Name: Eclipse Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 30, 2018 Received: May 1, 2018
Dear Mr. Coronado:
We have reviewed vour 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 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.
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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/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181145
Device Name Eclipse Treatment Planning System
Indications for Use (Describe)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
| 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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Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304
650.493.4000 800.544.4636
varian.com
510(k) Summary
[Information provided according to 21 CFR 807.92]
Image /page/3/Picture/7 description: The image is a document that contains information about the Eclipse Treatment Planning System v15.6. The document is divided into five sections: Submitter, Device, Predicate Device, Device Description, and Indications for Use/Intended Use Statement. The submitter is Varian Medical Systems, Inc. located in Palo Alto, California. The device is a treatment planning system used for planning radiotherapy treatments for patients with malignant or benign diseases.
Image /page/3/Picture/8 description: The image contains three blue circles arranged horizontally against a white background. The circles are evenly spaced and appear to be of the same size. The color of the circles is a bright, solid blue, and they are the only objects in the image.
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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVI
Both the subject device and the predicate provide software the treatment of malignant or benign diseases with radiation. They are computer-based software devices used by trained medical professionals to design and simulate radiation therapy treatments. They are both capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.
The significant changes compared with the predicate device are as follows:
- a) Adding treatment planning support for Halcyon v2.0 features
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- Planning with kV CBCT imaging for Halcyon
- Planning with two-laver beam shaping (SX2 mode) for Halcyon MLC 2.
- Planning with dynamic beam flattening for Halcyon fields 3.
- Planning with long treatment field (multi-isocenter) 4.
- Machine configuration changes 5.
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b) Modifications to existing Eclipse features
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- Hybrid IMRT-VMAT plan creation change to Eclipse's MCO feature
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- DVH Estimation model export fix for Eclipse's RapidPlan feature
Treatment planning support for Halcyon is present in both the predicate device and subject device. The modifications to existing features are considered further developments of predicate features. The above changes do not affect the intended use of the Eclipse device. No Eclipse hardware requirement modifications are associated with these changes.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
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.
The subject device conforms in whole or in part with the following standards:
- . IEC 62304:2006, Medical Device Software - Software Life Cycle Processes
- IEC 62366-1:2015, Medical Devices Part 1: Application of Usability Engineering to Medical Devices ●
- IEC 61217:2011, Radiotherapy Equipment - Coordinates, Movements, and Scales
- IEC 62083:2009, Medical Electrical Equipment Requirements for the Safety of Radiotherapy ● Treatment Planning Systems
No animal studies or clinical tests have been included with this pre-market submission.
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions. Varian therefore considers Eclipse Treatment Planning System v15.6 to have a similar level of safety and effectiveness as the predicate device.