(25 days)
No reference devices were used in this submission.
No
The document does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning software functionalities.
No.
The Eclipse TPS is a software device used for planning radiotherapy treatments, not for directly delivering therapy or having a therapeutic effect itself.
No
The device is a treatment planning system, not a diagnostic device. Its purpose is to plan radiotherapy treatments, not to diagnose diseases.
Yes
The device description explicitly states that Eclipse TPS is a "computer-based software device" and provides "software tools" for treatment planning. The summary of performance studies mentions "Software Verification and Validation Testing," further indicating its software-only nature. While it interacts with imaging data (DECT), the device itself is described solely as software.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Eclipse TPS Function: The description clearly states that Eclipse TPS is a software system used by trained medical professionals to plan and simulate radiation therapy treatments for malignant or benign diseases. It uses imaging data (DECT) to design treatment plans, not to analyze biological specimens for diagnostic information.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the human body. Its input is imaging data, and its output is a treatment plan.
Therefore, the function and intended use of the Eclipse TPS fall outside the scope of an In Vitro Diagnostic device. It is a treatment planning software used in the field of radiation oncology.
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.
Product codes
MUJ
Device Description
The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS consists of different applications, each used for specific purposes at a different phase of treatment planning.
Eclipse TPS 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Dual Energy Computed Tomography (DECT) images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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July 10, 2020
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Varian Medical Systems, Inc % Mr. Peter Coronado Senior Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K201607
Trade/Device Name: Eclipse Treatment Planning System, v16.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: June 10, 2020 Received: June 15, 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/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.
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) for devices or postmarketing safety reporting (21 CFR 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 (QS)
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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 mediation-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) K201607
Device Name Eclipse Treatment Planning System, v16.1
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.
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
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
510(k) Summary
The following information is provided as required by 21 CFR 807.92.
| SUBMITTER | |
|---|---|
| Name and Address: | Varian Medical Systems |
| 3100 Hansen Way, m/s E110 | |
| Palo Alto, CA 94304 | |
| Contact Person: | Peter J. Coronado |
| Sr. Director, Regulatory Affairs | |
| Phone: 650-424-6320 Fax: 650-646-9200 | |
| submissions.support@varian.com | |
| Date Prepared: | 10 June 2020 |
| DEVICE | |
| Subject Device Name: | Eclipse Treatment Planning System v16.1 |
| Common/Usual Name: | Eclipse Treatment Planning System (Eclipse TPS) |
| Product Code and Classification: | Medical charged-particle radiation therapy system |
| MUJ 21 CFR 892.5050 Class II | |
| PREDICATE DEVICE | |
| Predicate Device Name: | Eclipse Treatment Planning System v16.0 (K200608) |
| Reference Device(s): | No reference devices were used in this submission. |
DEVICE DESCRIPTION
The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS consists of different applications, each used for specific purposes at a different phase of treatment planning.
Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation (brachytherapy) treatments.
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INDICATIONS FOR USE
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The modified device, referred to as the "subject device" throughout this summary, is release version v16.1 (version 16.1) of the Eclipse Treatment Planning System with additional software changes incorporated since the release version of the predicate device, version 16.0 (K200608).
At a high level, both the predicate device and the subject device are based on the same characteristics:
- . Both the subject device and the predicate provide software tools for planning 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 following differences exist between the software release versions of the subject and the predicate devices:
The significant changes compared with the predicate device are as follows:
- Graphics processing unit (GPU) calculation can be used for the Acuros PT dose calculation. 1.
-
- Dual Energy Computed Tomography (DECT) images can be used in calculation of proton stopping power.
-
- Preventing dose calculation for DECT Rho and Z images.
Other changes compared with the predicate device are detailed in the document_" Predicate Comparison and Summary of Design Control Activities" in the Executive Summary section of this submission.
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PERFORMANCE DATA
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.
Standards conformance
The subject device conforms in whole or in part with the following standards:
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes ●
- IEC 62366-1 Edition 1.0 2015-02 Application of usability engineering to medical devices .
- IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment Coordinates, movements, and scales .
- IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning . systems
- IEC 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
Argument for substantial equivalence to the predicate device
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.
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 data supports the safety of the device, and verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. There were no remaining discrepancy reports (DRs) which could be classified as Safety or Customer Intolerable.
Therefore, Varian considers Eclipse Treatment Planning System v16.1 to be safe and effective and perform at least as well as the predicate device, Eclipse Treatment Planning System 16.0 (K200608).