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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Varian Eclipse Treatment Planning System, v16.1. It describes the device and claims substantial equivalence to a predicate device (Eclipse Treatment Planning System v16.0). However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document primarily focuses on software verification and validation, standards conformance, and a comparison to its predicate device. It explicitly states: "No animal studies or clinical tests have been included in this pre-market submission." This indicates that the type of performance data typically associated with studies proving a device meets specific clinical or diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy against a ground truth) is not present here.

Therefore, many of the requested fields cannot be directly extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy thresholds, sensitivity/specificity targets). The acceptance criteria mentioned are general conformance to requirements, specifications, and standards (e.g., IEC 62304, IEC 62366-1, IEC 61217, IEC 62083, IEC 82304-1).
Reported Device Performance: The document states, "Test results demonstrate conformance to applicable requirements and specifications." and "There were no remaining discrepancy reports (DRs) which could be classified as Safety or Customer Intolerable." This is a general statement about meeting system-level requirements, not specific quantitative performance metrics against a defined ground truth for a clinical indication.

Acceptance Criteria (General)	Reported Device Performance (General)
Conformance to applicable requirements and specifications	Test results demonstrate conformance.
Conformance with specified IEC standards	Conforms in whole or in part with IEC 62304, 62366-1, 61217, 62083, 82304-1.
No remaining critical discrepancy reports	No remaining DRs classified as Safety or Customer Intolerable.
Performs as intended in specified use conditions	Verification and validation demonstrate the subject device should perform as intended.
As safe and effective as the predicate device	Deemed as safe and effective and performs at least as well as the predicate device.

2. Sample size used for the test set and the data provenance:

Not specified. The document mentions "Software Verification and Validation Testing" but does not detail the size or nature of any specific test sets used for evaluating clinical performance or dose calculation accuracy with patient data. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). Given that no clinical studies were performed, any "test set" would likely refer to internal engineering tests, rather than a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. Since no clinical studies or "patient-like" test sets with established ground truths for diagnostic/clinical accuracy were mentioned, this information is not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This is relevant for studies involving human readers or expert consensus on ground truth, which were not part of this submission's provided performance data.

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:

No, an MRMC study was not done. The document explicitly states "No animal studies or clinical tests have been included in this pre-market submission." This type of study would fall under clinical testing.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not explicitly stated in terms of clinical performance. The "Software Verification and Validation Testing" implies testing of the algorithm, but the performance endpoints are not reported in clinical terms (e.g., sensitivity, specificity, accuracy of dose calculation compared to a gold standard in patients). The changes (GPU calculation for Acuros PT dose, DECT for proton stopping power, preventing dose calculation for DECT Rho and Z images) are technical enhancements that would have been validated through internal engineering tests for accuracy and consistency, but the specific results of these standalone performance evaluations against clinical ground truth are not provided here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified for clinical endpoints. For software verification and validation, the "ground truth" would be the expected output or behavior according to system requirements and specifications (e.g., a known correct dose calculation for a phantom, correct image processing results). However, this is not a ground truth related to clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

Not applicable/Not specified. Treatment planning systems typically use physics models and algorithms, not machine learning models that require "training sets" in the conventional sense. While there might be internal data used for calibration or model development, it's not referred to as a "training set" in this context, nor is its size provided.

9. How the ground truth for the training set was established:

Not applicable/Not specified. As there's no mention of a traditional machine learning "training set," this information is not relevant to the provided document.

In summary, the provided FDA 510(k) summary focuses primarily on software development practices, adherence to standards, and a comparison demonstrating substantial equivalence to a predicate device based on non-clinical testing. It explicitly states the absence of animal or clinical studies, meaning the type of performance evaluation you're asking about (related to clinical accuracy against ground truth using patient data) was not part of this specific submission.

Summary

{0}------------------------------------------------

July 10, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration" below it. The seal on the left is a stylized representation of human figures.

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)

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K201607

Device Name Eclipse Treatment Planning System, v16.1

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains three blue circles in a horizontal row. The circles are evenly spaced and appear to be the same size. The background is white, which makes the blue circles stand out. The circles are solid blue, with no visible patterns or textures.

varian

Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304

K201607

510(k) Summary

The following information is provided as required by 21 CFR 807.92.

SUBMITTER
Name and Address:	Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto, CA 94304
Contact Person:	Peter J. CoronadoSr. Director, Regulatory AffairsPhone: 650-424-6320 Fax: 650-646-9200submissions.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 systemMUJ 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

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.

{4}------------------------------------------------

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.
1. Dual Energy Computed Tomography (DECT) images can be used in calculation of proton stopping power.
1. 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.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.

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).

Regulation Number and Section

§ 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.