MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM by VARIAN MEDICAL SYSTEMS, INC.

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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

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 computerbased software device used by trained medical professionals to design and simulate radiation therapy treatments. 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 text does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria. The document is a 510(k) summary for the "Eclipse Treatment Planning System," primarily focused on establishing substantial equivalence to a predicate device.

However, based on the general nature of a 510(k) application for a treatment planning system, we can infer some general "acceptance criteria" related to the accuracy and functionality of dose calculation algorithms. The "study" would typically involve validation testing against known standards or other clinically accepted systems.

Here's an attempt to answer your questions based on what can be inferred, with explicit notes where information is missing:

Acceptance Criteria and Device Performance Study for Eclipse Treatment Planning System (K091492)

Note: The provided document is a 510(k) summary and primarily focuses on establishing substantial equivalence, not on detailing a specific performance study with explicit acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics is not present in the given text. The information below is based on general expectations for such devices and what can be vaguely inferred.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Dose Calculation Accuracy:	(Not explicitly stated in the provided text.)
Accuracy within clinical tolerances for various modalities (photon, electron, proton, brachytherapy).	The device's "Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye," suggesting it meets performance requirements for this specific application. The overall system is described as providing "software tools for planning the treatment... to design and simulate radiation therapy treatments," implying its calculations are considered clinically acceptable.
Agreement with established dose calculation methods or physical measurements.	Its substantial equivalence to the predicate device (Eclipse Treatment Planning System, K073020) suggests its performance is comparable and meets existing standards.
Functionality & Workflow:	(Not explicitly stated, but implied by device description.)
Ability to plan treatments for external beam (photon, electron, proton) and internal (brachytherapy).	"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."
User interface and features facilitating treatment design and simulation.	Described as a "computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments."
Safety & Control:	(Not explicitly stated, but implied by 510(k) process.)
Adherence to software development lifecycle and risk management.	The 510(k) process itself requires manufacturers to demonstrate compliance with general controls, including good manufacturing practices and risk management.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the document.
Data Provenance: Not specified. Any internal validation data would typically be generated in a controlled environment, but the originating country or whether it's retrospective/prospective is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. For a treatment planning system, ground truth would typically involve physical dosimetry measurements (e.g., ionization chambers, film, phantom studies) or comparisons to highly validated gold-standard algorithms, rather than direct expert consensus on a "test set" in the way one might evaluate diagnostic image interpretation. If human experts were involved in verifying the output, they would likely be medical physicists or radiation oncologists with extensive experience in dosimetry and treatment planning.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given the nature of a TPS, "adjudication" in the traditional sense (e.g., 2+1 for image interpretation) is less applicable. Validation would likely involve objective comparisons of calculated dose distributions against measured doses or established benchmark calculations, with deviations assessed against predetermined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, the provided document does not mention an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI tools where human reader performance is a key factor. For a treatment planning system, the focus is on the accuracy of the dose calculations and planning tools themselves, rather than how human readers improve with AI assistance in interpretation.

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

Standalone Performance: While not explicitly called "standalone performance," the validation of the dose calculation algorithms within the Eclipse TPS would inherently be a standalone evaluation of the algorithm's accuracy against physical measurements or benchmark data. The purpose of a TPS is to provide accurate calculations that a human then uses, so the core function of the algorithms operates "standalone" in generating a dose plan. However, the document does not detail this validation study.

7. The Type of Ground Truth Used

Type of Ground Truth: Not specified in the document. For a treatment planning system, ground truth typically involves:
- Physical Dosimetry Measurements: Using phantoms and dosimeters (e.g., ionization chambers, film, TLDs) to measure actual dose distributions under controlled conditions.
- Validated Reference Algorithms: Comparing the new algorithm's output to established, highly accurate dose calculation algorithms.
- Monte Carlo Simulations: Considered a gold standard for dose calculation due to its ability to model individual particle interactions.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable in the context of this device. The Eclipse Treatment Planning System is a deterministic software system based on physics principles and established dose calculation models (e.g., pencil beam, collapsed cone, Monte Carlo). It is not an AI/ML device that "learns" from a training set in the typical sense of pattern recognition or predictive analytics. Its algorithms are developed and refined based on physical models and experimental data, not trained on a "dataset."

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As explained in point 8, the Eclipse TPS is not an AI/ML system that requires a training set with associated ground truth in the way a diagnostic AI would. The "ground truth" equivalent during its development and validation would be derived from fundamental physics principles, extensive experimental dosimetry data, and clinical experience.

Summary

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K091492

JUN 18 2009

Premarket Notification 510(k) Summary

Submitter's Name:

Varian Medical Systems, Inc. 3100 Hansen Way E-110 Palo Alto, CA 94304 . Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 424-5040 Date: May 2009

Eclipse TPS

Proprietary Name:

Classification Name:

Predicate Devices:

Device Description:

Eclipse Treatment Planning System

Medical charged-particle radiation therapy system, 21 CFR §892.5050, MUJ, Class II

Common/Usual Name:

Eclipse Treatment Planning System, K073020

Technological Characteristics:

Statement of

Indications for Use:

Refer to the Substantial Equivalence Comparison Chart.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 18 2009

Ms. Vy Tran Corporate VP, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K091492

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: May 14, 2009 Received: May 20, 2009

Dear Ms. Tran:

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. 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.

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 (reporting of medical

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Eclipse Treatment Planning System (TPS)

Indications for Use

510(k) Number (if known):

Device Name: Eclipse Treatment Planning System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sig -Off

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

(Posted November 13, 2003)

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.