(87 days)
No reference devices were used in this submission.
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on traditional treatment planning software tools.
No
Explanation: The device is a software planning system used by medical professionals to design and simulate radiation therapy treatments, not directly administer therapy itself.
No
Explanation: The device is described as a "Treatment Planning System" used to "plan radiotherapy treatments," not to diagnose diseases. It is a tool for treatment design and simulation.
Yes
The device description explicitly states "Eclipse TPS is a computer-based software device" and the performance studies focus solely on "Software Verification and Validation Testing," indicating no associated hardware is part of the submitted device.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "plan radiotherapy treatments with malignant or benign diseases." This involves planning the delivery of radiation to a patient's body.
- Device Description: The description reinforces this by stating it's a "computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments."
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Eclipse TPS does not perform any such analysis of biological specimens.
The Eclipse TPS is a medical device used in the planning and delivery of radiation therapy, which is a form of treatment, not a diagnostic test performed on in vitro samples.
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 irradiation with photon, electron and proton beams, as well as for internal radiation (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
Not Found
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
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. 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.
Key Metrics
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.
0
May 26, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Varian Medical Systems, Inc. % Peter Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K230557
Trade/Device Name: Eclipse Treatment Planning System (v18.0) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: February 27, 2023 Received: February 28, 2023
Dear Peter 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-reporting
1
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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-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,
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Lora D. Weidner. The date of the signature is 2023.05.26, and the time is 12:52:05 -04'00'.
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
2
Indications for Use
510(k) Number (if known) K230557
Device Name Eclipse Treatment Planning System (v18.0)
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 irradiation with photon, electron and proton beams, as well as for internal radiation (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) |
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
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, Requlatory Affairs Phone: 650-424-6320 | Fax: 650-646-9200 submissions.support@varian.com Date Prepared: 27 February 2023 DEVICE Subject Device Name: Eclipse Treatment Planning System v18.0 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
DEVICE DESCRIPTION
Reference Device(s):
Predicate Device Name:
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 Treatment Planning System v16.1 (K201607)
No reference devices were used in this submission.
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.
Image /page/3/Picture/8 description: The image contains a portion of the letter 'V' in bold, black font against a white background. The letter is cropped, showing only the left side of the 'V'. The image is simple and focuses on the single character.
Image /page/3/Picture/9 description: The image shows the word "varian" in a bold, sans-serif font. The word is in lowercase letters and is black. The background is white, providing a high contrast that makes the word easily readable.
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
K230557
4
Image /page/4/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.
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 v18.0 (version 18.0) of the Eclipse Treatment Planning System with additional software changes incorporated since the release version of the predicate device, version 16.1 (K201607).
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:
Proton dose calculation changes:
- Proton Monte Carlo optimization
- Proton treatment time calculation ●
- Proton fast particle generation ●
Photon dose calculation and evaluation changes:
- General SBRT normal tissue objective (NTO) .
- Enhanced leaf tip modeling ●
- Speed improvement of GPU source model ●
- FTDC Fourier transformation dose calculator improvements
- Multi-criteria optimization (MCO) isodose line dragging ●
Other changes:
- UI support for treatment site
- Brachytherapy dwell control improvements
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
5
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, sans-serif font. The logo is black and white.
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 82304-1 Edition 1.0 2016-10 Health software - Part 1: General requirements for product safety
- . IEC 62083 Edition 2.0 2009-09 Requirements for the safety of radiotherapy treatment planning systems
- . IEC 61217 Edition 2.0 2011-12 Radiotherapy equipment - Coordinates, movements, and scales
- ISO 15223-1 Medical devices Symbols to be used with medical device labels, labeling, and ● information to be supplied
- . ISO 20417:2021 Information supplied by the manufacturer of medical devices
- . ISO 14971:2019+A1:2021 Medical devices - Application of risk management to medical devices
- EN ISO 13485:2016 Medical devices Quality management systems Requirements for . requlatory purposes
Arqument 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 v18.0 to be safe and effective and perform at least as well as the predicate device, Eclipse Treatment Planning System 16.1 (K201607).