(92 days)
Not Found
No
The document describes a treatment planning system with automatic processing tools, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The focus is on software tools for planning and simulation, not on learning or adaptive algorithms.
No.
The Varian Eclipse Treatment Planning System is a software device used to plan radiotherapy treatments, not to administer them directly. Therapeutic devices are directly involved in the treatment itself.
No
The device is described as a "Treatment Planning System" used for planning radiotherapy treatments. It designs and simulates radiation therapy treatments, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "computer-based software device" and provides "software tools," but it is a treatment planning system for radiotherapy. While the core functionality is software, it is intrinsically linked to and used to control or plan the use of physical radiation therapy delivery systems (external beam and brachytherapy). It is not a standalone software application that performs a medical function without interacting with or planning for a hardware medical device.
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 medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves analyzing biological samples like blood, urine, tissue, etc.
- Eclipse TPS Function: The Eclipse TPS is a software system used for planning radiation therapy treatments. It takes imaging data (CT, MR) and helps medical professionals design how radiation will be delivered to a patient's body to treat diseases. It does not analyze biological specimens.
- Intended Use: The stated intended use is "to plan radiotherapy treatments for patients with malignant or benign diseases." This is a treatment planning function, not a diagnostic function based on in vitro analysis.
- Device Description: The description reinforces that it's a "computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments."
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 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.
Product codes
MUJ, LHN
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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers Eclipse 12 to be safe and to perform at least as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
PREMARKET NOTIFICATION
510(k) Summary
Eclipse Treatment Planning System
As required by 21 CFR 807.92
Submitter's Name:
Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto CA94304
Contact Name: Peter J. Coronado Phone: 650/424.6230 Fax:650/842.5040 Date: 21 June 2013
Eclipse Treatment Planning System
Proprietary Name:
Classification Name:
Common/Usual Name:
Predicate Devices:
Device Description:
Indications for Use:
system,planning,radiation therapy treatment 21CFR892.5050, MUJ, Class II
Eclipse, TPS, Eclipse TPS, Eclipse 12, Eclipse 12 TPS, Eclipse TPS 12.
Eclipse Treatment Planning System (K102011)
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 is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.
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.
1
Changes in Technological Characteristics:
| FEATURE AND/OR
SPECIFICATION OF
NEW/MODIFIED
DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION
(ECLIPSE 10- K102011) | DEVICE WITH CHANGE
ECLIPSE 12 |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Supported
External Beams
& Accessories | • TrueBeam support | • TrueBeam support |
| Graphical User
Interface | • Nexus Phase 0 - Home
screen integration and
navigation not present | • Nexus Phase 0- Home screen integration
and navigation |
| Image
Segmentation | • Automatic on-demand
and pre-processing tools
for multiple
organs/structures | • No Automatic on-demand and pre-
processing tools for multiple
organs/structures
(SmartAdapt) toolset utilizing changed CT-
MR and MR-MR deformable registration |
| Dose
Calculation | • Photon calculation
○ RapidArc:
intermediate
dose calculation
○ RapidArc: Varian
linac and support
○ FFF support for
TrueBeam | • Photon calculation
○ RapidArc: enhancements in
intermediate dose calculation
○ IMRT: intermediate dose
calculation
○ RapidArc Varian linac, and Elekta
VMAT support
○ FFF: Support for C3 and
TrueBeam
• Dose-Volume Histogram (DVH) Estimation |
| | • Proton calculation
○ Modulated
scanning (spot
scanning)
technique
○ Spot editor | • Proton calculation
○ Modulated scanning technique
(spot and line scanning), support
block and MLC
○ Range uncertainty feature
○ Spot editor user interface
improvements
○ Dosimetrically equivalent
treatment units (for different
gantries)
○ Block drill bit corrections for
milling machines |
| | • Brachytherapy calculation
○ AcurosBV dose
calculation
algorithm
○ AcurosBV
calculates dose to
transport media
but reports it in
water | • Brachytherapy calculation
○ AcurosBV dose calculation
algorithm in 64 bit environment
○ AcurosBV calculates does to
transport media
○ Nexus phase 0 support |
| FEATURE AND/OR
SPECIFICATION OF
NEW/MODIFIED
DEVICE | CLEARED DEVICE
FEATURE/SPECIFICATION
(ECLIPSE 10- K102011) | DEVICE WITH CHANGE
ECLIPSE 12 |
| | 64 bit External Beam
Planning, BrachyVision
and Proton, PRO and
AcurosXB algorithms Fluence calculation by
LMC algorithm | 64 bit External Beam Planning,
BrachyVision and Proton, PRO, AcurosXB
AcurosBV and BAO & DVO algorithms and
DVH Estimation. Unified fluence calculation in Eclipse &
DCF by the final 3D dose calculation
algorithm |
| Import/Export
Interfaces | Film Scanner import | No Film Scanner import Eclipse Scripting API (ESAPI) read only
access |
| Infrastructure | Sybase Server | SQL Server migration Zero Clinical Downtime: Faster DB
upgrades Zero Clinical Downtime: Remote
deployment of the clients Nexus Phase 0 RT Prescription integration Plan validation and status change
service Dosimetrically Equivalent
machine change service Approval modifications |
.
:
2
and the commend of the comments of the country
:
. . . . . .
:
3
K131891
Page 4 of 4
Summary of Non-clinical Testing
Verification testing was performed to demonstrate that the performance and functionality of the new and existing features met the design input requirements.
Regression testing was performed to verify the integrity of any changes. Validation testing was performed on a production equivalent device, under clinically representative conditions by qualified personnel.
Conclusion of Non-Clinical testing
Results from Verification and Validation testing demonstrate that the product met defined user needs and defined design input requirements. Varian therefore considers Eclipse 12 to be safe and to perform at least as well as the predicate device.
4
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contral Center - WO66-Gold Silver Spring, MI) 20993-0002
September 25, 2013
DEPARTMENT OF HEALTH & HUMAN SERVICES
Varian Medical Systems. Inc. % Mr. Peter J. Coronado Director, Regulatory Affairs 911 Hansen Wav, M/S E110 PALO ALTO CA 94303
Re: K131891
Trade/Device Name: Eclipse 12 Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system. Regulatory Class: 11 Product Code: MUJ, L.HN Dated: June 21, 2013 Received: June 28, 2013
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 Amendnents, 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.
ff 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 I hat FDA has made a determination that your device complies with other requirements of the Act mar + Breaks intact and regulations administered by other Federal agencies. You must or any 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
Image /page/4/Picture/11 description: The image shows a logo with a stylized bird-like figure composed of three curved lines, suggesting movement or flight. The figure is positioned to the right of a circular arrangement of text, which appears to be a company name or slogan. The logo is simple, using only black lines on a white background, giving it a clean and modern look.
5
Page 2-Mr. Coronado
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours,
Mechal D. Offara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K131891
Eclipse 12 Treatment Planning System Device Name:
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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K 131891
Page 1 of 1