(49 days)
No
The document does not mention AI, ML, or related terms, and the description focuses on traditional treatment planning software functionalities.
No
The device is a treatment planning system (software) used by medical professionals to design and simulate radiation therapy treatments, not to directly treat patients.
No
The device is described as a "Treatment Planning System" used for planning radiotherapy treatments, not for diagnosing diseases.
No
The device is described as a "computerbased software device" and provides "software tools" for treatment planning. However, treatment planning systems typically require hardware components (like workstations, servers, and potentially interfaces to treatment machines) to function and deliver the treatment. While the 510(k) focuses on the software, the nature of a treatment planning system implies a necessary hardware dependency for its intended use.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Eclipse TPS Function: The description clearly states that Eclipse TPS is a software system used for planning radiotherapy treatments. It uses imaging data (CT, MR, PET) to design and simulate radiation delivery to a patient's body.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the patient's body.
The device's function is focused on treatment planning based on medical imaging, which falls under the category of medical devices used for therapy planning, not in vitro diagnostics.
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 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.
Mentions image processing
yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT/MR/PET Image Registration
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)
Not Found
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
Submitter's Name:
Varian Medical Systems, Inc. 3100 Hansen Way E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 424-5040 Fax: Date: July 2010
Proprietary Name:
Eclipse Treatment Planning System
Classification Name:
.
Medical charged-particle radiation therapy system, 21 CFR §892.5050, MUJ, Class II
Eclipse Treatment Planning System, K091492
irradiation, (brachytherapy) treatments.
Common/Usual Name:
Eclipse TPS
Predicate Devices:
Device Description:
Statement of 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.
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
Technological Characteristics:
Refer to the attached Substantial Equivalence Comparison Chart.
SEP 3 .
1
| 1. Indication for Use | See above | See above | |
|---|---|---|---|
| 2. General Usage | |||
| External beam PHOTON planning | yes | yes | |
| External beam PHOTON inverse planning | yes | yes | |
| External beam ELECTRON planning | yes | yes | |
| External beam PROTON planning | yes | yes | |
| External beam OCULAR PROTON | |||
| planning | yes | yes | |
| Internal BRACHYTHERAPY planning | yes | yes | |
| Stereotactic Frame Localization | yes | yes | |
| 3. Supported External Beams & | |||
| Accessories | |||
| Photon beams | yes | yes | |
| Electron beams | yes | yes | |
| Proton beams | yes | yes | |
| Coplanar fields | yes | yes | |
| Non-coplanar fields | yes | yes | |
| Multi-leaf Collimators | yes | yes | |
| Asymmetric collimators | yes | yes | |
| Stereotactic Cone collimators | yes | yes | |
| Arc fields | yes | yes | |
| Poured Blocks | yes | yes | |
| Compensators | yes | yes | |
| Physical wedges | yes | yes | |
| Dynamic wedges | yes | yes | |
| Rotating treatment couch | yes | yes | |
| 4. Supported Brachytherapy Sources & | |||
| Accessories | |||
| Plan for high dose rate afterloader | yes | yes | |
| Manual low dose rate brachytherapy: | |||
| seeds, line sources, wire | yes | yes | |
| Applicator library | yes | yes | |
| Needle templates | yes | yes | |
| 5. Graphical User Interface | |||
| Multiple-instance application | yes | yes | |
| Multiple-workspace layout | yes | yes | |
| Graphical display/editing of field | |||
| parameters | yes | yes | |
| Beam's-Eye-View display | yes | yes | |
| 3D patient image display | yes | yes | |
| Model for human Eye | yes | yes | |
| SRS Localization application | yes | yes | |
| SRS Planning application | yes | yes | |
| Biological Optimization application | yes | yes | |
| Biological Evaluation application | yes | yes | |
| 3D Conformal Optimization application | yes | yes | |
| 6. Image Processing | |||
| Orthogonal image displays (3) | yes | yes | |
| Oblique image display | yes | yes | |
| Edge enhancement filters | yes | yes | |
| Image smoothing filters | yes | yes | |
| CT/MR/PET Image Registration | yes | yes | |
| Image blending utility | yes | yes | |
| 4D image display (registration of time | |||
| series of 3D images) | yes | yes | |
| Digitally reconstructed radiographs | yes | yes | |
| Enclosed Volume measurement | yes | yes | |
| Stereotactic Frame Coordinate | |||
| transformation | yes | yes | |
| 7. Image Segmentation | |||
| Geometrical shapes | yes | yes | |
| Manual editing and manipulation tools | yes | yes | |
| Automatic /semi-automatic tools | yes | yes | |
| Automatic/semi-automatic on-demand and | |||
| post-processing tools for individual | |||
| organs/structures | yes | yes | |
| Automatic on-demand and pre-processing | |||
| tools for multiple organs/structures | yes | yes | |
| 3D Automargin | yes | yes | |
| Logical operators | yes | yes | |
| 8. Dose Calculation | |||
| Distributed Calculation Framework | yes | yes | |
| Photon calculation | yes | yes | |
| Energy Range: | 1 MV - 50 MV | 1 MV - 50 MV | |
| CT-based volumetric calculation | yes | yes | |
| Non-CT based IRREG calculation | yes | yes | |
| Convolution method | yes | yes | |
| Combined electron/photon scatter | yes | yes | |
| Directional heterogeneity correction | yes | yes | |
| Treatment head modeling | yes | yes | |
| Photon Monitor Unit calculation | yes | yes | |
| Beam Angle Optimization (GEOS) | yes | yes | |
| Leaf Motion Sequencing | yes | yes | |
| Dose Dynamic Arc planning | yes | yes | |
| Cone Dose Calculation | yes | yes | |
| Biological optimization | yes | yes | |
| 3D Conformal Optimization | yes | yes | |
| AcurosXB dose calculation algorithm | no | yes | |
| Electron calculation | yes | yes | |
| Energy Range: | 1 MeV - 50 MeV | 1 MeV - 50 MeV | |
| Gaussian Pencil Beam Model | yes | yes | |
| Electron Monte Carlo algorithm | yes | yes | |
| Electron Monitor Unit calculation | yes | yes | |
| Proton calculation | yes | yes | |
| Energy Range: | 50 MeV - 300 MeV | 50 MeV - 300 MeV | |
| Brachytherapy calculation | yes | yes | |
| AAPM TG 43 compliant | yes | yes | |
| Point Dose calculation | yes | yes | |
| Optimization to point dose constraints | yes | yes | |
| Geometric optimization | yes | yes | |
| Acuros dose calculation algorithm | yes | yes | |
| Eclipse Algorithm Application | |||
| Programming Interface (EAAPI) | no | yes | |
| 9. Dose evaluation | |||
| Dose color wash | 2D, 3D | 2D, 3D | |
| Isodose levels | 2D, 3D | 2D, 3D | |
| Isodose Surface | 3D | 3D | |
| Reference point dose summary | yes | yes | |
| Dose Volume Histogram plot | yes | yes | |
| Plan summing tool | yes | yes | |
| Plan comparison tools | yes | yes | |
| Evaluation using biological models | yes | yes | |
| 10. Plan Output - Hardcopy | |||
| Graphics window screen dump | yes | yes | |
| Patient administration data | yes | yes | |
| Plan parameters | yes | yes | |
| Geometrical displays of plan data | yes | yes | |
| Dose distribution | yes | yes | |
| DVH plot | yes | yes | |
| BEV display | yes | yes | |
| Patient orientation | yes | yes | |
| User Configurable hardcopy layouts | yes | yes | |
| 11. Import/Export Interfaces | |||
| VARIS/Vision database integration | yes | yes | |
| DICOM RT / 3.0 | yes | yes | |
| Other image formats | yes | yes | |
| Electromagnetic Digitizer | import | import | |
| Film Scanner | import | import | |
| Export field coordinates to Laser System | export | export |
2
3
4
Image /page/4/Picture/0 description: The image shows a logo with the text "DEPARTMENT OF HEALTH". To the left of the text is a symbol that appears to be three stylized human figures stacked on top of each other. The text "DEPARTMENT OF HEALTH" is in a bold, sans-serif font. The overall design is simple and professional.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Vy Tran Official Correspondent Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
2010 SEP 3
Re: K102011
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, LHN Dated: July 15, 2010 Received: July 16, 2010
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 200). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, vermits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796 5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 tollon the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
2010
SEP 3
Indications for Use
510(k) Number (if known):
Eclipse 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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
D.W.B
(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
ETPS 510(k) Indications
510K
Page 1 of 1
Date: June 30, 2010