(54 days)
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) (K071873) 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 provided text is a 510(k) Premarket Notification for the Varian Medical Systems, Inc. Eclipse Treatment Planning System (Eclipse TPS). It describes the device, its indications for use, and a comparison to a predicate device. However, this document does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document is primarily focused on demonstrating substantial equivalence to a previously cleared device (Eclipse K071873) by comparing their indications for use, algorithm features, and other features.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of detailed study information is typically found in engineering reports or validation studies submitted as part of the 510(k) application, but it is not commonly included in the publicly available 510(k) summary document itself. The summary focuses on high-level comparisons for substantial equivalence.
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KOTB020
pg. 1 of 2
DEC 1 % 2007
Premarket Notification 510(k) Summary
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| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Vy TranPhone: (650) 424-5731Fax: (650) 424-5040Date: October 24, 2007 |
|---|---|
| Proprietary Name: | Eclipse Treatment Planning System |
| Classification Name: | Medical charged-particle radiation therapy system,21 CFR 892.5050, MUJ, Class II |
| Common/Usual Name: | Eclipse TPS |
| Predicate Devices: | Eclipse Treatment Planning System, K071873 |
| Device Description: | The Varian Eclipse™ Treatment Planning System (Eclipse TPS)(K071873) provides software tools for planning the treatment ofmalignant or benign diseases with radiation. Eclipse TPS is acomputer-based software device used by trained medicalprofessionals to design and simulate radiation therapytreatments. Eclipse TPS is capable of planning treatments forexternal beam irradiation with photon, electron, and protonbeams, as well as for internal irradiation, (brachytherapy)treatments. |
| Statement ofIndications for Use: | The Eclipse Treatment Planning System (Eclipse TPS) is used toplan radiotherapy treatments for patients with malignant orbenign diseases. Eclipse TPS is used to plan external beamirradiation with photon, electron and proton beams, as well as forinternal irradiation (brachytherapy) treatments. In addition, theEclipse Proton Eye algorithm is specifically indicated forplanning proton treatment of neoplasms of the eye. |
| TechnologicalCharacteristics: | Refer to the Substantial Equivalence Comparison Chart. |
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K073026
Pg. 2 of 2
Substantial Equivalence Comparison Chart
Arc Planning was initially cleared as K010975, May 2, 2001 Arc Flaming was initially cleared as 1070978, 112, 120, May 22, 2002
| Predicate DeviceEclipse K071873 | Modified DevicePending 510(k) | |
|---|---|---|
| Indications for Use Statement | The Eclipse TreatmentPlanning System (EclipseTPS) is used to planradiotherapy treatments forpatients with malignant orbenign diseases. EclipseTPS is used to planexternal beam irradiationwith photon, electron andproton beams, as well asfor internal irradiation(brachytherapy)treatments. In addition, theEclipse Proton Eyealgorithm is specificallyindicated for planningproton treatment ofneoplasms of the eye. | The Eclipse TreatmentPlanning System (EclipseTPS) is used to planradiotherapy treatments forpatients with malignant orbenign diseases. EclipseTPS is used to plan externalbeam irradiation withphoton, electron and protonbeams, as well as forinternal irradiation(brachytherapy) treatments.In addition, the EclipseProton Eye algorithm isspecifically indicated forplanning proton treatmentof neoplasms of the eye. |
| Algorithm Features | a) IMRT optimization:Fast dose calculationalgorithm (Multi-Resolution DoseCalculation, mrdc) usedwith optimizationtechniques to produceoptimal fluences, thenLMC algorithm used toturn those into MLCsequences, finally dosecalculation (AAA) tocalculate the actual dosecleared in K021268b) Arc fields, i.e. gantryrotation while beam is oncleared in K010975 | Dose Dynamic Arcalgorithm producestreatment plans combiningArc and IMRT: Arc fieldswith IMRT optimization.Optimization uses the samefast dose calculation (mrdc)as previously. The sameAAA algorithm (K041403)is used to calculate actualdose. MLC modeling isimproved to better accountfor phenomena related tosmall MLC openingstypical of Dose DynamicArc fields. |
| Other Features | All other features clearedpreviously throughmultiple 510(k)s remainthe same and were mostrecently cleared in the lastEclipse 510(k) clearanceK071783 | Remain the same as in thelatest clearance K071873 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEC 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director of Regulatory Affairs Varian Medical System, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K073020
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: November 21, 2007 Received: November 26, 2007
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, Or o 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 such additional controls. Existing major regulations affecting your it ring can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FFDA may publish further announcements concerning your device in the Federal Register.
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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); 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.
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, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Nancy Cbrogdon
Nancy C. Brogdon 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: _________________________________________________________________________________________________________________________________________________________________
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 Device Evaluation (ODE)
Ioan M. Khan
(Division Sign-Off)
Division of Reproductive, Abdorninal and Radiological Devices 510(k) Number
Page of
(Posted November 13, 2003)
§ 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.