(133 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) (K050296) 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) summary for the Varian Eclipse Treatment Planning System (Eclipse TPS). It does not contain the detailed study information required to fill out the requested table and answer the specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or comparative effectiveness studies.
The document primarily focuses on the regulatory aspects of the device, such as:
- Submitter's information
- Proprietary and common device names
- Classification and predicate devices
- Device description and indications for use
- FDA's substantial equivalence determination letter
Therefore, I cannot extract the information required for your request from this document. To answer your questions, I would need a different type of document, such as a clinical study report, a validation study, or a more detailed technical submission that includes performance data and methodology.
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Premarket Notification 510(k) Summary
| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Vy TranPhone: (650) 424-5731Fax: (650) 424-5040Date: June 6, 2007NOV 0 9 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, K050296 |
| Device Description: | The Varian Eclipse™ Treatment Planning System (Eclipse TPS)(K050296) 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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Varian Medical Systems. Inc. 3100 Hansen Way. M/S E-110 PALO ALTO CA 94304
Re: K071760
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: October 15, 2007 Received: October 17, 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, 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 such 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.
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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 vours.
Nancy C. Brogdon
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 (ITPS)
Indications for U se
510(k) Number (if known): KO 7 1760
Device Name: Eclipse Treatment Planning System
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)
Hulut Leum
Division Sign-Off) Division of Reproductive, Abdominal, a 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.