(269 days)
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No
The document does not mention AI, ML, or related terms, nor does it describe features or processes typically associated with these technologies in medical devices.
No
The device is a treatment planning system used by medical professionals to design and simulate radiation therapy treatments. It does not directly deliver therapy but rather aids in the planning process for therapeutic interventions.
No
Explanation: The device is described as a "Treatment Planning System" used to "plan radiotherapy treatments". It designs and simulates treatments, but does not identify or diagnose a disease state.
Yes
The device description explicitly states that the Eclipse TPS is a "computer based software device" and provides "software tools" for planning radiation therapy treatments. There is no mention of accompanying hardware components being part of the device itself.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Eclipse TPS Function: The description clearly states that Eclipse TPS is a software system used by medical professionals to plan and simulate radiation therapy treatments for patients. It works with external and internal radiation sources and is used to design the treatment itself, not to analyze biological samples.
The device's function is focused on treatment planning based on patient anatomy and disease, not on analyzing biological samples for diagnostic purposes.
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 Eyc algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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 treatment for external beam irradiation with photons, 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Eye
Indicated Patient Age Range
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Intended User / Care Setting
trained medical professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K041403, K021268, K002312, K992762
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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ATTACHMENT B
NOV - 3 2005
Premarket Notification {510(k)} Summary
Submitter's Name: Varian Medical Systems 3100 Hansen Way M/S E-110 Palo Alto, CA 94304 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date: January 31, 2005
Proprietary Name: Eclipse Treatment Planning System (TPS)
Classification Name: System, planning, radiation therapy treatment, 21 CFR 892.5050 Class II Common/Usual Name: Eclipse
Predicate Device(s): 1. Varian Eclipse, K041403
Product 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 treatment for external beam irradiation with photons, 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.
Statement of Intended 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 Eyc algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Technological Characteristics: Refer to the "Substantial Equivalence Comparison Chart", Tab 8.
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Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the logo is a stylized depiction of an eagle or other bird-like figure, with three curved lines representing its wings or body. The logo is black and white.
NOV - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Vy Tran Corporate Director Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K050296
Trade/Device Name: Eclipse (TPS) Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MOS Dated: October 13, 2005 Received: October 17, 2005
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 (Premarket Approval), 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.
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.
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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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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ATTACHMENT A
PAGE 1 of 1
510(k) Number (if known): K050296
Device Name: Eclipse
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 irr clicting (brachytherapy) treatments. In addition, the Edinse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
✓
Marcy C. Gordon
(Division Sign-Off)/ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _