(54 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, but it does not directly apply therapy to the patient. It is a tool for planning treatments, not a therapeutic device itself.
No
Explanation: The Eclipse Treatment Planning System (TPS) is described as a tool used to "plan radiotherapy treatments." It's used by medical professionals to "design and simulate radiation therapy treatments." This indicates it's a treatment planning and simulation device, not a device used for diagnosis (identifying a disease or condition).
Yes
The device description explicitly states "Eclipse TPS is a computer-based software device". While it is used in conjunction with hardware (radiotherapy machines), the device itself, as described in the summary, is the software component for planning.
Based on the provided information, the Eclipse Treatment Planning System (Eclipse TPS) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Eclipse TPS Function: The description clearly states that Eclipse TPS is used to plan radiotherapy treatments for patients. It's a software tool used by medical professionals to design and simulate radiation therapy, which is a treatment applied to the patient's body.
The intended use and device description focus entirely on treatment planning and delivery, not on analyzing biological samples.
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
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K010975, K070978, K021268, K041403, K071783
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
KOTB020
pg. 1 of 2
DEC 1 % 2007
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
Fax: (650) 424-5040
Date: 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 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. |
| 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. |
| Technological
Characteristics: | Refer to the Substantial Equivalence Comparison Chart. |
.
1
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 Device
Eclipse K071873 | Modified Device
Pending 510(k) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use Statement | 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 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. |
| Algorithm Features | a) IMRT optimization:
Fast dose calculation
algorithm (Multi-
Resolution Dose
Calculation, mrdc) used
with optimization
techniques to produce
optimal fluences, then
LMC algorithm used to
turn those into MLC
sequences, finally dose
calculation (AAA) to
calculate the actual dose
cleared in K021268
b) Arc fields, i.e. gantry
rotation while beam is on
cleared in K010975 | Dose Dynamic Arc
algorithm produces
treatment plans combining
Arc and IMRT: Arc fields
with IMRT optimization.
Optimization uses the same
fast dose calculation (mrdc)
as previously. The same
AAA algorithm (K041403)
is used to calculate actual
dose. MLC modeling is
improved to better account
for phenomena related to
small MLC openings
typical of Dose Dynamic
Arc fields. |
| Other Features | All other features cleared
previously through
multiple 510(k)s remain
the same and were most
recently cleared in the last
Eclipse 510(k) clearance
K071783 | Remain the same as in the
latest clearance K071873 |
2
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.
3
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 .
4
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)