(61 days)
Not Found
No
The summary describes a dose calculation algorithm (AAA) which is a 3D convolution/superposition algorithm. While it models complex interactions, the description does not mention AI or ML techniques. The image processing mentioned (contouring and segmentation) is a common task in medical imaging and doesn't inherently imply AI/ML without further detail.
No
The device is a treatment planning system used to plan radiation therapy. It does not directly treat or diagnose patients, but rather provides tools and calculations for treatment preparation and review.
No
Explanation: The device is described as a treatment planning system and includes tools for treatment preparation. While it uses "diagnostic image and analysis," its primary function is planning radiation therapy treatments, not diagnosing medical conditions.
No
The device description explicitly states it is a "Treatment Planning System" and describes a "photon dose calculation algorithm." While it includes software components (the algorithm), the overall system is a treatment planning system used in conjunction with linear accelerators, implying a hardware component (the linear accelerator) is integral to the intended use and likely the overall system. The description focuses on the software algorithm as a modification to an existing system, not as a standalone software-only device.
Based on the provided information, the Varian Eclipse device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for planning radiation therapy treatments. This is a therapeutic application, not a diagnostic one that involves testing samples from the human body.
- Device Description: The description focuses on the dose calculation algorithm and its role in treatment planning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status based on such analysis.
The device is a treatment planning system used in the field of radiation oncology. While it uses diagnostic images as input, its purpose is to create a plan for delivering radiation therapy, not to diagnose a disease or condition based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments for teletherapy devices with x-ray energies from 1-50 MeV, and electron energies from 1-50 MeV. Eclipse will plan the 3D plans, combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators.
Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The Varian Eclipse™ Treatment Planning System has been modified to include a new a new photon dose calculation algorithm, Analytical Anisotropic Algorithm (AAA). The AAA dose calculation model is a 3D convolution/superposition algorithm that models primary photons, photons scattered in the medium, contamination electrons and transport electrons near tissue heterogeneities. The AAA dose calculation model is comprised of two main components, one being the configuration algorithm and the other one the actual dose calculation algorithm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
diagnostic image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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.
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.
Not Found
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).
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
KD41403
JUL 2 6 2004
VARIAN
medical systems
510(k) Summary
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
The following information is provided following the format of 21 CFR 807.92 for the Eclipse with AAA.
- Submitter: Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 (650) 842-5040 Fax: Email: vy.tran@varian.com Date summary was prepared: May 20, 2004
| 2. | Name of the Device: | Eclipse with AAA |
|---|---|---|
| Trade/Proprietary Name: | Eclipse with AAA | |
| Common or Usual Name: | Treatment Planning System | |
| Classification Name: | Medical charge-particle radiation therapy system | |
| 21 CFR §892.5050 | ||
| Class II | ||
| Product Code: 90 MUJ |
-
- Predicate Devices to claim substantial equivalence:
- a. Varian Eclipse, K030981
-
- Description of the Device: The Varian Eclipse™ Treatment Planning System has been modified to include a new a new photon dose calculation algorithm, Analytical Anisotropic Algorithm (AAA). The AAA dose calculation model is a 3D convolution/superposition algorithm that models primary photons, photons scattered in the medium, contamination electrons and transport electrons near tissue heterogeneities. The AAA dose calculation model is comprised of two main components, one being the configuration algorithm and the other one the actual dose calculation algorithm.
-
- Intended Use Statement: The Varian Eclipse device is a treatment planning system used for diagnostic image analysis, contouring and segmentation, geometrical planning, photon and electron dose calculation and plan review.
-
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. This chart is located in Tab 8 of the submission.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three stylized lines. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2004
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems. Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K041403
Trade/Device Name: Eclipse with AAA Regulatory Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ
Dated: July 9, 2004 Received: July 12, 2004
Dear Ms. Tran:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your we 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 may or subject 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.
2
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 promated 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
3
510(k) Number (if known): K041403 Device Name: Eclipse with AAA
Indications For Use:
The Varian Eclipse device is used to plan photon and electron radiation therapy treatments The Varian Lonpoo dovice to abot to presimilar teletherapy devices with x-ray energies from 1-50 employing mean accerers, and electron energies from 1-50 MeV. Eclipse will plan the 3D in t , as won as Obout ouj and breat to combined modality plans, coplanar and non-coplanar fields, static and ARC fields, beam modifiers, and beam intensity modulators.
Eclipse also includes tools for treatment preparation (diagnostic image and analysis, contouring and segmentation) and plan review.
(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)
Nancy C. hargdon
(Division Sign-Off) Division of Reproductive, Abdon Sadiological Devices ാ : (x) Number
Prescription Use