ECLIPSE WITH AAA

K041403 · Varian Medical Systems · MUJ · Jul 26, 2004 · Radiology

Device Facts

• Record ID: K041403
• Device Name: ECLIPSE WITH AAA
• Applicant: Varian Medical Systems
• Product Code: MUJ · Radiology
• Decision Date: Jul 26, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Eclipse with AAA is a treatment planning system (TPS) for radiation therapy. It processes diagnostic images to perform contouring, segmentation, and geometrical planning. The core addition is the Analytical Anisotropic Algorithm (AAA), a 3D convolution/superposition model that calculates photon dose by accounting for primary photons, scattered photons, contamination electrons, and electron transport near tissue heterogeneities. The system consists of a configuration algorithm and a dose calculation algorithm. Used by clinicians in clinical settings to generate radiation treatment plans; output is reviewed by healthcare providers to guide radiation delivery. Benefits include improved dose calculation accuracy in heterogeneous tissue, facilitating precise radiation therapy planning.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based treatment planning system. Features the Analytical Anisotropic Algorithm (AAA), a 3D convolution/superposition model for photon dose calculation. Models primary photons, scattered photons, contamination electrons, and electron transport. Operates on standard clinical computing hardware.

Indications for Use

Indicated for planning photon and electron radiation therapy treatments using teletherapy devices with x-ray energies from 1-50 MeV and electron energies from 1-50 MeV. Supports 3D, combined modality plans, coplanar/non-coplanar fields, static/ARC fields, beam modifiers, and beam intensity modulators. Includes tools for diagnostic image analysis, contouring, segmentation, and plan review.

Regulatory Classification

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.

Predicate Devices

• Varian Eclipse (K030981)

Submission Summary (Full Text)

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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 [phone] www.varian.com

The following information is provided following the format of 21 CFR 807.92 for the Eclipse with AAA.

1. Submitter: Varian Medical Systems 3100 Hansen Way M/S H055 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: [phone] [phone] Fax: Email: [e-mail] 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 |

- 3. Predicate Devices to claim substantial equivalence:
- a. Varian Eclipse, K030981
- 4. 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.
- 5. 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.
- 6. 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.

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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.

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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 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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*