ADVANCED TREATMENT PLANNING SYSTEM

K972816 · Advanced Radiation Therapy Systems, Inc. · IYE · Jan 23, 1998 · Radiology

Device Facts

• Record ID: K972816
• Device Name: ADVANCED TREATMENT PLANNING SYSTEM
• Applicant: Advanced Radiation Therapy Systems, Inc.
• Product Code: IYE · Radiology
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and electrons.

Device Story

Advanced Treatment Planning System (ATPS) is a software-based planning tool for external photon and electron radiation therapy. Input data includes patient anatomy from CT and MRI scans. System utilizes 3D visualization software (AVS) with X windows and Motif graphics to provide a graphical user interface. ATPS performs 2D and 3D dose calculations to assist clinicians in treatment planning. Used in clinical settings by radiation oncology staff to determine optimal radiation delivery parameters. Output consists of treatment plans that guide radiation therapy delivery, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based system running on Silicon Graphics, Inc. UNIX workstation. Incorporates 3D visualization software (AVS), X windows, and Motif graphics. Performs 2D and 3D dose calculation algorithms for photons and electrons. Inputs: CT and MRI imaging data.

Indications for Use

Indicated for planning radiation therapy treatments using external photons and electrons for patients requiring such therapy.

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

• Focus RTP (K915691)
• Xknifc-3 (K953482)

Submission Summary (Full Text)

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430 Jean Way Advanced Radiation The Khy Sun Parassia, PA 19406 610-265-6519 610-354-9226 (Fax)

Ka72816

JAN 23 1998

## TAB 10

## Premarket Notification |510(k)| Summary

July 25, 1997

Trade Name: Advanced Treatment Planning System

Common Name: Radiation Therapy Treatment Planning System

Medical charged particle radiation therapy system, 90 IYE (per Classification Name: 21 CFR section 892,5050)

Manufacturer's Name: Advanced Radiation Therapy Systems, Inc. 430 Jean Way Address: King of Prussia, Pa 19406

Corresponding Official: Mr. Alexander C. Cheung Chief Executive Officer Title:

Telephone: [phone] Fax: [phone]

Predicate: Focus RTP: K915691 and Xknifc-3: K953482

Device Description: The Advanced Treatment Planning System (ATPS) from Advanced Radiation Therapy Systems, Inc. (ARTS) is a software product that runs on a Silicon Graphics, Inc. UNIX Workstation in conjunction with specified accessory hardware. The ATPS provides the user the tools to easily perform patient treatment planning for the application of electron and photon radiation therapy utilizing input of patient anatomy from Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) devices. Incorporation of 3D visualization software from Advanced Visualization Systems (AVS), combined with X windows and Motif graphics, results in a graphical user interfacc that is both flexible and casy to use. See the User's Manual in Tab 5 for a more detailed description and examples of graphics. The ATPS provides both two dimensional (2D) and three dimensional (3D) dose calculation algorithms for photons and electrons.

Intended Use: The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and clectrons.

Technological Characteristics: See the attached "Predicate Comparison Table"

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 23 1998

Alexander C. Cheung Chief Executive Officer Advanced Radiation Therapy Systems, Inc. 430 Jean Way King of Prussia, PA 19406

K9

Re:

K972816 Radiation Therapy Treatment Planning System Dated: November 11, 1997 Received: November 13, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Cheung:

We have reviewed your Section 510k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 5100k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h.D.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## TAB 11

510(k) Number (if Known) *K972816*

Device Name: Advanced Treatment Planning System

Indications for Use:

The Advanced Radiation Therapy Systems, Inc., "Advanced Treatment Planning System" is used to plan patient treatments for radiation therapy with external photons and electrons.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109)

OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Chistopher de Leon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

000418