(178 days)
No
The document describes a standard radiation therapy planning system with 2D and 3D dose calculation algorithms and visualization tools. There is no mention of AI, ML, or related concepts in the provided text.
No
The device is a treatment planning system (software) used to plan radiation therapy. It does not deliver the therapy itself, which would make it a therapeutic device.
No.
The device is used for planning radiation therapy treatments, not for diagnosing diseases.
No
The device description explicitly states it is a "software product that runs on a Silicon Graphics, Inc. UNIX Workstation in conjunction with specified accessory hardware." This indicates it requires specific hardware components beyond a general-purpose computer, making it not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "plan patient treatments for radiation therapy with external photons and electrons." This is a therapeutic planning function, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is a software product that uses imaging data (CT and MRI) to perform dose calculations for radiation therapy. It does not involve the analysis of biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing blood, urine, tissue, or other biological samples to diagnose, monitor, or predict disease.
Therefore, the Advanced Treatment Planning System is a medical device used for treatment planning, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
90 IYE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the text "Advanced Radiation Therapy Systems, Inc." The text is arranged in a stacked format, with each word or phrase on a separate line. The font appears to be a bold, serif typeface, and the overall impression is that of a company logo or heading.
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: 610-265-6519 Fax: 610-354-9226
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"
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human figures connected at the shoulders, forming a wing-like shape. The figures are rendered in black and appear to be in motion. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
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 (301) 594-4613. Additionally, for question 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" (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 (800) 638-2041 or (301) 443-6597 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
2
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